Study of ASTX029 in Subjects With Advanced Solid Tumors | NCT03520075 | Trialant
NCT03520075
Sponsor
Taiho Oncology, Inc.
Status
Completed
Last Update Posted
Jul 3, 2025Actual
Enrollment
192Actual
Phase
Phase 1Phase 2
Conditions
Solid Tumor, Adult
Interventions
ASTX029
ASTX029
Countries
United States
France
Spain
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT03520075
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
ASTX029-01
Secondary IDs
Not provided
Brief Title
Study of ASTX029 in Subjects With Advanced Solid Tumors
Official Title
A Phase 1-2 Study of the Safety, Pharmacokinetics, and Activity of ASTX029 in Subjects With Advanced Solid Tumors
Acronym
Not provided
Organization
Taiho Oncology, Inc.INDUSTRY
Status Module
Record Verification Date
Jun 2025
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
May 7, 2018Actual
Primary Completion Date
Aug 1, 2024Actual
Completion Date
Mar 3, 2025Actual
First Submitted Date
Apr 18, 2018
First Submission Date that Met QC Criteria
May 8, 2018
First Posted Date
May 9, 2018Actual
Results Waived
Not provided
Results First Submitted Date
Jun 16, 2025
Results First Submitted that Met QC Criteria
Jun 16, 2025
Results First Posted Date
Jul 3, 2025Actual
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
Jun 16, 2025
Last Update Posted Date
Jul 3, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Taiho Oncology, Inc.INDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This study is a first-in-human, open-label, multicenter, Phase 1-2 study to assess the safety, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of ASTX029 administered orally to participants with advanced solid malignancies who are not candidates for approved or available therapies.
Detailed Description
ASTX029 is a synthetic small molecule inhibitor of extracellular signal-regulated kinases (ERKs) 1/2. ASTX029 has not been previously evaluated in human participants. The Phase 1 portion of this study will assess safety and determine the maximum tolerated dose, the recommended Phase 2 dose (RP2D), and the recommended dosing regimen of ASTX029 administered orally. The Phase 2 portion will assess preliminary clinical activity in tumors characterized by gene aberrations in the mitogen-activated protein kinase (MAPK) signal pathway that may confer sensitivity to ASTX029.
Conditions Module
Conditions
Solid Tumor, Adult
Keywords
Neoplasms
Solid Tumors
Antineoplastic Agents
MAPK
ERK
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
192Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Phase 1A: Cohort 1 Dose Escalation
Experimental
Participants received ASTX029 10 milligrams (mg), powder in bottle (PiB), orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
Drug: ASTX029
Phase 1A: Cohort 2 Dose Escalation
Experimental
Participants received ASTX029 20 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
Drug: ASTX029
Phase 1A: Cohort 3 Dose Escalation
Experimental
Participants received ASTX029 60 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
Drug: ASTX029
Phase 1A: Cohort 4 Dose Escalation
Experimental
Participants received ASTX029 120 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
Drug: ASTX029
Phase 1A: Cohort 5 Dose Escalation
Experimental
Participants received ASTX029 200 mg, orally, PiB, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
ASTX029
Drug
PiB
Phase 1A: Cohort 1 Dose Escalation
Phase 1A: Cohort 2 Dose Escalation
Phase 1A: Cohort 3 Dose Escalation
Phase 1A: Cohort 4 Dose Escalation
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs)
DLTs were defined as adverse events (AEs) graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03 criteria that occurred during the first cycle of treatment and represented any 1 of the following: grade 4 thrombocytopenia of any duration; ≥grade 3 hematologic toxicity with complications (e.g., grade 3 thrombocytopenia with bleeding or transfusion requirement); febrile neutropenia of any duration or grade 4 neutropenia of 5 days or more duration; liver-associated abnormalities; ≥grade 2 eye disorders; symptomatic grade 2 cutaneous toxicities (including skin rash); any other ≥grade 3 nonhematologic AE except grade 3 nausea, vomiting, or diarrhea; Any event that, in the opinion of the Data and Safety Review Committee (DSRC), would suggest that further dose escalation would put subjects at unacceptable risk.
Cycle 1 (cycle length = 21 days)
Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
An AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. TEAEs are defined as events that first occurred or worsened on or after the date of the first dose of study treatment until 30 days after the last dose of study treatment or until the start of a posttreatment alternative anti-cancer treatment, whichever occurs first, with the following exceptions: events that occurred after 30 days beyond the last dose of study treatment or the start of a posttreatment alternative anti-cancer treatment will also be considered treatment-emergent if the events are both serious and related to the study treatment.
From first dose of study drug up to 30 days after last dose (Up to 74 months)
Phase 2: Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
The ORR was calculated as the number of evaluable participants whose best response was complete response (CR) or partial response (PR), divided by the total number of participants evaluable for ORR analysis. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to <10 millimeters (mm). PR was defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Percentages were rounded off to the nearest single decimal place
Secondary Outcomes
Measure
Description
Time Frame
Phase 1: Area Under the Concentration-time Curve From Time Zero to 24 Hours (AUC0-24) of ASTX029
As per planned analysis, data for participants from Part A (Dose Escalation) and Part B (Expansion) were combined for Cohort 11 (200 mg). 2 participants who received 200 and 280 mg respectively, in Cycle 1 Day1 (C1D1), received 120 mg in Cycle 2 and Day 1 (C2D1) and hence counted in Cohort 10. 1 participant who received 280 mg in C1D1, received 200 mg in C2D1 and hence counted in Cohort 11.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Participants must fulfill all of the following inclusion criteria.
Able to understand and comply with study procedures, understand the risks involved in the study, and provide written informed consent before any study-specific procedure is performed.
Men or women 18 years of age or older.
Participants with histologically or cytologically confirmed advanced solid tumors that are metastatic or unresectable, who are refractory or have relapsed after treatment with available therapies or for whom standard life-prolonging measures or approved therapies are not available. In Phase 1 Part B and in the Phase 2 portion of the protocol, participants must also have documented gene alterations in the MAPK pathway as detailed in the protocol.
In Phase 1 Part B of the protocol, participants must have disease lesions that are amenable to biopsy.
In the Phase 2 portion of the protocol, participants must have measurable disease according to RECIST v1.1.
Eastern Cooperative Oncology Group performance status 0 to 2.
Acceptable organ function as evidenced by the following laboratory data:
Aspartate aminotransferase (AST) and alanine aminotransferase ≤2×upper limit of normal (ULN) or ≤3 ULN in the presence of liver metastases.
Total serum bilirubin ≤1.5×ULN.
Absolute neutrophil count (ANC) ≥1500 cells/mm3.
Platelet count ≥100,000 cells/mm3.
Calculated creatinine clearance (by the standard Cockcroft Gault formula) of ≥50 mL/min or glomerular filtration rate of ≥50 mL/min.
Women of child-bearing potential (according to recommendations of the Clinical Trial Facilitation Group [CTFG]; see protocol for details) must not be pregnant or breastfeeding and must have a negative pregnancy test within 24 hours before the first dose of study treatment. While receiving study treatment and for at least 5 half-lives of ASTX029 or metabolite plus 30 days after completing treatment, women of child-bearing potential must agree to practice highly effective contraceptive measures (as described in the protocol) and must refrain from donating eggs (ova, oocytes) for the purpose of reproduction.
Men with female partners of child-bearing potential (according to recommendations of the CTFG; see protocol for details) must agree to, during the treatment period and for at least 5 half-lives of ASTX029 or metabolite plus 90 days after completing treatment, practice highly effective contraceptive measures (as described in the protocol), not to father a child, and to refrain from donating sperm.
Exclusion Criteria:
Hypersensitivity to ASTX029 or excipients of the drug product.
Poor medical risk in the investigator's opinion because of systemic diseases in addition to the cancer under study, for example, uncontrolled infections.
Life-threatening illness, significant organ system dysfunction, or other condition that, in the investigator's opinion, could compromise participants safety or the integrity of study outcomes or interfere with the absorption or metabolism of ASTX029.
Prior anticancer treatments or therapies within the indicated time window prior to first dose of study treatment (ASTX029), as follows:
Cytotoxic chemotherapy or radiotherapy within 3 weeks prior. Palliative radiotherapy to a single lesion within 2 weeks prior. Any encountered treatment-related toxicities (excepting alopecia) not stabilized or resolved to ≤Grade 1.
Monoclonal antibodies within 4 weeks prior. Any encountered treatment-related toxicities not stabilized or resolved to ≤Grade 1.
Molecularly targeted drug or investigational drugs, without the potential for delayed toxicity, within 4 weeks of the first dose of study treatment or 5 half-lives (minimum 14 days), whichever is shorter. Any encountered treatment-related toxicities (excepting alopecia) not stabilized or resolved to ≤Grade 1.
Prior treatment with extracellular signal-regulated kinase (ERK) inhibitors.
History of, or at risk for, cardiac disease, as evidenced by 1 or more of the following conditions:
Abnormal left ventricular ejection fraction (LVEF; <50%) on echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scan.
Congestive cardiac failure of ≥Grade 3 severity according to New York Heart Association functional classification defined as patients with marked limitation of activity and who are comfortable only at rest.
Unstable cardiac disease including unstable angina or hypertension as defined by the need for overnight hospital admission within the last 3 months (90 days).
History or evidence of long QT interval corrected for heart rate (QTc), ventricular arrhythmias including ventricular bigeminy, complete left bundle branch block, clinically significant bradyarrhythmias such as sick sinus syndrome, second- and third-degree atrioventricular (AV) block, presence of cardiac pacemaker or defibrillator, or other significant arrhythmias.
Screening 12-lead electrocardiogram (ECG) with measurable QTc interval of ≥470 msec. (Fridericia's formula should be used to calculate the QTc interval throughout the study.)
Known history of human immunodeficiency virus (HIV) infection or seropositive results consistent with active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection.
Known brain metastases, unless previously treated and stable for at least 3 months with or without steroids.
Known significant mental illness or other conditions, such as active alcohol or other substance abuse that, in the opinion of the investigator, predispose the participant to high risk of noncompliance with the protocol treatment or assessments.
History or current evidence/risk of retinal vein occlusion (RVO) or central serous retinopathy (CSR) including:
Presence of predisposing factors to RVO or CSR (eg, uncontrolled glaucoma or ocular hypertension, uncontrolled diabetes mellitus) or
Visible retinal pathology as assessed by ophthalmic examination at screening that is considered a risk factor for RVO or CSR such as:
Evidence of optic disc cupping or
Evidence of new visual field defects on automated perimetry or
Intraocular pressure >21 mmHg as measured by tonography.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Not provided
Locations
Facility
Status
City
State
ZIP
Country
Contacts
City of Hope Comprehensive Cancer Center
Duarte
California
91010
United States
University of Southern California Norris Comprehensive Cancer Center Site#114
Munck JM, Berdini V, Bevan L, Brothwood JL, Castro J, Courtin A, East C, Ferraldeschi R, Heightman TD, Hindley CJ, Kucia-Tran J, Lyons JF, Martins V, Muench S, Murray CW, Norton D, O'Reilly M, Reader M, Rees DC, Rich SJ, Richardson CJ, Shah AD, Stanczuk L, Thompson NT, Wilsher NE, Woolford AJ, Wallis NG. ASTX029, a Novel Dual-mechanism ERK Inhibitor, Modulates Both the Phosphorylation and Catalytic Activity of ERK. Mol Cancer Ther. 2021 Oct;20(10):1757-1768. doi: 10.1158/1535-7163.MCT-20-0909. Epub 2021 Jul 30.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
A total of 192 participants were enrolled in the study to receive ASTX029, of which 2 participants died before receiving treatment. The study was conducted in 2 phases: Phase 1 included Cohorts 1-12 in Part A (Dose Escalation) and a single cohort for Part B (Dose Expansion) and Phase 2 included Cohorts A to F.
Recruitment Details
Participants took part at regional sites in United States (US), France, Spain, and United Kingdom (UK) from 07 May 2018 to 03 March 2025.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Phase 1A: Cohort 1 Dose Escalation
Participants received ASTX029 10 milligrams (mg), powder in bottle (PiB), orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
FG001
Phase 1A: Cohort 2 Dose Escalation
Periods
Title
Milestones
Reasons Not Completed
Phase 1 (Dose Escalation)
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
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
May 24, 2024
Jun 16, 2025
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
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
Drug: ASTX029
Phase 1A: Cohort 6 Dose Escalation
Experimental
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
Drug: ASTX029
Phase 1A: Cohort 7 Dose Escalation
Experimental
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
Drug: ASTX029
Phase 1A: Cohort 8 Dose Escalation
Experimental
Participants received ASTX029 40 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
Drug: ASTX029
Phase 1A: Cohort 9 Dose Escalation
Experimental
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
Drug: ASTX029
Phase 1A: Cohort 10 Dose Escalation
Experimental
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
Drug: ASTX029
Phase 1A: Cohort 11 Dose Escalation
Experimental
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
Drug: ASTX029
Phase 1A: Cohort 12 Dose Escalation
Experimental
Participants received ASTX029 280 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
Drug: ASTX029
Phase 1B Dose Expansion
Experimental
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
Drug: ASTX029
Phase 2: Cohort A
Experimental
Participants with neuroblastoma RAS (NRAS)-mutant melanoma received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
Drug: ASTX029
Phase 2: Cohort B
Experimental
Participants with Kirsten RAS (KRAS)-mutant or KRAS-amplified non-small cell lung cancer (NSCLC) received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
Drug: ASTX029
Phase 2: Cohort C
Experimental
Participants with B isoform of RAF kinase (BRAF) V600-mutant cancers (non-colorectal cancers) received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
Drug: ASTX029
Phase 2: Cohort D
Experimental
Participants with BRAF-fusion cancers received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
Drug: ASTX029
Phase 2: Cohort E
Experimental
Participants with gynecological cancers with alterations in the mitogen-activated protein kinase (MAPK) pathway received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
Drug: ASTX029
Phase 2: Cohort F
Experimental
Participants with tumors that were characterized by other gene aberrations (that upregulate the MAPK signal pathway) received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
Drug: ASTX029
Phase 1A: Cohort 5 Dose Escalation
ASTX029
Drug
Tablet
Phase 1A: Cohort 10 Dose Escalation
Phase 1A: Cohort 11 Dose Escalation
Phase 1A: Cohort 12 Dose Escalation
Phase 1A: Cohort 6 Dose Escalation
Phase 1A: Cohort 7 Dose Escalation
Phase 1A: Cohort 8 Dose Escalation
Phase 1A: Cohort 9 Dose Escalation
Phase 1B Dose Expansion
Phase 2: Cohort A
Phase 2: Cohort B
Phase 2: Cohort C
Phase 2: Cohort D
Phase 2: Cohort E
Phase 2: Cohort F
Every 2 cycles for the first 4 cycles and then every 4 cycles thereafter until disease progression (Up to 74 months)
Pre-dose on Day 1 of Cycles 1 and 2 and at 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose on Day 1 of Cycles 1 and 2 (Cycle length = 21 days)
Phase 1: Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of ASTX029
As per planned analysis, data for participants from Part A (Dose Escalation) and Part B (Expansion) were combined for Cohort 11 (200 mg). 2 participants who received 200 and 280 mg respectively, in C1D1 received 120 mg in C2D1 and hence counted in Cohort 10. 1 participant who received 280 mg in C1D1, received 200 mg in C2D1 and hence counted in Cohort 11.
Pre-dose on Day 1 of Cycles 1 and 2 and at 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose on Day 1 of Cycles 1 and 2 (Cycle length = 21 days)
Phase 1: Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of ASTX029
As per planned analysis, data for participants from Part A (Dose Escalation) and Part B (Expansion) were combined for Cohort 11 (200 mg). 2 participants who received 200 and 280 mg respectively, in C1D1, received 120 mg in C2D1 and hence counted in Cohort 10. 1 participant who received 280 mg in C1D1, received 200 mg in C2D1 and hence counted in Cohort 11.
Pre-dose on Day 1 of Cycles 1 and 2 and at 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose on Day 1 of Cycles 1 and 2 (Cycle length = 21 days)
Phase 1: Maximum Observed Plasma Concentration (Cmax) of ASTX029
As per planned analysis, data for participants from Part A (Dose Escalation) and Part B (Expansion) were combined for Cohort 11 (200 mg). 2 participants who received 200 and 280 mg respectively, in C1D1, received 120 mg in C2D1 and hence counted in Cohort 10. 1 participant who received 280 mg in C1D1, received 200 mg in C2D1 and hence counted in Cohort 11.
Pre-dose on Day 1 of Cycles 1 and 2 and at 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose on Day 1 of Cycles 1 and 2 (Cycle length = 21 days)
Phase 1: Minimum Plasma Concentration (Cmin) of ASTX029
As per planned analysis, data for participants from Part A (Dose Escalation) and Part B (Expansion) were combined for Cohort 11 (200 mg). 2 participants who received 200 and 280 mg respectively, in C1D1, received 120 mg in C2D1 and hence counted in Cohort 10. 1 participant who received 280 mg in C1D1, received 200 mg in C2D1 and hence counted in Cohort 11. Data for Cmin was calculated and analyzed for C2D1 only.
Pre-dose and at 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose on Day 1 of Cycle 2 (Cycle length = 21 days)
Phase 1: Time to Reach Maximum Concentration (Tmax) of ASTX029
As per planned analysis, data for participants from Part A (Dose Escalation) and Part B (Expansion) were combined for Cohort 11 (200 mg). 2 participants who received 200 and 280 mg respectively, in C1D1, received 120 mg in C2D1 and hence counted in Cohort 10. 1 participant who received 280 mg in C1D1, received 200 mg in C2D1 and hence counted in Cohort 11.
Pre-dose on Day 1 of Cycles 1 and 2 and at 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose on Day 1 of Cycles 1 and 2 (Cycle length = 21 days)
Phase 1: Elimination Half-Life (T1/2) of ASTX029
As per planned analysis, data for participants from Part A (Dose Escalation) and Part B (Expansion) were combined for Cohort 11 (200 mg). 2 participants who received 200 and 280 mg respectively, in C1D1, received 120 mg in C2D1 and hence counted in Cohort 10. 1 participant who received 280 mg in C1D1, received 200 mg in C2D1 and hence counted in Cohort 11.
Pre-dose on Day 1 of Cycles 1 and 2 and at 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose on Day 1 of Cycles 1 and 2 (Cycle length = 21 days)
Phase 1: Effect of Food on AUC0-24 of ASTX029
The food effect was to be analyzed only for tablet dosage forms. The participants who were administered 80 mg and 120 mg tablets, under both fed and fasted conditions were reported. As 200 mg dose was administered, as tablets, only under fasted conditions, hence food effect was not assessed for 200 mg dose. The statistical comparison between fed and fasted state treatment arm groups of 80 mg and 120 mg doses is reported in this outcome measure for food effect. The 2 participants who received 200 and 280 mg respectively, in C1D1, received 120 mg in C2D1 and hence counted in Cohort 10.
Pre-dose on Day 1 of Cycles 1 and 2 and at 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose on Day 1 of Cycles 1 and 2 (Cycle length = 21 days)
Phase 1: Effect of Food on AUC0-inf of ASTX029
The food effect was to be analyzed only for tablet dosage forms. The participants who were administered 80 mg and 120 mg tablets, under both fed and fasted conditions were reported. As 200 mg dose was administered, as tablets, only under fasted conditions, hence food effect was not assessed for 200 mg dose. The statistical comparison between fed and fasted state treatment arm groups of 80 mg and 120 mg doses is reported in this outcome measure for food effect. The 2 participants who received 200 and 280 mg respectively, in C1D1, received 120 mg in C2D1 and hence counted in Cohort 10.
Pre-dose on Day 1 of Cycles 1 and 2 and at 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose on Day 1 of Cycles 1 and 2 (Cycle length = 21 days)
Phase 1: Effect of Food on Cmax of ASTX029
The food effect was to be analyzed only for tablet dosage forms. The participants who were administered 80 mg and 120 mg tablets, under both fed and fasted conditions were reported. As 200 mg dose was administered, as tablets, only under fasted conditions, hence food effect was not assessed for 200 mg dose. The statistical comparison between fed and fasted state treatment arm groups of 80 mg and 120 mg doses is reported in this outcome measure for food effect. The 2 participants who received 200 and 280 mg respectively, in C1D1, received 120 mg in C2D1 and hence counted in Cohort 10.
Pre-dose on Day 1 of Cycles 1 and 2 and at 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose on Day 1 of Cycles 1 and 2 (Cycle length = 21 days)
Phase 1: Effect of Food on Tmax of ASTX029
The food effect was to be analyzed only for tablet dosage forms. The participants who were administered 80 mg and 120 mg tablets, under both fed and fasted conditions were reported. As 200 mg dose was administered, as tablets, only under fasted conditions, hence food effect was not assessed for 200 mg dose. The statistical comparison between fed and fasted state treatment arm groups of 80 mg and 120 mg doses is reported in this outcome measure for food effect. The 2 participants who received 200 and 280 mg respectively, in C1D1, received 120 mg in C2D1 and hence counted in Cohort 10.
Pre-dose on Day 1 of Cycles 1 and 2 and at 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose on Day 1 of Cycles 1 and 2 (Cycle length = 21 days)
Phase 1: Inhibition of Phosphorylated Ribosomal S6 Kinase (pRSK) Protein in Response to ASTX029 Treatment in Tumor Biopsies as Assessed by H Score
The protein expression level is quantified through the H-score, calculated from staining intensity within the target cell region. H-Score = (3x % of cells with staining graded 3) + (2x % of cells with staining graded 2) + % of cells with staining graded 1. H-Score ranges between 0 to 300. The H-score is for sum of cytoplasmic H-Score (C pRSK H-Score) and nuclear H-Scores (N pRSK H-Score). C pRSK H-Scores, and nuclear H-Scores were combined to give a single H-score.
4 hours post-dose on Day 8 of Cycle 2 (Cycle length = 21 days)
Phase 1: Progression Free Survival (PFS)
The PFS was defined as the number of months from the start of the study treatment to disease progression or death, whichever occurs first. The PFS was analyzed using a Kaplan-Meier method, with PFS time being censored on the date of the last disease assessment. The 90% CI for median PFS was provided using the Kaplan-Meier procedure.
Every 2 cycles for the first 4 cycles and then every 4 cycles thereafter until disease progression (Up to 82 months)
Phase 1: Overall Survival (OS)
The OS was defined as the number of months from the day the participant was randomized to the date of death (regardless of cause). Participants without a documented death date were censored on the last date they were known to be alive. The OS was presented using a Kaplan-Meier estimate.
The 90% CI for median OS was provided using the Kaplan-Meier procedure.
Up to 82 months
Phase 1: Disease Control Rate (DCR)
DCR was calculated as the number of participants whose best response was CR, PR, or stable disease (SD), divided by the total number of participants evaluable for DCR analysis. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to <10 mm. PR was defined as at least a 30 % decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable disease was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. Percentages were rounded off to the nearest single decimal place.
Every 2 cycles for the first 4 cycles and then every 4 cycles thereafter until disease progression (Up to 82 months)
Phase 1: Duration of Response (DoR)
Duration of response was calculated for all responders from the date of the earliest assessment of CR or PR to the date of relapse or death, whichever occurred earlier, or the last disease assessment date for participants without a relapse or death. Duration of SD was calculated for participants whose best response is CR, PR, or SD from the day study drug was first taken to the date of disease progression or death, whichever occurred earlier, or the last disease assessment for participants without disease progression or death.
Every 2 cycles for the first 4 cycles and then every 4 cycles thereafter until disease progression (Up to 82 months)
Phase 2: AUC0-24 of ASTX029
Pre-dose on Day 1 of Cycles 1, and 3; at 0.5,1, 2, 3, 4, 6, and 8 hours post-dose on Day 1 of Cycle 1, and at 0.5,1, 2, 4, and 8 hours post-dose on Day 1 of Cycle 3 (Cycle length = 21 days)
Phase 2: AUC0-last of ASTX029
Pre-dose on Day 1 of Cycles 1, and 3; at 0.5,1, 2, 3, 4, 6, and 8 hours post-dose on Day 1 of Cycle 1, and at 0.5,1, 2, 4, and 8 hours post-dose on Day 1 of Cycle 3 (Cycle length = 21 days)
Phase 2: AUC0-inf of ASTX029
Data for Auc0-inf was collected and analyzed for C1D1 only.
Pre-dose on Day 1 of Cycle 1; and at 0.5,1, 2, 3, 4, 6, and 8 hours post-dose on Day 1 of Cycle 1 (Cycle length = 21 days)
Phase 2: Cmax of ASTX029
Pre-dose on Day 1 of Cycles 1, and 3; at 0.5,1, 2, 3, 4, 6, and 8 hours post-dose on Day 1 of Cycle 1, and at 0.5,1, 2, 4, and 8 hours post-dose on Day 1 of Cycle 3 (Cycle length = 21 days)
Phase 2: Cmin of ASTX029
Data for Cmin was calculated and analyzed for C3D1 only.
Pre-dose on Day 1 of Cycle 3; and at 0.5,1, 2, 4, and 8 post-dose on Day 1 of Cycle 3 (Cycle length = 21 days)
Phase 2: Tmax of ASTX029
Pre-dose on Day 1 of Cycles 1, and 3; at 0.5,1, 2, 3, 4, 6, and 8 hours post-dose on Day 1 of Cycle 1, and at 0.5,1, 2, 4, and 8 hours post-dose on Day 1 of Cycle 3 (Cycle length = 21 days)
Phase 2: T1/2 of ASTX029
Data for T1/2 was collected and analyzed for C1D1 only.
Pre-dose on Day 1 of Cycle 1; at 0.5,1, 2, 3, 4, 6, and 8 hours post-dose on Day 1 of Cycle 1 (Cycle length = 21 days)
Phase 2: Progression Free Survival
The PFS was defined as the number of months from the start of the study treatment to disease progression or death, whichever occurs first. The PFS was analyzed using a Kaplan-Meier method, with PFS time being censored on the date of the last disease assessment. The 90% CI for median PFS was provided using the Kaplan-Meier procedure.
Every 2 cycles for the first 4 cycles and then every 4 cycles thereafter until disease progression (Up to 82 months)
Phase 2: Overall Survival
The OS was defined as the number of months from the day the participant was randomized to the date of death (regardless of cause). Participants without a documented death date were censored on the last date they were known to be alive. The OS was presented using a KM estimate. The 90% CI for median OS was provided using the Kaplan-Meier procedure.
Up to 82 months
Phase 2: Disease Control Rate
DCR was calculated as the number of participants whose best response was CR, PR, or SD, divided by the total number of participants evaluable for DCR analysis. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to <10 mm. PR was defined as at least a 30 % decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable disease was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Every 2 cycles for the first 4 cycles and then every 4 cycles thereafter until disease progression (Up to 82 months)
Phase 2: Duration of Response
Duration of response was calculated for all responders from the date of the earliest assessment of CR or PR to the date of relapse or death, whichever occurred earlier, or the last disease assessment date for participants without a relapse or death. Duration of SD was calculated for participants whose best response is CR, PR, or SD from the day study drug was first taken to the date of disease progression or death, whichever occurred earlier, or the last disease assessment for participants without disease progression or death.
Every 2 cycles for the first 4 cycles and then every 4 cycles thereafter until disease progression (Up to 82 months)
Los Angeles
California
90033
United States
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute Site# 107
Los Angeles
California
90048
United States
Hoag Memorial Hospital Site#115
Newport Beach
California
92658
United States
University of California Davis Medical Center Site #121
Sacramento
California
95817
United States
California Pacific Medical Center - Sutter Pacific Medical Center Site#117
San Francisco
California
94115-2378
United States
Smilow Cancer Hospital at Yale New Haven Site#105
New Haven
Connecticut
06510
United States
Holden Comprehensive Cancer Center
Iowa City
Iowa
52242
United States
The Sidney Kimmel Comprehensive Cancer Center Site#106
Baltimore
Maryland
21231
United States
Massachusetts General Hospital Site#103
Boston
Massachusetts
02114
United States
Dana Farber Cancer Institute Site#104
Boston
Massachusetts
02215
United States
University of Michigan Rogel Cancer Center Site #113
Ann Arbor
Michigan
48109
United States
Columbia University Irving Medical Center - Herbert Irving Pavilion Site#112
New York
New York
10032
United States
Providence Portland Medical Center Site #118
Portland
Oregon
97223
United States
Oregon Health and Science University Site #122
Portland
Oregon
97239
United States
University of Pennsylvania-Abramson Cancer Center
Philadelphia
Pennsylvania
19104
United States
The University of Texas MD Anderson Cancer Center Site#111
Houston
Texas
77030
United States
START - South Texas Accelerated Research Therapeutics, LLC Site# 101
San Antonio
Texas
78229
United States
Virginia Cancer Specialists Site#102
Fairfax
Virginia
22031
United States
Centre Léon Bérard Service d'Oncologie Médicale Site#202
Lyon
Auvergne-Rhône-Alpes
69373
France
Hôpital de la Timone Site #201
Marseille
13005
France
Institut Català d'Oncologia Badalona Site#240
Barcelona
08028
Spain
Hospital Universitari Vall d'Hebrón Servicio de Oncología, Sala coordinación UITM Site#243
Barcelona
08035
Spain
Hospital Universitari Germans Trias i Pujol
Barcelona
08916
Spain
Hospital Universitario Dexeus Site#241
Barcelona
8028
Spain
Clinica Universidad de Navarra Madrid Site #242
Madrid
28027
Spain
Clínica Universidad de Navarra Site#242
Madrid
28027
Spain
The Christie NHS Foundation Trust Site#220
Manchester
England
M20 4BX
United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge
CB2 0QQ
United Kingdom
The Newcastle Upon Tyne Hospitals NHS Foundation Trust Site #221
Newcastle upon Tyne
NE7 7DN
United Kingdom
Churchill Hospital Site #224
Oxford
OX3 7LE
United Kingdom
Participants received ASTX029 20 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
FG002
Phase 1A: Cohort 3 Dose Escalation
Participants received ASTX029 60 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
FG003
Phase 1A: Cohort 4 Dose Escalation
Participants received ASTX029 120 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
FG004
Phase 1A: Cohort 5 Dose Escalation
Participants received ASTX029 200 mg, orally, PiB, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
FG005
Phase 1A: Cohort 6 Dose Escalation
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
FG006
Phase 1A: Cohort 7 Dose Escalation
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
FG007
Phase 1A: Cohort 8 Dose Escalation
Participants received ASTX029 40 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
FG008
Phase 1A: Cohort 9 Dose Escalation
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
FG009
Phase 1A: Cohort 10 Dose Escalation
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
FG010
Phase 1A: Cohort 11 Dose Escalation
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
FG011
Phase 1A: Cohort 12 Dose Escalation
Participants received ASTX029 280 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
FG012
Phase 1B Dose Expansion
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
FG013
Phase 2: Cohort A
Participants with neuroblastoma RAS (NRAS)-mutant melanoma received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
FG014
Phase 2: Cohort B
Participants with Kirsten RAS (KRAS)-mutant or KRAS-amplified non-small cell lung cancer (NSCLC) received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
FG015
Phase 2: Cohort C
Participants with B isoform of RAF kinase (BRAF) V600-mutant cancers (non-colorectal cancers) received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
FG016
Phase 2: Cohort D
Participants with BRAF-fusion cancers received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
FG017
Phase 2: Cohort E
Participants with gynecological cancers with alterations in the mitogen-activated protein kinase (MAPK) pathway received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
FG018
Phase 2: Cohort F
Participants with tumors that were characterized by other gene aberrations (that upregulate the MAPK signal pathway) received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
FG0003 subjects
FG0013 subjects
FG0023 subjects
FG0035 subjects
FG00410 subjects
FG0057 subjects
FG0063 subjects
FG0073 subjects
FG0083 subjects
FG0093 subjects
FG0107 subjects
FG0117 subjects
FG01220 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
Safety Analysis Set Included All Participants Who Received Any Amount of Study Drug.
FG0003 subjects
FG0013 subjects
FG0023 subjects
FG0035 subjects
FG00410 subjects
FG0056 subjects
FG0063 subjects
FG0073 subjects
FG0083 subjects
FG0093 subjects
FG0107 subjects
FG0117 subjects
FG01220 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0101 subjects
FG0110 subjects
FG0121 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
NOT COMPLETED
FG0003 subjects
FG0013 subjects
FG0023 subjects
FG0035 subjects
FG00410 subjects
FG0057 subjects
FG0063 subjects
FG0073 subjects
FG0083 subjects
FG0093 subjects
FG0106 subjects
FG0117 subjects
FG01219 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
Type
Comment
Reasons
Death
FG0002 subjects
FG0012 subjects
FG0023 subjects
FG0032 subjects
FG0046 subjects
FG0055 subjects
FG0063 subjects
FG0072 subjects
FG0083 subjects
FG0091 subjects
FG0105 subjects
FG0117 subjects
FG01211 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
Complete Consent Withdrawal
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG004
Study Terminated by Sponsor
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Phase 2 (Dose Expansion)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG01332 subjects
FG01415 subjects
FG01512 subjects
FG0169 subjects
FG01732 subjects
FG01815 subjects
Safety Analysis Set Included All Participants Who Received Any Amount of Study Drug.
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
The Safety Analysis Set included data from all participants who received any amount of study drug.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Phase 1A: Cohort 1 Dose Escalation
Participants received ASTX029 10 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
BG001
Phase 1A: Cohort 2 Dose Escalation
Participants received ASTX029 20 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
BG002
Phase 1A: Cohort 3 Dose Escalation
Participants received ASTX029 60 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
BG003
Phase 1A: Cohort 4 Dose Escalation
Participants received ASTX029 120 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
BG004
Phase 1A: Cohort 5 Dose Escalation
Participants received ASTX029 200 mg, orally, PiB, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
BG005
Phase 1A: Cohort 6 Dose Escalation
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
BG006
Phase 1A: Cohort 7 Dose Escalation
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
BG007
Phase 1A: Cohort 8 Dose Escalation
Participants received ASTX029 40 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
BG008
Phase 1A: Cohort 9 Dose Escalation
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
BG009
Phase 1A: Cohort 10 Dose Escalation
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
BG010
Phase 1A: Cohort 11 Dose Escalation
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
BG011
Phase 1A: Cohort 12 Dose Escalation
Participants received ASTX029 280 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
BG012
Phase 1B Dose Expansion
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
BG013
Phase 2: Cohort A
Participants with NRAS-mutant melanoma received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
BG014
Phase 2: Cohort B
Participants with KRAS-mutant or KRAS-amplified NSCLC received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
BG015
Phase 2: Cohort C
Participants with BRAF V600-mutant cancers (non-colorectal cancers) received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
BG016
Phase 2: Cohort D
Participants with BRAF-fusion cancers received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
BG017
Phase 2: Cohort E
Participants with gynecological cancers with alterations in the MAPK pathway received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
BG018
Phase 2: Cohort F
Participants with tumors that were characterized by other gene aberrations (that upregulate the MAPK signal pathway) received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
BG019
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0003
BG0013
BG0023
BG0035
BG00410
BG0056
BG0063
BG0073
BG0083
BG0093
BG0107
BG0117
BG01220
BG01332
BG01415
BG01512
BG0169
BG01732
BG01814
BG019190
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
18 - 64
Title
Measurements
BG0000
BG0012
BG0023
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0003
BG0012
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Hispanic, Latino/a, or Spanish origin
Title
Measurements
BG0001
BG0010
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Asian
Title
Measurements
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs)
DLTs were defined as adverse events (AEs) graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03 criteria that occurred during the first cycle of treatment and represented any 1 of the following: grade 4 thrombocytopenia of any duration; ≥grade 3 hematologic toxicity with complications (e.g., grade 3 thrombocytopenia with bleeding or transfusion requirement); febrile neutropenia of any duration or grade 4 neutropenia of 5 days or more duration; liver-associated abnormalities; ≥grade 2 eye disorders; symptomatic grade 2 cutaneous toxicities (including skin rash); any other ≥grade 3 nonhematologic AE except grade 3 nausea, vomiting, or diarrhea; Any event that, in the opinion of the Data and Safety Review Committee (DSRC), would suggest that further dose escalation would put subjects at unacceptable risk.
The safety analysis set included data from all participants who received any amount of study drug.
Posted
Count of Participants
Participants
Cycle 1 (cycle length = 21 days)
ID
Title
Description
OG000
Phase 1A: Cohort 1 Dose Escalation
Participants received ASTX029 10 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG001
Phase 1A: Cohort 2 Dose Escalation
Participants received ASTX029 20 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG002
Phase 1A: Cohort 3 Dose Escalation
Participants received ASTX029 60 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG003
Phase 1A: Cohort 4 Dose Escalation
Participants received ASTX029 120 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG004
Phase 1A: Cohort 5 Dose Escalation
Participants received ASTX029 200 mg, orally, PiB, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG005
Phase 1A: Cohort 6 Dose Escalation
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG006
Phase 1A: Cohort 7 Dose Escalation
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
An AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. TEAEs are defined as events that first occurred or worsened on or after the date of the first dose of study treatment until 30 days after the last dose of study treatment or until the start of a posttreatment alternative anti-cancer treatment, whichever occurs first, with the following exceptions: events that occurred after 30 days beyond the last dose of study treatment or the start of a posttreatment alternative anti-cancer treatment will also be considered treatment-emergent if the events are both serious and related to the study treatment.
The safety analysis set included data from all participants who received any amount of study drug.
Posted
Count of Participants
Participants
From first dose of study drug up to 30 days after last dose (Up to 74 months)
ID
Title
Description
OG000
Phase 1A: Cohort 1 Dose Escalation
Participants received ASTX029 10 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG001
Phase 1A: Cohort 2 Dose Escalation
Participants received ASTX029 20 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
Primary
Phase 2: Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
The ORR was calculated as the number of evaluable participants whose best response was complete response (CR) or partial response (PR), divided by the total number of participants evaluable for ORR analysis. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to <10 millimeters (mm). PR was defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Percentages were rounded off to the nearest single decimal place
The efficacy analysis set included all participants who received any amount of study drug. The ORR analysis was based on participants who were in the efficacy analysis set and who had disease assessment at baseline and at least 1 follow-up disease assessment or participants who died or stopped treatment before the first scheduled disease assessment due to clinical progression or toxicity.
Posted
Number
90% Confidence Interval
percentage of participants
Every 2 cycles for the first 4 cycles and then every 4 cycles thereafter until disease progression (Up to 74 months)
ID
Title
Description
OG000
Phase 2: Cohort A
Participants with NRAS-mutant melanoma received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
OG001
Phase 2: Cohort B
Secondary
Phase 1: Area Under the Concentration-time Curve From Time Zero to 24 Hours (AUC0-24) of ASTX029
As per planned analysis, data for participants from Part A (Dose Escalation) and Part B (Expansion) were combined for Cohort 11 (200 mg). 2 participants who received 200 and 280 mg respectively, in Cycle 1 Day1 (C1D1), received 120 mg in Cycle 2 and Day 1 (C2D1) and hence counted in Cohort 10. 1 participant who received 280 mg in C1D1, received 200 mg in C2D1 and hence counted in Cohort 11.
The pharmacokinetics (PK) analysis set included all participants who had received study drug with available plasma concentrations and PK parameters for ASTX029. Overall number of participants analyzed is the number of participants with data available for analysis. Number analyzed are unique number of participants out of all the assessed participants with data available at the specified timepoint.
Posted
Geometric Mean
Geometric Coefficient of Variation
hours*nanograms/milliliters (h*ng/mL)
Pre-dose on Day 1 of Cycles 1 and 2 and at 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose on Day 1 of Cycles 1 and 2 (Cycle length = 21 days)
ID
Title
Description
OG000
Phase 1A: Cohort 1 Dose Escalation
Participants received ASTX029 10 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG001
Phase 1A: Cohort 2 Dose Escalation
Participants received ASTX029 20 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
Secondary
Phase 1: Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of ASTX029
As per planned analysis, data for participants from Part A (Dose Escalation) and Part B (Expansion) were combined for Cohort 11 (200 mg). 2 participants who received 200 and 280 mg respectively, in C1D1 received 120 mg in C2D1 and hence counted in Cohort 10. 1 participant who received 280 mg in C1D1, received 200 mg in C2D1 and hence counted in Cohort 11.
The PK analysis set included all participants who had received study drug with available plasma concentrations and PK parameters for ASTX029. Overall number of participants analyzed is the number of participants with data available for analysis. Number analyzed are unique number of participants out of all the assessed participants with data available at the specified timepoint.
Posted
Geometric Mean
Geometric Coefficient of Variation
h*ng/mL
Pre-dose on Day 1 of Cycles 1 and 2 and at 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose on Day 1 of Cycles 1 and 2 (Cycle length = 21 days)
ID
Title
Description
OG000
Phase 1A: Cohort 1 Dose Escalation
Participants received ASTX029 10 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG001
Phase 1A: Cohort 2 Dose Escalation
Participants received ASTX029 20 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
Secondary
Phase 1: Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of ASTX029
As per planned analysis, data for participants from Part A (Dose Escalation) and Part B (Expansion) were combined for Cohort 11 (200 mg). 2 participants who received 200 and 280 mg respectively, in C1D1, received 120 mg in C2D1 and hence counted in Cohort 10. 1 participant who received 280 mg in C1D1, received 200 mg in C2D1 and hence counted in Cohort 11.
The PK analysis set included all participants who had received study drug with available plasma concentrations and PK parameters for ASTX029. Overall number of participants analyzed is the number of participants with data available for analysis. Number analyzed are unique number of participants out of all the assessed participants with data available at the specified timepoint.
Posted
Geometric Mean
Geometric Coefficient of Variation
h*ng/mL
Pre-dose on Day 1 of Cycles 1 and 2 and at 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose on Day 1 of Cycles 1 and 2 (Cycle length = 21 days)
ID
Title
Description
OG000
Phase 1A: Cohort 1 Dose Escalation
Participants received ASTX029 10 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG001
Phase 1A: Cohort 2 Dose Escalation
Participants received ASTX029 20 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
Secondary
Phase 1: Maximum Observed Plasma Concentration (Cmax) of ASTX029
As per planned analysis, data for participants from Part A (Dose Escalation) and Part B (Expansion) were combined for Cohort 11 (200 mg). 2 participants who received 200 and 280 mg respectively, in C1D1, received 120 mg in C2D1 and hence counted in Cohort 10. 1 participant who received 280 mg in C1D1, received 200 mg in C2D1 and hence counted in Cohort 11.
The PK analysis set included all participants who had received study drug with available plasma concentrations and PK parameters for ASTX029. Overall number of participants analyzed is the number of participants with data available for analysis. Number analyzed are unique number of participants out of all the assessed participants with data available at the specified timepoint.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanograms/milliliter (ng/mL)
Pre-dose on Day 1 of Cycles 1 and 2 and at 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose on Day 1 of Cycles 1 and 2 (Cycle length = 21 days)
ID
Title
Description
OG000
Phase 1A: Cohort 1 Dose Escalation
Participants received ASTX029 10 mg, PiB, orally, once daily, up to median duration of 1.6 months, under fed state.
OG001
Phase 1A: Cohort 2 Dose Escalation
Participants received ASTX029 20 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
Secondary
Phase 1: Minimum Plasma Concentration (Cmin) of ASTX029
As per planned analysis, data for participants from Part A (Dose Escalation) and Part B (Expansion) were combined for Cohort 11 (200 mg). 2 participants who received 200 and 280 mg respectively, in C1D1, received 120 mg in C2D1 and hence counted in Cohort 10. 1 participant who received 280 mg in C1D1, received 200 mg in C2D1 and hence counted in Cohort 11. Data for Cmin was calculated and analyzed for C2D1 only.
The PK analysis set included all participants who had received study drug with available plasma concentrations and PK parameters for ASTX029. Overall number of participants analyzed is the number of participants with data available for analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Pre-dose and at 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose on Day 1 of Cycle 2 (Cycle length = 21 days)
ID
Title
Description
OG000
Phase 1A: Cohort 1 Dose Escalation
Participants received ASTX029 10 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG001
Phase 1A: Cohort 2 Dose Escalation
Participants received ASTX029 20 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG002
Secondary
Phase 1: Time to Reach Maximum Concentration (Tmax) of ASTX029
As per planned analysis, data for participants from Part A (Dose Escalation) and Part B (Expansion) were combined for Cohort 11 (200 mg). 2 participants who received 200 and 280 mg respectively, in C1D1, received 120 mg in C2D1 and hence counted in Cohort 10. 1 participant who received 280 mg in C1D1, received 200 mg in C2D1 and hence counted in Cohort 11.
The PK analysis set included all participants who had received study drug with available plasma concentrations and PK parameters for ASTX029. Overall number of participants analyzed is the number of participants with data available for analysis. Number analyzed are unique number of participants out of all the assessed participants with data available at the specified timepoint.
Posted
Median
Full Range
hours
Pre-dose on Day 1 of Cycles 1 and 2 and at 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose on Day 1 of Cycles 1 and 2 (Cycle length = 21 days)
ID
Title
Description
OG000
Phase 1A: Cohort 1 Dose Escalation
Participants received ASTX029 10 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG001
Phase 1A: Cohort 2 Dose Escalation
Participants received ASTX029 20 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
Secondary
Phase 1: Elimination Half-Life (T1/2) of ASTX029
As per planned analysis, data for participants from Part A (Dose Escalation) and Part B (Expansion) were combined for Cohort 11 (200 mg). 2 participants who received 200 and 280 mg respectively, in C1D1, received 120 mg in C2D1 and hence counted in Cohort 10. 1 participant who received 280 mg in C1D1, received 200 mg in C2D1 and hence counted in Cohort 11.
The PK analysis set included all participants who had received study drug with available plasma concentrations and PK parameters for ASTX029. Overall number of participants analyzed is the number of participants with data available for analysis. Number analyzed are unique number of participants out of all the assessed participants with data available at the specified timepoint.
Posted
Geometric Mean
Geometric Coefficient of Variation
hours
Pre-dose on Day 1 of Cycles 1 and 2 and at 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose on Day 1 of Cycles 1 and 2 (Cycle length = 21 days)
ID
Title
Description
OG000
Phase 1A: Cohort 1 Dose Escalation
Participants received ASTX029 10 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG001
Phase 1A: Cohort 2 Dose Escalation
Participants received ASTX029 20 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
Secondary
Phase 1: Effect of Food on AUC0-24 of ASTX029
The food effect was to be analyzed only for tablet dosage forms. The participants who were administered 80 mg and 120 mg tablets, under both fed and fasted conditions were reported. As 200 mg dose was administered, as tablets, only under fasted conditions, hence food effect was not assessed for 200 mg dose. The statistical comparison between fed and fasted state treatment arm groups of 80 mg and 120 mg doses is reported in this outcome measure for food effect. The 2 participants who received 200 and 280 mg respectively, in C1D1, received 120 mg in C2D1 and hence counted in Cohort 10.
The PK analysis set included all participants who had received study drug with available plasma concentrations and PK parameters for ASTX029. The data is reported here for the arm groups of 80 mg and 120 mg, in both fed and fasted to compare food effect. Overall number of participants analyzed is the number of participants with data available for analysis. Number analyzed are unique number of participants out of all the assessed participants with data available at the specified timepoint.
Posted
Geometric Mean
Geometric Coefficient of Variation
h*ng/mL
Pre-dose on Day 1 of Cycles 1 and 2 and at 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose on Day 1 of Cycles 1 and 2 (Cycle length = 21 days)
ID
Title
Description
OG000
Phase 1A: Cohort 6 Dose Escalation
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG001
Secondary
Phase 1: Effect of Food on AUC0-inf of ASTX029
The food effect was to be analyzed only for tablet dosage forms. The participants who were administered 80 mg and 120 mg tablets, under both fed and fasted conditions were reported. As 200 mg dose was administered, as tablets, only under fasted conditions, hence food effect was not assessed for 200 mg dose. The statistical comparison between fed and fasted state treatment arm groups of 80 mg and 120 mg doses is reported in this outcome measure for food effect. The 2 participants who received 200 and 280 mg respectively, in C1D1, received 120 mg in C2D1 and hence counted in Cohort 10.
The PK analysis set included all participants who had received study drug with available plasma concentrations and PK parameters for ASTX029. The data is reported here for the arm groups of 80 mg and 120 mg, in both fed and fasted to compare food effect. Overall number of participants analyzed is the number of participants with data available for analysis. Number analyzed are unique number of participants out of all the assessed participants with data available at the specified timepoint.
Posted
Geometric Least Squares Mean
Geometric Coefficient of Variation
h*ng/mL
Pre-dose on Day 1 of Cycles 1 and 2 and at 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose on Day 1 of Cycles 1 and 2 (Cycle length = 21 days)
ID
Title
Description
OG000
Phase 1A: Cohort 6 Dose Escalation
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG001
Secondary
Phase 1: Effect of Food on Cmax of ASTX029
The food effect was to be analyzed only for tablet dosage forms. The participants who were administered 80 mg and 120 mg tablets, under both fed and fasted conditions were reported. As 200 mg dose was administered, as tablets, only under fasted conditions, hence food effect was not assessed for 200 mg dose. The statistical comparison between fed and fasted state treatment arm groups of 80 mg and 120 mg doses is reported in this outcome measure for food effect. The 2 participants who received 200 and 280 mg respectively, in C1D1, received 120 mg in C2D1 and hence counted in Cohort 10.
The PK analysis set included all participants who had received study drug with available plasma concentrations and PK parameters for ASTX029. The data is reported here for the arm groups of 80 mg and 120 mg, in both fed and fasted to compare food effect. Overall number of participants analyzed is the number of participants with data available for analysis. Number analyzed are unique number of participants out of all the assessed participants with data available at the specified timepoint.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Pre-dose on Day 1 of Cycles 1 and 2 and at 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose on Day 1 of Cycles 1 and 2 (Cycle length = 21 days)
ID
Title
Description
OG000
Phase 1A: Cohort 6 Dose Escalation
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG001
Phase 1A: Cohort 7 Dose Escalation
Secondary
Phase 1: Effect of Food on Tmax of ASTX029
The food effect was to be analyzed only for tablet dosage forms. The participants who were administered 80 mg and 120 mg tablets, under both fed and fasted conditions were reported. As 200 mg dose was administered, as tablets, only under fasted conditions, hence food effect was not assessed for 200 mg dose. The statistical comparison between fed and fasted state treatment arm groups of 80 mg and 120 mg doses is reported in this outcome measure for food effect. The 2 participants who received 200 and 280 mg respectively, in C1D1, received 120 mg in C2D1 and hence counted in Cohort 10.
The PK analysis set included all participants who had received study drug with available plasma concentrations and PK parameters for ASTX029. The data is reported here for the arm groups of 80 mg and 120 mg, in both fed and fasted to compare food effect. Overall number of participants analyzed is the number of participants with data available for analysis. Number analyzed are unique number of participants out of all the assessed participants with data available at the specified timepoint.
Posted
Median
Full Range
hours
Pre-dose on Day 1 of Cycles 1 and 2 and at 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose on Day 1 of Cycles 1 and 2 (Cycle length = 21 days)
ID
Title
Description
OG000
Phase 1A: Cohort 6 Dose Escalation
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG001
Phase 1A: Cohort 7 Dose Escalation
Secondary
Phase 1: Inhibition of Phosphorylated Ribosomal S6 Kinase (pRSK) Protein in Response to ASTX029 Treatment in Tumor Biopsies as Assessed by H Score
The protein expression level is quantified through the H-score, calculated from staining intensity within the target cell region. H-Score = (3x % of cells with staining graded 3) + (2x % of cells with staining graded 2) + % of cells with staining graded 1. H-Score ranges between 0 to 300. The H-score is for sum of cytoplasmic H-Score (C pRSK H-Score) and nuclear H-Scores (N pRSK H-Score). C pRSK H-Scores, and nuclear H-Scores were combined to give a single H-score.
Pharmacodynamics analysis set included in the pharmacodynamic and biomarker analyses if they have received study drug and their samples were successfully collected and analyzed. Overall number of participants analyzed is the number of participants with data available for analysis. The data for this outcome measure was collected and analyzed for Phase 1B Dose Expansion cohort only.
Posted
Mean
Standard Deviation
score on a scale
4 hours post-dose on Day 8 of Cycle 2 (Cycle length = 21 days)
ID
Title
Description
OG000
Phase 1B Dose Expansion
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
Units
Counts
Participants
Secondary
Phase 1: Progression Free Survival (PFS)
The PFS was defined as the number of months from the start of the study treatment to disease progression or death, whichever occurs first. The PFS was analyzed using a Kaplan-Meier method, with PFS time being censored on the date of the last disease assessment. The 90% CI for median PFS was provided using the Kaplan-Meier procedure.
The efficacy analysis set included all participants who received any amount of study drug.
Posted
Median
95% Confidence Interval
months
Every 2 cycles for the first 4 cycles and then every 4 cycles thereafter until disease progression (Up to 82 months)
ID
Title
Description
OG000
Phase 1A: Cohort 1 Dose Escalation
Participants received ASTX029 10 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG001
Phase 1A: Cohort 2 Dose Escalation
Participants received ASTX029 20 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG002
Phase 1A: Cohort 3 Dose Escalation
Participants received ASTX029 60 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
Secondary
Phase 1: Overall Survival (OS)
The OS was defined as the number of months from the day the participant was randomized to the date of death (regardless of cause). Participants without a documented death date were censored on the last date they were known to be alive. The OS was presented using a Kaplan-Meier estimate.
The 90% CI for median OS was provided using the Kaplan-Meier procedure.
The efficacy analysis set included all participants who received any amount of study drug.
Posted
Median
95% Confidence Interval
months
Up to 82 months
ID
Title
Description
OG000
Phase 1A: Cohort 1 Dose Escalation
Participants received ASTX029 10 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG001
Phase 1A: Cohort 2 Dose Escalation
Participants received ASTX029 20 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG002
Phase 1A: Cohort 3 Dose Escalation
Participants received ASTX029 60 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
Secondary
Phase 1: Disease Control Rate (DCR)
DCR was calculated as the number of participants whose best response was CR, PR, or stable disease (SD), divided by the total number of participants evaluable for DCR analysis. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to <10 mm. PR was defined as at least a 30 % decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable disease was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. Percentages were rounded off to the nearest single decimal place.
The efficacy analysis set included all participants who received any amount of study drug. The DCR analysis was based on participants who were in the efficacy analysis set and who had disease assessment at baseline and at least 1 follow-up disease assessment or participants who died or stopped treatment before the first scheduled disease assessment due to clinical progression or toxicity.
Posted
Number
90% Confidence Interval
percentage of participants
Every 2 cycles for the first 4 cycles and then every 4 cycles thereafter until disease progression (Up to 82 months)
ID
Title
Description
OG000
Phase 1A: Cohort 1 Dose Escalation
Participants received ASTX029 10 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG001
Secondary
Phase 1: Duration of Response (DoR)
Duration of response was calculated for all responders from the date of the earliest assessment of CR or PR to the date of relapse or death, whichever occurred earlier, or the last disease assessment date for participants without a relapse or death. Duration of SD was calculated for participants whose best response is CR, PR, or SD from the day study drug was first taken to the date of disease progression or death, whichever occurred earlier, or the last disease assessment for participants without disease progression or death.
The efficacy analysis set included all participants who received any amount of study drug. Overall number of participants analyzed is the number of participants with data available for analysis.
Posted
Median
Full Range
days
Every 2 cycles for the first 4 cycles and then every 4 cycles thereafter until disease progression (Up to 82 months)
ID
Title
Description
OG000
Phase 1A: Cohort 1 Dose Escalation
Participants received ASTX029 10 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG001
Phase 1A: Cohort 2 Dose Escalation
Participants received ASTX029 20 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG002
Secondary
Phase 2: AUC0-24 of ASTX029
The PK analysis set included all participants who had received study drug with available plasma concentrations and PK parameters for ASTX029. Overall number of participants analyzed is the number of participants with data available for analysis. Number analyzed are unique number of participants out of all the assessed participants with data available at the specified timepoint.
Posted
Geometric Mean
Geometric Coefficient of Variation
h*ng/mL
Pre-dose on Day 1 of Cycles 1, and 3; at 0.5,1, 2, 3, 4, 6, and 8 hours post-dose on Day 1 of Cycle 1, and at 0.5,1, 2, 4, and 8 hours post-dose on Day 1 of Cycle 3 (Cycle length = 21 days)
ID
Title
Description
OG000
Phase 2: Cohort A
Participants with NRAS-mutant melanoma received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
OG001
Phase 2: Cohort B
Participants with KRAS-mutant or KRAS-amplified NSCLC received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
OG002
Phase 2: Cohort C
Participants with BRAF V600-mutant cancers (non-colorectal cancers) received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
Secondary
Phase 2: AUC0-last of ASTX029
The PK analysis set included all participants who had received study drug with available plasma concentrations and PK parameters for ASTX029. Overall number of participants analyzed is the number of participants with data available for analysis. Number analyzed are unique number of participants out of all the assessed participants with data available at the specified timepoint.
Posted
Geometric Mean
Geometric Coefficient of Variation
h*ng/mL
Pre-dose on Day 1 of Cycles 1, and 3; at 0.5,1, 2, 3, 4, 6, and 8 hours post-dose on Day 1 of Cycle 1, and at 0.5,1, 2, 4, and 8 hours post-dose on Day 1 of Cycle 3 (Cycle length = 21 days)
ID
Title
Description
OG000
Phase 2: Cohort A
Participants with NRAS-mutant melanoma received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
OG001
Phase 2: Cohort B
Participants with KRAS-mutant or KRAS-amplified NSCLC received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
OG002
Phase 2: Cohort C
Participants with BRAF V600-mutant cancers (non-colorectal cancers) received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
Secondary
Phase 2: AUC0-inf of ASTX029
Data for Auc0-inf was collected and analyzed for C1D1 only.
The PK analysis set included all participants who had received study drug with available plasma concentrations and PK parameters for ASTX029. Overall number of participants analyzed is the number of participants with data available for analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
h*ng/mL
Pre-dose on Day 1 of Cycle 1; and at 0.5,1, 2, 3, 4, 6, and 8 hours post-dose on Day 1 of Cycle 1 (Cycle length = 21 days)
ID
Title
Description
OG000
Phase 2: Cohort A
Participants with NRAS-mutant melanoma received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
OG001
Phase 2: Cohort B
Participants with KRAS-mutant or KRAS-amplified NSCLC received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
OG002
Phase 2: Cohort C
Participants with BRAF V600-mutant cancers (non-colorectal cancers) received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
Secondary
Phase 2: Cmax of ASTX029
The PK analysis set included all participants who had received study drug with available plasma concentrations and PK parameters for ASTX029. Overall number of participants analyzed is the number of participants with data available for analysis. Number analyzed are unique number of participants out of all the assessed participants with data available at the specified timepoint.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Pre-dose on Day 1 of Cycles 1, and 3; at 0.5,1, 2, 3, 4, 6, and 8 hours post-dose on Day 1 of Cycle 1, and at 0.5,1, 2, 4, and 8 hours post-dose on Day 1 of Cycle 3 (Cycle length = 21 days)
ID
Title
Description
OG000
Phase 2: Cohort A
Participants with NRAS-mutant melanoma received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
OG001
Phase 2: Cohort B
Participants with KRAS-mutant or KRAS-amplified NSCLC received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
OG002
Phase 2: Cohort C
Participants with BRAF V600-mutant cancers (non-colorectal cancers) received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
Secondary
Phase 2: Cmin of ASTX029
Data for Cmin was calculated and analyzed for C3D1 only.
The PK analysis set included all participants who had received study drug with available plasma concentrations and PK parameters for ASTX029. Overall number of participants analyzed is the number of participants with data available for analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Pre-dose on Day 1 of Cycle 3; and at 0.5,1, 2, 4, and 8 post-dose on Day 1 of Cycle 3 (Cycle length = 21 days)
ID
Title
Description
OG000
Phase 2: Cohort A
Participants with NRAS-mutant melanoma received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
OG001
Phase 2: Cohort B
Participants with KRAS-mutant or KRAS-amplified NSCLC received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
OG002
Phase 2: Cohort C
Participants with BRAF V600-mutant cancers (non-colorectal cancers) received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
Secondary
Phase 2: Tmax of ASTX029
The PK analysis set included all participants who had received study drug with available plasma concentrations and PK parameters for ASTX029. Overall number of participants analyzed is the number of participants with data available for analysis. Number analyzed are unique number of participants out of all the assessed participants with data available at the specified timepoint.
Posted
Median
Full Range
hours
Pre-dose on Day 1 of Cycles 1, and 3; at 0.5,1, 2, 3, 4, 6, and 8 hours post-dose on Day 1 of Cycle 1, and at 0.5,1, 2, 4, and 8 hours post-dose on Day 1 of Cycle 3 (Cycle length = 21 days)
ID
Title
Description
OG000
Phase 2: Cohort A
Participants with NRAS-mutant melanoma received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
OG001
Phase 2: Cohort B
Participants with KRAS-mutant or KRAS-amplified NSCLC received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
OG002
Phase 2: Cohort C
Participants with BRAF V600-mutant cancers (non-colorectal cancers) received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
Secondary
Phase 2: T1/2 of ASTX029
Data for T1/2 was collected and analyzed for C1D1 only.
The PK analysis set included all participants who had received study drug with available plasma concentrations and PK parameters for ASTX029. Overall number of participants analyzed is the number of participants with data available for analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
hours
Pre-dose on Day 1 of Cycle 1; at 0.5,1, 2, 3, 4, 6, and 8 hours post-dose on Day 1 of Cycle 1 (Cycle length = 21 days)
ID
Title
Description
OG000
Phase 2: Cohort A
Participants with NRAS-mutant melanoma received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
OG001
Phase 2: Cohort B
Participants with KRAS-mutant or KRAS-amplified NSCLC received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
OG002
Phase 2: Cohort C
Participants with BRAF V600-mutant cancers (non-colorectal cancers) received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
Secondary
Phase 2: Progression Free Survival
The PFS was defined as the number of months from the start of the study treatment to disease progression or death, whichever occurs first. The PFS was analyzed using a Kaplan-Meier method, with PFS time being censored on the date of the last disease assessment. The 90% CI for median PFS was provided using the Kaplan-Meier procedure.
The efficacy analysis set included all participants who received any amount of study drug.
Posted
Median
95% Confidence Interval
months
Every 2 cycles for the first 4 cycles and then every 4 cycles thereafter until disease progression (Up to 82 months)
ID
Title
Description
OG000
Phase 2: Cohort A
Participants with NRAS-mutant melanoma received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
OG001
Phase 2: Cohort B
Participants with KRAS-mutant or KRAS-amplified NSCLC received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
OG002
Phase 2: Cohort C
Participants with BRAF V600-mutant cancers (non-colorectal cancers) received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
Secondary
Phase 2: Overall Survival
The OS was defined as the number of months from the day the participant was randomized to the date of death (regardless of cause). Participants without a documented death date were censored on the last date they were known to be alive. The OS was presented using a KM estimate. The 90% CI for median OS was provided using the Kaplan-Meier procedure.
The efficacy analysis set included all participants who received any amount of study drug.
Posted
Median
95% Confidence Interval
months
Up to 82 months
ID
Title
Description
OG000
Phase 2: Cohort A
Participants with NRAS-mutant melanoma received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
OG001
Phase 2: Cohort B
Participants with KRAS-mutant or KRAS-amplified NSCLC received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
OG002
Phase 2: Cohort C
Participants with BRAF V600-mutant cancers (non-colorectal cancers) received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
Secondary
Phase 2: Disease Control Rate
DCR was calculated as the number of participants whose best response was CR, PR, or SD, divided by the total number of participants evaluable for DCR analysis. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to <10 mm. PR was defined as at least a 30 % decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable disease was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
The efficacy analysis set included all participants who received any amount of study drug. The DCR analysis was based on participants who were in the efficacy analysis set and who had disease assessment at baseline and at least 1 follow-up disease assessment or participants who died or stopped treatment before the first scheduled disease assessment due to clinical progression or toxicity.
Posted
Number
95% Confidence Interval
percentage of participants
Every 2 cycles for the first 4 cycles and then every 4 cycles thereafter until disease progression (Up to 82 months)
ID
Title
Description
OG000
Phase 2: Cohort A
Participants with NRAS-mutant melanoma received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
OG001
Phase 2: Cohort B
Secondary
Phase 2: Duration of Response
Duration of response was calculated for all responders from the date of the earliest assessment of CR or PR to the date of relapse or death, whichever occurred earlier, or the last disease assessment date for participants without a relapse or death. Duration of SD was calculated for participants whose best response is CR, PR, or SD from the day study drug was first taken to the date of disease progression or death, whichever occurred earlier, or the last disease assessment for participants without disease progression or death.
The efficacy analysis set included all participants who received any amount of study drug. Overall number of participants analyzed is the number of participants with data available for analysis.
Posted
Median
Full Range
days
Every 2 cycles for the first 4 cycles and then every 4 cycles thereafter until disease progression (Up to 82 months)
ID
Title
Description
OG000
Phase 2: Cohort A
Participants with NRAS-mutant melanoma received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
OG001
Phase 2: Cohort B
Participants with KRAS-mutant or KRAS-amplified NSCLC received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
OG002
Time Frame
From first dose of study drug up to end of the study (Up to 82 months)
Description
The Safety Analysis Set included data from all participants who received any amount of study drug.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Phase 1A: Cohort 1 Dose Escalation
Participants received ASTX029 10 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
3
3
0
3
3
3
EG001
Phase 1A: Cohort 2 Dose Escalation
Participants received ASTX029 20 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
2
3
1
3
3
3
EG002
Phase 1A: Cohort 3 Dose Escalation
Participants received ASTX029 60 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
3
3
2
3
3
3
EG003
Phase 1A: Cohort 4 Dose Escalation
Participants received ASTX029 120 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
3
5
2
5
5
5
EG004
Phase 1A: Cohort 5 Dose Escalation
Participants received ASTX029 200 mg, orally, PiB, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
9
10
7
10
8
10
EG005
Phase 1A: Cohort 6 Dose Escalation
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
4
6
1
6
6
6
EG006
Phase 1A: Cohort 7 Dose Escalation
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
3
3
2
3
3
3
EG007
Phase 1A: Cohort 8 Dose Escalation
Participants received ASTX029 40 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
3
3
0
3
3
3
EG008
Phase 1A: Cohort 9 Dose Escalation
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
3
3
1
3
3
3
EG009
Phase 1A: Cohort 10 Dose Escalation
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
1
3
1
3
3
3
EG010
Phase 1A: Cohort 11 Dose Escalation
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
5
7
3
7
7
7
EG011
Phase 1A: Cohort 12 Dose Escalation
Participants received ASTX029 280 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
7
7
1
7
7
7
EG012
Phase 1B Dose Expansion
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
13
20
9
20
20
20
EG013
Phase 2: Cohort A
Participants with NRAS-mutant melanoma received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
23
32
11
32
31
32
EG014
Phase 2: Cohort B
Participants with KRAS-mutant or KRAS-amplified NSCLC received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
13
15
5
15
15
15
EG015
Phase 2: Cohort C
Participants with BRAF V600-mutant cancers (non-colorectal cancers) received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
10
12
4
12
12
12
EG016
Phase 2: Cohort D
Participants with BRAF-fusion cancers received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
5
9
3
9
9
9
EG017
Phase 2: Cohort E
Participants with gynecological cancers with alterations in the MAPK pathway received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
14
32
12
32
32
32
EG018
Phase 2: Cohort F
Participants with tumors that were characterized by other gene aberrations (that upregulate the MAPK signal pathway) received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
11
14
4
14
13
14
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0030 affected5 at risk
EG0040 affected10 at risk
EG0050 affected6 at risk
EG0061 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected7 at risk
EG0110 affected7 at risk
EG0120 affected20 at risk
EG0130 affected32 at risk
EG0140 affected15 at risk
EG0150 affected12 at risk
EG0161 affected9 at risk
EG0170 affected32 at risk
EG0180 affected14 at risk
Leukocytosis
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Large intestinal obstruction
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Erosive duodenitis
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Abdominal strangulated hernia
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Intestinal perforation
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Malaise
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pyrexia
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Chest pain
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Fatigue
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Organ failure
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Enterocolitis infectious
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Wound infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Sepsis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Urinary tract infection bacterial
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Biliary tract infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Device related infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pneumonia aspiration
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Urosepsis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Intracranial mass
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Encephalopathy
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Respiratory disorder
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Renal impairment
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Embolism
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Embolism venous
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Aortic dissection
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypertension
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypotension
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Fracture
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Gastrointestinal stoma output decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0002 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0032 affected5 at risk
EG0043 affected10 at risk
EG0050 affected6 at risk
EG0062 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0091 affected3 at risk
EG0100 affected7 at risk
EG0113 affected7 at risk
EG0127 affected20 at risk
EG0139 affected32 at risk
EG0143 affected15 at risk
EG0155 affected12 at risk
EG0162 affected9 at risk
EG01714 affected32 at risk
EG0185 affected14 at risk
Leukocytosis
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Anaemia of malignant disease
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Thrombocytosis
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Thrombotic thrombocytopenic purpura
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Sinus bradycardia
Cardiac disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Middle ear effusion
Ear and labyrinth disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Inner ear disorder
Ear and labyrinth disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Dyschromatopsia
Eye disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Periorbital oedema
Eye disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Photophobia
Eye disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Vision blurred
Eye disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Visual field defect
Eye disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Retinal degeneration
Eye disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Cataract
Eye disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Diplopia
Eye disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Macular detachment
Eye disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Retinopathy
Eye disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Visual impairment
Eye disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Central serous chorioretinopathy
Eye disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Exophthalmos
Eye disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Subretinal fluid
Eye disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Visual acuity reduced
Eye disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Detachment of retinal pigment epithelium
Eye disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Eye disorder
Eye disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Retinal detachment
Eye disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Dry eye
Eye disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Presbyopia
Eye disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Vitreous floaters
Eye disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Blepharitis
Eye disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Keratitis
Eye disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Ocular discomfort
Eye disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Visual brightness
Eye disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0023 affected3 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0021 affected3 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Lip oedema
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Gastric ulcer
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Cheilitis
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Lower gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Oral dysaesthesia
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Swollen tongue
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Glossodynia
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Large intestinal ulcer
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Large intestine polyp
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Melaena
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Tongue oedema
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Retching
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Angular cheilitis
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Lip blister
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Odynophagia
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Tongue haemorrhage
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Asthenia
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Chills
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Fatigue
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0022 affected3 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Oedema
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pyrexia
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Catheter site erythema
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Generalised oedema
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Malaise
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Nodule
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Chest pain
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Oedema peripheral
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Secretion discharge
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Catheter site pain
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Chest discomfort
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Injection site bruising
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Localised oedema
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pain
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Face oedema
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Thirst
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Gait disturbance
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Peripheral swelling
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Paronychia
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Skin infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Wound infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Ear infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Rash pustular
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Injection site infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
COVID-19
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Coronavirus infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Folliculitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hordeolum
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Metapneumovirus infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Periorbital infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Urethritis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hepatic pain
Hepatobiliary disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypertransaminasaemia
Hepatobiliary disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0001 affected3 at risk
EG0012 affected3 at risk
EG0020 affected3 at risk
EG003
Activated partial thromboplastin time prolonged
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Blood cholesterol increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Lipase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Platelet count decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Weight decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Blood glucose increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
International normalised ratio increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Ammonia increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Blood magnesium decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Ejection fraction decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Weight increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Amylase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Blood corticotrophin decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Blood creatine increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Blood iron decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Blood potassium increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypoproteinaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Cachexia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Malnutrition
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Limb mass
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Spinal pain
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Connective tissue disorder
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Joint range of motion decreased
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Osteonecrosis
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Osteoporosis
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Headache
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Balance disorder
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Sciatica
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Aphasia
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Embolic stroke
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Tremor
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Burning sensation
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Post herpetic neuralgia
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Seizure
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Neuralgia
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Migraine
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Ophthalmic migraine
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Syncope
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Dizziness postural
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Delirium
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Agitation
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Depression
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Mental disorder
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Sleep disorder
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Chromaturia
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Balanoposthitis
Reproductive system and breast disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Breast pain
Reproductive system and breast disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypercapnia
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Lung opacity
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Nasal dryness
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Tachypnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Laryngeal haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Respiratory distress
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Onychoclasis
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Skin fissures
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Skin indentation
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Scab
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Onycholysis
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Palmar-plantar erythrodysaesthesia syndrome
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Skin hyperpigmentation
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Nail disorder
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Rosacea
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypotension
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Phlebitis
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypertension
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Peripheral coldness
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Lymphoedema
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Embolism
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hot flush
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Post procedural complication
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Post procedural discharge
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Stoma site haemorrhage
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Post procedural contusion
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Venous injury
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Phimosis
Congenital, familial and genetic disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Adrenal insufficiency
Endocrine disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
The ASTX029 clinical development program was terminated by the sponsor due to the changing treatment landscape.
Participants received ASTX029 40 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
OG008
Phase 1A: Cohort 9 Dose Escalation
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
OG009
Phase 1A: Cohort 10 Dose Escalation
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
OG010
Phase 1A: Cohort 11 Dose Escalation
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
OG011
Phase 1A: Cohort 12 Dose Escalation
Participants received ASTX029 280 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
OG012
Phase 1B Dose Expansion
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
5
OG00410
OG0056
OG0063
OG0073
OG0083
OG0093
OG0107
OG0117
OG01220
0
OG0041
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0111
OG0120
OG002
Phase 1A: Cohort 3 Dose Escalation
Participants received ASTX029 60 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG003
Phase 1A: Cohort 4 Dose Escalation
Participants received ASTX029 120 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG004
Phase 1A: Cohort 5 Dose Escalation
Participants received ASTX029 200 mg, orally, PiB, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG005
Phase 1A: Cohort 6 Dose Escalation
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG006
Phase 1A: Cohort 7 Dose Escalation
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG007
Phase 1A: Cohort 8 Dose Escalation
Participants received ASTX029 40 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
OG008
Phase 1A: Cohort 9 Dose Escalation
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
OG009
Phase 1A: Cohort 10 Dose Escalation
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state
OG010
Phase 1A: Cohort 11 Dose Escalation
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
OG011
Phase 1A: Cohort 12 Dose Escalation
Participants received ASTX029 280 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
OG012
Phase 1B Dose Expansion
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0035
OG00410
OG0056
OG0063
OG0073
OG0083
OG0093
OG0107
OG0117
OG01220
Title
Denominators
Categories
Title
Measurements
OG0003
OG0013
OG0023
OG0035
OG00410
OG0056
OG0063
OG0073
OG0083
OG0093
OG0107
OG0117
OG01220
Participants with KRAS-mutant or KRAS-amplified NSCLC received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
OG002
Phase 2: Cohort C
Participants with BRAF V600-mutant cancers (non-colorectal cancers) received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
OG003
Phase 2: Cohort D
Participants with BRAF-fusion cancers received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
OG004
Phase 2: Cohort E
Participants with gynecological cancers with alterations in the MAPK pathway received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
OG005
Phase 2: Cohort F
Participants with tumors that were characterized by other gene aberrations (that upregulate the MAPK signal pathway) received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
Units
Counts
Participants
OG00032
OG00115
OG00212
OG0039
OG00432
OG00514
Title
Denominators
Categories
Title
Measurements
OG00012.5(4.4 to 26.4)
OG0010(0 to 18.1)
OG0028.3(0.4 to 33.9)
OG0030(0 to 28.3)
OG00412.5(4.4 to 26.4)
OG0057.1(0.4 to 29.7)
OG002
Phase 1A: Cohort 3 Dose Escalation
Participants received ASTX029 60 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG003
Phase 1A: Cohort 4 Dose Escalation
Participants received ASTX029 120 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG004
Phase 1A: Cohort 5 Dose Escalation
Participants received ASTX029 200 mg, orally, PiB, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state
OG005
Phase 1A: Cohort 6 Dose Escalation
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG006
Phase 1A: Cohort 7 Dose Escalation
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG007
Phase 1A: Cohort 8 Dose Escalation
Participants received ASTX029 40 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
OG008
Phase 1A: Cohort 9 Dose Escalation
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
OG009
Phase 1A: Cohort 10 Dose Escalation
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
OG011
Phase 1A: Cohort 12 Dose Escalation
Participants received ASTX029 280 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0035
OG00410
OG0056
OG0063
OG0072
OG0083
OG0095
OG01026
OG0117
Title
Denominators
Categories
Cycle 1 Day 1 (C1D1)
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0035
ParticipantsOG00410
ParticipantsOG0056
ParticipantsOG0063
ParticipantsOG0072
ParticipantsOG0083
ParticipantsOG0093
ParticipantsOG01026
ParticipantsOG0117
Title
Measurements
OG000277± 20.1
OG001361± 222.0
OG0021150± 10.0
OG003
Cycle 2 Day 1 (C2D1)
ParticipantsOG0003
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0034
OG002
Phase 1A: Cohort 3 Dose Escalation
Participants received ASTX029 60 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG003
Phase 1A: Cohort 4 Dose Escalation
Participants received ASTX029 120 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG004
Phase 1A: Cohort 5 Dose Escalation
Participants received ASTX029 200 mg, orally, PiB, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG005
Phase 1A: Cohort 6 Dose Escalation
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG006
Phase 1A: Cohort 7 Dose Escalation
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG007
Phase 1A: Cohort 8 Dose Escalation
Participants received ASTX029 40 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
OG008
Phase 1A: Cohort 9 Dose Escalation
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
OG009
Phase 1A: Cohort 10 Dose Escalation
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
OG011
Phase 1A: Cohort 12 Dose Escalation
Participants received ASTX029 280 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0035
OG00410
OG0056
OG0063
OG0073
OG0083
OG0095
OG01027
OG0117
Title
Denominators
Categories
C1D1
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0035
ParticipantsOG00410
ParticipantsOG0056
ParticipantsOG0063
ParticipantsOG0073
ParticipantsOG0083
ParticipantsOG0093
ParticipantsOG01027
ParticipantsOG0117
Title
Measurements
OG000262± 18.5
OG001347± 215.6
OG0021140± 10.0
OG003
C2D1
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0034
OG002
Phase 1A: Cohort 3 Dose Escalation
Participants received ASTX029 60 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG003
Phase 1A: Cohort 4 Dose Escalation
Participants received ASTX029 120 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG004
Phase 1A: Cohort 5 Dose Escalation
Participants received ASTX029 200 mg, orally, PiB, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG005
Phase 1A: Cohort 6 Dose Escalation
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG006
Phase 1A: Cohort 7 Dose Escalation
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG007
Phase 1A: Cohort 8 Dose Escalation
Participants received ASTX029 40 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
OG008
Phase 1A: Cohort 9 Dose Escalation
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
OG009
Phase 1A: Cohort 10 Dose Escalation
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
OG011
Phase 1A: Cohort 12 Dose Escalation
Participants received ASTX029 280 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0035
OG0049
OG0054
OG0063
OG0072
OG0083
OG0095
OG01025
OG0117
Title
Denominators
Categories
C1D1
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0035
ParticipantsOG0049
ParticipantsOG0054
ParticipantsOG0063
ParticipantsOG0072
ParticipantsOG0083
ParticipantsOG0093
ParticipantsOG01025
ParticipantsOG0117
Title
Measurements
OG000327± 3.6
OG001358± 209.2
OG0021150± 14.1
OG003
C2D1
ParticipantsOG0003
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0033
OG002
Phase 1A: Cohort 3 Dose Escalation
Participants received ASTX029 60 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG003
Phase 1A: Cohort 4 Dose Escalation
Participants received ASTX029 120 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG004
Phase 1A: Cohort 5 Dose Escalation
Participants received ASTX029 200 mg, orally, PiB, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG005
Phase 1A: Cohort 6 Dose Escalation
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG006
Phase 1A: Cohort 7 Dose Escalation
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG007
Phase 1A: Cohort 8 Dose Escalation
Participants received ASTX029 40 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
OG008
Phase 1A: Cohort 9 Dose Escalation
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
OG009
Phase 1A: Cohort 10 Dose Escalation
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
OG011
Phase 1A: Cohort 12 Dose Escalation
Participants received ASTX029 280 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0035
OG00410
OG0056
OG0063
OG0073
OG0083
OG0095
OG01027
OG0117
Title
Denominators
Categories
C1D1
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0035
ParticipantsOG00410
ParticipantsOG0056
ParticipantsOG0063
ParticipantsOG0073
ParticipantsOG0083
ParticipantsOG0095
ParticipantsOG01027
ParticipantsOG0117
Title
Measurements
OG000109± 48.5
OG001217± 165.4
OG002469± 9.5
OG003
C2D1
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0034
Phase 1A: Cohort 3 Dose Escalation
Participants received ASTX029 60 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG003
Phase 1A: Cohort 4 Dose Escalation
Participants received ASTX029 120 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG004
Phase 1A: Cohort 5 Dose Escalation
Participants received ASTX029 200 mg, orally, PiB, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG005
Phase 1A: Cohort 6 Dose Escalation
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG006
Phase 1A: Cohort 7 Dose Escalation
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG007
Phase 1A: Cohort 8 Dose Escalation
Participants received ASTX029 40 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
OG008
Phase 1A: Cohort 9 Dose Escalation
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
OG009
Phase 1A: Cohort 10 Dose Escalation
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
OG011
Phase 1A: Cohort 12 Dose Escalation
Participants received ASTX029 280 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0034
OG0045
OG0054
OG0063
OG0072
OG0083
OG0095
OG01025
OG0113
Title
Denominators
Categories
Title
Measurements
OG0004.38± 86.7
OG0011.45± 173.2
OG00223.4± 127.8
OG00319.3± 149.7
OG00418.1± 39.7
OG0057.88± 79.3
OG00668.1± 128.8
OG0078.68± 64.0
OG00820.1± 114.7
OG00985.3± 206.9
OG010188± 194.3
OG011168± 85.6
OG002
Phase 1A: Cohort 3 Dose Escalation
Participants received ASTX029 60 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG003
Phase 1A: Cohort 4 Dose Escalation
Participants received ASTX029 120 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG004
Phase 1A: Cohort 5 Dose Escalation
Participants received ASTX029 200 mg, orally, PiB, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG005
Phase 1A: Cohort 6 Dose Escalation
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG006
Phase 1A: Cohort 7 Dose Escalation
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG007
Phase 1A: Cohort 8 Dose Escalation
Participants received ASTX029 40 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
OG008
Phase 1A: Cohort 9 Dose Escalation
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
OG009
Phase 1A: Cohort 10 Dose Escalation
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
OG011
Phase 1a: Cohort 12
Phase 1A: Cohort 12 Dose Escalation Participants received ASTX029 280 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0035
OG00410
OG0056
OG0063
OG0073
OG0083
OG0095
OG01027
OG0117
Title
Denominators
Categories
C1D1
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0035
ParticipantsOG00410
ParticipantsOG0056
ParticipantsOG0063
ParticipantsOG0073
ParticipantsOG0083
ParticipantsOG0093
ParticipantsOG01027
ParticipantsOG0117
Title
Measurements
OG0001.08(0.57 to 3.05)
OG0010.50(0.50 to 0.58)
OG0020.55(0.47 to 0.97)
OG003
C2D1
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0034
OG002
Phase 1A: Cohort 3 Dose Escalation
Participants received ASTX029 60 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG003
Phase 1A: Cohort 4 Dose Escalation
Participants received ASTX029 120 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG004
Phase 1A: Cohort 5 Dose Escalation
Participants received ASTX029 200 mg, orally, PiB, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG005
Phase 1A: Cohort 6 Dose Escalation
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG006
Phase 1A: Cohort 7 Dose Escalation
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG007
Phase 1A: Cohort 8 Dose Escalation
Participants received ASTX029 40 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
OG008
Phase 1A: Cohort 9 Dose Escalation
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
OG009
Phase 1A: Cohort 10 Dose Escalation
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
OG011
Phase 1A: Cohort 12 Dose Escalation
Participants received ASTX029 280 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0035
OG0049
OG0054
OG0063
OG0072
OG0083
OG0095
OG01025
OG0117
Title
Denominators
Categories
C1D1
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0035
ParticipantsOG0049
ParticipantsOG0054
ParticipantsOG0063
ParticipantsOG0072
ParticipantsOG0083
ParticipantsOG0093
ParticipantsOG01025
ParticipantsOG0117
Title
Measurements
OG0002.42± 42.1
OG0011.63± 18.7
OG0024.42± 1.8
OG003
C2D1
ParticipantsOG0003
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0033
Phase 1A: Cohort 7 Dose Escalation
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG002
Phase 1A: Cohort 9 Dose Escalation
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
OG003
Phase 1A: Cohort 10 Dose Escalation
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
Units
Counts
Participants
OG0006
OG0013
OG0023
OG0035
Title
Denominators
Categories
C1D1
ParticipantsOG0006
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
Title
Measurements
OG0001810± 126.9
OG0013360± 140.4
OG0026500± 64.3
OG003
C2D1
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0035
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
OG002
Comparison of effect of food on AUC0-24 between Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029 in C1D1.
Geometric Least Squares Mean (Geo LSM)
27.8
2-Sided
90
8.50
91.2
Ratio of Geo LSM was calculated for Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029.
Superiority
OG000
OG002
Comparison of effect of food on AUC0-24 between Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029 in C2D1.
Geo LSM
38.8
2-Sided
90
11.4
132
Ratio of Geo LSM was calculated for Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029.
Superiority
OG001
OG003
Comparison of effect of food on AUC0-24 between Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029 in C1D1.
Geo LSM
58.9
2-Sided
90
15.7
222
Ratio of Geo LSM was calculated for Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029.
Superiority
OG001
OG003
Comparison of effect of food on AUC0-24 between Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029 in C2D1.
Geo LSM
47.2
2-Sided
90
20.7
108
Ratio of Geo LSM was calculated for Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029.
Superiority
Phase 1A: Cohort 7 Dose Escalation
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG002
Phase 1A: Cohort 9 Dose Escalation
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
OG003
Phase 1A: Cohort 10 Dose Escalation
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
Units
Counts
Participants
OG0004
OG0013
OG0023
OG0035
Title
Denominators
Categories
C1D1
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
Title
Measurements
OG0001180± 112.9
OG0013390± 139.3
OG0026520± 66.6
OG003
C2D1
ParticipantsOG0004
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0035
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
OG002
Comparison of effect of food on AUC0-inf between Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029 in C1D1.
Geo LSM
18.1
2-Sided
90
5.28
61.9
Ratio of Geo LSM was calculated for Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029.
Superiority
OG000
OG002
Comparison of effect of food on AUC0-inf between Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029 in C2D1.
Geo LSM
44.1
2-Sided
90
8.32
234
Ratio of Geo LSM was calculated for Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029.
Superiority
OG001
OG003
Comparison of effect of food on AUC0-inf between Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029 in C1D1.
Geo LSM
58.7
2-Sided
90
15.7
220
Ratio of Geo LSM was calculated for Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029.
Superiority
OG001
OG003
Comparison of effect of food on AUC0-inf between Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029 in C2D1.
Geo LSM
40.2
2-Sided
90
14.3
113
Ratio of Geo LSM was calculated for Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029.
Superiority
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG002
Phase 1A: Cohort 9 Dose Escalation
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
OG003
Phase 1A: Cohort 10 Dose Escalation
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
Units
Counts
Participants
OG0006
OG0013
OG0023
OG0035
Title
Denominators
Categories
C1D1
ParticipantsOG0006
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
Title
Measurements
OG000496± 127.7
OG0011490± 141.7
OG0022840± 30.8
OG003
C2D1
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0035
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
OG002
Comparison of effect of food on Cmax between Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029 in C1D1.
Geo LSM
17.5
2-Sided
90
5.62
54.3
Ratio of Geo LSM was calculated for Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029.
Superiority
OG000
OG002
Comparison of effect of food on Cmax between Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029 in C2D1.
Geo LSM
34.5
2-Sided
90
12.0
99.4
Ratio of Geo LSM was calculated for Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029.
Superiority
OG001
OG003
Comparison of effect of food on Cmax between Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029 in C1D1.
Geo LSM
72.6
2-Sided
90
17.6
299
Ratio of Geo LSM was calculated for Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029.
Superiority
OG001
OG003
Comparison of effect of food on Cmax between Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029 in C1D1.
Geo LSM
72.5
2-Sided
90
29.1
181
Ratio of Geo LSM was calculated for Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029.
Superiority
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG002
Phase 1A: Cohort 9 Dose Escalation
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
OG003
Phase 1A: Cohort 10 Dose Escalation
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
Units
Counts
Participants
OG0006
OG0013
OG0023
OG0035
Title
Denominators
Categories
C1D1
ParticipantsOG0006
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
Title
Measurements
OG0003.03(1.08 to 5.73)
OG0011.00(0.98 to 3.00)
OG0021.00(0.47 to 1.88)
OG003
C2D1
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0035
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
OG002
Comparison of effect of food on Tmax between Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029 in C1D1.
Wilcoxon (Mann-Whitney)
0.0388671
Hodges-Lehmann Estimator
-2.275
2-Sided
90
-5.2160
-0.0830
The Hodges-Lehmann estimator and 90% confidence interval (CI) was calculated using the Moses approximation.
Superiority
OG000
OG002
Comparison of effect of food on Tmax between Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029 in C2D1.
Wilcoxon (Mann-Whitney)
0.4795001
Hodges-Lehmann Estimator
1.45
2-Sided
90
-0.9170
5.1500
The Hodges-Lehmann estimator and 90% CI was calculated using the Moses approximation.
Superiority
OG001
OG003
Comparison of effect of food on Tmax between Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029 in C1D1.
Wilcoxon (Mann-Whitney)
0.8272593
Hodges-Lehmann Estimator
-0.45
2-Sided
90
-2.4670
0.9500
The Hodges-Lehmann estimator and 90% CI was calculated using the Moses approximation.
Superiority
OG001
OG003
Comparison of effect of food on Tmax between Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029 in C2D1.
Wilcoxon (Mann-Whitney)
0.5126908
Hodges-Lehmann Estimator
0.583
2-Sided
90
-6.4500
3.5000
The Hodges-Lehmann estimator and 90% CI was calculated using the Moses approximation.
Superiority
OG0008
Title
Denominators
Categories
Title
Measurements
OG000181.6± 172.31
OG003
Phase 1A: Cohort 4 Dose Escalation
Participants received ASTX029 120 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG004
Phase 1A: Cohort 5 Dose Escalation
Participants received ASTX029 200 mg, orally, PiB, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG005
Phase 1A: Cohort 6 Dose Escalation
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG006
Phase 1A: Cohort 7 Dose Escalation
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG007
Phase 1A: Cohort 8 Dose Escalation
Participants received ASTX029 40 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
OG008
Phase 1A: Cohort 9 Dose Escalation
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
OG009
Phase 1A: Cohort 10 Dose Escalation
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
OG010
Phase 1A: Cohort 11 Dose Escalation
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
OG011
Phase 1A: Cohort 12 Dose Escalation
Participants received ASTX029 280 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
OG012
Phase 1B Dose Expansion
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0035
OG00410
OG0056
OG0063
OG0073
OG0083
OG0093
OG0107
OG0117
OG01220
Title
Denominators
Categories
Title
Measurements
OG0001.3(1.2 to NA)Upper limit of 95% CI was not estimable because there was no event time for which the upper bound of the CI for the Kaplan-Meier estimate was less than 0.5.
OG0011.2(1.2 to NA)Upper limit of 95% CI was not estimable because there was no event time for which the upper bound of the CI for the Kaplan-Meier estimate was less than 0.5.
OG0028.1(2.7 to NA)Upper limit of 95% CI was not estimable because there was no event time for which the upper bound of the CI for the Kaplan-Meier estimate was less than 0.5.
OG0032.0(1.1 to NA)Upper limit of 95% CI was not estimable because there was no event time for which the upper bound of the CI for the Kaplan-Meier estimate was less than 0.5.
OG0041.2(0.2 to 4.8)
OG0051.3(0.9 to NA)Upper limit of 95% CI was not estimable because there was no event time for which the upper bound of the CI for the Kaplan-Meier estimate was less than 0.5.
OG0063.0(1.2 to NA)Upper limit of 95% CI was not estimable because there was no event time for which the upper bound of the CI for the Kaplan-Meier estimate was less than 0.5.
OG0071.1(1.0 to NA)Upper limit of 95% CI was not estimable because there was no event time for which the upper bound of the CI for the Kaplan-Meier estimate was less than 0.5.
OG0081.3(1.0 to NA)Upper limit of 95% CI was not estimable because there was no event time for which the upper bound of the CI for the Kaplan-Meier estimate was less than 0.5.
OG0092.3(1.4 to NA)Upper limit of 95% CI was not estimable because there was no event time for which the upper bound of the CI for the Kaplan-Meier estimate was less than 0.5.
OG0103.0(0.7 to NA)Upper limit of 95% CI was not estimable because there was no event time for which the upper bound of the CI for the Kaplan-Meier estimate was less than 0.5.
OG0112.5(0.4 to 4.0)
OG0121.4(1.2 to 4.2)
OG003
Phase 1A: Cohort 4 Dose Escalation
Participants received ASTX029 120 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG004
Phase 1A: Cohort 5 Dose Escalation
Participants received ASTX029 200 mg, orally, PiB, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG005
Phase 1A: Cohort 6 Dose Escalation
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG006
Phase 1A: Cohort 7 Dose Escalation
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG007
Phase 1A: Cohort 8 Dose Escalation
Participants received ASTX029 40 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
OG008
Phase 1A: Cohort 9 Dose Escalation
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
OG009
Phase 1A: Cohort 10 Dose Escalation
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
OG010
Phase 1A: Cohort 11 Dose Escalation
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
OG011
Phase 1A: Cohort 12 Dose Escalation
Participants received ASTX029 280 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
OG012
Phase 1B Dose Expansion
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0035
OG00410
OG0056
OG0063
OG0073
OG0083
OG0093
OG0107
OG0117
OG01220
Title
Denominators
Categories
Title
Measurements
OG00013.5(4.4 to NA)Upper limit of 95% CI was not estimable because there was no event time for which the upper bound of the CI for the Kaplan-Meier estimate was less than 0.5.
OG0014.5(3.4 to NA)Upper limit of 95% CI was not estimable because there was no event time for which the upper bound of the CI for the Kaplan-Meier estimate was less than 0.5.
OG00210.2(4.1 to NA)Upper limit of 95% CI was not estimable because there was no event time for which the upper bound of the CI for the Kaplan-Meier estimate was less than 0.5.
OG0033.8(2.1 to NA)Upper limit of 95% CI was not estimable because there was no event time for which the upper bound of the CI for the Kaplan-Meier estimate was less than 0.5.
OG0042.1(0.5 to 25.5)
OG00511.3(4.8 to NA)Upper limit of 95% CI was not estimable because there was no event time for which the upper bound of the CI for the Kaplan-Meier estimate was less than 0.5.
OG0068.7(2.6 to NA)Upper limit of 95% CI was not estimable because there was no event time for which the upper bound of the CI for the Kaplan-Meier estimate was less than 0.5.
OG0072.0(1.1 to NA)Upper limit of 95% CI was not estimable because there was no event time for which the upper bound of the CI for the Kaplan-Meier estimate was less than 0.5.
OG00810.9(1.3 to NA)Upper limit of 95% CI was not estimable because there was no event time for which the upper bound of the CI for the Kaplan-Meier estimate was less than 0.5.
OG009NA(NA to NA)Median was not reached. The lower limit and upper limit of 95% CI was not estimable because there was no event time for which the upper bound of the CI for the Kaplan-Meier estimate was less than 0.5.
OG01014.8(2.7 to NA)Upper limit of 95% CI was not estimable because there was no event time for which the upper bound of the CI for the Kaplan-Meier estimate was less than 0.5.
OG0112.5(1.2 to 13.1)
OG01215.1(2.7 to 26.3)
Phase 1A: Cohort 2 Dose Escalation
Participants received ASTX029 20 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG002
Phase 1A: Cohort 3 Dose Escalation
Participants received ASTX029 60 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG003
Phase 1A: Cohort 4 Dose Escalation
Participants received ASTX029 120 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG004
Phase 1A: Cohort 5 Dose Escalation
Participants received ASTX029 200 mg, orally, PiB, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG005
Phase 1A: Cohort 6 Dose Escalation
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG006
Phase 1A: Cohort 7 Dose Escalation
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG007
Phase 1A: Cohort 8 Dose Escalation
Participants received ASTX029 40 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
OG008
Phase 1A: Cohort 9 Dose Escalation
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
OG009
Phase 1A: Cohort 10 Dose Escalation
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
OG010
Phase 1A: Cohort 11 Dose Escalation
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
OG011
Phase 1A: Cohort 12 Dose Escalation
Participants received ASTX029 280 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
OG012
Phase 1B Dose Expansion
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0035
OG00410
OG0056
OG0063
OG0073
OG0083
OG0093
OG0107
OG0117
OG01220
Title
Denominators
Categories
Title
Measurements
OG0000(0 to 63.2)
OG0010(0 to 63.2)
OG002100(36.8 to 100)
OG00340.0(7.6 to 81.1)
OG00420.0(3.7 to 50.7)
OG00516.7(0.9 to 58.2)
OG00666.7(13.5 to 98.3)
OG00733.3(1.7 to 86.5)
OG00833.3(1.7 to 86.5)
OG00933.3(1.7 to 86.5)
OG01085.7(47.9 to 99.3)
OG01142.9(12.9 to 77.5)
OG01230.0(14 to 50.8)
Phase 1A: Cohort 3 Dose Escalation
Participants received ASTX029 60 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state
OG003
Phase 1A: Cohort 4 Dose Escalation
Participants received ASTX029 120 mg, PiB, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG004
Phase 1A: Cohort 5 Dose Escalation
Participants received ASTX029 200 mg, orally, PiB, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG005
Phase 1A: Cohort 6 Dose Escalation
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG006
Phase 1A: Cohort 7 Dose Escalation
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fed state.
OG007
Phase 1A: Cohort 8 Dose Escalation
Participants received ASTX029 40 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
OG008
Phase 1A: Cohort 9 Dose Escalation
Participants received ASTX029 80 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
OG009
Phase 1A: Cohort 10 Dose Escalation
Participants received ASTX029 120 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
OG010
Phase 1A: Cohort 11 Dose Escalation
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
OG011
Phase 1A: Cohort 12 Dose Escalation
Participants received ASTX029 280 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
OG012
Phase 1B Dose Expansion
Participants received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months, under fasted state.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0091
OG0101
OG0110
OG0122
Title
Denominators
Categories
Title
Measurements
OG009484.0(484.0 to 484.0)
OG01061.0(61.0 to 61.00)
OG012252.50(252.0 to 253.0)
OG003
Phase 2: Cohort D
Participants with BRAF-fusion cancers received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
OG004
Phase 2: Cohort E
Participants with gynecological cancers with alterations in the MAPK pathway received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
OG005
Phase 2: Cohort F
Participants with tumors that were characterized by other gene aberrations (that upregulate the MAPK signal pathway) received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
Units
Counts
Participants
OG00024
OG00113
OG0029
OG0039
OG00428
OG00512
Title
Denominators
Categories
C1D1
ParticipantsOG00024
ParticipantsOG00113
ParticipantsOG0029
ParticipantsOG0039
ParticipantsOG00428
ParticipantsOG00512
Title
Measurements
OG00012200± 69.1
OG00113000± 57.2
OG0029570± 80.3
OG003
Cycle 3 Day 1 (C3D1)
ParticipantsOG00015
ParticipantsOG0014
ParticipantsOG0021
ParticipantsOG0034
OG003
Phase 2: Cohort D
Participants with BRAF-fusion cancers received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
OG004
Phase 2: Cohort E
Participants with gynecological cancers with alterations in the MAPK pathway received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
OG005
Phase 2: Cohort F
Participants with tumors that were characterized by other gene aberrations (that upregulate the MAPK signal pathway) received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
Units
Counts
Participants
OG00032
OG00115
OG00212
OG0039
OG00432
OG00514
Title
Denominators
Categories
C1D1
ParticipantsOG00032
ParticipantsOG00115
ParticipantsOG00212
ParticipantsOG0039
ParticipantsOG00432
ParticipantsOG00514
Title
Measurements
OG00012300± 70.4
OG00115000± 68.5
OG0027800± 81.7
OG003
C3D1
ParticipantsOG00019
ParticipantsOG0017
ParticipantsOG0025
ParticipantsOG0035
OG003
Phase 2: Cohort D
Participants with BRAF-fusion cancers received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
OG004
Phase 2: Cohort E
Participants with gynecological cancers with alterations in the MAPK pathway received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
OG005
Phase 2: Cohort F
Participants with tumors that were characterized by other gene aberrations (that upregulate the MAPK signal pathway) received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
Units
Counts
Participants
OG00028
OG00113
OG0026
OG0037
OG00430
OG00513
Title
Denominators
Categories
Title
Measurements
OG00012500± 66.6
OG00117100± 60.4
OG00210700± 103.0
OG00311800± 62.5
OG00412500± 74.5
OG00513300± 67.5
OG003
Phase 2: Cohort D
Participants with BRAF-fusion cancers received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
OG004
Phase 2: Cohort E
Participants with gynecological cancers with alterations in the MAPK pathway received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
OG005
Phase 2: Cohort F
Participants with tumors that were characterized by other gene aberrations (that upregulate the MAPK signal pathway) received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
Units
Counts
Participants
OG00032
OG00115
OG00212
OG0039
OG00432
OG00514
Title
Denominators
Categories
C1D1
ParticipantsOG00032
ParticipantsOG00115
ParticipantsOG00212
ParticipantsOG0039
ParticipantsOG00432
ParticipantsOG00514
Title
Measurements
OG0004430± 70.9
OG0015930± 81.3
OG0022890± 97.7
OG003
C3D1
ParticipantsOG00019
ParticipantsOG0017
ParticipantsOG0025
ParticipantsOG0035
OG003
Phase 2: Cohort D
Participants with BRAF-fusion cancers received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
OG004
Phase 2: Cohort E
Participants with gynecological cancers with alterations in the MAPK pathway received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
OG005
Phase 2: Cohort F
Participants with tumors that were characterized by other gene aberrations (that upregulate the MAPK signal pathway) received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
Units
Counts
Participants
OG00019
OG0017
OG0025
OG0035
OG00420
OG0055
Title
Denominators
Categories
Title
Measurements
OG000189± 181.0
OG001260± 95.5
OG00281.7± 102.0
OG003144± 78.2
OG004205± 104.9
OG005246± 67.6
OG003
Phase 2: Cohort D
Participants with BRAF-fusion cancers received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
OG004
Phase 2: Cohort E
Participants with gynecological cancers with alterations in the MAPK pathway received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
OG005
Phase 2: Cohort F
Participants with tumors that were characterized by other gene aberrations (that upregulate the MAPK signal pathway) received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
Units
Counts
Participants
OG00032
OG00115
OG00212
OG0039
OG00432
OG00514
Title
Denominators
Categories
C1D1
ParticipantsOG00032
ParticipantsOG00115
ParticipantsOG00212
ParticipantsOG0039
ParticipantsOG00432
ParticipantsOG00514
Title
Measurements
OG0002.03(0.50 to 4.08)
OG0011.95(0.95 to 6.08)
OG0022.90(0.50 to 7.55)
OG003
C3D1
ParticipantsOG00019
ParticipantsOG0017
ParticipantsOG0025
ParticipantsOG0035
OG003
Phase 2: Cohort D
Participants with BRAF-fusion cancers received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
OG004
Phase 2: Cohort E
Participants with gynecological cancers with alterations in the MAPK pathway received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
OG005
Phase 2: Cohort F
Participants with tumors that were characterized by other gene aberrations (that upregulate the MAPK signal pathway) received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
Units
Counts
Participants
OG00028
OG00113
OG0026
OG0037
OG00430
OG00513
Title
Denominators
Categories
Title
Measurements
OG0002.68± 68.8
OG0013.45± 52.0
OG0023.79± 19.1
OG0033.73± 12.2
OG0043.64± 43.2
OG0053.39± 48.2
OG003
Phase 2: Cohort D
Participants with BRAF-fusion cancers received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
OG004
Phase 2: Cohort E
Participants with gynecological cancers with alterations in the MAPK pathway received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
OG005
Phase 2: Cohort F
Participants with tumors that were characterized by other gene aberrations (that upregulate the MAPK signal pathway) received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
Units
Counts
Participants
OG00032
OG00115
OG00212
OG0039
OG00432
OG00514
Title
Denominators
Categories
Title
Measurements
OG0002.8(1.5 to 5.5)
OG0012.8(0.9 to 4.6)
OG0021.7(0.8 to 6.1)
OG0038.0(1.0 to 9.6)
OG0043.5(2.2 to 6.2)
OG0052.0(1.2 to 5.5)
OG003
Phase 2: Cohort D
Participants with BRAF-fusion cancers received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
OG004
Phase 2: Cohort E
Participants with gynecological cancers with alterations in the MAPK pathway received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
OG005
Phase 2: Cohort F
Participants with tumors that were characterized by other gene aberrations (that upregulate the MAPK signal pathway) received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
Units
Counts
Participants
OG00032
OG00115
OG00212
OG0039
OG00432
OG00514
Title
Denominators
Categories
Title
Measurements
OG0008.0(4.4 to 13.6)
OG0014.9(1.5 to 10.1)
OG0026.1(1.1 to 19.3)
OG00311.6(2.0 to NA)Upper limit of 95% CI was not estimable because there was no event time for which the upper bound of the CI for the Kaplan-Meier estimate was less than 0.5.
OG00411.2(6.8 to NA)Upper limit of 95% CI was not estimable because there was no event time for which the upper bound of the CI for the Kaplan-Meier estimate was less than 0.5.
OG0059.9(3.5 to 15.9)
Participants with KRAS-mutant or KRAS-amplified NSCLC received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
OG002
Phase 2: Cohort C
Participants with BRAF V600-mutant cancers (non-colorectal cancers) received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
OG003
Phase 2: Cohort D
Participants with BRAF-fusion cancers received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
OG004
Phase 2: Cohort E
Participants with gynecological cancers with alterations in the MAPK pathway received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
OG005
Phase 2: Cohort F
Participants with tumors that were characterized by other gene aberrations (that upregulate the MAPK signal pathway) received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
Units
Counts
Participants
OG00032
OG00115
OG00212
OG0039
OG00432
OG00514
Title
Denominators
Categories
Title
Measurements
OG00065.6(49.6 to 79.4)
OG00160.0(36 to 80.9)
OG00241.7(18.1 to 68.5)
OG00377.8(45 to 95.9)
OG00468.8(52.8 to 82)
OG00542.9(20.6 to 67.5)
Phase 2: Cohort C
Participants with BRAF V600-mutant cancers (non-colorectal cancers) received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
OG003
Phase 2: Cohort D
Participants with BRAF-fusion cancers received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
OG004
Phase 2: Cohort E
Participants with gynecological cancers with alterations in the MAPK pathway received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
OG005
Phase 2: Cohort F
Participants with tumors that were characterized by other gene aberrations (that upregulate the MAPK signal pathway) received ASTX029 200 mg, tablets, orally, once daily, on Days 1-21 of each 21-day cycle, up to median duration of 1.6 months.
Units
Counts
Participants
OG0004
OG0010
OG0021
OG0030
OG0044
OG0051
Title
Denominators
Categories
Title
Measurements
OG000193.00(65.0 to 219.0)
OG002144.00(144.00 to 144.00)
OG004189.50(102.0 to 260.0)
OG005750.00(750.00 to 750.00)
0 affected
5 at risk
EG0040 affected10 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected7 at risk
EG0110 affected7 at risk
EG0120 affected20 at risk
EG0130 affected32 at risk
EG0141 affected15 at risk
EG0150 affected12 at risk
EG0160 affected9 at risk
EG0170 affected32 at risk
EG0180 affected14 at risk
0 affected
5 at risk
EG0041 affected10 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected7 at risk
EG0110 affected7 at risk
EG0120 affected20 at risk
EG0130 affected32 at risk
EG0140 affected15 at risk
EG0150 affected12 at risk
EG0160 affected9 at risk
EG0170 affected32 at risk
EG0180 affected14 at risk
0 affected
5 at risk
EG0040 affected10 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected7 at risk
EG0110 affected7 at risk
EG0120 affected20 at risk
EG0130 affected32 at risk
EG0141 affected15 at risk
EG0150 affected12 at risk
EG0160 affected9 at risk
EG0170 affected32 at risk
EG0180 affected14 at risk
0 affected
5 at risk
EG0041 affected10 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected7 at risk
EG0110 affected7 at risk
EG0120 affected20 at risk
EG0130 affected32 at risk
EG0140 affected15 at risk
EG0150 affected12 at risk
EG0160 affected9 at risk
EG0170 affected32 at risk
EG0180 affected14 at risk
0 affected
5 at risk
EG0041 affected10 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected7 at risk
EG0110 affected7 at risk
EG0120 affected20 at risk
EG0130 affected32 at risk
EG0140 affected15 at risk
EG0151 affected12 at risk
EG0160 affected9 at risk
EG0170 affected32 at risk
EG0180 affected14 at risk
1 affected
5 at risk
EG0040 affected10 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected7 at risk
EG0110 affected7 at risk
EG0120 affected20 at risk
EG0130 affected32 at risk
EG0140 affected15 at risk
EG0150 affected12 at risk
EG0160 affected9 at risk
EG0171 affected32 at risk
EG0180 affected14 at risk
0 affected
5 at risk
EG0040 affected10 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected7 at risk
EG0111 affected7 at risk
EG0120 affected20 at risk
EG0130 affected32 at risk
EG0140 affected15 at risk
EG0150 affected12 at risk
EG0160 affected9 at risk
EG0170 affected32 at risk
EG0180 affected14 at risk
0 affected
5 at risk
EG0040 affected10 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected7 at risk
EG0111 affected7 at risk
EG0120 affected20 at risk
EG0130 affected32 at risk
EG0140 affected15 at risk
EG0150 affected12 at risk
EG0160 affected9 at risk
EG0170 affected32 at risk
EG0180 affected14 at risk
0 affected
5 at risk
EG0040 affected10 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0081 affected3 at risk
EG0090 affected3 at risk
EG0100 affected7 at risk
EG0110 affected7 at risk
EG0120 affected20 at risk
EG0130 affected32 at risk
EG0140 affected15 at risk
EG0150 affected12 at risk
EG0160 affected9 at risk
EG0171 affected32 at risk
EG0180 affected14 at risk
0 affected
5 at risk
EG0040 affected10 at risk
EG0050 affected6 at risk
EG0061 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected7 at risk
EG0110 affected7 at risk
EG0120 affected20 at risk
EG0131 affected32 at risk
EG0140 affected15 at risk
EG0150 affected12 at risk
EG0160 affected9 at risk
EG0170 affected32 at risk
EG0180 affected14 at risk
0 affected
5 at risk
EG0040 affected10 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected7 at risk
EG0110 affected7 at risk
EG0121 affected20 at risk
EG0130 affected32 at risk
EG0140 affected15 at risk
EG0150 affected12 at risk
EG0160 affected9 at risk
EG0170 affected32 at risk
EG0180 affected14 at risk
0 affected
5 at risk
EG0040 affected10 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected7 at risk
EG0110 affected7 at risk
EG0121 affected20 at risk
EG0131 affected32 at risk
EG0140 affected15 at risk
EG0150 affected12 at risk
EG0160 affected9 at risk
EG0170 affected32 at risk
EG0180 affected14 at risk
0 affected
5 at risk
EG0040 affected10 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected7 at risk
EG0110 affected7 at risk
EG0121 affected20 at risk
EG0130 affected32 at risk
EG0141 affected15 at risk
EG0150 affected12 at risk
EG0160 affected9 at risk
EG0170 affected32 at risk
EG0180 affected14 at risk
0 affected
5 at risk
EG0040 affected10 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected7 at risk
EG0110 affected7 at risk
EG0121 affected20 at risk
EG0131 affected32 at risk
EG0141 affected15 at risk
EG0150 affected12 at risk
EG0160 affected9 at risk
EG0171 affected32 at risk
EG0180 affected14 at risk
0 affected
5 at risk
EG0040 affected10 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected7 at risk
EG0110 affected7 at risk
EG0120 affected20 at risk
EG0132 affected32 at risk
EG0140 affected15 at risk
EG0150 affected12 at risk
EG0160 affected9 at risk
EG0170 affected32 at risk
EG0181 affected14 at risk
0 affected
5 at risk
EG0040 affected10 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected7 at risk
EG0110 affected7 at risk
EG0120 affected20 at risk
EG0130 affected32 at risk
EG0140 affected15 at risk
EG0150 affected12 at risk
EG0161 affected9 at risk
EG0170 affected32 at risk
EG0180 affected14 at risk
0 affected
5 at risk
EG0040 affected10 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected7 at risk
EG0110 affected7 at risk
EG0120 affected20 at risk
EG0130 affected32 at risk
EG0140 affected15 at risk
EG0150 affected12 at risk
EG0160 affected9 at risk
EG0171 affected32 at risk
EG0180 affected14 at risk
0 affected
5 at risk
EG0040 affected10 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected7 at risk
EG0110 affected7 at risk
EG0120 affected20 at risk
EG0130 affected32 at risk
EG0140 affected15 at risk
EG0150 affected12 at risk
EG0160 affected9 at risk
EG0170 affected32 at risk
EG0181 affected14 at risk
0 affected
5 at risk
EG0040 affected10 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected7 at risk
EG0110 affected7 at risk
EG0120 affected20 at risk
EG0131 affected32 at risk
EG0140 affected15 at risk
EG0150 affected12 at risk
EG0160 affected9 at risk
EG0170 affected32 at risk
EG0180 affected14 at risk
0 affected
5 at risk
EG0040 affected10 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected7 at risk
EG0110 affected7 at risk
EG0120 affected20 at risk
EG0130 affected32 at risk
EG0140 affected15 at risk
EG0150 affected12 at risk
EG0160 affected9 at risk
EG0171 affected32 at risk
EG0180 affected14 at risk
0 affected
5 at risk
EG0040 affected10 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected7 at risk
EG0110 affected7 at risk
EG0120 affected20 at risk
EG0131 affected32 at risk
EG0140 affected15 at risk
EG0150 affected12 at risk
EG0160 affected9 at risk
EG0170 affected32 at risk
EG0180 affected14 at risk
0 affected
5 at risk
EG0041 affected10 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected7 at risk
EG0110 affected7 at risk
EG0120 affected20 at risk
EG0130 affected32 at risk
EG0140 affected15 at risk
EG0150 affected12 at risk
EG0160 affected9 at risk
EG0170 affected32 at risk
EG0180 affected14 at risk
0 affected
5 at risk
EG0040 affected10 at risk
EG0050 affected6 at risk
EG0061 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected7 at risk
EG0110 affected7 at risk
EG0120 affected20 at risk
EG0130 affected32 at risk
EG0140 affected15 at risk
EG0150 affected12 at risk
EG0160 affected9 at risk
EG0170 affected32 at risk
EG0180 affected14 at risk
0 affected
5 at risk
EG0040 affected10 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected7 at risk
EG0110 affected7 at risk
EG0120 affected20 at risk
EG0130 affected32 at risk
EG0141 affected15 at risk
EG0150 affected12 at risk
EG0160 affected9 at risk
EG0171 affected32 at risk
EG0180 affected14 at risk
0 affected
5 at risk
EG0040 affected10 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected7 at risk
EG0110 affected7 at risk
EG0120 affected20 at risk
EG0130 affected32 at risk
EG0141 affected15 at risk
EG0150 affected12 at risk
EG0160 affected9 at risk
EG0170 affected32 at risk
EG0180 affected14 at risk
0 affected
5 at risk
EG0040 affected10 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected7 at risk
EG0110 affected7 at risk
EG0120 affected20 at risk
EG0130 affected32 at risk
EG0140 affected15 at risk
EG0150 affected12 at risk
EG0160 affected9 at risk
EG0171 affected32 at risk
EG0180 affected14 at risk
0 affected
5 at risk
EG0040 affected10 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected7 at risk
EG0110 affected7 at risk
EG0120 affected20 at risk
EG0131 affected32 at risk
EG0140 affected15 at risk
EG0150 affected12 at risk
EG0160 affected9 at risk
EG0170 affected32 at risk
EG0180 affected14 at risk
0 affected
5 at risk
EG0044 affected10 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected7 at risk
EG0110 affected7 at risk
EG0120 affected20 at risk
EG0131 affected32 at risk
EG0141 affected15 at risk
EG0150 affected12 at risk
EG0160 affected9 at risk
EG0170 affected32 at risk
EG0180 affected14 at risk
0 affected
5 at risk
EG0040 affected10 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected7 at risk
EG0110 affected7 at risk
EG0120 affected20 at risk
EG0130 affected32 at risk
EG0140 affected15 at risk
EG0150 affected12 at risk
EG0160 affected9 at risk
EG0170 affected32 at risk
EG0180 affected14 at risk
1 affected
5 at risk
EG0040 affected10 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected7 at risk
EG0110 affected7 at risk
EG0120 affected20 at risk
EG0130 affected32 at risk
EG0140 affected15 at risk
EG0150 affected12 at risk
EG0160 affected9 at risk
EG0171 affected32 at risk
EG0180 affected14 at risk
1 affected
5 at risk
EG0040 affected10 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected7 at risk
EG0110 affected7 at risk
EG0120 affected20 at risk
EG0130 affected32 at risk
EG0140 affected15 at risk
EG0150 affected12 at risk
EG0160 affected9 at risk
EG0170 affected32 at risk
EG0180 affected14 at risk
0 affected
5 at risk
EG0040 affected10 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0101 affected7 at risk
EG0111 affected7 at risk
EG0120 affected20 at risk
EG0132 affected32 at risk
EG0140 affected15 at risk
EG0150 affected12 at risk
EG0160 affected9 at risk
EG0170 affected32 at risk
EG0180 affected14 at risk
0 affected
5 at risk
EG0040 affected10 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected7 at risk
EG0111 affected7 at risk
EG0120 affected20 at risk
EG0130 affected32 at risk
EG0140 affected15 at risk
EG0150 affected12 at risk
EG0160 affected9 at risk
EG0170 affected32 at risk
EG0180 affected14 at risk
0 affected
5 at risk
EG0040 affected10 at risk
EG0051 affected6 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected7 at risk
EG0110 affected7 at risk
EG0120 affected20 at risk
EG0130 affected32 at risk
EG0140 affected15 at risk
EG0150 affected12 at risk
EG0160 affected9 at risk
EG0170 affected32 at risk
EG0180 affected14 at risk
0 affected
5 at risk
EG0040 affected10 at risk
EG0050 affected6 at risk
EG0061 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected7 at risk
EG0110 affected7 at risk
EG0120 affected20 at risk
EG0130 affected32 at risk
EG0140 affected15 at risk
EG0150 affected12 at risk
EG0161 affected9 at risk
EG0171 affected32 at risk
EG0180 affected14 at risk
0 affected
5 at risk
EG0040 affected10 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected7 at risk
EG0110 affected7 at risk
EG0120 affected20 at risk
EG0130 affected32 at risk
EG0140 affected15 at risk
EG0150 affected12 at risk
EG0160 affected9 at risk
EG0171 affected32 at risk
EG0180 affected14 at risk
0 affected
5 at risk
EG0040 affected10 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected7 at risk
EG0110 affected7 at risk
EG0120 affected20 at risk
EG0130 affected32 at risk
EG0140 affected15 at risk
EG0150 affected12 at risk
EG0161 affected9 at risk
EG0170 affected32 at risk
EG0180 affected14 at risk
0 affected
5 at risk
EG0040 affected10 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected7 at risk
EG0110 affected7 at risk
EG0120 affected20 at risk
EG0130 affected32 at risk
EG0140 affected15 at risk
EG0150 affected12 at risk
EG0160 affected9 at risk
EG0171 affected32 at risk
EG0180 affected14 at risk
0 affected
5 at risk
EG0040 affected10 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected7 at risk
EG0110 affected7 at risk
EG0120 affected20 at risk
EG0131 affected32 at risk
EG0140 affected15 at risk
EG0150 affected12 at risk
EG0160 affected9 at risk
EG0170 affected32 at risk
EG0180 affected14 at risk
0 affected
5 at risk
EG0041 affected10 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected7 at risk
EG0110 affected7 at risk
EG0120 affected20 at risk
EG0130 affected32 at risk
EG0140 affected15 at risk
EG0150 affected12 at risk
EG0160 affected9 at risk
EG0170 affected32 at risk
EG0180 affected14 at risk
0 affected
5 at risk
EG0040 affected10 at risk
EG0050 affected6 at risk
EG0061 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected7 at risk
EG0110 affected7 at risk
EG0121 affected20 at risk
EG0130 affected32 at risk
EG0140 affected15 at risk
EG0150 affected12 at risk
EG0160 affected9 at risk
EG0170 affected32 at risk
EG0180 affected14 at risk
0 affected
5 at risk
EG0040 affected10 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected7 at risk
EG0110 affected7 at risk
EG0120 affected20 at risk
EG0130 affected32 at risk
EG0140 affected15 at risk
EG0150 affected12 at risk
EG0160 affected9 at risk
EG0170 affected32 at risk
EG0181 affected14 at risk
0 affected
5 at risk
EG0040 affected10 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected7 at risk
EG0110 affected7 at risk
EG0120 affected20 at risk
EG0130 affected32 at risk
EG0141 affected15 at risk
EG0150 affected12 at risk
EG0160 affected9 at risk
EG0170 affected32 at risk
EG0180 affected14 at risk
0 affected
5 at risk
EG0040 affected10 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected7 at risk
EG0110 affected7 at risk
EG0120 affected20 at risk
EG0130 affected32 at risk
EG0140 affected15 at risk
EG0150 affected12 at risk
EG0160 affected9 at risk
EG0170 affected32 at risk
EG0180 affected14 at risk
0 affected
5 at risk
EG0040 affected10 at risk
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EG0040 affected10 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0091 affected3 at risk
EG0101 affected7 at risk
EG0112 affected7 at risk
EG0123 affected20 at risk
EG0136 affected32 at risk
EG0144 affected15 at risk
EG0152 affected12 at risk
EG0161 affected9 at risk
EG0179 affected32 at risk
EG0182 affected14 at risk
0 affected
5 at risk
EG0040 affected10 at risk
EG0051 affected6 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0091 affected3 at risk
EG0103 affected7 at risk
EG0112 affected7 at risk
EG0124 affected20 at risk
EG0136 affected32 at risk
EG0142 affected15 at risk
EG0150 affected12 at risk
EG0160 affected9 at risk
EG0173 affected32 at risk
EG0183 affected14 at risk
0 affected
5 at risk
EG0040 affected10 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected7 at risk
EG0111 affected7 at risk
EG0120 affected20 at risk
EG0130 affected32 at risk
EG0140 affected15 at risk
EG0150 affected12 at risk
EG0160 affected9 at risk
EG0170 affected32 at risk
EG0180 affected14 at risk
0 affected
5 at risk
EG0040 affected10 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected7 at risk
EG0111 affected7 at risk
EG0120 affected20 at risk
EG0132 affected32 at risk
EG0140 affected15 at risk
EG0150 affected12 at risk
EG0160 affected9 at risk
EG0170 affected32 at risk
EG0180 affected14 at risk
0 affected
5 at risk
EG0040 affected10 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected7 at risk
EG0111 affected7 at risk
EG0120 affected20 at risk
EG0130 affected32 at risk
EG0140 affected15 at risk
EG0150 affected12 at risk
EG0160 affected9 at risk
EG0170 affected32 at risk
EG0180 affected14 at risk
0 affected
5 at risk
EG0040 affected10 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0101 affected7 at risk
EG0110 affected7 at risk
EG0120 affected20 at risk
EG0130 affected32 at risk
EG0140 affected15 at risk
EG0150 affected12 at risk
EG0160 affected9 at risk
EG0170 affected32 at risk
EG0180 affected14 at risk
0 affected
5 at risk
EG0040 affected10 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0101 affected7 at risk
EG0110 affected7 at risk
EG0120 affected20 at risk
EG0130 affected32 at risk
EG0140 affected15 at risk
EG0150 affected12 at risk
EG0160 affected9 at risk
EG0170 affected32 at risk
EG0180 affected14 at risk
0 affected
5 at risk
EG0040 affected10 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected7 at risk
EG0110 affected7 at risk
EG0120 affected20 at risk
EG0132 affected32 at risk
EG0141 affected15 at risk
EG0150 affected12 at risk
EG0160 affected9 at risk
EG0170 affected32 at risk
EG0180 affected14 at risk
0 affected
5 at risk
EG0040 affected10 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected7 at risk
EG0110 affected7 at risk
EG0120 affected20 at risk
EG0132 affected32 at risk
EG0140 affected15 at risk
EG0150 affected12 at risk
EG0160 affected9 at risk
EG0170 affected32 at risk
EG0180 affected14 at risk
0 affected
5 at risk
EG0040 affected10 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected7 at risk
EG0110 affected7 at risk
EG0120 affected20 at risk
EG0131 affected32 at risk
EG0140 affected15 at risk
EG0150 affected12 at risk
EG0160 affected9 at risk
EG0170 affected32 at risk
EG0181 affected14 at risk
0 affected
5 at risk
EG0040 affected10 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected7 at risk
EG0110 affected7 at risk
EG0120 affected20 at risk
EG0130 affected32 at risk
EG0141 affected15 at risk
EG0150 affected12 at risk
EG0160 affected9 at risk
EG0170 affected32 at risk
EG0181 affected14 at risk
0 affected
5 at risk
EG0040 affected10 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected7 at risk
EG0110 affected7 at risk
EG0120 affected20 at risk
EG0130 affected32 at risk
EG0140 affected15 at risk
EG0151 affected12 at risk
EG0160 affected9 at risk
EG0171 affected32 at risk
EG0180 affected14 at risk
0 affected
5 at risk
EG0040 affected10 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected7 at risk
EG0110 affected7 at risk
EG0121 affected20 at risk
EG0130 affected32 at risk
EG0140 affected15 at risk
EG0150 affected12 at risk
EG0160 affected9 at risk
EG0170 affected32 at risk
EG0180 affected14 at risk
0 affected
5 at risk
EG0040 affected10 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected7 at risk
EG0110 affected7 at risk
EG0121 affected20 at risk
EG0130 affected32 at risk
EG0140 affected15 at risk
EG0150 affected12 at risk
EG0160 affected9 at risk
EG0170 affected32 at risk
EG0180 affected14 at risk
0 affected
5 at risk
EG0040 affected10 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected7 at risk
EG0110 affected7 at risk
EG0120 affected20 at risk
EG0130 affected32 at risk
EG0140 affected15 at risk
EG0150 affected12 at risk
EG0161 affected9 at risk
EG0170 affected32 at risk
EG0180 affected14 at risk
0 affected
5 at risk
EG0040 affected10 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected7 at risk
EG0110 affected7 at risk
EG0120 affected20 at risk
EG0130 affected32 at risk
EG0140 affected15 at risk
EG0150 affected12 at risk
EG0160 affected9 at risk
EG0170 affected32 at risk
EG0181 affected14 at risk
0 affected
5 at risk
EG0040 affected10 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected7 at risk
EG0110 affected7 at risk
EG0120 affected20 at risk
EG0130 affected32 at risk
EG0140 affected15 at risk
EG0151 affected12 at risk
EG0160 affected9 at risk
EG0170 affected32 at risk
EG0180 affected14 at risk
1 affected
5 at risk
EG0041 affected10 at risk
EG0050 affected6 at risk
EG0061 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0101 affected7 at risk
EG0111 affected7 at risk
EG0120 affected20 at risk
EG0130 affected32 at risk
EG0141 affected15 at risk
EG0151 affected12 at risk
EG0160 affected9 at risk
EG0171 affected32 at risk
EG0180 affected14 at risk
0 affected
5 at risk
EG0041 affected10 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected7 at risk
EG0110 affected7 at risk
EG0120 affected20 at risk
EG0130 affected32 at risk
EG0140 affected15 at risk
EG0150 affected12 at risk
EG0160 affected9 at risk
EG0170 affected32 at risk
EG0180 affected14 at risk
0 affected
5 at risk
EG0040 affected10 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected7 at risk
EG0111 affected7 at risk
EG0120 affected20 at risk
EG0130 affected32 at risk
EG0140 affected15 at risk
EG0150 affected12 at risk
EG0160 affected9 at risk
EG0170 affected32 at risk
EG0180 affected14 at risk
0 affected
5 at risk
EG0040 affected10 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected7 at risk
EG0111 affected7 at risk
EG0121 affected20 at risk
EG0131 affected32 at risk
EG0140 affected15 at risk
EG0151 affected12 at risk
EG0161 affected9 at risk
EG0172 affected32 at risk
EG0181 affected14 at risk
0 affected
5 at risk
EG0040 affected10 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0101 affected7 at risk
EG0110 affected7 at risk
EG0120 affected20 at risk
EG0130 affected32 at risk
EG0140 affected15 at risk
EG0150 affected12 at risk
EG0160 affected9 at risk
EG0170 affected32 at risk
EG0180 affected14 at risk
0 affected
5 at risk
EG0040 affected10 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected7 at risk
EG0110 affected7 at risk
EG0121 affected20 at risk
EG0130 affected32 at risk
EG0140 affected15 at risk
EG0150 affected12 at risk
EG0160 affected9 at risk
EG0170 affected32 at risk
EG0180 affected14 at risk
0 affected
5 at risk
EG0040 affected10 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected7 at risk
EG0110 affected7 at risk
EG0120 affected20 at risk
EG0130 affected32 at risk
EG0140 affected15 at risk
EG0150 affected12 at risk
EG0160 affected9 at risk
EG0170 affected32 at risk
EG0181 affected14 at risk
0 affected
5 at risk
EG0040 affected10 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected7 at risk
EG0110 affected7 at risk
EG0120 affected20 at risk
EG0130 affected32 at risk
EG0140 affected15 at risk
EG0150 affected12 at risk
EG0161 affected9 at risk
EG0170 affected32 at risk
EG0180 affected14 at risk
0 affected
5 at risk
EG0040 affected10 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected7 at risk
EG0111 affected7 at risk
EG0121 affected20 at risk
EG0131 affected32 at risk
EG0141 affected15 at risk
EG0150 affected12 at risk
EG0160 affected9 at risk
EG0170 affected32 at risk
EG0181 affected14 at risk
0 affected
5 at risk
EG0040 affected10 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected7 at risk
EG0110 affected7 at risk
EG0120 affected20 at risk
EG0131 affected32 at risk
EG0140 affected15 at risk
EG0150 affected12 at risk
EG0160 affected9 at risk
EG0170 affected32 at risk
EG0181 affected14 at risk
0 affected
5 at risk
EG0040 affected10 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected7 at risk
EG0110 affected7 at risk
EG0120 affected20 at risk
EG0130 affected32 at risk
EG0140 affected15 at risk
EG0151 affected12 at risk
EG0160 affected9 at risk
EG0170 affected32 at risk
EG0180 affected14 at risk
0 affected
5 at risk
EG0040 affected10 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected7 at risk
EG0110 affected7 at risk
EG0120 affected20 at risk
EG0130 affected32 at risk
EG0140 affected15 at risk
EG0150 affected12 at risk
EG0160 affected9 at risk
EG0170 affected32 at risk
EG0181 affected14 at risk
0 affected
5 at risk
EG0040 affected10 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected7 at risk
EG0111 affected7 at risk
EG0120 affected20 at risk
EG0130 affected32 at risk
EG0140 affected15 at risk
EG0150 affected12 at risk
EG0160 affected9 at risk
EG0170 affected32 at risk
EG0180 affected14 at risk
0 affected
5 at risk
EG0040 affected10 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected7 at risk
EG0111 affected7 at risk
EG0120 affected20 at risk
EG0130 affected32 at risk
EG0140 affected15 at risk
EG0150 affected12 at risk
EG0160 affected9 at risk
EG0170 affected32 at risk
EG0180 affected14 at risk
0 affected
5 at risk
EG0040 affected10 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0101 affected7 at risk
EG0110 affected7 at risk
EG0120 affected20 at risk
EG0130 affected32 at risk
EG0140 affected15 at risk
EG0150 affected12 at risk
EG0160 affected9 at risk
EG0170 affected32 at risk
EG0180 affected14 at risk
0 affected
5 at risk
EG0040 affected10 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected7 at risk
EG0110 affected7 at risk
EG0121 affected20 at risk
EG0130 affected32 at risk
EG0140 affected15 at risk
EG0150 affected12 at risk
EG0160 affected9 at risk
EG0170 affected32 at risk
EG0180 affected14 at risk
0 affected
5 at risk
EG0040 affected10 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected7 at risk
EG0110 affected7 at risk
EG0121 affected20 at risk
EG0130 affected32 at risk
EG0140 affected15 at risk
EG0150 affected12 at risk
EG0160 affected9 at risk
EG0170 affected32 at risk
EG0180 affected14 at risk
0 affected
5 at risk
EG0040 affected10 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected7 at risk
EG0110 affected7 at risk
EG0120 affected20 at risk
EG0130 affected32 at risk
EG0140 affected15 at risk
EG0150 affected12 at risk
EG0161 affected9 at risk
EG0170 affected32 at risk
EG0180 affected14 at risk
0 affected
5 at risk
EG0040 affected10 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0101 affected7 at risk
EG0110 affected7 at risk
EG0120 affected20 at risk
EG0130 affected32 at risk
EG0140 affected15 at risk
EG0150 affected12 at risk
EG0160 affected9 at risk
EG0170 affected32 at risk
EG0180 affected14 at risk
0 affected
5 at risk
EG0040 affected10 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0091 affected3 at risk
EG0100 affected7 at risk
EG0110 affected7 at risk
EG0120 affected20 at risk
EG0130 affected32 at risk
EG0140 affected15 at risk
EG0150 affected12 at risk
EG0160 affected9 at risk
EG0170 affected32 at risk
EG0180 affected14 at risk
0 affected
5 at risk
EG0040 affected10 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0071 affected3 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected7 at risk
EG0110 affected7 at risk
EG0120 affected20 at risk
EG0130 affected32 at risk
EG0140 affected15 at risk
EG0150 affected12 at risk
EG0160 affected9 at risk
EG0170 affected32 at risk
EG0180 affected14 at risk
0 affected
5 at risk
EG0040 affected10 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected7 at risk
EG0110 affected7 at risk
EG0121 affected20 at risk
EG0130 affected32 at risk
EG0140 affected15 at risk
EG0150 affected12 at risk
EG0161 affected9 at risk
EG0170 affected32 at risk
EG0180 affected14 at risk
4020
± 83.0
OG0047250± 63.7
OG0051810± 126.9
OG0063360± 140.4
OG0073080± 128.2
OG0086500± 64.3
OG0095710± 27.1
OG01013400± 46.4
OG01117800± 83.6
ParticipantsOG0045
ParticipantsOG0054
ParticipantsOG0063
ParticipantsOG0072
ParticipantsOG0083
ParticipantsOG0095
ParticipantsOG01023
ParticipantsOG0113
Title
Measurements
OG000339± 58.4
OG001618± 11.7
OG0021410± 61.4
OG0033530± 104.5
OG0047550± 76.9
OG0052490± 108.4
OG0063710± 106.0
OG0073370± 117.8
OG0086430± 71.6
OG0097850± 37.1
OG01015400± 57.5
OG01125600± 91.9
4020
± 82.9
OG0047250± 63.7
OG0051740± 137.5
OG0063360± 140.4
OG0071620± 215.6
OG0086450± 65.8
OG0095710± 26.9
OG01012800± 51.2
OG01117800± 83.6
Participants
OG004
5
ParticipantsOG0054
ParticipantsOG0063
ParticipantsOG0072
ParticipantsOG0083
ParticipantsOG0095
ParticipantsOG01025
ParticipantsOG0113
Title
Measurements
OG000321± 56.1
OG001298± 177.3
OG0021410± 61.5
OG0033530± 104.5
OG0047530± 77.2
OG0052430± 116.3
OG0063660± 104.2
OG0073340± 116.4
OG0086450± 72.0
OG0097850± 37.1
OG01013500± 80.0
OG01125300± 93.7
4050
± 82.5
OG0048170± 53.5
OG0051180± 112.9
OG0063390± 139.3
OG0073120± 126.3
OG0086520± 66.6
OG0095770± 26.7
OG01013500± 47.1
OG01117900± 83.1
Participants
OG004
5
ParticipantsOG0054
ParticipantsOG0062
ParticipantsOG0072
ParticipantsOG0082
ParticipantsOG0095
ParticipantsOG01025
ParticipantsOG0113
Title
Measurements
OG000346± 52.9
OG001243± 228.9
OG0021430± 60.9
OG0035160± 55.0
OG0047670± 75.3
OG0052470± 116.1
OG0063190± 169.8
OG0073420± 113.6
OG0085590± 101.3
OG0097930± 37.2
OG01015700± 59.0
OG01125600± 92.2
1650
± 56.8
OG0041850± 66.7
OG005496± 127.7
OG0061490± 141.7
OG007742± 301.5
OG0082840± 30.8
OG0092060± 49.5
OG0105240± 61.0
OG0116040± 58.4
Participants
OG004
5
ParticipantsOG0054
ParticipantsOG0063
ParticipantsOG0072
ParticipantsOG0083
ParticipantsOG0095
ParticipantsOG01025
ParticipantsOG0113
Title
Measurements
OG000143± 177.8
OG001107± 119.2
OG002598± 111.0
OG003903± 228.8
OG0041830± 177.6
OG005641± 91.4
OG0061710± 124.4
OG0072330± 130.8
OG0081860± 55.8
OG0092360± 40.9
OG0105350± 78.7
OG0118070± 50.7
0.50
(0.50 to 1.00)
OG0040.71(0.43 to 4.08)
OG0053.03(1.08 to 5.73)
OG0061.00(0.98 to 3.00)
OG0071.07(1.00 to 4.02)
OG0081.00(0.47 to 1.88)
OG0091.88(0.53 to 1.93)
OG0101.97(0.50 to 6.00)
OG0112.03(1.00 to 4.00)
Participants
OG004
5
ParticipantsOG0054
ParticipantsOG0063
ParticipantsOG0072
ParticipantsOG0083
ParticipantsOG0095
ParticipantsOG01025
ParticipantsOG0113
Title
Measurements
OG0000.53(0.50 to 2.20)
OG0011.00(0.55 to 1.05)
OG0020.50(0.47 to 0.92)
OG0032.52(0.92 to 5.7)
OG0040.55(0.50 to 1.00)
OG0052.48(0.52 to 3.85)
OG0061.02(0.50 to 7.53)
OG0071.52(1.00 to 2.03)
OG0083.00(2.93 to 5.67)
OG0092.1(1.08 to 4)
OG0102.02(0.92 to 7.52)
OG0111.90(0.55 to 3.85)
3.75
± 26.9
OG0043.84± 21.8
OG0052.08± 102.4
OG0064.28± 11.6
OG0075.68± 31.7
OG0083.30± 74.7
OG0094.00± 13.6
OG0103.92± 40.9
OG0113.71± 32.9
Participants
OG004
5
ParticipantsOG0054
ParticipantsOG0062
ParticipantsOG0072
ParticipantsOG0082
ParticipantsOG0095
ParticipantsOG01021
ParticipantsOG0113
Title
Measurements
OG0003.37± 119.7
OG0011.85± 64.8
OG0024.98± 31.5
OG0033.61± 13.5
OG0044.11± 15.9
OG0052.58± 95.1
OG0061.01± 11.6
OG0073.13± 276.4
OG0084.67± 24.1
OG0093.88± 25.6
OG0103.80± 47.2
OG0111.28± 72.1
5710
± 27.1
Title
Measurements
OG0002490± 108.4
OG0013710± 106.0
OG0026430± 71.6
OG0037850± 37.1
5770
± 26.7
Title
Measurements
OG0002470± 116.1
OG0013190± 169.8
OG0025590± 101.3
OG0037930± 37.2
2060
± 49.5
Title
Measurements
OG000641± 91.4
OG0011710± 124.4
OG0021860± 55.8
OG0032360± 40.9
1.88
(0.53 to 1.93)
Title
Measurements
OG0002.48(0.52 to 3.85)
OG0011.02(0.50 to 7.53)
OG0023.00(2.93 to 5.67)
OG0032.1(1.08 to 4)
8730
± 100.0
OG00412000± 83.3
OG00513400± 71.3
ParticipantsOG00416
ParticipantsOG0055
Title
Measurements
OG00011600± 76.1
OG00127600± 47.3
OG00211500± NAGeometric coefficient of variation was not estimable due to low number of participants at specified time point.