Onvansertib in Combination With Either Low-dose Cytarabin... | NCT03303339 | Trialant
NCT03303339
Sponsor
Cardiff Oncology
Status
Completed
Last Update Posted
Feb 27, 2023Actual
Enrollment
72Actual
Phase
Phase 1Phase 2
Conditions
Acute Myeloid Leukemia
Interventions
Onvansertib
Cytarabine
Decitabine
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT03303339
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
TROV-052
Secondary IDs
ID
Type
Description
Link
U1111-1201-6416
Other Identifier
WHO
Brief Title
Onvansertib in Combination With Either Low-dose Cytarabine or Decitabine in Adult Patients With Acute Myeloid Leukemia (AML)
Official Title
A Phase 1b/2 Study of PCM-075 (Onvansertib) in Combination With Either Low-Dose Cytarabine or Decitabine in Subjects With Acute Myeloid Leukemia (AML)
Acronym
Not provided
Organization
Cardiff OncologyINDUSTRY
Status Module
Record Verification Date
Dec 2022
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Nov 17, 2017Actual
Primary Completion Date
Nov 17, 2021Actual
Completion Date
Nov 17, 2021Actual
First Submitted Date
Sep 6, 2017
First Submission Date that Met QC Criteria
Oct 2, 2017
First Posted Date
Oct 6, 2017Actual
Results Waived
Not provided
Results First Submitted Date
Nov 11, 2022
Results First Submitted that Met QC Criteria
Jan 31, 2023
Results First Posted Date
Feb 27, 2023Actual
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
Jan 31, 2023
Last Update Posted Date
Feb 27, 2023Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Cardiff OncologyINDUSTRY
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
The purpose of the phase 1b/2 study is to determine whether Onvansertib given orally daily for 5 consecutive days every 28 days is safe and tolerable in adult patients who have relapsed/refractory Acute Myeloid Leukemia (AML), or are ineligible for intensive induction therapy, and to determine the maximum tolerated dose and recommended phase 2 dose of Onvansertib in combination with decitabine or Onvansertib in combination with low-dose cytarabine. In the phase 2 portion of the study, Onvansertib in combination with decitabine will be studied to provide further data on the safety profile of the combination and to preliminarily assess the activity of the chosen combination in patients with untreated AML who are not candidates for aggressive induction therapy, or who have received one prior treatment for their AML.
Detailed Description
Not provided
Conditions Module
Conditions
Acute Myeloid Leukemia
Keywords
PLK1
PLK Inhibitor
Onvansertib
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
72Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Phase 1b: Onvansertib + low-dose cytarabine
Experimental
Onvansertib, administered in escalating doses orally Day 1 through Day 5 every 28 days (1 cycle) in combination with cytarabine, which will be administered in all cohorts as 20 mg/m^2 subcutaneously, once daily on Day 1 through Day 10 every 28 days (1 cycle). Onvansertib administration, in combination with cytarabine, will be initiated at a starting dose of 12 mg/m^2 orally, daily for 5 days. Onvansertib dose will be escalated in successive cohorts until the recommended phase 2 dose is achieved.
Drug: Onvansertib
Drug: Cytarabine
Phase 1b: Onvansertib + decitabine
Experimental
Onvansertib will be administered in escalating doses orally, Day 1 through Day 5 every 28 days (1 cycle) in combination with decitabine, administered consistently in all cohorts as 20 mg/m^2 intravenously over 1 hour on Day 1 through Day 5 every 28 days (1 cycle). Onvansertib administration, in combination with decitabine, will be initiated at a starting dose of 12 mg/m^2 orally, daily for 5 days (Day 1 through Day 5). Onvansertib dose will be escalated in successive cohorts until the recommended phase 2 dose is achieved.
Drug: Onvansertib
Drug: Decitabine
Phase 2: Onvansertib + decitabine
Experimental
Onvansertib recommended phase 2 dose, orally Day 1 through Day 5 every 28 days (1 cycle) and decitabine, administered consistently as 20 mg/m^2 intravenously over 1 hour on Day 1 through Day 5 every 28 days (1 cycle), with treatment modifications or delays based on return of hematopoietic function to baseline or Grade ≤1 toxicity for optimal subject management.
Drug: Onvansertib
Drug: Decitabine
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Onvansertib
Drug
Onvansertib orally
Phase 1b: Onvansertib + decitabine
Phase 1b: Onvansertib + low-dose cytarabine
Phase 2: Onvansertib + decitabine
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants Who Experienced Dose Limiting Toxicities (DLT)
Dose-limiting toxicities were defined as events related to onvansertib that were considered an adverse reaction or suspected adverse reaction during the first cycle of therapy and that fulfilled one of the following: Hematologic (persistent pancytopenia resistant to current standards of care that continues for ≥42 days and is not related to leukemic infiltration or another cause unrelated to study therapy) or Non-Hematologic (any Grade 3 abnormalities that persist >7 days without decreasing in severity despite standards of care, are clinically significant, or that are Grade 4 and symptomatic).
Up to Day 28 of Cycle 1
Number of Participants With Change From Baseline in Eastern Co-operative Oncology Group (ECOG) Performance Status
ECOG performance status was determined using 6-point scale from 0-5, with 0 meaning a participant was fully active/able to carry on all pre-disease activities without restriction and 5 meaning the participant was deceased.
Baseline and end of study (approximately up to up to 27 months)
Phase 2: Number of Participants Who Achieved a Complete Response (CR)
Complete Response also includes Complete Response with Incomplete Blood Count Recovery (CRi). Complete response is defined by the following criteria:
Morphologic leukemia-free state plus:
Subject is independent of transfusions
Absolute neutrophil count of >1000/mm3
Platelets of ≥100,000/mm3
Complete response with incomplete blood count recovery meets all criteria for CR except for either neutropenia (ANC <1000/mm3) or thrombocytopenia (<100,000/mm3) but must include transfusion independence.
Up to 27 months
Number of Participants With Adverse Events (AEs)
Any clinically significant change in electrocardiogram (ECG), physical examination findings, body weight, vital signs, and laboratory parameters were recorded as Adverse Events.
Baseline up to 30 days after last dose of study drug (up to 27 months)
Secondary Outcomes
Measure
Description
Time Frame
Phase 2: Number of Participants Who Achieved a Morphologic Leukemia-free (MLF) State
Defined as bone marrow (BM) <5% blasts in an aspirate with spicules and no blasts with Auer rods or persistence of extramedullary disease.
Up to 27 months
Phase 2: Number of Participants With Partial Response (PR)
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Disease Status and Prior Therapy:
Histologically confirmed AML with >20% blasts
Phase 1b: Participants with AML who are refractory to or have relapsed after initial treatment for their disease, with no more than three prior lines of therapy. Participants who have received prior treatment with cytarabine or decitabine are not excluded.
Phase 2:
i. Participants with AML who are refractory to, or have relapsed after, initial treatment for their disease, with no more than one prior line of therapy, and are judged not to be candidates for re-induction therapy that includes hematopoietic cell transplantation. Participants who have received prior cytarabine or decitabine are not excluded.
OR
ii. Participants with newly diagnosed, untreated AML ineligible for, or who have refused, standard intensive induction therapy
Age ≥18 years
ECOG performance status ≤2
Participants must be willing and able to review, understand, and provide written consent before starting any study-specific procedures or therapy.
All men and women must agree to practice effective contraception during the entire study period and after discontinuing study drug, unless documentation of infertility exists
Sexually active, fertile women must use two effective forms of contraception (abstinence, intrauterine device, oral contraceptive, or double barrier device) from the time of informed consent and until at least 6 months after discontinuing study drug
Sexually active men and their sexual partners must use effective contraceptive methods from the time of participant informed consent and until at least 3 months after discontinuing study drug
Exclusion Criteria:
Treatment-related AML or acute promyelocytic leukemia (APL)
Active malignancies within 12 months with the exception of those with a negligible risk of metastasis or death
Clinical evidence of active central nervous system leukemia at the time of screening
Alanine aminotransferase and/or aspartate aminotransferase ≥2.5 x upper limit of normal (ULN)
Total bilirubin > 2.0 mg/dL (or > 3.0 mg/dL in participants with documented Gilbert syndrome)
Serum creatinine ≥2.0 mg/dL
New York Heart Association Class III or IV heart disease, active ischemia or any other uncontrolled cardiac condition, or hypertensive or metabolic condition
Myocardial infarction in the previous 12 weeks (from the start of treatment)
Resting left ventricular ejection fraction <50% at the time of screening
QT (Interval from the beginning of the QRS complex to the end of the T wave on an electrocardiogram) interval with Fridericia's correction [QTcF] >450 milliseconds. The QTcF should be calculated as the arithmetic mean of the QTcF on triplicate ECGs. In the case of potentially correctible causes of QT prolongation (e.g., medications, hypokalemia), the triplicate ECG may be repeated once during screening and that result may be used to determine eligibility.
Active and uncontrolled disease (other than AML) or infection as judged by the treating physician
Treatment with systemic therapy for the primary disease within 14 days (except for hydroxyurea or isolated doses of cytarabine or decitabine for white blood cell control)
Grade 2 or greater toxicities from prior therapy, except for Grade 2 toxicities that are not expected to resolve and that in the judgment of the Investigator do not pose a significant safety risk to subject participation.
Participants with any other medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with the participant's ability to sign the informed consent form or his/her ability to cooperate and participate in the study, or to interfere with the interpretation of the results.
Hagege A, Ambrosetti D, Boyer J, Bozec A, Doyen J, Chamorey E, He X, Bourget I, Rousset J, Saada E, Rastoin O, Parola J, Luciano F, Cao Y, Pages G, Dufies M. The Polo-like kinase 1 inhibitor onvansertib represents a relevant treatment for head and neck squamous cell carcinoma resistant to cisplatin and radiotherapy. Theranostics. 2021 Sep 21;11(19):9571-9586. doi: 10.7150/thno.61711. eCollection 2021.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
Undecided
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
72 participants were enrolled across 8 sites in the United States.
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to Day 10 of each cycle, in order to determine the recommended phase 2 dose (RP2D) of onvansertib.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Aug 7, 2019
Nov 4, 2022
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Single Group 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
Cytarabine
Drug
subcutaneously
Phase 1b: Onvansertib + low-dose cytarabine
Decitabine
Drug
intravenously
Phase 1b: Onvansertib + decitabine
Phase 2: Onvansertib + decitabine
PR criteria includes all of the hematologic values for a CR but with a decrease of at least 50% in the percentage of blasts to 5% to 25% in the bone marrow aspirate and a normalization of blood counts.
Up to 27 months
Phase 2: Duration of Response (DOR)
Duration of Response (DOR) is the time (in months) from the first response of CR, CRi or PR until recurrence of or progression of disease (or death). MLF State is also included as a response when calculating DOR. Responding subjects without death or progression will be censored at the date of their last evaluable disease assessment.
Up to 27 months
Phase 2: Event-free Survival (EFS)
EFS is defined as the time from enrollment until disease progression or death from any cause and reported as the proportion of participants event free at 12 months.
12 Months
Phase 2: Overall Survival (OS)
OS is defined as the time from enrollment until death from any cause and reported as the proportion of participants alive at 12 months.
12 Months
Pharmacokinetic Parameter: Maximum Observed Plasma Concentration (Cmax) for Onvansertib
Cycle 1: Days 1 and 5
Pharmacokinetic Parameter: Time to Reach the Maximum Observed Plasma Concentration (Tmax) for Onvansertib
Cycle 1: Days 1 and 5
Pharmacokinetic Parameter: Area Under the Curve Over the First 24 Hours AUC(0-24) for Onvansertib
Cycle 1: Days 1 and 5
Pharmacokinetic Parameter: Plasma Terminal Elimination Half-life (t1/2) for Onvansertib
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to Day 10 of each cycle, in order to determine the RP2D of onvansertib.
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of onvansertib.
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of onvansertib
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to Day 10 of each cycle, in order to determine the RP2D of onvansertib.
FG005
Phase 1b: Onvansertib 12 mg/m^2 + Decitabine
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of onvansertib.
FG006
Phase 1b: Onvansertib 18 mg/m^2 + Decitabine
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of onvansertib.
FG007
Phase 1b: Onvansertib 27 mg/m^2 + Decitabine
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of onvansertib.
FG008
Phase 1b: Onvansertib 40 mg/m^2 + Decitabine
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of onvansertib.
FG009
Phase 1b: Onvansertib 60 mg/m^2 + Decitabine
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of onvansertib.
FG010
Phase 1b: Onvansertib 90 mg/m^2 + Decitabine
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of onvansertib.
FG011
Phase 2: Onvansertib 60 mg/m^2 + Decitabine
Participants were administered onvansertib at the RP2D on Day 1 up to Day 5 of each cycle (where each cycle is 28 days), in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle.
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to Day 10 of each cycle, in order to determine the RP2D of onvansertib.
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to Day 10 of each cycle, in order to determine the RP2D of onvansertib.
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to Day 10 of each cycle, in order to determine the RP2D of onvansertib.
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to Day 10 of each cycle, in order to determine the RP2D of onvansertib.
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to Day 10 of each cycle, in order to determine the RP2D of onvansertib.
BG005
Phase 1b: Onvansertib 12 mg/m^2 + Decitabine
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of onvansertib
BG006
Phase 1b: Onvansertib 18 mg/m^2 + Decitabine
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of onvansertib
BG007
Phase 1b: Onvansertib 27 mg/m^2 + Decitabine
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of onvansertib
BG008
Phase 1b: Onvansertib 40 mg/m^2 + Decitabine
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of onvansertib
BG009
Phase 1b: Onvansertib 60 mg/m^2 + Decitabine
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of onvansertib
BG010
Phase 1b: Onvansertib 90 mg/m^2 + Decitabine
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of onvansertib
BG011
Phase 2: Onvansertib 60 mg/m^2 + Decitabine
Participants were administered onvansertib at the RP2D on Day 1 up to Day 5 of each cycle (where each cycle is 28 days), in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle.
BG012
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0003
BG0013
BG0023
BG0033
BG0045
BG0054
BG0063
BG0073
BG0084
BG0093
BG0106
BG01132
BG01272
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0000
BG0011
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0012
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
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
Number of Participants Who Experienced Dose Limiting Toxicities (DLT)
Dose-limiting toxicities were defined as events related to onvansertib that were considered an adverse reaction or suspected adverse reaction during the first cycle of therapy and that fulfilled one of the following: Hematologic (persistent pancytopenia resistant to current standards of care that continues for ≥42 days and is not related to leukemic infiltration or another cause unrelated to study therapy) or Non-Hematologic (any Grade 3 abnormalities that persist >7 days without decreasing in severity despite standards of care, are clinically significant, or that are Grade 4 and symptomatic).
The safety analysis set was comprised of all subjects who received at least one dose of onvansertib.
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of onvansertib.
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of onvansertib.
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of onvansertib.
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of onvansertib.
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of onvansertib.
OG005
Phase 1b: Onvansertib 12 mg/m^2 + Decitabine
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of onvansertib.
OG006
Phase 1b: Onvansertib 18 mg/m^2 + Decitabine
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of onvansertib.
OG007
Phase 1b: Onvansertib 27 mg/m^2 + Decitabine
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of onvansertib.
OG008
Phase 1b: Onvansertib 40 mg/m^2 + Decitabine
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of onvansertib.
OG009
Phase 1b: Onvansertib 60 mg/m^2 + Decitabine
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of onvansertib.
OG010
Phase 1b: Onvansertib 90 mg/m^2 + Decitabine
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of onvansertib.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
OG003
OG004
OG005
OG006
OG007
OG008
OG009
OG010
Maximum Tolerated Dose
60
2-Sided
Other
Primary
Number of Participants With Change From Baseline in Eastern Co-operative Oncology Group (ECOG) Performance Status
ECOG performance status was determined using 6-point scale from 0-5, with 0 meaning a participant was fully active/able to carry on all pre-disease activities without restriction and 5 meaning the participant was deceased.
Per SAP It was pre-planned to report this data by treatment type instead of by dose.
Posted
Count of Participants
Participants
Baseline and end of study (approximately up to up to 27 months)
ID
Title
Description
OG000
Phase 1b: Onvansertib + Low-dose Cytarabine
Participants were administered escalating doses of Onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the recommended phase 2 dose (RP2D) of Onvansertib.
OG001
Phase 1b: Onvansertib + Decitabine
Participants were administered escalating doses of Onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the recommended phase 2 dose (RP2D) of Onvansertib.
OG002
Primary
Phase 2: Number of Participants Who Achieved a Complete Response (CR)
Complete Response also includes Complete Response with Incomplete Blood Count Recovery (CRi). Complete response is defined by the following criteria:
Morphologic leukemia-free state plus:
Subject is independent of transfusions
Absolute neutrophil count of >1000/mm3
Platelets of ≥100,000/mm3
Complete response with incomplete blood count recovery meets all criteria for CR except for either neutropenia (ANC <1000/mm3) or thrombocytopenia (<100,000/mm3) but must include transfusion independence.
Only participants in Phase 2 were included in this analysis.
Posted
Count of Participants
Participants
Up to 27 months
ID
Title
Description
OG000
Phase 2: Onvansertib + Decitabine
Participants were administered Onvansertib at the recommended phase 2 dose (RP2D) on Day 1 up to Day 5 of each cycle (where each cycle is 28 days), in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle.
Units
Counts
Participants
OG000
Primary
Number of Participants With Adverse Events (AEs)
Any clinically significant change in electrocardiogram (ECG), physical examination findings, body weight, vital signs, and laboratory parameters were recorded as Adverse Events.
The safety analysis set was comprised of all subjects who received at least one dose of onvansertib.
Posted
Count of Participants
Participants
Baseline up to 30 days after last dose of study drug (up to 27 months)
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.
Phase 2: Number of Participants Who Achieved a Morphologic Leukemia-free (MLF) State
Defined as bone marrow (BM) <5% blasts in an aspirate with spicules and no blasts with Auer rods or persistence of extramedullary disease.
Only participants in Phase 2 were included in this analysis.
Posted
Count of Participants
Participants
Up to 27 months
ID
Title
Description
OG000
Phase 2: Onvansertib + Decitabine
Onvansertib recommended phase 2 dose, orally Day 1 through Day 5 every 28 days (1 cycle) and decitabine, administered consistently as 20 mg/m^2 intravenously over 1 hour on Day 1 through Day 5 every 28 days (1 cycle), with treatment modifications or delays based on return of hematopoietic function to baseline or Grade ≤1 toxicity for optimal subject management.
Onvansertib: Onvansertib orally
Decitabine: intravenously
Units
Counts
Participants
OG000
Secondary
Phase 2: Number of Participants With Partial Response (PR)
PR criteria includes all of the hematologic values for a CR but with a decrease of at least 50% in the percentage of blasts to 5% to 25% in the bone marrow aspirate and a normalization of blood counts.
Only participants included in Phase 2 were used in this analysis.
Posted
Count of Participants
Participants
Up to 27 months
ID
Title
Description
OG000
Phase 2: Onvansertib + Decitabine
Participants were administered Onvansertib at the recommended phase 2 dose (RP2D) on Day 1 up to Day 5 of each cycle (where each cycle is 28 days), in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle.
Units
Counts
Participants
OG000
Secondary
Phase 2: Duration of Response (DOR)
Duration of Response (DOR) is the time (in months) from the first response of CR, CRi or PR until recurrence of or progression of disease (or death). MLF State is also included as a response when calculating DOR. Responding subjects without death or progression will be censored at the date of their last evaluable disease assessment.
Only participants in Phase 2 were included in this analysis.
Posted
Median
Full Range
months
Up to 27 months
ID
Title
Description
OG000
Phase 2: Onvansertib + Decitabine
Participants were administered Onvansertib at the recommended phase 2 dose (RP2D) on Day 1 up to Day 5 of each cycle (where each cycle is 28 days), in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle.
Units
Counts
Participants
OG000
Secondary
Phase 2: Event-free Survival (EFS)
EFS is defined as the time from enrollment until disease progression or death from any cause and reported as the proportion of participants event free at 12 months.
Only participants in Phase 2 were included in this analysis.
Posted
Number
95% Confidence Interval
Proportion of Participants
12 Months
ID
Title
Description
OG000
Phase 2: Onvansertib + Decitabine
Participants were administered Onvansertib at the recommended phase 2 dose (RP2D) on Day 1 up to Day 5 of each cycle (where each cycle is 28 days), in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle.
Units
Counts
Participants
OG000
Secondary
Phase 2: Overall Survival (OS)
OS is defined as the time from enrollment until death from any cause and reported as the proportion of participants alive at 12 months.
Only participants included in Phase 2 were included in this analysis.
Posted
Number
95% Confidence Interval
Proportion of Participants
12 Months
ID
Title
Description
OG000
Phase 2: Onvansertib + Decitabine
Participants were administered Onvansertib at the recommended phase 2 dose (RP2D) on Day 1 up to Day 5 of each cycle (where each cycle is 28 days), in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle.
Units
Counts
Participants
OG000
Secondary
Pharmacokinetic Parameter: Maximum Observed Plasma Concentration (Cmax) for Onvansertib
The PK analysis set consisted of all subjects in the safety analysis set who received onvansertib and had adequate plasma onvansertib concentration data as determined by the PK scientist.
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.
Secondary
Pharmacokinetic Parameter: Time to Reach the Maximum Observed Plasma Concentration (Tmax) for Onvansertib
The PK analysis set consisted of all subjects in the safety analysis set who received onvansertib and had adequate plasma onvansertib concentration data as determined by the PK scientist.
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.
Secondary
Pharmacokinetic Parameter: Area Under the Curve Over the First 24 Hours AUC(0-24) for Onvansertib
The PK analysis set consisted of all subjects in the safety analysis set who received onvansertib and had adequate plasma onvansertib concentration data as determined by the PK scientist.
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.
Secondary
Pharmacokinetic Parameter: Plasma Terminal Elimination Half-life (t1/2) for Onvansertib
The PK analysis set consisted of all subjects in the safety analysis set who received onvansertib and had adequate plasma onvansertib concentration data as determined by the PK scientist.
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.
Time Frame
27 months
Description
Participants included in the Safety Analysis Set were included in this analysis.
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the recommended phase 2 dose (RP2D) of onvansertib.
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the recommended phase 2 dose (RP2D) of onvansertib.
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the recommended phase 2 dose (RP2D) of onvansertib.
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the recommended phase 2 dose (RP2D) of onvansertib.
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the recommended phase 2 dose (RP2D) of onvansertib.
4
5
3
5
5
5
EG005
Phase 1b: Onvansertib 12 mg/m^2 + Decitabine
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the recommended phase 2 dose (RP2D) of onvansertib.
2
4
2
4
4
4
EG006
Phase 1b: Onvansertib 18 mg/m^2 + Decitabine
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the recommended phase 2 dose (RP2D) of onvansertib.
2
3
3
3
3
3
EG007
Phase 1b: Onvansertib 27 mg/m^2 + Decitabine
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the recommended phase 2 dose (RP2D) of onvansertib.
2
3
3
3
3
3
EG008
Phase 1b: Onvansertib 40 mg/m^2 + Decitabine
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the recommended phase 2 dose (RP2D) of onvansertib.
3
4
4
4
4
4
EG009
Phase 1b: Onvansertib 60 mg/m^2 + Decitabine
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the recommended phase 2 dose (RP2D) of onvansertib.
3
3
2
3
3
3
EG010
Phase 1b: Onvansertib 90 mg/m^2 + Decitabine
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the recommended phase 2 dose (RP2D) of onvansertib.
4
6
5
6
6
6
EG011
Phase 2: Onvansertib 60 mg/m^2 + Decitabine
Participants were administered onvansertib at the recommended phase 2 dose (RP2D) on Day 1 up to Day 5 of each cycle (where each cycle is 28 days), in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle.
24
32
27
32
32
32
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Lung infection
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected5 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0091 events1 affected3 at risk
EG0101 events1 affected6 at risk
EG0114 events4 affected32 at risk
Pneumonia
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Septic shock
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA (20.1)
Systematic Assessment
EG0002 events1 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Asthenia
General disorders
MedDRA (20.1)
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Oedema peripheral
General disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pyrexia
General disorders
MedDRA (20.1)
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Urine output decreased
Investigations
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pharyngeal oedema
Respiratory, thoracic and mediastinal disorders
MedDRA (20.1)
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA (20.1)
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Seroma
Injury, poisoning and procedural complications
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Tumour lysis syndrome
Metabolism and nutrition disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA (20.1)
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Acute myeloid leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Leukaemic infiltration pulmonary
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Sepsis
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Escherichia bacteraemia
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Appendicitis
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Candida infection
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Cellulitis
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Granulicatella bacteraemia
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Kidney infection
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Klebsiella bacteraemia
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pneumonia fungal
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Serratia bacteraemia
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Skin infection
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Soft tissue infection
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Staphylococcal bacteraemia
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pancytopenia
Blood and lymphatic system disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Lower gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Mallory-Weiss syndrome
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Melaena
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Neutropenic colitis
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Proctalgia
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Lung consolidation
Respiratory, thoracic and mediastinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pulmonary mass
Respiratory, thoracic and mediastinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pain
General disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Palmar-plantar erythodysaesthesia syndrome
Skin and subcutaneous tissue disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Transfusion reaction
Injury, poisoning and procedural complications
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Aphasia
Nervous system disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Fatigue
General disorders
MedDRA (20.1)
Systematic Assessment
EG0001 events1 affected3 at risk
EG0013 events2 affected3 at risk
EG0022 events2 affected3 at risk
EG0032 events2 affected3 at risk
EG0041 events1 affected5 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected3 at risk
EG0081 events1 affected4 at risk
EG0092 events2 affected3 at risk
EG0103 events3 affected6 at risk
EG0118 events8 affected32 at risk
Asthenia
General disorders
MedDRA (20.1)
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Oedema peripheral
General disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pyrexia
General disorders
MedDRA (20.1)
Systematic Assessment
EG0001 events1 affected3 at risk
EG0012 events2 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Chills
General disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Face oedema
General disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Injection site pain
General disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Oedema
General disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pain
General disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0023 events2 affected3 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0013 events3 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0002 events2 affected3 at risk
EG0012 events2 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Gingival bleeding
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Haemorrhoidal haemorrhage
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Lung infection
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Cellulitis
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Sepsis
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Headache
Nervous system disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0013 events2 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (20.1)
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA (20.1)
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Lethargy
Nervous system disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Tremor
Nervous system disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (20.1)
Systematic Assessment
EG0001 events1 affected3 at risk
EG0012 events2 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (20.1)
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Increased bronchial secretion
Respiratory, thoracic and mediastinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Laryngeal inflammation
Respiratory, thoracic and mediastinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Orthopnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pharyngeal oedema
Respiratory, thoracic and mediastinal disorders
MedDRA (20.1)
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Stridor
Respiratory, thoracic and mediastinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA (20.1)
Systematic Assessment
EG0004 events1 affected3 at risk
EG0011 events1 affected3 at risk
EG0022 events1 affected3 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA (20.1)
Systematic Assessment
EG0002 events1 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Disseminated intravascular coagulation
Blood and lymphatic system disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0022 events1 affected3 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA (20.1)
Systematic Assessment
EG0005 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Dermatitis bullous
Skin and subcutaneous tissue disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Onychoclasis
Skin and subcutaneous tissue disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Petechiae
Skin and subcutaneous tissue disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Red man syndrome
Skin and subcutaneous tissue disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Platelet count decreased
Investigations
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Blood alkaline phosphatase
Investigations
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Urine output decreased
Investigations
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Weight decreased
Investigations
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Agitation
Psychiatric disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Restlessness
Psychiatric disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Laceration
Injury, poisoning and procedural complications
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Seroma
Injury, poisoning and procedural complications
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Transfusion reaction
Injury, poisoning and procedural complications
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA (20.1)
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA (20.1)
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Tumour lysis syndrome
Metabolism and nutrition disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (20.1)
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Muscle haemorrhage
Musculoskeletal and connective tissue disorders
MedDRA (20.1)
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA (20.1)
Systematic Assessment
EG0002 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (20.1)
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA (20.1)
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Eye pruritus
Eye disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Photophobia
Eye disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Visual acuity reduced
Eye disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Otorrhoea
Ear and labyrinth disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Acute myeloid leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Leukaemic infiltration pulmonary
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Participants were administered Onvansertib at the recommended phase 2 dose (RP2D) on Day 1 up to Day 5 of each cycle (where each cycle is 28 days), in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle.
Units
Counts
Participants
OG00017
OG00123
OG00232
Title
Denominators
Categories
Title
Measurements
OG00011
OG00114
OG00222
32
Title
Denominators
Categories
Title
Measurements
OG0003
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.
OG005
Phase 1b: Onvansertib 12 mg/m^2 + Decitabine
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.
OG006
Phase 1b: Onvansertib 18 mg/m^2 + Decitabine
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.
OG007
Phase 1b: Onvansertib 27 mg/m^2 + Decitabine
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.
OG008
Phase 1b: Onvansertib 40 mg/m^2 + Decitabine
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.
OG009
Phase 1b: Onvansertib 60 mg/m^2 + Decitabine
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.
OG010
Phase 1b: Onvansertib 90 mg/m^2 + Decitabine
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.
OG011
Phase 2: Onvansertib 60 mg/m^2 + Decitabine
Participants were administered onvansertib on Day 1 through Day 5 every 21 to 28 days, in combination with decitabine, administered consistently as 20 mg/m^2 over 1 hour on Day 1 through Day 5 every 28 days.
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.
OG005
Phase 1b: Onvansertib 12 mg/m^2 + Decitabine
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.
OG006
Phase 1b: Onvansertib 18 mg/m^2 + Decitabine
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.
OG007
Phase 1b: Onvansertib 27 mg/m^2 + Decitabine
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.
OG008
Phase 1b: Onvansertib 40 mg/m^2 + Decitabine
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.
OG009
Phase 1b: Onvansertib 60 mg/m^2 + Decitabine
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.
OG010
Phase 1b: Onvansertib 90 mg/m^2 + Decitabine
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.
OG011
Phase 2: Onvansertib 60 mg/m^2 + Decitabine
Participants were administered onvansertib at the RP2D on Day 1 up to Day 5 of each cycle (where each cycle is 28 days), in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle.
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.
OG005
Phase 1b: Onvansertib 12 mg/m^2 + Decitabine
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.
OG006
Phase 1b: Onvansertib 18 mg/m^2 + Decitabine
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.
OG007
Phase 1b: Onvansertib 27 mg/m^2 + Decitabine
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.
OG008
Phase 1b: Onvansertib 40 mg/m^2 + Decitabine
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.
OG009
Phase 1b: Onvansertib 60 mg/m^2 + Decitabine
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.
OG010
Phase 1b: Onvansertib 90 mg/m^2 + Decitabine
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.
OG011
Phase 2: Onvansertib 60 mg/m^2 + Decitabine
Participants were administered onvansertib at the RP2D on Day 1 up to Day 5 of each cycle (where each cycle is 28 days), in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle.
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.
OG005
Phase 1b: Onvansertib 12 mg/m^2 + Decitabine
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.
OG006
Phase 1b: Onvansertib 18 mg/m^2 + Decitabine
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.
OG007
Phase 1b: Onvansertib 27 mg/m^2 + Decitabine
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.
OG008
Phase 1b: Onvansertib 40 mg/m^2 + Decitabine
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.
OG009
Phase 1b: Onvansertib 60 mg/m^2 + Decitabine
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.
OG010
Phase 1b: Onvansertib 90 mg/m^2 + Decitabine
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.
OG011
Phase 2: Onvansertib 60 mg/m^2 + Decitabine
Participants were administered onvansertib at the RP2D on Day 1 up to Day 5 of each cycle (where each cycle is 28 days), in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle.
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of onvansertib.
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.
OG005
Phase 1b: Onvansertib 12 mg/m^2 + Decitabine
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.
OG006
Phase 1b: Onvansertib 18 mg/m^2 + Decitabine
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.
OG007
Phase 1b: Onvansertib 27 mg/m^2 + Decitabine
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.
OG008
Phase 1b: Onvansertib 40 mg/m^2 + Decitabine
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.
OG009
Phase 1b: Onvansertib 60 mg/m^2 + Decitabine
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.
OG010
Phase 1b: Onvansertib 90 mg/m^2 + Decitabine
Participants were administered escalating doses of onvansertib starting at 12mg/m^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.
OG011
Phase 2: Onvansertib 60 mg/m^2 + Decitabine
Participants were administered onvansertib at the RP2D on Day 1 up to Day 5 of each cycle (where each cycle is 28 days), in combination with decitabine at a dose of 20mg/m^2 once daily on Day 1 up to day 10 of each cycle.
Units
Counts
Participants
OG0002
OG0012
OG0022
OG0033
OG0045
OG0052
OG0062
OG0073
OG0084
OG0092
OG0103
OG01122
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0033
ParticipantsOG0045
ParticipantsOG0052
ParticipantsOG0062
ParticipantsOG0073
ParticipantsOG0084
ParticipantsOG0092
ParticipantsOG0103
ParticipantsOG01122
Title
Measurements
OG00011.294± 11.098
OG0017.993± NANot calculable due to only 1 participant being analyzed.
OG00212.197± 71.258
OG003
Cycle 1 Day 5
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0033
2 events
1 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected4 at risk
EG0090 events0 affected3 at risk
EG0101 events1 affected6 at risk
EG0112 events2 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0111 events1 affected32 at risk
0 events
0 affected
3 at risk
EG0043 events2 affected5 at risk
EG0051 events1 affected4 at risk
EG0061 events1 affected3 at risk
EG0072 events2 affected3 at risk
EG0084 events2 affected4 at risk
EG0091 events1 affected3 at risk
EG01010 events5 affected6 at risk
EG0118 events8 affected32 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0111 events1 affected32 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected32 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0111 events1 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0115 events5 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0115 events4 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0101 events1 affected6 at risk
EG0112 events2 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0111 events1 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0111 events1 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0111 events1 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0111 events1 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0111 events1 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0101 events1 affected6 at risk
EG0110 events0 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0111 events1 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0101 events1 affected6 at risk
EG0110 events0 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0101 events1 affected6 at risk
EG0110 events0 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0091 events1 affected3 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0111 events1 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0113 events2 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0101 events1 affected6 at risk
EG0111 events1 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0111 events1 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0111 events1 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0111 events1 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0112 events1 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0111 events1 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0111 events1 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0112 events1 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0112 events2 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0111 events1 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0112 events2 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0101 events1 affected6 at risk
EG0110 events0 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0111 events1 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0072 events2 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0116 events4 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
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EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0104 events1 affected6 at risk
EG0113 events3 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0111 events1 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0101 events1 affected6 at risk
EG0111 events1 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0051 events1 affected4 at risk
EG0061 events1 affected3 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0111 events1 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0111 events1 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0091 events1 affected3 at risk
EG0100 events0 affected6 at risk
EG0112 events2 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0111 events1 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0091 events1 affected3 at risk
EG0102 events1 affected6 at risk
EG0111 events1 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0101 events1 affected6 at risk
EG0111 events1 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected32 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected3 at risk
EG0082 events1 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0115 events5 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0102 events2 affected6 at risk
EG0115 events4 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0092 events2 affected3 at risk
EG0105 events3 affected6 at risk
EG0113 events3 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0101 events1 affected6 at risk
EG0113 events3 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected3 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected4 at risk
EG0090 events0 affected3 at risk
EG0101 events1 affected6 at risk
EG0113 events3 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0113 events2 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0113 events3 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0112 events2 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0112 events2 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0112 events2 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0114 events2 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected3 at risk
EG0081 events1 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0101 events1 affected6 at risk
EG0113 events3 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0112 events2 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0113 events3 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0114 events3 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0112 events2 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0112 events2 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0073 events2 affected3 at risk
EG0082 events2 affected4 at risk
EG0091 events1 affected3 at risk
EG0101 events1 affected6 at risk
EG0111 events1 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected4 at risk
EG0090 events0 affected3 at risk
EG0101 events1 affected6 at risk
EG0113 events3 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0102 events2 affected6 at risk
EG0112 events2 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0113 events3 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0091 events1 affected3 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected4 at risk
EG0090 events0 affected3 at risk
EG0101 events1 affected6 at risk
EG0117 events4 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected3 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected4 at risk
EG0090 events0 affected3 at risk
EG0104 events3 affected6 at risk
EG0113 events2 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0112 events2 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0112 events2 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0052 events1 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0101 events1 affected6 at risk
EG0110 events0 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0115 events4 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected4 at risk
EG0090 events0 affected3 at risk
EG0101 events1 affected6 at risk
EG0111 events1 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0112 events2 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0101 events1 affected6 at risk
EG0110 events0 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected3 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0111 events1 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0114 events3 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0082 events1 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0112 events2 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected3 at risk
EG0081 events1 affected4 at risk
EG0091 events1 affected3 at risk
EG0103 events2 affected6 at risk
EG01111 events10 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0091 events1 affected3 at risk
EG0101 events1 affected6 at risk
EG0116 events5 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0083 events1 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0116 events5 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0083 events2 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0116 events4 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG00510 events2 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0084 events2 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0111 events1 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0092 events1 affected3 at risk
EG0101 events1 affected6 at risk
EG0111 events1 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0112 events2 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0055 events1 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0112 events2 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0113 events2 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0072 events2 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0116 events4 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0112 events2 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0101 events1 affected6 at risk
EG0110 events0 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0113 events3 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0091 events1 affected3 at risk
EG0101 events1 affected6 at risk
EG0114 events4 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected4 at risk
EG0091 events1 affected3 at risk
EG0101 events1 affected6 at risk
EG0112 events2 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected4 at risk
EG0090 events0 affected3 at risk
EG0101 events1 affected6 at risk
EG0110 events0 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0082 events1 affected4 at risk
EG0090 events0 affected3 at risk
EG0101 events1 affected6 at risk
EG0110 events0 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0112 events2 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0112 events2 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0115 events3 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0111 events1 affected32 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected6 at risk
EG0111 events1 affected32 at risk
2 events
1 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected4 at risk
EG0091 events1 affected3 at risk
EG0101 events1 affected6 at risk
EG0113 events3 affected32 at risk
2
OG0043
OG0052
OG0063
OG0073
OG0084
OG0092
OG0105
OG01127
1
OG0040
OG0050
OG0060
OG0071
OG0080
OG0091
OG0103
OG0115
339.52
± 31.25
OG004857.29± 38.54
OG005146.10± 56.75
OG006197.67± 85.14
OG007398.38± 32.95
OG008496.24± 52.72
OG009955.59± 54.78
OG0101137.16± 61.56
OG011861.86± 46.68
1.474
± 67.999
OG0042.148± 55.159
OG0052.438± 24.524
OG0061.583± 96.305
OG0073.145± 33.877
OG0083.161± 41.350
OG0093.161± 41.350
OG0103.189± 29.775
OG0112.665± 51.333
7415.04
± 64.35
OG00419470.17± 17.10
OG0051868.69± 70.99
OG0063626.44± 5.33
OG0075343.01± 2.11
OG0087415.04± 64.35
OG00919470.17± 17.10
OG01012981.17± 56.18
OG01111767.29± 39.78
11.747
± 63.901
OG0047.309± 99.539
OG00516.960± 54.430
OG00613.795± 28.866
OG0079.394± 20.598
OG00811.389± 39.530
OG00912.917± 41.715
OG01012.633± 50.655
OG01111.904± 29.602
Participants
OG004
5
ParticipantsOG0052
ParticipantsOG0062
ParticipantsOG0073
ParticipantsOG0084
ParticipantsOG0091
ParticipantsOG0103
ParticipantsOG01122
Title
Measurements
OG00016.413± 28.186
OG00112.561± 38.983
OG00212.246± 38.286
OG0037.321± 8.094
OG00414.484± 32.002
OG00513.282± 39.361
OG0069.082± 25.356
OG00710.713± 23.782
OG00816.337± 27.365
OG00944.018± NANot calculable due to only 1 participant being analyzed.