Open-label Study of FT-2102 With or Without Azacitidine o... | NCT02719574 | Trialant
NCT02719574
Sponsor
Forma Therapeutics, Inc.
Status
Completed
Last Update Posted
Jun 29, 2026Actual
Enrollment
336Actual
Phase
Phase 1Phase 2
Conditions
Acute Myeloid Leukemia
Acute Myelogenous Leukemia
Myelodysplastic Syndrome
Interventions
FT-2102 (olutasidenib)
Azacitidine
Cytarabine
Countries
United States
Australia
Canada
France
Germany
Italy
South Korea
Spain
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT02719574
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
2102-HEM-101
Secondary IDs
Not provided
Brief Title
Open-label Study of FT-2102 With or Without Azacitidine or Cytarabine in Patients With AML or MDS With an IDH1 Mutation
Official Title
A Phase 1/2, Multicenter, Open-label Study of FT-2102 as a Single Agent and in Combination With Azacitidine or Cytarabine in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome With an IDH1 Mutation
Acronym
Not provided
Organization
Novo Nordisk A/SINDUSTRY
Status Module
Record Verification Date
Jun 2026
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
Apr 30, 2016Actual
Primary Completion Date
Dec 28, 2023Actual
Completion Date
Jan 24, 2024Actual
First Submitted Date
Mar 21, 2016
First Submission Date that Met QC Criteria
Mar 21, 2016
First Posted Date
Mar 25, 2016Estimated
Results Waived
Not provided
Results First Submitted Date
Mar 12, 2025
Results First Submitted that Met QC Criteria
Jun 6, 2025
Results First Posted Date
Jun 26, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jun 11, 2026
Last Update Posted Date
Jun 29, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Forma Therapeutics, Inc.INDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This Phase 1/2 study will evaluate the safety, efficacy, PK, and PD of FT-2102 (olutasidenib) as a single agent or in combination with azacitidine or cytarabine. The Phase 1 stage of the study is split into 2 distinct parts: a dose escalation part, which will utilize an open-label design of FT-2102 (olutasidenib) (single agent) and FT-2102 (olutasidenib) + azacitidine (combination agent) administered via one or more intermittent dosing schedules followed by a dose expansion part. The dose expansion part will enroll patients in up to 5 expansion cohorts, exploring single-agent FT-2102 (olutasidenib) activity as well as combination activity with azacitidine or cytarabine. Following the completion of the relevant Phase 1 cohorts, Phase 2 will begin enrollment. Patients will be enrolled across 8 different cohorts, examining the effect of FT-2102 (olutasidenib) (as a single agent) and FT-2102 (olutasidenib) + azacitidine (combination) on various AML/MDS disease states.
PH1 Esc. and Exp. FT-2102 (olutasidenib)+Azacitidine
Experimental
Drug: FT-2102 (olutasidenib)
Drug: Azacitidine
PH1 Esc. and Exp. FT-2102 (olutasidenib)+Cytarabine
Experimental
Drug: FT-2102 (olutasidenib)
Drug: Cytarabine
PH2 Cohort 1 FT-2102 (olutasidenib) Single Agent
Experimental
Relapsed or Refractory (R/R) AML
Drug: FT-2102 (olutasidenib)
PH2 Cohort 2 FT-2102 (olutasidenib) Single Agent
Experimental
AML in morphologic complete remission or complete remission with incomplete blood count recovery (CR/CRi) after prior therapy with residual IDH1-R132 mutation
Drug: FT-2102 (olutasidenib)
PH2 Cohort 3 FT-2102 (olutasidenib) Single Agent
Experimental
R/R AML/MDS, previously treated with FT-2102
Interventions
Name
Type
Description
Arm Group Labels
Other Names
FT-2102 (olutasidenib)
Drug
FT-2102 (olutasidenib) will be supplied as 50 mg or 150 mg capsules and will be administered per the protocol defined frequency and dose level
Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
A TEAE was defined as an adverse event (AE) that emerges during treatment, having been absent pre-treatment, or worsens relative to the pre-treatment state. An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in death, or is life-threatening, or requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, or may have caused a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage. Number of participants with TEAEs and SAEs is reported. Safety analysis set (SAS) included all the participants who have received at least one dose of study drug (FT-2102, azacitidine, or cytarabine).
Phase 1: From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Number of participants with change from baseline in clinically significant abnormal laboratory values for hematology, chemistry and coagulation with Grade <1 to 4 is reported. National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 toxicity grade used to determine severity of AE. Grade 1: mild;asymptomatic/mild symptoms; Grade 2: moderate; minimal; Grade 3: severe/medically significant; Grade 4: life-threatening consequences, Grade 5: death.
Phase 1: From Baseline up to 28 days after last dose of study drug (up to 82 months)
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Electrocardiogram (ECG)
Number of participants with change from baseline in clinically significant abnormal ECG parameter (QTcF) is reported. QT interval was the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTcF was the QT interval corrected for heart rate using Fridericia's formula: QTcF = QT divided by cube root of 60/heart rate.
Secondary Outcomes
Measure
Description
Time Frame
Phase 1: Area Under the Curve (AUClast) for FT-2102
Area under the plasma concentration-time curve from zero time until the last measurable concentration is presented.
Phase 1: Cycle 1 Day 1 and Cycle 2 Day 1 (Cycle length= 28 days)
Phase 1: Maximum Plasma Concentration (Cmax) for FT-2102
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Pathologically proven acute myeloid leukemia (AML) (except acute promyelocytic leukemia [APL] with the t(15;17) translocation) or intermediate, high-risk, or very high risk Myelodysplastic Syndrome (MDS) as defined by the World Health Organization (WHO) criteria or Revised International Prognostic Scoring System (IPSS-R) which is relapsed or refractory (R/R) to standard therapy and/or for which standard therapy is contraindicated or which has not adequately responded to standard therapy.
Patients must have documented IDH1-R132 gene-mutated disease as evaluated by the site
Good performance status
Good kidney and liver function
Exclusion Criteria:
Patients with symptomatic central nervous system (CNS) metastases or other tumor location (such as spinal cord compression, other compressive mass, uncontrolled painful lesion, bone fracture, etc.) necessitating an urgent therapeutic intervention, palliative care, surgery or radiation therapy
Congestive heart failure (New York Heart Association Class III or IV) or unstable angina pectoris. Previous history of myocardial infarction within 1 year prior to study entry, uncontrolled hypertension or uncontrolled arrhythmias
Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
Cortes J, Curti A, Fenaux P, Jonas BA, Krauter J, Montesinos P, Recher C, Taussig DC, Wang ES, Watts J, Wei A, Yee KW, Tian H, Sheppard A, Marzac C, de Botton S. Olutasidenib for mutated IDH1 acute myeloid leukemia: final five-year results from the phase 2 pivotal cohort. J Hematol Oncol. 2025 Nov 14;18(1):102. doi: 10.1186/s13045-025-01751-w.
This study is comprised of 3 stages: A Phase 1 dose-escalation stage, a Phase 1 dose-expansion stage, and a Phase 2 stage. Participants with relapsed or refractory (R/R) acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) with IDH1-R132 mutations received olutasidenib (FT-2102) alone or with azacitidine/ cytarabine in Phase 1 and 2. Based on the totality of data from Phase 1, Recommended Phase 2 dose (RP2D) for single-agent and combination treatment was determined.
Recruitment Details
Total 336 participants enrolled in the study. In phase I, 78 participants were enrolled in single cohorts (FT-2102) and combination cohorts (FT-2102 with azacitidine/cytarabine) and in phase 2, 258 participants were enrolled in single cohorts (FT-2102) and combination cohorts (FT-2102 with azacitidine).
R/R AML/MDS that are naïve to prior hypomethylating therapy and IDH1 inhibitor therapy
Drug: FT-2102 (olutasidenib)
Drug: Azacitidine
PH2 Cohort 5 FT-2102 (olutasidenib)+Azacitidine
Experimental
R/R AML/MDS that have inadequately responded to or have progressed on prior hypomethylating therapy
Drug: FT-2102 (olutasidenib)
Drug: Azacitidine
PH2 Cohort 6 FT-2102 (olutasidenib)+Azacitidine
Experimental
R/R AML/MDS that have been previously treated with single-agent FT-2102 as their last therapy prior to study enrollment
Drug: FT-2102 (olutasidenib)
Drug: Azacitidine
PH2 Cohort 7 FT-2102 (olutasidenib) Single Agent
Experimental
Treatment naïve AML for whom standard treatments are contraindicated
Drug: FT-2102 (olutasidenib)
PH2 Cohort 8 FT-2102 (olutasidenib)+Azacitidine
Experimental
Treatment naïve AML who are candidates for azacitidine first line treatment
Drug: FT-2102 (olutasidenib)
Drug: Azacitidine
PH1 Esc. and Exp. FT-2102 (olutasidenib)+Azacitidine
PH1 Esc. and Exp. FT-2102 (olutasidenib)+Cytarabine
PH2 Cohort 1 FT-2102 (olutasidenib) Single Agent
PH2 Cohort 2 FT-2102 (olutasidenib) Single Agent
PH2 Cohort 3 FT-2102 (olutasidenib) Single Agent
PH2 Cohort 4 FT-2102 (olutasidenib)+Azacitidine
PH2 Cohort 5 FT-2102 (olutasidenib)+Azacitidine
PH2 Cohort 6 FT-2102 (olutasidenib)+Azacitidine
PH2 Cohort 7 FT-2102 (olutasidenib) Single Agent
PH2 Cohort 8 FT-2102 (olutasidenib)+Azacitidine
Azacitidine
Drug
azacitidine will be administered per site's standard of care
PH1 Esc. and Exp. FT-2102 (olutasidenib)+Azacitidine
PH2 Cohort 4 FT-2102 (olutasidenib)+Azacitidine
PH2 Cohort 5 FT-2102 (olutasidenib)+Azacitidine
PH2 Cohort 6 FT-2102 (olutasidenib)+Azacitidine
PH2 Cohort 8 FT-2102 (olutasidenib)+Azacitidine
Vidaza
Cytarabine
Drug
low-dose cytarabine will be administered per site's standard of care
PH1 Esc. and Exp. FT-2102 (olutasidenib)+Cytarabine
Phase 1: From Baseline up to 28 days after last dose of study drug (up to 82 months)
Phase 2, Cohort 1: Percentage of Participants With Complete Remission (CR) Plus Complete Remission With Partial Hematological Recovery (CRh) for Acute Myeloid Leukemia Assessed by Investigator Based on International Working Group (IWG) Response Criteria
Percentage of participants with CR plus CRh (CR, Molecular CR [CRm], Cytogenetic CR [CRc], CRh) is re-ported. CR is defined as bone marrow blasts less than (<) 5 percent (%) (in aspirate with spicules and 200 nucleated cells), no blasts with auer rods, no extramedullary disease, absolute neutrophil count (ANC) greater than or equal to (>=) 1000/μL, platelet count >=100,000/μL and transfusion independ-ence. CRc is defined as CR with no residual cytogenetic abnormalities. CRm is defined as CR with unde-tectable IDH1m minimal residual disease (MRD) and CRh is defined as bone marrow blasts and partial recovery of peripheral blood counts (platelet count >50 × 10^9/L and ANC > 0.5 × 10^9/L).
Phase 2: up to 3 weeks post last dose of study drug or until the introduction of new anticancer therapy, whichever is earlier (up to 82 months)
Phase 2, Cohort 3, 4, 5, 6, 7, 8: Percentage of Participants With CR Plus CRh for Acute Myeloid Leukemia Assessed by Investigator Based on IWG Response Criteria
Percentage of participants with CR plus CRh (CR, Molecular CR [CRm]), Cytogenetic CR [CRc], CRh) is re-ported. CR is defined as bone marrow blasts <5 % (in aspirate with spicules and 200 nucleated cells), no blasts with auer rods, no extramedullary disease, ANC >=1000/μL, platelet count >=100,000/μL and transfusion independ-ence. CRc is defined as CR with no residual cytogenetic abnormalities. CRm is de-fined as CR with undetectable IDH1m MRD and CRh is defined as bone marrow blasts and partial recovery of peripheral blood counts (platelet count >50 × 10^9/L and ANC > 0.5 × 10^9/L).
Phase 2: up to 3 weeks post last dose of study drug or until the introduction of new anticancer therapy, whichever is earlier (up to 82 months)
Phase 2, Cohort 4 and 5: Percentage of Participants With CR for MDS Assessed by IWG Response Criteria
Percentage of participants with complete remission (CR) is reported. CR is defined as bone marrow blast ≤ 5% myeloblasts with normal maturation of all cell lines, peripheral blood: Hgb ≥11 grams per deciliter (g/dL), platelets ≥ 100 × 10^9/L, neutrophils ≥ 1.0 × 10^9/L and blasts 0%.
Phase 2: up to 3 weeks post last dose of study drug or until the introduction of new anticancer therapy, whichever is earlier (up to 82 months)
RFS is defined as the time between the date of first dose until relapse or death from any cause, whichever occurs first. RFS is calculated for all participants in Phase 2 Cohort 2. 4-Month RFS rate is defined as the percentage of participants in Phase 2 Cohort 2 who have not relapsed or died on or before their 4-month response evaluation.
Phase 2: From the date of first dose until relapse or death from any cause, whichever occurs first (up to 4 months)
Maximum plasma concentration (Cmax) for FT-2102 is presented.
Phase 1: Cycle 1 Day 1 and Cycle 2 Day 1 (Cycle length= 28 days)
Phase 1: Time to Maximum Plasma Concentration (Tmax) for FT-2102
Time to reach the maximum plasma concentration (Tmax) is presented.
Phase 1: Cycle 1 Day 1 and Cycle 2 Day 1 (Cycle length= 28 days)
Phase 1: Time to Response (TTR) for AML
TTR is the time in months between the first dose of study drug and documentation of the first overall response for participants who achieve a PR or better. This analysis was performed only on participants who have achieved PR or better as a best overall response.
Phase 1: Time from first dose of study drug until documentation of the first overall response (up to 82 months)
Phase 1: Duration of Overall Response for AML
Duration of response is defined as the time from the date of the first response to the date of the relapse or death. The estimation of median duration of overall response was done by Kaplan-Meier method.
Phase 1: From date of the first response to the date of the relapse or death (up to 82 months)
Phase 1: Time to Response (TTR ) for MDS
TTR is the time in months between the first dose of study drug and documentation of the first overall response for participants who achieve a PR or better. This analysis was performed only on participants who have achieved PR or better as a best overall response.
Phase 1: Time from first dose of study drug until documentation of the first overall response (up to 82 months)
Phase 2: Time to Response (TTR) for Acute Myeloid Leukemia (AML)
TTR is the time in months between the first dose of study drug and documentation of the first overall response for participants who achieve a PR or better. This analysis was performed only on participants who have achieved PR or better as a best overall response.
Phase 2: Time from first dose of study drug until documentation of the first overall response (up to 82 months)
Phase 2: Duration of Overall Response for Acute Myeloid Leukemia (AML)
Duration of overall response is defined as the time from the date of the first response to the date of the relapse or death. The estimation of median duration of overall response was done by Kaplan-Meier method.
Phase 2: From the date of the first response to the date of the relapse or death (up to 82 months)
Phase 2, Cohort 4 and Cohort 5: Time to Response (TTR) for Myelodysplastic Syndrome (MDS)
TTR is the time in months between the first dose of study drug and documentation of the first overall response for participants who achieve a PR or better. This analysis was performed only on participants who have achieved PR or better as a best overall response.
Phase 2: Time from first dose of study drug until documentation of the first overall response (up to 82 months)
Phase 2, Cohort 4 and Cohort 5: Duration of Overall Response for Myelodysplastic Syndrome (MDS)
Duration of overall response was calculated similarly to DCR but was assessed the time in months between documentation of the first response of PR or better until the date of relapse, death, whichever is earlier. The estimation of median duration of overall response was done by Kaplan-Meier method. The median duration of overall response is defined as the time at which 50% of the participants in a study have experienced the event of interest (relapse or death). Given the presence of only a single participant in the sample, there is an absence of variability in outcomes, and therefore, it was not possible to ascertain a time point at which half of the participants have experienced the event. Hence, median value could not be calculated.
Phase 2: From the documentation of the first response of PR or better until the date of relapse, death, whichever is earlier (up to 82 months)
Phase 2, Cohort 2: Time to Relapse-Free Survival (RFS)
RFS was calculated for all participants in Phase 2 Cohort 2. RFS is defined as the time (in months) between the date of first dose until relapse or death from any cause, whichever occurs first. Relapse free survival time to event is reported for all participants in Cohort 2.
Phase 2: From the date of first dose until relapse or death from any cause, whichever occurs first (up to 82 months)
Phase 2: Overall Survival (OS)
OS is defined as the time in months from the first dose of study drug until death from any cause. For the participants who are not known to have died by the end of study follow-up, OS will be censored on the date the participants was last known to be alive. OS is calculated using Kaplan-Meier method.
Phase 2: From first dose of study drug until death from any cause (up to 82 months)
Phase 2: Event-free Survival (EFS)
EFS is defined as the time in months between first dose of study drug and disease progression, relapse, death from any cause, treatment failure, or start of other (non-protocol study drug) new antileukemia therapy, whichever occurs first.
Phase 2: From first dose of study drug to disease progression, relapse, death from any cause, treatment failure, or start of other (non-protocol study drug) new antileukemia therapy (up to 82 months)
Phase 2: Transfusion Independence
Transfusion independence is defined as the number of participants who experience at least a 56-day period during any point on treatment without requiring a transfusion of RBC and/or platelet transfusion. Participants are classified as either "dependent" or "independent" at baseline based on their transfusion history. Those who received either platelets or pRBC or both within 8 weeks prior to the first dose of FT-2102 are considered "dependent". Number of participants with transfusion independent is reported here.
Phase 2: From baseline (8 weeks prior to first dose) up to treatment period (up to 82 months)
Phase 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
A TEAE was defined as an AE that emerges during treatment, having been absent pre-treatment, or worsens relative to the pre-treatment state. An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. A SAE is defined as any untoward medical occur-rence that at any dose results in death, or is life-threatening, or requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, or may have caused a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage. Number of participants with TEAEs and SAEs is reported.
Phase 2: From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Number of participants with change from baseline in clinically significant abnormal laboratory values for hematology, chemistry and coagulation with Grade <1 to 4 is reported. National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 toxicity grade used to determine severity of AE. Grade 1: mild;asymptomatic/mild symptoms; Grade 2: moderate; minimal; Grade 3: severe/medically significant; Grade 4: life-threatening consequences, Grade 5: death.
Phase 2: From Baseline up to 28 days after last dose of study drug (up to 82 months)
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Electrocardiogram (ECG)
Number of participants with change from baseline in clinically significant abnormal ECG parameter (QTcF) is reported. QT interval was the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTcF was the QT interval corrected for heart rate using Fridericia's formula: QTcF = QT divided by cube root of 60/heart rate.
Phase 2: From Baseline up to 28 days after last dose of study drug (up to 82 months)
Phase 2: Area Under the Curve (AUClast) for FT-2102
Area under the plasma concentration-time curve from zero time until the last measurable concentration is presented.
Phase 2: Cycle 1 Day 1 and Cycle 2 Day 1 (Cycle length= 28 days)
Phase 2: Maximum Plasma Concentration (Cmax) for FT-2102
Maximum Plasma Concentartion (Cmax) for FT-2102 is presented.
Phase 2: Cycle 1 Day 1 and Cycle 2 Day 1 (Cycle length= 28 days)
Phase 2: Time to Maximum Plasma Concentration (Tmax) for FT-2102
Time to reach the maximum plasma concentration (Tmax) for FT-2102 is presented.
Phase 2: Cycle 1 Day 1 and Cycle 2 Day 1 (Cycle length= 28 days)
Sacramento
California
95817
United States
Yale University
New Haven
Connecticut
06510
United States
University of Miami
Miami
Florida
33136
United States
Emory Winship Cancer Institute
Atlanta
Georgia
30322
United States
Northwestern University Feinberg School of Medicine
Chicago
Illinois
60611
United States
University of Maryland Greenebaum Cancer Center
Baltimore
Maryland
21201
United States
Karmanos Cancer Institute
Detroit
Michigan
48201
United States
Roswell Park Cancer Institute
Buffalo
New York
14263
United States
New York Medical College
Hawthorne
New York
10532
United States
Columbia University Medical Center
New York
New York
10032
United States
Cornell University Weill Medical College
New York
New York
10065
United States
Duke University Medical Center
Durham
North Carolina
27705
United States
The Ohio State University
Columbus
Ohio
43210
United States
Oregon Health & Science University
Portland
Oregon
97229
United States
Sarah Cannon Research Institute - Tennessee Oncology
Nashville
Tennessee
37203
United States
Vanderbilt University Medical Center
Nashville
Tennessee
37232
United States
University of Texas Southwestern Medical Center
Dallas
Texas
75390
United States
MD Anderson Cancer Center
Houston
Texas
77030
United States
Royal Adelaide Hospital
Adelaide
South Australia
5000
Australia
The Alfred Hospital
Melbourne
Victoria
3004
Australia
Victoria Cancer Care Center
Parkville
Victoria
3000
Australia
Sir Charles Gairdner Hospital
Nedlands
Western Australia
6009
Australia
Box Hill Hospital, Monash University and Eastern Health Clinical School
Box Hill
3128
Australia
Princess Margaret Hospital
Toronto
Ontario
M5G 2M9
Canada
Service d'Hématologie Clinique, Hôpital Avicenne-APHP-Université Paris
Bobigny
93000
France
Assistance Publique Hopitaux de Marseille (AP-HM) - Hopital Nord
Marseille
13005
France
Centre Hospitalier Universitaire Nantes
Nantes
44093
France
Hôpital Saint-Louis
Paris
75010
France
Hopitaux Universitaires Est Parisien Hopital Saint-Antoine
Paris
75012
France
Centre Hospitalier Universitaire (CHU) Bordeaux - Hospitaux du Haut Leveque
Pessac
33604
France
Centre Hospitalier Lyon Sud
Pierre-Bénite
69495
France
University Hospital of Rennes
Rennes
35033
France
Institut Universitaire du Cancer Toulouse - Oncopole
Toulouse
31059
France
Centre Hospitalier Universitaire de Nancy - Hopital Brabois
Vandœuvre-lès-Nancy
54511
France
Institut de Cancérologie Gustave Roussy
Villejuif
94805
France
Staedtisches Klinikum Braunschweig gGmbH
Braunschweig
Germany
Universitaetsklinikum Giessen und Marburg GmbH - Klinik fuer Innere Medizin
Giessen
Germany
Landeszentrum fuer Zell- und Gentherapie
Halle
Germany
Universitätsklinikum Münster Medizinische Klinik A, Hämatologie, Hämostaseologi
Münster
Germany
AOU S. Luigi Gonzaga - Orbassano
Orbassano
Turin
Italy
Ospedale Mazzoni - UOC Ematologia Ascoli Piceno
Ascoli Piceno
Italy
Universita di Bologna
Bologna
Italy
Dipartimento di Oncologia Medica - IRST IRCC
Meldola
Italy
Università degli Studi di Parma
Parma
Italy
U.O. Ematologia Ravenna
Ravenna
Italy
Hospital Rimini Hematology, Department of Oncology and Hematoloy
Rimini
Italy
Seoul National University Bundang Hospital
Gumi
13620
South Korea
Seoul National University Hospital
Seoul
03080
South Korea
Hospital Vall d'Hebron
Barcelona
08035
Spain
Hospital Clinic de Barcelona
Barcelona
8036
Spain
Institut Català d'Oncologia-Hospital Duran i Reynals
Barcelona
8908
Spain
Hospital Universitario 12 De Octubre
Madrid
28041
Spain
Hospital Clínico Universitario de Salamanca
Salamanca
37007
Spain
Hospital La Fe
Valencia
46026
Spain
University College London Hospitals NHS Foundation Trust
London
NW1 2PG
United Kingdom
St. George's University Hospital
London
United Kingdom
Churchill Hospital
Oxford
United Kingdom
Southampton General Hospital
Southampton
United Kingdom
Royal Marsden Hospital
Sutton
SM2 5PT
United Kingdom
Derived
Cortes JE, Yang J, Roboz GJ, Dinner SN, Wang ES, Wei AH, Tian H, di Trapani F, Baer MR, Donnellan W, Watts JM. Olutasidenib alone or combined with azacitidine in patients with mutant IDH1 myelodysplastic syndrome. Blood Adv. 2025 Oct 28;9(20):5293-5305. doi: 10.1182/bloodadvances.2025016718.
Cortes JE, Roboz GJ, Baer MR, Jonas BA, Schiller GJ, Yee K, Ferrell PB, Yang J, Wang ES, Blum WG, Mims A, Tian H, Sheppard A, de Botton S, Montesinos P, Curti A, Watts JM; Olutasidenib Combination Therapy Study Group. Olutasidenib in combination with azacitidine induces durable complete remissions in patients with relapsed or refractory mIDH1 acute myeloid leukemia: a multicohort open-label phase 1/2 trial. J Hematol Oncol. 2025 Jan 16;18(1):7. doi: 10.1186/s13045-024-01657-z.
de Botton S, Fenaux P, Yee K, Recher C, Wei AH, Montesinos P, Taussig DC, Pigneux A, Braun T, Curti A, Grove C, Jonas BA, Khwaja A, Legrand O, Peterlin P, Arnan M, Blum W, Cilloni D, Hiwase DK, Jurcic JG, Krauter J, Thomas X, Watts JM, Yang J, Polyanskaya O, Brevard J, Sweeney J, Barrett E, Cortes J. Olutasidenib (FT-2102) induces durable complete remissions in patients with relapsed or refractory IDH1-mutated AML. Blood Adv. 2023 Jul 11;7(13):3117-3127. doi: 10.1182/bloodadvances.2022009411.
Participants with AML or MDS received combination therapy (FT-2102 150 mg QD and azacitidine administered at the dose of 75 mg/m^2 for 7 days IV/SC per every 28-day cycle) until treatment discontinuation.
Participants with AML or MDS received combination therapy (FT-2102 150 mg BID and azacitidine administered at the dose of 75 mg/m^2 for 7 days IV/SC per every 28-day cycle) until treatment discontinuation.
Participants with AML or MDS received combination therapy (FT-2102 150 mg BID and azacitidine administered at the dose of 75 mg/m^2 for 7 days IV/SC per every 28-day cycle) until treatment discontinuation.
Participants with AML harboring IDH1 mutation received FT-2102 150 mg BID in combination with low-dose cytarabine (LDAC) administered at the dose of 20 mg BID SC for 10 days every 28-day cycle until treatment discontinuation.
FG009
Phase 2: Cohort 1; FT-2102 (Single Agent)
Participants with relapsed/refractory (R/R) AML received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
FG010
Phase 2: Cohort 2; FT-2102 (Single Agent)
Participants with AML in morphologic complete remission (CR)/ complete remission with incomplete blood count recovery (CRi) after prior therapy with residual isocitrate dehydrogenase 1 ([IDH1]-R132 mutation were received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
FG011
Phase 2: Cohort 3; FT-2102 (Single Agent)
Participants with R/R AML or MDS who were previously treated with FT-2102 and who underwent HSCT on-study then relapsed post-HSCT received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
Participants with relapsed/refractory (R/R) AML that is naïve to prior hypomethylating therapy and IDH1 inhibitor therapy received combination therapy of azacitidine 75 mg/m^2 + FT-2102 150 mg BID in continuous 28-day cycles.
Participants with R/R AML/MDS that have inadequately responded to or have progressed on prior hypo-methylating therapy received combination therapy of azacitidine 75 mg/m^2 + FT-2102 150 mg BID in continuous 28-day cycles.
Participants with R/R AML/MDS that have been previously treated with single agent FT-2102 as their last therapy prior to study enrolment received combination therapy of azacitidine + FT-2102 150 mg BID in continuous 28-day cycles. Participants from the FT-2102 single agent cohorts of this study allowed to be enrolled in Cohort 6 after their disease progression.
FG015
Phase 2: Cohort 7; FT-2102 (Single Agent)
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given single agent of FT-2102 150 mg BID in continuous 28-day cycles.
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m^2 + FT-2102 150 mg BID in continuous 28-day cycles.
FG0003 subjects
FG0018 subjects
FG0027 subjects
FG0034 subjects
FG0047 subjects
FG0058 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
NOT COMPLETED
FG0003 subjects
FG0018 subjects
FG0027 subjects
FG0034 subjects
FG0047 subjects
FG0058 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
Type
Comment
Reasons
Other
FG0000 subjects
FG0012 subjects
FG0021 subjects
FG0032 subjects
FG0042 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
Progressive Disease
FG0001 subjects
FG0013 subjects
FG0022 subjects
FG0032 subjects
FG004
HSCT Transplant
FG0000 subjects
FG0011 subjects
FG0022 subjects
FG0030 subjects
FG004
Death
FG0002 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG004
Adverse Event
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Phase 1 (Dose Expansion)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0069 subjects
FG00731 subjects
FG0081 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Progressive Disease
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Phase 2
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG009153 subjects
FG01018 subjects
FG0115 subjects
FG01220 subjects
FG01321 subjects
FG01420 subjects
FG01510 subjects
FG01611 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Protocol Defined Disease Progression
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Full Analysis Set (FAS) included all the participants who were enrolled in the study and have received at least one dose of FT-2102.
Participants with AML or MDS received combination therapy (FT-2102 150 mg QD and azacitidine administered at the dose of 75 mg/m^2 for 7 days IV/SC per every 28-day cycle) until treatment discontinuation.
Participants with AML or MDS received combination therapy (FT-2102 150 mg BID and azacitidine administered at the dose of 75 mg/m^2 for 7 days IV/SC per every 28-day cycle) until treatment discontinuation.
Participants with AML or MDS received combination therapy (FT-2102 150 mg BID and azacitidine administered at the dose of 75 mg/m^2 for 7 days IV/SC per every 28-day cycle) until treatment discontinuation.
Participants with AML harboring IDH1 mutation received FT-2102 150 mg BID in combination with LDAC administered at the dose of 20 mg BID SC for 10 days every 28-day cycle until treatment discontinuation.
BG009
Phase 2: Cohort 1; FT-2102 (Single Agent)
Participants with R/R AML received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
BG010
Phase 2: Cohort 2; FT-2102 (Single Agent)
Participants with AML in morphologic CR/CRi after prior therapy with residual IDH1-R132 mutation were received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
BG011
Phase 2: Cohort 3; FT-2102 (Single Agent)
Participants with R/R AML or MDS who were previously treated with FT-2102 and who underwent HSCT on-study then relapsed post-HSCT received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
Participants with R/R AML that is naïve to prior hypomethylating therapy and IDH1 inhibitor therapy received combination therapy of azacitidine 75 mg/m^2 + FT-2102 150 mg BID in continuous 28-day cycles.
Participants with R/R AML/MDS that have inadequately responded to or have progressed on prior hypo-methylating therapy received combination therapy of azacitidine 75 mg/m^2 + FT-2102 150 mg BID in continuous 28-day cycles.
Participants with R/R AML/MDS that have been previously treated with single agent FT-2102 as their last therapy prior to study enrolment received combination therapy of azacitidine + FT-2102 150 mg BID in continuous 28-day cycles. Participants from the FT-2102 single agent cohorts of this study allowed to be enrolled in Cohort 6 after their disease progression.
BG015
Phase 2: Cohort 7; FT-2102 (Single Agent)
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given single agent of FT-2102 150 mg BID in continuous 28-day cycles.
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m^2 + FT-2102 150 mg BID in continuous 28-day cycles.
BG017
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0003
BG0018
BG0027
BG0034
BG0047
BG0058
BG0069
BG00731
BG0081
BG009153
BG01018
BG0115
BG01220
BG01321
BG01420
BG01510
BG01611
BG017336
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<65 years
BG0000
BG0013
BG0021
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0002
BG0015
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
Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
A TEAE was defined as an adverse event (AE) that emerges during treatment, having been absent pre-treatment, or worsens relative to the pre-treatment state. An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in death, or is life-threatening, or requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, or may have caused a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage. Number of participants with TEAEs and SAEs is reported. Safety analysis set (SAS) included all the participants who have received at least one dose of study drug (FT-2102, azacitidine, or cytarabine).
SAS analyzed. Since 150 mg BID has been established as MTD, the analysis was directed towards emphasizing findings that are most relevant for determining a safe and effective treatment strategy. Accordingly, data for the other dose levels (100 mg QD, 150 mg QD, and 300 mg QD) were combined as prespecified in statistical analysis plan (SAP).
Posted
Count of Participants
Participants
Phase 1: From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
ID
Title
Description
OG000
Phase 1: FT-2102 (Single Agent)
Participants with AML or MDS received single agent FT-2102 orally BID in 28-day cycles at dose levels of 150 mg until maximum MTD or maximum MED achieved.
OG001
Phase 1: Total FT-2102 (Single Agent)
Participants with AML or MDS received single agent FT-2102 orally QD and BID in 28-day cycles at the different dose levels (150 mg and ≤ 300 mg) until MTD or MED achieved.
Participants with AML or MDS received combination therapy (FT-2102 + azacitidine 75 mg/m^2) orally BID in 28-day cycles at dose levels of 150 mg until MTD or MED achieved.
OG003
Phase 1: Total FT-2102; FT-2102 + Azacitidine (Combination Therapy)
Participants with AML or MDS received combination therapy (FT-2102 150 mg and ≤ 300 mg and azacitidine administered at the dose of 75 mg/m^2 for 7 days IV/SC per every 28-day cycle) until treatment discontinuation.
Units
Counts
Participants
OG00016
OG00131
OG00239
OG003
Title
Denominators
Categories
TEAEs
Title
Measurements
OG00016
OG00131
OG00239
OG003
Primary
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Number of participants with change from baseline in clinically significant abnormal laboratory values for hematology, chemistry and coagulation with Grade <1 to 4 is reported. National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 toxicity grade used to determine severity of AE. Grade 1: mild;asymptomatic/mild symptoms; Grade 2: moderate; minimal; Grade 3: severe/medically significant; Grade 4: life-threatening consequences, Grade 5: death.
SAS analyzed. Since 150 mg BID has been established as MTD, the analysis was directed towards emphasizing findings that are most relevant for determining a safe and effective treatment strategy. Accordingly, data for the other dose levels (100 mg QD, 150 mg QD, and 300 mg QD) were combined as prespecified in SAP.
Posted
Count of Participants
Participants
Phase 1: From Baseline up to 28 days after last dose of study drug (up to 82 months)
ID
Title
Description
OG000
Phase 1: FT-2102 (Single Agent)
Participants with AML or MDS received single agent FT-2102 orally BID in 28-day cycles at dose levels of 150 mg until maximum MTD or maximum MED achieved.
OG001
Phase 1: Total FT-2102 (Single Agent)
Participants with AML or MDS received single agent FT-2102 orally QD and BID in 28-day cycles at the differ-ent dose levels (150 mg and ≤ 300 mg) until MTD or MED achieved.
Primary
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Electrocardiogram (ECG)
Number of participants with change from baseline in clinically significant abnormal ECG parameter (QTcF) is reported. QT interval was the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTcF was the QT interval corrected for heart rate using Fridericia's formula: QTcF = QT divided by cube root of 60/heart rate.
SAS. Here, N=Number of participants with available data. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels (100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
Posted
Count of Participants
Participants
Phase 1: From Baseline up to 28 days after last dose of study drug (up to 82 months)
ID
Title
Description
OG000
Phase 1: FT-2102 (Single Agent)
Participants with AML or MDS received single agent FT-2102 orally BID in 28-day cycles at dose levels of 150 mg until maximum MTD or maximum MED achieved.
OG001
Phase 1: Total FT-2102 (Single Agent)
Participants with AML or MDS received single agent FT-2102 orally QD and BID in 28-day cycles at the differ-ent dose levels (150 mg and ≤ 300 mg) until MTD or MED achieved.
Primary
Phase 2, Cohort 1: Percentage of Participants With Complete Remission (CR) Plus Complete Remission With Partial Hematological Recovery (CRh) for Acute Myeloid Leukemia Assessed by Investigator Based on International Working Group (IWG) Response Criteria
Percentage of participants with CR plus CRh (CR, Molecular CR [CRm], Cytogenetic CR [CRc], CRh) is re-ported. CR is defined as bone marrow blasts less than (<) 5 percent (%) (in aspirate with spicules and 200 nucleated cells), no blasts with auer rods, no extramedullary disease, absolute neutrophil count (ANC) greater than or equal to (>=) 1000/μL, platelet count >=100,000/μL and transfusion independ-ence. CRc is defined as CR with no residual cytogenetic abnormalities. CRm is defined as CR with unde-tectable IDH1m minimal residual disease (MRD) and CRh is defined as bone marrow blasts and partial recovery of peripheral blood counts (platelet count >50 × 10^9/L and ANC > 0.5 × 10^9/L).
Efficacy evaluable analysis set included all participants in Phase 2, Cohort 1 with confirmed IDH1-R132 who have received the first dose of FT-2102 180 days or more prior to the analysis cutoff date. This outcome measure is applicable only for Cohort 1.
Posted
Number
95% Confidence Interval
Percentage of participants
Phase 2: up to 3 weeks post last dose of study drug or until the introduction of new anticancer therapy, whichever is earlier (up to 82 months)
ID
Title
Description
OG000
Phase 2: Cohort 1; FT-2102 (Single Agent)
Participants with R/R AML received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
Primary
Phase 2, Cohort 3, 4, 5, 6, 7, 8: Percentage of Participants With CR Plus CRh for Acute Myeloid Leukemia Assessed by Investigator Based on IWG Response Criteria
Percentage of participants with CR plus CRh (CR, Molecular CR [CRm]), Cytogenetic CR [CRc], CRh) is re-ported. CR is defined as bone marrow blasts <5 % (in aspirate with spicules and 200 nucleated cells), no blasts with auer rods, no extramedullary disease, ANC >=1000/μL, platelet count >=100,000/μL and transfusion independ-ence. CRc is defined as CR with no residual cytogenetic abnormalities. CRm is de-fined as CR with undetectable IDH1m MRD and CRh is defined as bone marrow blasts and partial recovery of peripheral blood counts (platelet count >50 × 10^9/L and ANC > 0.5 × 10^9/L).
FAS included all the participants who were enrolled in the study and have received at least one dose of FT-2102. This outcome measure is applicable for Cohort 3, 4, 5, 6, 7 and 8. Here, Overall Number of Participants Analyzed = participants with available data for this outcome measure.
Posted
Number
95% Confidence Interval
Percentage of participants
Phase 2: up to 3 weeks post last dose of study drug or until the introduction of new anticancer therapy, whichever is earlier (up to 82 months)
ID
Title
Description
OG000
Phase 2: Cohort 3; FT-2102 (Single Agent)
Participants with R/R AML or MDS who were previously treated with FT-2102 and who underwent HSCT on-study then relapsed post-HSCT received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
Phase 2, Cohort 4 and 5: Percentage of Participants With CR for MDS Assessed by IWG Response Criteria
Percentage of participants with complete remission (CR) is reported. CR is defined as bone marrow blast ≤ 5% myeloblasts with normal maturation of all cell lines, peripheral blood: Hgb ≥11 grams per deciliter (g/dL), platelets ≥ 100 × 10^9/L, neutrophils ≥ 1.0 × 10^9/L and blasts 0%.
FAS included all the participants who were enrolled in the study and have received at least one dose of FT-2102. This outcome measure is applicable for Cohort 4 and 5. Here, Overall Number of Participants Analyzed = participants with available data for this outcome measure.
Posted
Number
95% Confidence Interval
Percentage of participants
Phase 2: up to 3 weeks post last dose of study drug or until the introduction of new anticancer therapy, whichever is earlier (up to 82 months)
Participants with R/R AML that is naïve to prior hypomethylating therapy and IDH1 inhibitor therapy received combination therapy of azacitidine 75 mg/m^2 + FT-2102 150 mg BID in continuous 28-day cycles.
Participants with R/R AML/MDS that have inadequately responded to or have progressed on prior hypo-methylating therapy received combination therapy of azacitidine 75 mg/m^2 + FT-2102 150 mg BID in continuous 28-day cycles.
RFS is defined as the time between the date of first dose until relapse or death from any cause, whichever occurs first. RFS is calculated for all participants in Phase 2 Cohort 2. 4-Month RFS rate is defined as the percentage of participants in Phase 2 Cohort 2 who have not relapsed or died on or before their 4-month response evaluation.
FAS included all the participants who were enrolled in the study and have received at least one dose of FT-2102. This outcome measure is applicable for Cohort 2.
Posted
Number
95% Confidence Interval
Percentage of participants
Phase 2: From the date of first dose until relapse or death from any cause, whichever occurs first (up to 4 months)
ID
Title
Description
OG000
Phase 2: Cohort 2; FT-2102 (Single Agent)
Participants with AML in morphologic complete remission (CR)/ complete remission with incomplete blood count recovery (CRi) after prior therapy with residual isocitrate dehydrogenase 1 ([IDH1]-R132 mutation were received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
Units
Counts
Participants
OG000
Secondary
Phase 1: Area Under the Curve (AUClast) for FT-2102
Area under the plasma concentration-time curve from zero time until the last measurable concentration is presented.
The pharmacokinetic (PK) analysis set included those participants for whom it was possible to calculate at least 1 primary PK parameter and who had no major protocol deviations thought to influence the absorption, distribution, metabolism, and excretion of the FT-2102. Here, number anaylzed (n) = participants with available data for specific timepoints.
Posted
Geometric Mean
Geometric Coefficient of Variation
Hour*nanograms per millilitre (h*ng/mL)
Phase 1: Cycle 1 Day 1 and Cycle 2 Day 1 (Cycle length= 28 days)
ID
Title
Description
OG000
Phase 1: FT-2102 100 mg QD (Single Agent)
Participants with AML or MDS received single agent FT-2102 orally QD in 28-day cycles at dose level of 100 mg until MTD or MED achieved.
OG001
Phase 1: FT-2102 150 mg QD (Single Agent)
Participants with AML or MDS received single agent FT-2102 orally QD in 28-day cycles at dose levels of 150 mg until MTD or MED achieved.
OG002
Phase 1: FT-2102 300 mg QD (Single Agent)
Participants with AML or MDS received single agent FT-2102 orally QD in 28-day cycles at dose levels of 300 mg until MTD or MED achieved.
Secondary
Phase 1: Maximum Plasma Concentration (Cmax) for FT-2102
Maximum plasma concentration (Cmax) for FT-2102 is presented.
The PK analysis set included those participants for whom it was possible to calculate at least 1 primary PK parameter and who had no major protocol deviations thought to influence the absorption, distribution, metabolism, and excretion of the FT-2102. Here, number anaylzed (n) = participants with available data for specific timepoints.
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanograms per millilitre (ng/mL)
Phase 1: Cycle 1 Day 1 and Cycle 2 Day 1 (Cycle length= 28 days)
ID
Title
Description
OG000
Phase 1: FT-2102 100 mg QD (Single Agent)
Participants with AML or MDS received single agent FT-2102 orally QD in 28-day cycles at dose level of 100 mg until MTD or MED achieved.
OG001
Phase 1: FT-2102 150 mg QD (Single Agent)
Participants with AML or MDS received single agent FT-2102 orally QD in 28-day cycles at dose levels of 150 mg until MTD or MED achieved.
OG002
Phase 1: FT-2102 300 mg QD (Single Agent)
Participants with AML or MDS received single agent FT-2102 orally QD in 28-day cycles at dose levels of 300 mg until MTD or MED achieved.
Secondary
Phase 1: Time to Maximum Plasma Concentration (Tmax) for FT-2102
Time to reach the maximum plasma concentration (Tmax) is presented.
The PK analysis set included those participants for whom it was possible to calculate at least 1 primary PK parameter and who had no major protocol deviations thought to influence the absorption, distribution, metabolism, and excretion of the FT-2102. Here, number anaylzed (n) = participants with available data for specific timepoints.
Posted
Median
Full Range
hour
Phase 1: Cycle 1 Day 1 and Cycle 2 Day 1 (Cycle length= 28 days)
ID
Title
Description
OG000
Phase 1: FT-2102 100 mg QD (Single Agent)
Participants with AML or MDS received single agent FT-2102 orally QD in 28-day cycles at dose level of 100 mg until MTD or MED achieved.
OG001
Phase 1: FT-2102 150 mg QD (Single Agent)
Participants with AML or MDS received single agent FT-2102 orally QD in 28-day cycles at dose levels of 150 mg until MTD or MED achieved.
OG002
Phase 1: FT-2102 300 mg QD (Single Agent)
Participants with AML or MDS received single agent FT-2102 orally QD in 28-day cycles at dose levels of 300 mg until MTD or MED achieved.
Secondary
Phase 1: Time to Response (TTR) for AML
TTR is the time in months between the first dose of study drug and documentation of the first overall response for participants who achieve a PR or better. This analysis was performed only on participants who have achieved PR or better as a best overall response.
FAS. N=participants with PR or better as best overall response. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels (100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
Posted
Median
Full Range
Months
Phase 1: Time from first dose of study drug until documentation of the first overall response (up to 82 months)
ID
Title
Description
OG000
Phase 1: FT-2102 (Single Agent)
Participants with AML or MDS received single agent FT-2102 orally BID in 28-day cycles at dose levels of 150 mg until maximum MTD or maximum MED achieved.
OG001
Phase 1: Total FT-2102 (Single Agent)
Participants with AML or MDS received single agent FT-2102 orally QD and BID in 28-day cycles at the differ-ent dose levels (150 mg and ≤ 300 mg) until MTD or MED achieved.
Duration of response is defined as the time from the date of the first response to the date of the relapse or death. The estimation of median duration of overall response was done by Kaplan-Meier method.
FAS. N=participants with available data for this outcome measure. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD)were combined as prespecified in SAP.
Posted
Median
95% Confidence Interval
Months
Phase 1: From date of the first response to the date of the relapse or death (up to 82 months)
ID
Title
Description
OG000
Phase 1: FT-2102 (Single Agent)
Participants with AML or MDS received single agent FT-2102 orally BID in 28-day cycles at dose levels of 150 mg until maximum MTD or maximum MED achieved.
OG001
Phase 1: Total FT-2102 (Single Agent)
Participants with AML or MDS received single agent FT-2102 orally QD and BID in 28-day cycles at the differ-ent dose levels (150 mg and ≤ 300 mg) until MTD or MED achieved.
TTR is the time in months between the first dose of study drug and documentation of the first overall response for participants who achieve a PR or better. This analysis was performed only on participants who have achieved PR or better as a best overall response.
FAS. N=participants with PR or better as best overall response. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
Posted
Median
Full Range
Months
Phase 1: Time from first dose of study drug until documentation of the first overall response (up to 82 months)
ID
Title
Description
OG000
Phase 1: FT-2102 (Single Agent)
Participants with AML or MDS received single agent FT-2102 orally BID in 28-day cycles at dose levels of 150 mg until maximum MTD or maximum MED achieved.
OG001
Phase 1: Total FT-2102 (Single Agent)
Participants with AML or MDS received single agent FT-2102 orally QD and BID in 28-day cycles at the differ-ent dose levels (150 mg and ≤ 300 mg) until MTD or MED achieved.
Phase 2: Time to Response (TTR) for Acute Myeloid Leukemia (AML)
TTR is the time in months between the first dose of study drug and documentation of the first overall response for participants who achieve a PR or better. This analysis was performed only on participants who have achieved PR or better as a best overall response.
FAS included all the participants who were enrolled in the study and have received at least one dose of FT-2102. Here, Overall Number of Participants Analyzed = participants with PR or better as a best overall response. Data is reported only for Cohort 1, 3, 4, 5, 6, 7 and 8.
Posted
Median
Full Range
Months
Phase 2: Time from first dose of study drug until documentation of the first overall response (up to 82 months)
ID
Title
Description
OG000
Phase 2: Cohort 1; FT-2102 (Single Agent)
Participants with R/R AML received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
OG001
Phase 2: Cohort 3; FT-2102 (Single Agent)
Participants with R/R AML or MDS who were previously treated with FT-2102 and who underwent HSCT on-study then relapsed post-HSCT received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
Phase 2: Duration of Overall Response for Acute Myeloid Leukemia (AML)
Duration of overall response is defined as the time from the date of the first response to the date of the relapse or death. The estimation of median duration of overall response was done by Kaplan-Meier method.
FAS included all the participants who were enrolled in the study and have received at least one dose of FT-2102. Data is reported only for Cohort 1, 4, 5, 6, 7 and 8. No participants achieved an overall response in Phase 2 Cohort 3. Duration of Response is not calculated for Phase 2 Cohort 2. Here, Overall Number of Participants Analyzed = participants with overall response for this outcome measure.
Posted
Median
95% Confidence Interval
Months
Phase 2: From the date of the first response to the date of the relapse or death (up to 82 months)
ID
Title
Description
OG000
Phase 2: Cohort 1; FT-2102 (Single Agent)
Participants with R/R AML received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
Participants with R/R AML that is naïve to prior hypomethylating therapy and IDH1 inhibitor therapy received combination therapy of azacitidine 75 mg/m^2 + FT-2102 150 mg BID in continuous 28-day cycles.
Phase 2, Cohort 4 and Cohort 5: Time to Response (TTR) for Myelodysplastic Syndrome (MDS)
TTR is the time in months between the first dose of study drug and documentation of the first overall response for participants who achieve a PR or better. This analysis was performed only on participants who have achieved PR or better as a best overall response.
FAS included all the participants who were enrolled in the study and have received at least one dose of FT-2102. This outcome measure is applicable for Cohort 4 and 5. Here, Overall Number of Participants Analyzed = participants with PR or better as a best overall response.
Posted
Median
Full Range
Months
Phase 2: Time from first dose of study drug until documentation of the first overall response (up to 82 months)
Participants with R/R AML that is naïve to prior hypomethylating therapy and IDH1 inhibitor therapy received combination therapy of azacitidine 75 mg/m^2 + FT-2102 150 mg BID in continuous 28-day cycles.
Participants with R/R AML/MDS that have inadequately responded to or have progressed on prior hypo-methylating therapy received combination therapy of azacitidine 75 mg/m^2 + FT-2102 150 mg BID in continuous 28-day cycles.
Secondary
Phase 2, Cohort 4 and Cohort 5: Duration of Overall Response for Myelodysplastic Syndrome (MDS)
Duration of overall response was calculated similarly to DCR but was assessed the time in months between documentation of the first response of PR or better until the date of relapse, death, whichever is earlier. The estimation of median duration of overall response was done by Kaplan-Meier method. The median duration of overall response is defined as the time at which 50% of the participants in a study have experienced the event of interest (relapse or death). Given the presence of only a single participant in the sample, there is an absence of variability in outcomes, and therefore, it was not possible to ascertain a time point at which half of the participants have experienced the event. Hence, median value could not be calculated.
FAS included all the participants who were enrolled in the study and have received at least one dose of FT-2102. This outcome measure is applicable only for cohort 4 and 5. Here, Overall Number of Participants Analyzed = participants with overall response for this outcome measure.
Posted
Median
95% Confidence Interval
Months
Phase 2: From the documentation of the first response of PR or better until the date of relapse, death, whichever is earlier (up to 82 months)
Participants with R/R AML that is naïve to prior hypomethylating therapy and IDH1 inhibitor therapy received combination therapy of azacitidine 75 mg/m^2 + FT-2102 150 mg BID in continuous 28-day cycles.
OG001
Secondary
Phase 2, Cohort 2: Time to Relapse-Free Survival (RFS)
RFS was calculated for all participants in Phase 2 Cohort 2. RFS is defined as the time (in months) between the date of first dose until relapse or death from any cause, whichever occurs first. Relapse free survival time to event is reported for all participants in Cohort 2.
Full analysis set (FAS) included all the participants who were enrolled in the study and have received at least one dose of FT-2102. This outcome measure is applicable for Cohort 2.
Posted
Median
95% Confidence Interval
Months
Phase 2: From the date of first dose until relapse or death from any cause, whichever occurs first (up to 82 months)
ID
Title
Description
OG000
Phase 2: Cohort 2; FT-2102 (Single Agent)
Participants with AML in morphologic CR/CRi after prior therapy with residual IDH1-R132 mutation were received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
Units
Counts
Participants
OG000
Secondary
Phase 2: Overall Survival (OS)
OS is defined as the time in months from the first dose of study drug until death from any cause. For the participants who are not known to have died by the end of study follow-up, OS will be censored on the date the participants was last known to be alive. OS is calculated using Kaplan-Meier method.
FAS included all the participants who were enrolled in the study and have received at least one dose of FT-2102.
Posted
Median
95% Confidence Interval
Months
Phase 2: From first dose of study drug until death from any cause (up to 82 months)
ID
Title
Description
OG000
Phase 2: Cohort 1; FT-2102 (Single Agent)
Participants with R/R AML received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
OG001
Phase 2: Cohort 2; FT-2102 (Single Agent)
Participants with AML in morphologic CR/CRi after prior therapy with residual IDH1-R132 mutation were received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
OG002
Phase 2: Cohort 3; FT-2102 (Single Agent)
Participants with R/R AML or MDS who were previously treated with FT-2102 and who underwent HSCT on-study then relapsed post-HSCT received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
Secondary
Phase 2: Event-free Survival (EFS)
EFS is defined as the time in months between first dose of study drug and disease progression, relapse, death from any cause, treatment failure, or start of other (non-protocol study drug) new antileukemia therapy, whichever occurs first.
FAS included all the participants who were enrolled in the study and have received at least one dose of FT-2102
Posted
Median
95% Confidence Interval
Months
Phase 2: From first dose of study drug to disease progression, relapse, death from any cause, treatment failure, or start of other (non-protocol study drug) new antileukemia therapy (up to 82 months)
ID
Title
Description
OG000
Phase 2: Cohort 1; FT-2102 (Single Agent)
Participants with R/R AML received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
OG001
Phase 2: Cohort 2; FT-2102 (Single Agent)
Participants with AML in morphologic CR/CRi after prior therapy with residual IDH1-R132 mutation were received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
OG002
Phase 2: Cohort 3; FT-2102 (Single Agent)
Participants with R/R AML or MDS who were previously treated with FT-2102 and who underwent HSCT on-study then relapsed post-HSCT received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
Secondary
Phase 2: Transfusion Independence
Transfusion independence is defined as the number of participants who experience at least a 56-day period during any point on treatment without requiring a transfusion of RBC and/or platelet transfusion. Participants are classified as either "dependent" or "independent" at baseline based on their transfusion history. Those who received either platelets or pRBC or both within 8 weeks prior to the first dose of FT-2102 are considered "dependent". Number of participants with transfusion independent is reported here.
FAS included all the participants who were enrolled in the study and have received at least one dose of FT-2102.
Posted
Count of Participants
Participants
Phase 2: From baseline (8 weeks prior to first dose) up to treatment period (up to 82 months)
ID
Title
Description
OG000
Phase 2: Cohort 1; FT-2102 (Single Agent)
Participants with R/R AML received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
OG001
Phase 2: Cohort 2; FT-2102 (Single Agent)
Participants with AML in morphologic CR/CRi after prior therapy with residual IDH1-R132 mutation were received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
OG002
Phase 2: Cohort 3; FT-2102 (Single Agent)
Secondary
Phase 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
A TEAE was defined as an AE that emerges during treatment, having been absent pre-treatment, or worsens relative to the pre-treatment state. An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. A SAE is defined as any untoward medical occur-rence that at any dose results in death, or is life-threatening, or requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, or may have caused a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage. Number of participants with TEAEs and SAEs is reported.
Safety analysis set included all the participants who have received at least one dose of study drug (FT-2102, azacitidine, or cytarabine).
Posted
Count of Participants
Participants
Phase 2: From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
ID
Title
Description
OG000
Phase 2: Cohort 1; FT-2102 (Single Agent)
Participants with R/R AML received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
OG001
Phase 2: Cohort 2; FT-2102 (Single Agent)
Participants with AML in morphologic CR/CRi after prior therapy with residual IDH1-R132 mutation were received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
Secondary
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Number of participants with change from baseline in clinically significant abnormal laboratory values for hematology, chemistry and coagulation with Grade <1 to 4 is reported. National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 toxicity grade used to determine severity of AE. Grade 1: mild;asymptomatic/mild symptoms; Grade 2: moderate; minimal; Grade 3: severe/medically significant; Grade 4: life-threatening consequences, Grade 5: death.
Safety analysis set included all the participants who have received at least one dose of study drug (FT-2102, azacitidine, or cytarabine).
Posted
Count of Participants
Participants
Phase 2: From Baseline up to 28 days after last dose of study drug (up to 82 months)
ID
Title
Description
OG000
Phase 2: Cohort 1; FT-2102 (Single Agent)
Participants with R/R AML received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
OG001
Phase 2: Cohort 2; FT-2102 (Single Agent)
Participants with AML in morphologic CR)/CRi after prior therapy with residual IDH1-R132 mutation were received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
OG002
Phase 2: Cohort 3; FT-2102 (Single Agent)
Secondary
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Electrocardiogram (ECG)
Number of participants with change from baseline in clinically significant abnormal ECG parameter (QTcF) is reported. QT interval was the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTcF was the QT interval corrected for heart rate using Fridericia's formula: QTcF = QT divided by cube root of 60/heart rate.
Safety analysis set included all the participants who have received at least one dose of study drug (FT-2102, azacitidine, or cytarabine). Here, Overall Number of Participants Analyzed = participants with available data for this outcome measure.
Posted
Count of Participants
Participants
Phase 2: From Baseline up to 28 days after last dose of study drug (up to 82 months)
ID
Title
Description
OG000
Phase 2: Cohort 1; FT-2102 (Single Agent)
Participants with R/R AML received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
OG001
Phase 2: Cohort 2; FT-2102 (Single Agent)
Participants with AML in morphologic CR/CRi after prior therapy with residual IDH1-R132 mutation were received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
OG002
Phase 2: Cohort 3; FT-2102 (Single Agent)
Secondary
Phase 2: Area Under the Curve (AUClast) for FT-2102
Area under the plasma concentration-time curve from zero time until the last measurable concentration is presented.
The PK analysis set included those participants for whom it was possible to calculate at least 1 primary PK parameter and who had no major protocol deviations thought to influence the absorption, distribution, metabolism, and excretion of the FT-2102. Here, Overall Number of Participants Analyzed (N) and number analyzed (n) = participants with available data for specific timepoints.
Posted
Geometric Mean
Geometric Coefficient of Variation
h*ng/mL
Phase 2: Cycle 1 Day 1 and Cycle 2 Day 1 (Cycle length= 28 days)
Participants with AML in morphologic CR/CRi after prior therapy with residual IDH1-R132 mutation were received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
Participants with R/R AML or MDS who were previously treated with FT-2102 and who underwent HSCT on-study then relapsed post-HSCT received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
Secondary
Phase 2: Maximum Plasma Concentration (Cmax) for FT-2102
Maximum Plasma Concentartion (Cmax) for FT-2102 is presented.
The PK analysis set included those participants for whom it was possible to calculate at least 1 primary PK parameter and who had no major protocol deviations thought to influence the absorption, distribution, metabolism, and excretion of the FT-2102. Here, Overall Number of Participants Analyzed (N) and number analyzed (n) = participants with available data for specific timepoints.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Phase 2: Cycle 1 Day 1 and Cycle 2 Day 1 (Cycle length= 28 days)
Participants with AML in morphologic CR/CRi after prior therapy with residual IDH1-R132 mutation were received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
Participants with R/R AML or MDS who were previously treated with FT-2102 and who underwent HSCT on-study then relapsed post-HSCT received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
Secondary
Phase 2: Time to Maximum Plasma Concentration (Tmax) for FT-2102
Time to reach the maximum plasma concentration (Tmax) for FT-2102 is presented.
The PK analysis set included those participants for whom it was possible to calculate at least 1 primary PK parameter and who had no major protocol deviations thought to influence the absorption, distribution, metabolism, and excretion of the FT-2102. Here, Overall Number of Participants Analyzed (N) and number analyzed (n) = participants with available data for specific timepoints.
Posted
Median
Full Range
hour
Phase 2: Cycle 1 Day 1 and Cycle 2 Day 1 (Cycle length= 28 days)
Participants with AML in morphologic CR/CRi after prior therapy with residual IDH1-R132 mutation were received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
Participants with R/R AML or MDS who were previously treated with FT-2102 and who underwent HSCT on-study then relapsed post-HSCT received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
Time Frame
From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
Description
All presented AEs are TEAEs. TEAE is AE that emerges during treatment and absent pre-treatment/worsens relative to pre-treatment. 1 participant received FT-2102 with cytarabine, included in Phase 1 total column. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels(100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Phase 1: FT-2102 (Single Agent)
Participants with AML or MDS received single agent FT-2102 orally BID in 28-day cycles at dose levels of 150 mg until MTD or MED achieved.
4
16
10
16
15
16
EG001
Phase 1: Total FT-2102 (Single Agent)
Participants with AML or MDS received single agent FT-2102 orally QD and BID in 28-day cycles at the different dose levels (150 mg and ≤ 300 mg) until MTD or MED achieved.
Participants with AML or MDS received combination therapy (FT-2102 + azacitidine 75 mg/m^2) orally BID in 28-day cycles at dose levels of 150 mg until MTD or MED achieved.
9
39
30
39
39
39
EG003
Phase 1: Total FT-2102; FT-2102 + Azacitidine (Combination Therapy)
Participants with AML or MDS received combination therapy (FT-2102 150 mg and ≤ 300 mg and azacitidine administered at the dose of 75 mg/m^2 for 7 days IV/SC per every 28-day cycle) until treatment discontinuation.
10
46
36
46
46
46
EG004
Phase 1: Overall
Participants with AML or MDS received single agent (FT-2102), combination therapy (FT-2102 + azacitidine, FT-2102+ LDAC) starting at 150 mg BID dose level until MTD or MED achieved or treatment discontinuation.
21
78
60
78
76
78
EG005
Phase 2: Cohort 1; FT-2102 (Single Agent)
Participants with R/R AML received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
50
153
115
153
152
153
EG006
Phase 2: Cohort 2; FT-2102 (Single Agent)
Participants with AML in morphologic CR/CRi after prior therapy with residual IDH1-R132 mutation were received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
0
18
6
18
18
18
EG007
Phase 2: Cohort 3; FT-2102 (Single Agent)
Participants with R/R AML or MDS who were previously treated with FT-2102 and who underwent HSCT on-study then relapsed post-HSCT received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
Participants with R/R AML that is naïve to prior hypomethylating therapy and IDH1 inhibitor therapy received combination therapy of azacitidine 75 mg/m^2 + FT-2102 150 mg BID in continuous 28-day cycles.
Participants with R/R AML/MDS that have inadequately responded to or have progressed on prior hypo-methylating therapy received combination therapy of azacitidine 75 mg/m^2 + FT-2102 150 mg BID in continuous 28-day cycles.
Participants with R/R AML/MDS that have been previously treated with single agent FT-2102 as their last therapy prior to study enrolment received combination therapy of azacitidine + FT-2102 150 mg BID in continuous 28-day cycles. Participants from the FT-2102 single agent cohorts of this study allowed to be enrolled in Cohort 6 after their disease progression.
7
20
13
20
19
20
EG011
Phase 2: Cohort 7; FT-2102 (Single Agent)
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given single agent of FT-2102 150 mg BID in continuous 28-day cycles.
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m^2 + FT-2102 150 mg BID in continuous 28-day cycles.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 19.1
Systematic Assessment
EG0005 events2 affected16 at risk
EG0016 events3 affected31 at risk
EG0028 events5 affected39 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 19.1
Systematic Assessment
EG0008 events4 affected16 at risk
EG0018 events4 affected31 at risk
EG0022 events2 affected39 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected16 at risk
EG0011 events1 affected31 at risk
EG0026 events5 affected39 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected31 at risk
EG0021 events1 affected39 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0023 events3 affected39 at risk
EG003
Brain natriuretic peptide increased
Investigations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Chest X-ray abnormal
Investigations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Chills
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected31 at risk
EG00210 events6 affected39 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected39 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0013 events2 affected31 at risk
EG0023 events3 affected39 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0004 events4 affected16 at risk
EG0017 events7 affected31 at risk
EG00235 events24 affected39 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 19.1
Systematic Assessment
EG0002 events2 affected16 at risk
EG0014 events4 affected31 at risk
EG0024 events4 affected39 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Systematic Assessment
EG0003 events3 affected16 at risk
EG0015 events5 affected31 at risk
EG00216 events15 affected39 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 19.1
Systematic Assessment
EG0003 events3 affected16 at risk
EG0017 events7 affected31 at risk
EG00212 events8 affected39 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected16 at risk
EG0012 events2 affected31 at risk
EG0026 events3 affected39 at risk
EG003
Depression
Psychiatric disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0025 events4 affected39 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0006 events5 affected16 at risk
EG0018 events7 affected31 at risk
EG00221 events16 affected39 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG0005 events3 affected16 at risk
EG00110 events7 affected31 at risk
EG00216 events11 affected39 at risk
EG003
Dry eye
Eye disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0012 events2 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected31 at risk
EG0022 events2 affected39 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected31 at risk
EG0023 events3 affected39 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected16 at risk
EG0011 events1 affected31 at risk
EG0025 events5 affected39 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected16 at risk
EG0012 events2 affected31 at risk
EG0025 events4 affected39 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected16 at risk
EG0011 events1 affected31 at risk
EG0022 events2 affected39 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Systematic Assessment
EG0005 events4 affected16 at risk
EG0018 events7 affected31 at risk
EG00222 events12 affected39 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected31 at risk
EG0021 events1 affected39 at risk
EG003
Early satiety
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0002 events2 affected16 at risk
EG0013 events3 affected31 at risk
EG0024 events3 affected39 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0024 events3 affected39 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Systematic Assessment
EG0003 events2 affected16 at risk
EG0016 events5 affected31 at risk
EG0028 events7 affected39 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected16 at risk
EG0012 events2 affected31 at risk
EG0025 events3 affected39 at risk
EG003
Eye haemorrhage
Eye disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected16 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Facial pain
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 19.1
Systematic Assessment
EG0002 events2 affected16 at risk
EG0014 events3 affected31 at risk
EG0027 events4 affected39 at risk
EG003
Fatigue
General disorders
MedDRA 19.1
Systematic Assessment
EG0009 events6 affected16 at risk
EG00116 events13 affected31 at risk
EG00225 events16 affected39 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected31 at risk
EG0027 events5 affected39 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Systematic Assessment
EG0002 events1 affected16 at risk
EG0013 events2 affected31 at risk
EG0022 events2 affected39 at risk
EG003
Fluid overload
Metabolism and nutrition disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected31 at risk
EG0022 events2 affected39 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected39 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected16 at risk
EG0011 events1 affected31 at risk
EG0024 events4 affected39 at risk
EG003
Generalised oedema
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected31 at risk
EG0021 events1 affected39 at risk
EG003
Gingival hypertrophy
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0023 events3 affected39 at risk
EG003
Gingival pain
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected16 at risk
EG0012 events2 affected31 at risk
EG0022 events2 affected39 at risk
EG003
Gingival swelling
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Haematoma
Vascular disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0014 events3 affected31 at risk
EG0021 events1 affected39 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 19.1
Systematic Assessment
EG0003 events3 affected16 at risk
EG0014 events4 affected31 at risk
EG0025 events5 affected39 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0022 events2 affected39 at risk
EG003
Headache
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected16 at risk
EG0017 events6 affected31 at risk
EG00220 events13 affected39 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected16 at risk
EG0013 events3 affected31 at risk
EG0023 events3 affected39 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected16 at risk
EG0013 events3 affected31 at risk
EG0021 events1 affected39 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected31 at risk
EG0021 events1 affected39 at risk
EG003
Hyperphosphataemia
Metabolism and nutrition disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0012 events2 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Hypertension
Vascular disorders
MedDRA 19.1
Systematic Assessment
EG0003 events3 affected16 at risk
EG0015 events5 affected31 at risk
EG0029 events7 affected39 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 19.1
Systematic Assessment
EG0002 events2 affected16 at risk
EG0014 events4 affected31 at risk
EG0023 events3 affected39 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected16 at risk
EG0012 events2 affected31 at risk
EG0023 events3 affected39 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected16 at risk
EG0013 events3 affected31 at risk
EG0026 events3 affected39 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 19.1
Systematic Assessment
EG0002 events2 affected16 at risk
EG0018 events7 affected31 at risk
EG00218 events13 affected39 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 19.1
Systematic Assessment
EG0002 events2 affected16 at risk
EG0013 events3 affected31 at risk
EG0025 events5 affected39 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected16 at risk
EG0013 events3 affected31 at risk
EG0025 events5 affected39 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0022 events2 affected39 at risk
EG003
Hypotension
Vascular disorders
MedDRA 19.1
Systematic Assessment
EG0002 events2 affected16 at risk
EG0015 events4 affected31 at risk
EG0025 events5 affected39 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected16 at risk
EG0012 events2 affected31 at risk
EG0021 events1 affected39 at risk
EG003
Injection site reaction
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0024 events3 affected39 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 19.1
Systematic Assessment
EG0004 events4 affected16 at risk
EG0016 events6 affected31 at risk
EG0026 events5 affected39 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0012 events1 affected31 at risk
EG0021 events1 affected39 at risk
EG003
Laceration
Injury, poisoning and procedural complications
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected31 at risk
EG0022 events1 affected39 at risk
EG003
Lethargy
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected31 at risk
EG0021 events1 affected39 at risk
EG003
Lipase increased
Investigations
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected16 at risk
EG0011 events1 affected31 at risk
EG0026 events4 affected39 at risk
EG003
Liver function test abnormal
Investigations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 19.1
Systematic Assessment
EG0002 events2 affected16 at risk
EG0013 events3 affected31 at risk
EG0025 events4 affected39 at risk
EG003
Malaise
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected31 at risk
EG0022 events2 affected39 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA 19.1
Systematic Assessment
EG0002 events2 affected16 at risk
EG0013 events3 affected31 at risk
EG0021 events1 affected39 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Systematic Assessment
EG0003 events2 affected16 at risk
EG0013 events2 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected16 at risk
EG0012 events2 affected31 at risk
EG0022 events2 affected39 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected31 at risk
EG0021 events1 affected39 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Systematic Assessment
EG0003 events2 affected16 at risk
EG0015 events3 affected31 at risk
EG0024 events4 affected39 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected16 at risk
EG0013 events3 affected31 at risk
EG0022 events2 affected39 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Systematic Assessment
EG0002 events2 affected16 at risk
EG0012 events2 affected31 at risk
EG0023 events3 affected39 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected16 at risk
EG0012 events2 affected31 at risk
EG0024 events3 affected39 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG00011 events6 affected16 at risk
EG00123 events14 affected31 at risk
EG00237 events26 affected39 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0015 events3 affected31 at risk
EG00235 events12 affected39 at risk
EG003
Oedema peripheral
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected31 at risk
EG00210 events8 affected39 at risk
EG003
Onychoclasis
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0022 events2 affected39 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0026 events5 affected39 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Pain
General disorders
MedDRA 19.1
Systematic Assessment
EG0002 events1 affected16 at risk
EG0013 events2 affected31 at risk
EG0023 events3 affected39 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Systematic Assessment
EG0002 events2 affected16 at risk
EG0014 events4 affected31 at risk
EG00213 events8 affected39 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0022 events2 affected39 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0025 events5 affected39 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected39 at risk
EG003
Paronychia
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0012 events2 affected31 at risk
EG0022 events2 affected39 at risk
EG003
Peripheral swelling
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected31 at risk
EG0029 events7 affected39 at risk
EG003
Petechiae
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected16 at risk
EG0013 events2 affected31 at risk
EG0021 events1 affected39 at risk
EG003
Platelet count decreased
Investigations
MedDRA 19.1
Systematic Assessment
EG0007 events4 affected16 at risk
EG00116 events8 affected31 at risk
EG00267 events18 affected39 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Systematic Assessment
EG0002 events2 affected16 at risk
EG0013 events3 affected31 at risk
EG0022 events2 affected39 at risk
EG003
Pleuritic pain
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected16 at risk
EG0011 events1 affected31 at risk
EG0024 events4 affected39 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 19.1
Systematic Assessment
EG0002 events1 affected16 at risk
EG0013 events2 affected31 at risk
EG0029 events5 affected39 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Proctalgia
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0012 events1 affected31 at risk
EG0022 events1 affected39 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected39 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0003 events3 affected16 at risk
EG0014 events4 affected31 at risk
EG0028 events7 affected39 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Pyrexia
General disorders
MedDRA 19.1
Systematic Assessment
EG0005 events4 affected16 at risk
EG00112 events9 affected31 at risk
EG00214 events9 affected39 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0024 events4 affected39 at risk
EG003
Red blood cell count decreased
Investigations
MedDRA 19.1
Systematic Assessment
EG0006 events4 affected16 at risk
EG00110 events6 affected31 at risk
EG00226 events8 affected39 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Systematic Assessment
EG0003 events3 affected16 at risk
EG0013 events3 affected31 at risk
EG0026 events5 affected39 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected31 at risk
EG0021 events1 affected39 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Skin hyperpigmentation
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected31 at risk
EG0022 events2 affected39 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0022 events1 affected39 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected16 at risk
EG0012 events2 affected31 at risk
EG0023 events3 affected39 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected16 at risk
EG0012 events2 affected31 at risk
EG0023 events3 affected39 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 19.1
Systematic Assessment
EG0003 events3 affected16 at risk
EG0016 events5 affected31 at risk
EG0024 events3 affected39 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0012 events2 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Transfusion reaction
Injury, poisoning and procedural complications
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected39 at risk
EG003
Tremor
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0013 events2 affected31 at risk
EG0021 events1 affected39 at risk
EG003
Tumour lysis syndrome
Metabolism and nutrition disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected16 at risk
EG0015 events4 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0024 events4 affected39 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected31 at risk
EG0024 events3 affected39 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected31 at risk
EG0023 events3 affected39 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected31 at risk
EG0024 events3 affected39 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected31 at risk
EG0024 events3 affected39 at risk
EG003
Vision blurred
Eye disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected31 at risk
EG0022 events2 affected39 at risk
EG003
Visual acuity reduced
Eye disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0003 events3 affected16 at risk
EG00112 events8 affected31 at risk
EG00220 events14 affected39 at risk
EG003
Weight decreased
Investigations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0024 events4 affected39 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected16 at risk
EG0012 events2 affected31 at risk
EG0029 events6 affected39 at risk
EG003
White blood cell count increased
Investigations
MedDRA 19.1
Systematic Assessment
EG0003 events2 affected16 at risk
EG0014 events3 affected31 at risk
EG00210 events8 affected39 at risk
EG003
Abdominal rigidity
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Abdominal tenderness
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Abnormal loss of weight
Metabolism and nutrition disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Actinic keratosis
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Administration site pain
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Adrenal adenoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Affective disorder
Psychiatric disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Ageusia
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Agitation
Psychiatric disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0022 events2 affected39 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Anal fissure
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected39 at risk
EG003
Anal ulcer
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected16 at risk
EG0011 events1 affected31 at risk
EG0021 events1 affected39 at risk
EG003
Angioedema
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Aortic calcification
Vascular disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Articular calcification
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Atrial tachycardia
Cardiac disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Atrioventricular block first degree
Cardiac disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Blister
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Blood bicarbonate decreased
Investigations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Blood creatine increased
Investigations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected39 at risk
EG003
Blood fibrinogen decreased
Investigations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Blood phosphorus decreased
Investigations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Blood urea increased
Investigations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Blood uric acid increased
Investigations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Bone marrow failure
Blood and lymphatic system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Bone swelling
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Breast haemorrhage
Reproductive system and breast disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Breast mass
Reproductive system and breast disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Bronchopulmonary aspergillosis
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Candida infection
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected39 at risk
EG003
Catarrh
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Catheter site bruise
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Catheter site haemorrhage
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Catheter site rash
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected39 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0022 events1 affected39 at risk
EG003
Chalazion
Eye disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Cholestasis
Hepatobiliary disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Chronic sinusitis
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0022 events2 affected39 at risk
EG003
Conjunctival haemorrhage
Eye disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0022 events2 affected39 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected39 at risk
EG003
Corona virus infection
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected39 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Coronavirus test positive
Investigations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Cystitis
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Delirium
Psychiatric disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected39 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Device related infection
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected39 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Disseminated intravascular coagulation
Blood and lymphatic system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Drug intolerance
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Dyspnoea paroxysmal nocturnal
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected39 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected31 at risk
EG0025 events3 affected39 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected16 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Embolism
Vascular disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Endotheliomatosis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Enterobacter bacteraemia
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Enterococcal bacteraemia
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected39 at risk
EG003
Enterococcus test positive
Investigations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Eosinophilia
Blood and lymphatic system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Eosinophilic colitis
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Erysipelas
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Escherichia urinary tract infection
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Essential tremor
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Eye oedema
Eye disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Eyelid ptosis
Eye disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Febrile bone marrow aplasia
Blood and lymphatic system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Flat affect
Psychiatric disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected16 at risk
EG0011 events1 affected31 at risk
EG0021 events1 affected39 at risk
EG003
Food poisoning
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Frequent bowel movements
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Fungal rhinitis
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected16 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected39 at risk
EG003
General physical health deterioration
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Genital erythema
Reproductive system and breast disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Genital infection fungal
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Gingival bleeding
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0003 events2 affected16 at risk
EG0013 events2 affected31 at risk
EG0023 events2 affected39 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected39 at risk
EG003
Haemorrhagic diathesis
Blood and lymphatic system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected39 at risk
EG003
Haemorrhoidal haemorrhage
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Hand fracture
Injury, poisoning and procedural complications
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Heart rate increased
Investigations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Hepatic steatosis
Hepatobiliary disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected16 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Herpes virus infection
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Hidradenitis
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Hyperaesthesia
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Hyperferritinaemia
Metabolism and nutrition disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Hyperkeratosis
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Hypersomnia
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Hypertensive crisis
Vascular disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Hypervolaemia
Metabolism and nutrition disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected16 at risk
EG0011 events1 affected31 at risk
EG0023 events3 affected39 at risk
EG003
Hypogammaglobulinaemia
Immune system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Influenza like illness
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Injection site erythema
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected39 at risk
EG003
Injection site pain
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0022 events2 affected39 at risk
EG003
Iron deficiency
Metabolism and nutrition disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Jaundice
Hepatobiliary disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Joint effusion
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Klebsiella infection
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Lactic acidosis
Metabolism and nutrition disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Left ventricular dysfunction
Cardiac disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Liver function test increased
Investigations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected39 at risk
EG003
Lower respiratory tract infection fungal
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Lung infection
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Macular fibrosis
Eye disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected39 at risk
EG003
Malnutrition
Metabolism and nutrition disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0024 events4 affected39 at risk
EG003
Medication error
Injury, poisoning and procedural complications
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Melanocytic naevus
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected39 at risk
EG003
Mental disorder
Psychiatric disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Miliaria
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Motor dysfunction
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Mouth haemorrhage
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0023 events3 affected39 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected16 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Mucosal dryness
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Muscle twitching
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Myocardial ischaemia
Cardiac disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Nail infection
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Nasal septum perforation
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected16 at risk
EG0011 events1 affected31 at risk
EG0022 events2 affected39 at risk
EG003
Neuralgia
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected16 at risk
EG0011 events1 affected31 at risk
EG0021 events1 affected39 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected39 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0022 events2 affected39 at risk
EG003
Odynophagia
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Onycholysis
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Ophthalmic herpes zoster
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected16 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Oral fungal infection
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Orchitis
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0022 events2 affected39 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Papule
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Parainfluenzae virus infection
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected39 at risk
EG003
Periarthritis
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Periorbital haematoma
Injury, poisoning and procedural complications
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Peritonsillar abscess
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Platelet count increased
Investigations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Pneumonia pseudomonal
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Post procedural haemorrhage
Injury, poisoning and procedural complications
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Proctitis
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Pruritus generalised
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Pseudomonal sepsis
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Purpura
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected39 at risk
EG003
Pyoderma gangrenosum
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Rales
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected39 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0022 events2 affected39 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected39 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Rash pustular
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected39 at risk
EG003
Renal colic
Renal and urinary disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected16 at risk
EG0011 events1 affected31 at risk
EG0022 events2 affected39 at risk
EG003
Respiratory syncytial virus infection
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Restless legs syndrome
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Restlessness
Psychiatric disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Rheumatoid arthritis
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0025 events4 affected39 at risk
EG003
Scab
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Seronegative arthritis
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Sinus pain
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected39 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0023 events2 affected39 at risk
EG003
Skin mass
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0024 events4 affected39 at risk
EG003
Skin reaction
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0023 events2 affected39 at risk
EG003
Splenomegaly
Blood and lymphatic system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected39 at risk
EG003
Sputum discoloured
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0022 events1 affected39 at risk
EG003
Staphylococcal bacteraemia
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected39 at risk
EG003
Staphylococcal sepsis
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Staphylococcus test positive
Investigations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Stomatitis haemorrhagic
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Syncope
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Tachypnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Temperature intolerance
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Thrombophlebitis superficial
Vascular disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Thrombosis
Vascular disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Thrombotic thrombocytopenic purpura
Blood and lymphatic system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected39 at risk
EG003
Tongue dysplasia
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Tooth infection
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected16 at risk
EG0011 events1 affected31 at risk
EG0021 events1 affected39 at risk
EG003
Toxic skin eruption
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Transaminases increased
Investigations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0022 events2 affected39 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Urinary hesitation
Renal and urinary disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected16 at risk
EG0011 events1 affected31 at risk
EG0025 events4 affected39 at risk
EG003
Varices oesophageal
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Venous thrombosis limb
Vascular disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Ventricular tachycardia
Cardiac disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected39 at risk
EG003
Vessel puncture site bruise
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Visual field defect
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Visual impairment
Eye disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Vitamin D deficiency
Metabolism and nutrition disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Vulvovaginal dryness
Reproductive system and breast disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Vulvovaginal mycotic infection
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Wound secretion
Injury, poisoning and procedural complications
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected16 at risk
EG0012 events2 affected31 at risk
EG0021 events1 affected39 at risk
EG003
Amnesia
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0022 events2 affected39 at risk
EG003
Blood blister
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected16 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Calculus urinary
Renal and urinary disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected16 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected16 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Cataract
Eye disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected16 at risk
EG0012 events2 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Catheter site pain
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0022 events2 affected39 at risk
EG003
Chest discomfort
General disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected16 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Coagulopathy
Blood and lymphatic system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0022 events2 affected39 at risk
EG003
Device related thrombosis
General disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected16 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Disturbance in attention
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected16 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Ejection fraction decreased
Investigations
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected16 at risk
EG0012 events2 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Escherichia bacteraemia
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0022 events2 affected39 at risk
EG003
Eye contusion
Injury, poisoning and procedural complications
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected16 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Faeces discoloured
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected16 at risk
EG0013 events2 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Flushing
Vascular disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected16 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0022 events2 affected39 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected16 at risk
EG0011 events1 affected31 at risk
EG0021 events1 affected39 at risk
EG003
Hypernatraemia
Metabolism and nutrition disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected16 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0022 events2 affected39 at risk
EG003
Hypovolaemia
Metabolism and nutrition disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected16 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Increased appetite
Metabolism and nutrition disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected16 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected16 at risk
EG0011 events1 affected31 at risk
EG0021 events1 affected39 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0023 events3 affected39 at risk
EG003
Muscle tightness
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected16 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Nasal dryness
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected16 at risk
EG0011 events1 affected31 at risk
EG0021 events1 affected39 at risk
EG003
Ocular hyperaemia
Eye disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0022 events2 affected39 at risk
EG003
Oral disorder
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected16 at risk
EG0011 events1 affected31 at risk
EG0022 events2 affected39 at risk
EG003
Osteoporosis
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected16 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0022 events2 affected39 at risk
EG003
Sinus bradycardia
Cardiac disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected16 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected16 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Skin wound
Injury, poisoning and procedural complications
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0022 events2 affected39 at risk
EG003
Sneezing
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected16 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Systemic inflammatory response syndrome
General disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected16 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Urinary tract pain
Renal and urinary disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected16 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Vulvovaginal pain
Reproductive system and breast disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected31 at risk
EG0022 events2 affected39 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected16 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Arrhythmia
Cardiac disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected16 at risk
EG0012 events2 affected31 at risk
EG0020 events0 affected39 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.
Participants with AML or MDS received combination therapy (FT-2102 + azacitidine 75 mg/m^2) orally BID in 28-day cycles at dose levels of 150 mg until MTD or MED achieved.
OG003
Phase 1: Total FT-2102; FT-2102 + Azacitidine (Combination Therapy)
Participants with AML or MDS received combination therapy (FT-2102 150 mg and ≤ 300 mg and azacitidine administered at the dose of 75 mg/m^2 for 7 days IV/SC per every 28-day cycle) until treatment discontinuation.
Participants with AML or MDS received combination therapy (FT-2102 + azacitidine 75 mg/m^2) orally BID in 28-day cycles at dose levels of 150 mg until MTD or MED achieved.
OG003
Phase 1: Total FT-2102; FT-2102 + Azacitidine (Combination Therapy)
Participants with AML or MDS received combination therapy (FT-2102 150 mg and ≤ 300 mg and azacitidine administered at the dose of 75 mg/m^2 for 7 days IV/SC per every 28-day cycle) until treatment discontinuation.
Units
Counts
Participants
OG00015
OG00130
OG00238
OG00345
Title
Denominators
Categories
<=450 msec
Title
Measurements
OG00010
OG00116
OG00223
OG00326
>450 to <=480 msec
Title
Measurements
OG0004
OG00111
OG00210
OG003
>480 to <=500 msec
Title
Measurements
OG0000
OG0012
OG0021
OG003
>500 msec
Title
Measurements
OG0001
OG0011
OG0024
OG003
>30 to <=60 msec
Title
Measurements
OG0002
OG0018
OG00213
OG003
>60 msec
Title
Measurements
OG0001
OG0012
OG0025
OG003
Units
Counts
Participants
OG000147
Title
Denominators
Categories
Title
Measurements
OG00035(27.0 to 43.0)
Participants with R/R AML that is naïve to prior hypomethylating therapy and IDH1 inhibitor therapy received combination therapy of azacitidine 75 mg/m^2 + FT-2102 150 mg BID in continuous 28-day cycles.
Participants with R/R AML/MDS that have inadequately responded to or have progressed on prior hypo-methylating therapy received combination therapy of azacitidine 75 mg/m^2 + FT-2102 150 mg BID in continuous 28-day cycles.
Participants with R/R AML/MDS that have been previously treated with single agent FT-2102 as their last therapy prior to study enrolment received combination therapy of azacitidine + FT-2102 150 mg BID in continuous 28-day cycles. Participants from the FT-2102 single agent cohorts of this study allowed to be enrolled in Cohort 6 after their disease progression.
OG004
Phase 2: Cohort 7; FT-2102 (Single Agent)
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given single agent of FT-2102 150 mg BID in continuous 28-day cycles.
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m^2 + FT-2102 150 mg BID in continuous 28-day cycles.
Units
Counts
Participants
OG0005
OG00119
OG00213
OG00320
OG00410
OG00511
Title
Denominators
Categories
Title
Measurements
OG0000(0.0 to 52.2)
OG00147(24.4 to 71.1)
OG00238(13.9 to 68.4)
OG00330(11.9 to 54.3)
OG00440(12.2 to 73.8)
OG00545(16.7 to 76.6)
Units
Counts
Participants
OG0001
OG0018
Title
Denominators
Categories
Title
Measurements
OG0000(0.0 to 97.5)
OG00113(0.3 to 52.7)
18
Title
Denominators
Categories
Title
Measurements
OG00083(58.6 to 96.4)
OG003
Phase 1: FT-2102 150 mg BID (Single Agent)
Participants with AML or MDS received single agent FT-2102 orally BID in 28-day cycles at dose levels of 150 mg until MTD or MED achieved.
Participants with AML or MDS received combination therapy (FT-2102 + azacitidine 75 mg/m^2) orally QD in 28-day cycles at dose levels of 150 mg until MTD or MED achieved
Participants with AML or MDS received combination therapy (FT-2102 + azacitidine 75 mg/m^2) orally BID in 28-day cycles at dose levels of 150 mg until MTD or MED achieved.
Units
Counts
Participants
OG0003
OG0018
OG0024
OG0036
OG0047
OG0058
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0003
ParticipantsOG0018
ParticipantsOG0024
ParticipantsOG0036
ParticipantsOG0047
ParticipantsOG0058
Title
Measurements
OG0005505± 146.9
OG0018955± 63.7
OG00212100± 75.4
OG003
Cycle 2 Day 1
ParticipantsOG0003
ParticipantsOG0015
ParticipantsOG0024
ParticipantsOG0036
OG003
Phase: FT-2102 150 mg BID (Single Agent)
Participants with AML or MDS received single agent FT-2102 orally BID in 28-day cycles at dose levels of 150 mg until MTD or MED achieved.
Participants with AML or MDS received combination therapy (FT-2102 + azacitidine 75 mg/m^2) orally QD in 28-day cycles at dose levels of 150 mg until MTD or MED achieved
Participants with AML or MDS received combination therapy (FT-2102 + azacitidine 75 mg/m^2) orally BID in 28-day cycles at dose levels of 150 mg until MTD or MED achieved.
Units
Counts
Participants
OG0003
OG0018
OG0024
OG0036
OG0047
OG0058
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0003
ParticipantsOG0018
ParticipantsOG0024
ParticipantsOG0036
ParticipantsOG0047
ParticipantsOG0058
Title
Measurements
OG000571.5± 53.1
OG001535.0± 58.7
OG002708.0± 58.2
OG003
Cycle 2 Day 1
ParticipantsOG0003
ParticipantsOG0015
ParticipantsOG0024
ParticipantsOG0036
OG003
Phase 1: FT-2102 150 mg BID (Single Agent)
Participants with AML or MDS received single agent FT-2102 orally BID in 28-day cycles at dose levels of 150 mg until MTD or MED achieved.
Participants with AML or MDS received combination therapy (FT-2102 + azacitidine 75 mg/m^2) orally QD in 28-day cycles at dose levels of 150 mg until MTD or MED achieved
Participants with AML or MDS received combination therapy (FT-2102 + azacitidine 75 mg/m^2) orally BID in 28-day cycles at dose levels of 150 mg until MTD or MED achieved.
Units
Counts
Participants
OG0003
OG0018
OG0024
OG0036
OG0047
OG0058
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0003
ParticipantsOG0018
ParticipantsOG0024
ParticipantsOG0036
ParticipantsOG0047
ParticipantsOG0058
Title
Measurements
OG0004.05(2.22 to 4.12)
OG0014.00(2.02 to 24.00)
OG00223.83(4.00 to 24.00)
OG003
Cycle 2 Day 1
ParticipantsOG0003
ParticipantsOG0015
ParticipantsOG0024
ParticipantsOG0036
Participants with AML or MDS received combination therapy (FT-2102 + azacitidine 75 mg/m^2) orally BID in 28-day cycles at dose levels of 150 mg until MTD or MED achieved.
OG003
Phase 1: Total FT-2102; FT-2102 + Azacitidine (Combination Therapy)
Participants with AML or MDS received combination therapy (FT-2102 150 mg and ≤ 300 mg and azacitidine administered at the dose of 75 mg/m^2 for 7 days IV/SC per every 28-day cycle) until treatment discontinuation.
Units
Counts
Participants
OG0005
OG00110
OG00218
OG00322
Title
Denominators
Categories
Title
Measurements
OG0001.90(1.0 to 2.9)
OG0011.90(1.0 to 4.7)
OG0021.90(1.0 to 5.6)
OG0031.90(1.0 to 5.6)
Participants with AML or MDS received combination therapy (FT-2102 + azacitidine 75 mg/m^2) orally BID in 28-day cycles at dose levels of 150 mg until MTD or MED achieved.
OG003
Phase 1: Total FT-2102; FT-2102 + Azacitidine (Combination Therapy)
Participants with AML or MDS received combination therapy (FT-2102 150 mg and ≤ 300 mg and azacitidine administered at the dose of 75 mg/m^2 for 7 days IV/SC per every 28-day cycle) until treatment discontinuation.
Units
Counts
Participants
OG0005
OG00110
OG00218
OG00322
Title
Denominators
Categories
Title
Measurements
OG0003.60(1.70 to NA)Since the upper confidence limits for the survivor function lies above 0.5, it is not possible to estimate the upper confidence limit for the median.
OG0012.90(0.90 to 6.40)
OG00222.00(3.20 to NA)Since the upper confidence limits for the survivor function lies above 0.5, it is not possible to estimate the upper confidence limit for the median.
OG00322.00(3.20 to NA)Since the upper confidence limits for the survivor function lies above 0.5, it is not possible to estimate the upper confidence limit for the median.
Participants with AML or MDS received combination therapy (FT-2102 + azacitidine 75 mg/m^2) orally BID in 28-day cycles at dose levels of 150 mg until MTD or MED achieved.
OG003
Phase 1: Total FT-2102; FT-2102 + Azacitidine (Combination Therapy)
Participants with AML or MDS received combination therapy (FT-2102 150 mg and ≤ 300 mg and azacitidine administered at the dose of 75 mg/m^2 for 7 days IV/SC per every 28-day cycle) until treatment discontinuation.
Units
Counts
Participants
OG0002
OG0012
OG0026
OG0036
Title
Denominators
Categories
Title
Measurements
OG0004.65(1.0 to 8.3)
OG0014.65(1.0 to 8.3)
OG0022.20(1.0 to 8.5)
OG0032.20(1.0 to 8.5)
Participants with R/R AML that is naïve to prior hypomethylating therapy and IDH1 inhibitor therapy received combination therapy of azacitidine 75 mg/m^2 + FT-2102 150 mg BID in continuous 28-day cycles.
Participants with R/R AML/MDS that have inadequately responded to or have progressed on prior hypo-methylating therapy received combination therapy of azacitidine 75 mg/m^2 + FT-2102 150 mg BID in continuous 28-day cycles.
Participants with R/R AML/MDS that have been previously treated with single agent FT-2102 as their last therapy prior to study enrolment received combination therapy of azacitidine + FT-2102 150 mg BID in continuous 28-day cycles. Participants from the FT-2102 single agent cohorts of this study allowed to be enrolled in Cohort 6 after their disease progression.
OG005
Phase 2: Cohort 7; FT-2102 (Single Agent)
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given single agent of FT-2102 150 mg BID in continuous 28-day cycles.
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m^2 + FT-2102 150 mg BID in continuous 28-day cycles.
Units
Counts
Participants
OG00075
OG0010
OG00213
OG0036
OG0048
OG0055
OG0067
Title
Denominators
Categories
Title
Measurements
OG0001.90(0.9 to 10.2)
OG0021.80(0.9 to 3.8)
OG0032.50(1.0 to 4.2)
OG0042.50(1.0 to 7.6)
OG0051.90(1.8 to 3.9)
OG0062.80(1.1 to 5.6)
Participants with R/R AML/MDS that have inadequately responded to or have progressed on prior hypo-methylating therapy received combination therapy of azacitidine 75 mg/m^2 + FT-2102 150 mg BID in continuous 28-day cycles.
Participants with R/R AML/MDS that have been previously treated with single agent FT-2102 as their last therapy prior to study enrolment received combination therapy of azacitidine + FT-2102 150 mg BID in continuous 28-day cycles. Participants from the FT-2102 single agent cohorts of this study allowed to be enrolled in Cohort 6 after their disease progression.
OG004
Phase 2: Cohort 7; FT-2102 (Single Agent)
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given single agent of FT-2102 150 mg BID in continuous 28-day cycles.
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m^2 + FT-2102 150 mg BID in continuous 28-day cycles.
Units
Counts
Participants
OG00075
OG00113
OG0026
OG0038
OG0045
OG0057
Title
Denominators
Categories
Title
Measurements
OG00014.80(7.40 to 19.40)
OG00120.00(1.90 to 28.80)
OG0027.25(4.90 to NA)Since the upper confidence limits for the survivor function lies above 0.5, it is not possible to estimate the upper confidence limit for the median.
OG0034.65(2.80 to NA)Since the upper confidence limits for the survivor function lies above 0.5, it is not possible to estimate the upper confidence limit for the median.
OG00410.60(3.5 to 39.6)
OG00520.90(5.60 to NA)Since the upper confidence limits for the survivor function lies above 0.5, it is not possible to estimate the upper confidence limit for the median.
Participants with R/R AML/MDS that have inadequately responded to or have progressed on prior hypo-methylating therapy received combination therapy of azacitidine 75 mg/m^2 + FT-2102 150 mg BID in continuous 28-day cycles.
Units
Counts
Participants
OG0001
OG0014
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Median and 95% CI could not be calculated since there is only one participant for Cohort 4.
OG00111.90(2.80 to NA)Since the upper confidence limits for the survivor function lies above 0.5, it is not possible to estimate the upper confidence limit for the median for Cohort 5.
18
Title
Denominators
Categories
Title
Measurements
OG00018.40(9.50 to NA)Since the upper confidence limits for the survivor function lies above 0.5, it is not possible to estimate the upper confidence limit for the median.
Participants with R/R AML that is naïve to prior hypomethylating therapy and IDH1 inhibitor therapy received combination therapy of azacitidine 75 mg/m^2 + FT-2102 150 mg BID in continuous 28-day cycles.
Participants with R/R AML/MDS that have inadequately responded to or have progressed on prior hypo-methylating therapy received combination therapy of azacitidine 75 mg/m^2 + FT-2102 150 mg BID in continuous 28-day cycles.
Participants with R/R AML/MDS that have been previously treated with single agent FT-2102 as their last therapy prior to study enrolment received combination therapy of azacitidine + FT-2102 150 mg BID in continuous 28-day cycles. Participants from the FT-2102 single agent cohorts of this study allowed to be enrolled in Cohort 6 after their disease progression.
OG006
Phase 2: Cohort 7; FT-2102 (Single Agent)
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given single agent of FT-2102 150 mg BID in continuous 28-day cycles.
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m^2 + FT-2102 150 mg BID in continuous 28-day cycles.
Units
Counts
Participants
OG000153
OG00118
OG0025
OG00320
OG00421
OG00520
OG00610
OG00711
Title
Denominators
Categories
Title
Measurements
OG00011.60(8.90 to 15.50)
OG001NA(27.30 to NA)The median was not reached, since more than half of the participants in the study had not experienced the event of death at the time of analysis.
OG0021.20(1.10 to NA)Since the upper confidence limits for the survivor function lies above 0.5, it is not possible to estimate the upper confidence limit for the median.
OG00325.20(13.60 to NA)Since the upper confidence limits for the survivor function lies above 0.5, it is not possible to estimate the upper confidence limit for the median.
OG00411.60(5.00 to 27.50)
OG00510.20(4.40 to 17.90)
OG00614.00(1.00 to 19.10)
OG00718.70(1.60 to NA)Since the upper confidence limits for the survivor function lies above 0.5, it is not possible to estimate the upper confidence limit for the median.
Participants with R/R AML that is naïve to prior hypomethylating therapy and IDH1 inhibitor therapy received combination therapy of azacitidine 75 mg/m^2 + FT-2102 150 mg BID in continuous 28-day cycles.
Participants with R/R AML/MDS that have inadequately responded to or have progressed on prior hypo-methylating therapy received combination therapy of azacitidine 75 mg/m^2 + FT-2102 150 mg BID in continuous 28-day cycles.
Participants with R/R AML/MDS that have been previously treated with single agent FT-2102 as their last therapy prior to study enrolment received combination therapy of azacitidine + FT-2102 150 mg BID in continuous 28-day cycles. Participants from the FT-2102 single agent cohorts of this study allowed to be enrolled in Cohort 6 after their disease progression.
OG006
Phase 2: Cohort 7; FT-2102 (Single Agent)
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given single agent of FT-2102 150 mg BID in continuous 28-day cycles.
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m^2 + FT-2102 150 mg BID in continuous 28-day cycles.
Units
Counts
Participants
OG000153
OG00118
OG0025
OG00320
OG00421
OG00520
OG00610
OG00711
Title
Denominators
Categories
Title
Measurements
OG0005.50(4.30 to 7.40)
OG00118.40(9.50 to NA)Since the upper confidence limits for the survivor function lies above 0.5, it is not possible to estimate the upper confidence limit for the median.
OG0021.05(0.80 to NA)Since the upper confidence limits for the survivor function lies above 0.5, it is not possible to estimate the upper confidence limit for the median.
OG0035.70(1.90 to 16.40)
OG0047.80(2.10 to 10.20)
OG0054.80(2.50 to 9.70)
OG0065.50(0.30 to NA)Since the upper confidence limits for the survivor function lies above 0.5, it is not possible to estimate the upper confidence limit for the median.
OG0078.10(1.60 to 33.00)
Participants with R/R AML or MDS who were previously treated with FT-2102 and who underwent HSCT on-study then relapsed post-HSCT received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
Participants with R/R AML that is naïve to prior hypomethylating therapy and IDH1 inhibitor therapy received combination therapy of azacitidine 75 mg/m^2 + FT-2102 150 mg BID in continuous 28-day cycles.
Participants with R/R AML/MDS that have inadequately responded to or have progressed on prior hypo-methylating therapy received combination therapy of azacitidine 75 mg/m^2 + FT-2102 150 mg BID in continuous 28-day cycles.
Participants with R/R AML/MDS that have been previously treated with single agent FT-2102 as their last therapy prior to study enrolment received combination therapy of azacitidine + FT-2102 150 mg BID in continuous 28-day cycles. Participants from the FT-2102 single agent cohorts of this study allowed to be enrolled in Cohort 6 after their disease progression.
OG006
Phase 2: Cohort 7; FT-2102 (Single Agent)
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given single agent of FT-2102 150 mg BID in continuous 28-day cycles.
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m^2 + FT-2102 150 mg BID in continuous 28-day cycles.
Units
Counts
Participants
OG000153
OG00118
OG0025
OG00320
OG00421
OG00520
OG00610
OG00711
Title
Denominators
Categories
Title
Measurements
OG00072
OG00115
OG0020
OG00312
OG00413
OG00514
OG0063
OG0078
OG002
Phase 2: Cohort 3; FT-2102 (Single Agent)
Participants with R/R AML or MDS who were previously treated with FT-2102 and who underwent HSCT on-study then relapsed post-HSCT received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
Participants with R/R AML that is naïve to prior hypomethylating therapy and IDH1 inhibitor therapy received combination therapy of azacitidine 75 mg/m^2 + FT-2102 150 mg BID in continuous 28-day cycles.
Participants with R/R AML/MDS that have inadequately responded to or have progressed on prior hypo-methylating therapy received combination therapy of azacitidine 75 mg/m^2 + FT-2102 150 mg BID in continuous 28-day cycles.
Participants with R/R AML/MDS that have been previously treated with single agent FT-2102 as their last therapy prior to study enrolment received combination therapy of azacitidine + FT-2102 150 mg BID in continuous 28-day cycles. Participants from the FT-2102 single agent cohorts of this study allowed to be enrolled in Cohort 6 after their disease progression.
OG006
Phase 2: Cohort 7; FT-2102 (Single Agent)
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given single agent of FT-2102 150 mg BID in continuous 28-day cycles.
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m^2 + FT-2102 150 mg BID in continuous 28-day cycles.
Units
Counts
Participants
OG000153
OG00118
OG0025
OG00320
OG00421
OG00520
OG00610
OG00711
Title
Denominators
Categories
TEAEs
Title
Measurements
OG000153
OG00118
OG0025
OG00319
OG00421
OG00519
OG00610
OG00711
SAEs
Title
Measurements
OG000115
OG0016
OG0024
OG003
Participants with R/R AML or MDS who were previously treated with FT-2102 and who underwent HSCT on-study then relapsed post-HSCT received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
Participants with R/R AML that is naïve to prior hypomethylating therapy and IDH1 inhibitor therapy received combination therapy of azacitidine 75 mg/m^2 + FT-2102 150 mg BID in continuous 28-day cycles.
Participants with R/R AML/MDS that have inadequately responded to or have progressed on prior hypo-methylating therapy received combination therapy of azacitidine 75 mg/m^2 + FT-2102 150 mg BID in continuous 28-day cycles.
Participants with R/R AML/MDS that have been previously treated with single agent FT-2102 as their last therapy prior to study enrolment received combination therapy of azacitidine + FT-2102 150 mg BID in continuous 28-day cycles. Participants from the FT-2102 single agent cohorts of this study allowed to be enrolled in Cohort 6 after their disease progression.
OG006
Phase 2: Cohort 7; FT-2102 (Single Agent)
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given single agent of FT-2102 150 mg BID in continuous 28-day cycles.
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m^2 + FT-2102 150 mg BID in continuous 28-day cycles.
Coagulation: Activated partial Thromboplastin Time; Increase (Grade 3 or 4)
Title
Measurements
OG0001
OG0010
OG0020
OG003
Participants with R/R AML or MDS who were previously treated with FT-2102 and who underwent HSCT on-study then relapsed post-HSCT received single agent of FT-2102 150 mg BID in continuous 28-day cycles.
Participants with R/R AML that is naïve to prior hypomethylating therapy and IDH1 inhibitor therapy received combination therapy of azacitidine 75 mg/m^2 + FT-2102 150 mg BID in continuous 28-day cycles.
Participants with R/R AML/MDS that have inadequately responded to or have progressed on prior hypo-methylating therapy received combination therapy of azacitidine 75 mg/m^2 + FT-2102 150 mg BID in continuous 28-day cycles.
Participants with R/R AML/MDS that have been previously treated with single agent FT-2102 as their last therapy prior to study enrolment received combination therapy of azacitidine + FT-2102 150 mg BID in continuous 28-day cycles. Participants from the FT-2102 single agent cohorts of this study allowed to be enrolled in Cohort 6 after their disease progression.
OG006
Phase 2: Cohort 7; FT-2102 (Single Agent)
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given single agent of FT-2102 150 mg BID in continuous 28-day cycles.
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m^2 + FT-2102 150 mg BID in continuous 28-day cycles.
Participants with R/R AML that is naïve to prior hypomethylating therapy and IDH1 inhibitor therapy received combination therapy of azacitidine 75 mg/m^2 + FT-2102 150 mg BID in continuous 28-day cycles.
Participants with R/R AML/MDS that have inadequately responded to or have progressed on prior hypo-methylating therapy received combination therapy of azacitidine 75 mg/m^2 + FT-2102 150 mg BID in continuous 28-day cycles.
Participants with R/R AML/MDS that have been previously treated with single agent FT-2102 as their last therapy prior to study enrolment received combination therapy of azacitidine + FT-2102 150 mg BID in continuous 28-day cycles. Participants from the FT-2102 single agent cohorts of this study allowed to be enrolled in Cohort 6 after their disease progression.
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given single agent of FT-2102 150 mg BID in continuous 28-day cycles.
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m^2 + FT-2102 150 mg BID in continuous 28-day cycles.
Participants with R/R AML that is naïve to prior hypomethylating therapy and IDH1 inhibitor therapy received combination therapy of azacitidine 75 mg/m^2 + FT-2102 150 mg BID in continuous 28-day cycles.
Participants with R/R AML/MDS that have inadequately responded to or have progressed on prior hypo-methylating therapy received combination therapy of azacitidine 75 mg/m^2 + FT-2102 150 mg BID in continuous 28-day cycles.
Participants with R/R AML/MDS that have been previously treated with single agent FT-2102 as their last therapy prior to study enrolment received combination therapy of azacitidine + FT-2102 150 mg BID in continuous 28-day cycles. Participants from the FT-2102 single agent cohorts of this study allowed to be enrolled in Cohort 6 after their disease progression.
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given single agent of FT-2102 150 mg BID in continuous 28-day cycles.
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m^2 + FT-2102 150 mg BID in continuous 28-day cycles.
Participants with R/R AML that is naïve to prior hypomethylating therapy and IDH1 inhibitor therapy received combination therapy of azacitidine 75 mg/m^2 + FT-2102 150 mg BID in continuous 28-day cycles.
Participants with R/R AML/MDS that have inadequately responded to or have progressed on prior hypo-methylating therapy received combination therapy of azacitidine 75 mg/m^2 + FT-2102 150 mg BID in continuous 28-day cycles.
Participants with R/R AML/MDS that have been previously treated with single agent FT-2102 as their last therapy prior to study enrolment received combination therapy of azacitidine + FT-2102 150 mg BID in continuous 28-day cycles. Participants from the FT-2102 single agent cohorts of this study allowed to be enrolled in Cohort 6 after their disease progression.
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given single agent of FT-2102 150 mg BID in continuous 28-day cycles.
Participants who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m^2 + FT-2102 150 mg BID in continuous 28-day cycles.
Units
Counts
Participants
OG000120
OG00114
OG0022
OG00313
OG00416
OG0054
OG0062
OG0071
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG000120
ParticipantsOG00114
ParticipantsOG0022
ParticipantsOG00313
ParticipantsOG00416
ParticipantsOG0053
ParticipantsOG0062
ParticipantsOG0071
Title
Measurements
OG0004.00(1.00 to 8.00)
OG0014.00(2.00 to 8.00)
OG0025.00(2.00 to 8.00)
OG003
Cycle 2 Day 1
ParticipantsOG00088
ParticipantsOG00112
ParticipantsOG0020
ParticipantsOG00311
0 events
0 affected
46 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected153 at risk
EG0060 events0 affected18 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected20 at risk
EG0090 events0 affected21 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected10 at risk
EG0121 events1 affected11 at risk
0 events
0 affected
46 at risk
EG0040 events0 affected78 at risk
EG0052 events2 affected153 at risk
EG0060 events0 affected18 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected20 at risk
EG0090 events0 affected21 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected11 at risk
1 events
1 affected
46 at risk
EG0042 events2 affected78 at risk
EG0052 events2 affected153 at risk
EG0060 events0 affected18 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected20 at risk
EG0090 events0 affected21 at risk
EG0100 events0 affected20 at risk
EG0111 events1 affected10 at risk
EG0120 events0 affected11 at risk
4 events
4 affected
46 at risk
EG0046 events6 affected78 at risk
EG00516 events14 affected153 at risk
EG0060 events0 affected18 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected20 at risk
EG0092 events2 affected21 at risk
EG0100 events0 affected20 at risk
EG0112 events2 affected10 at risk
EG0120 events0 affected11 at risk
0 events
0 affected
46 at risk
EG0040 events0 affected78 at risk
EG0051 events1 affected153 at risk
EG0060 events0 affected18 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected20 at risk
EG0090 events0 affected21 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected11 at risk
0 events
0 affected
46 at risk
EG0040 events0 affected78 at risk
EG0051 events1 affected153 at risk
EG0060 events0 affected18 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected20 at risk
EG0090 events0 affected21 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected11 at risk
0 events
0 affected
46 at risk
EG0041 events1 affected78 at risk
EG0050 events0 affected153 at risk
EG0060 events0 affected18 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected20 at risk
EG0090 events0 affected21 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected11 at risk
0 events
0 affected
46 at risk
EG0041 events1 affected78 at risk
EG0051 events1 affected153 at risk
EG0060 events0 affected18 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected20 at risk
EG0090 events0 affected21 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected11 at risk
0 events
0 affected
46 at risk
EG0040 events0 affected78 at risk
EG0051 events1 affected153 at risk
EG0060 events0 affected18 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected20 at risk
EG0090 events0 affected21 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected11 at risk
0 events
0 affected
46 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected153 at risk
EG0060 events0 affected18 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected20 at risk
EG0090 events0 affected21 at risk
EG0100 events0 affected20 at risk
EG0111 events1 affected10 at risk
EG0120 events0 affected11 at risk
1 events
1 affected
46 at risk
EG0041 events1 affected78 at risk
EG0050 events0 affected153 at risk
EG0060 events0 affected18 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected20 at risk
EG0090 events0 affected21 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected11 at risk
0 events
0 affected
46 at risk
EG0040 events0 affected78 at risk
EG0052 events1 affected153 at risk
EG0060 events0 affected18 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected20 at risk
EG0090 events0 affected21 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected11 at risk
0 events
0 affected
46 at risk
EG0040 events0 affected78 at risk
EG0051 events1 affected153 at risk
EG0060 events0 affected18 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected20 at risk
EG0090 events0 affected21 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected11 at risk
0 events
0 affected
46 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected153 at risk
EG0060 events0 affected18 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected20 at risk
EG0090 events0 affected21 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected11 at risk
0 events
0 affected
46 at risk
EG0040 events0 affected78 at risk
EG0051 events1 affected153 at risk
EG0060 events0 affected18 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected20 at risk
EG0090 events0 affected21 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected11 at risk
0 events
0 affected
46 at risk
EG0040 events0 affected78 at risk
EG0052 events2 affected153 at risk
EG0060 events0 affected18 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected20 at risk
EG0090 events0 affected21 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected10 at risk
EG0121 events1 affected11 at risk
1 events
1 affected
46 at risk
EG0042 events2 affected78 at risk
EG0050 events0 affected153 at risk
EG0060 events0 affected18 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected20 at risk
EG0091 events1 affected21 at risk
EG0103 events2 affected20 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected11 at risk
0 events
0 affected
46 at risk
EG0040 events0 affected78 at risk
EG0051 events1 affected153 at risk
EG0060 events0 affected18 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected20 at risk
EG0090 events0 affected21 at risk
EG0101 events1 affected20 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected11 at risk
0 events
0 affected
46 at risk
EG0040 events0 affected78 at risk
EG0051 events1 affected153 at risk
EG0060 events0 affected18 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected20 at risk
EG0090 events0 affected21 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected11 at risk
1 events
1 affected
46 at risk
EG0041 events1 affected78 at risk
EG0052 events2 affected153 at risk
EG0060 events0 affected18 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected20 at risk
EG0090 events0 affected21 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected11 at risk
1 events
1 affected
46 at risk
EG0043 events2 affected78 at risk
EG0051 events1 affected153 at risk
EG0060 events0 affected18 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected20 at risk
EG0090 events0 affected21 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected11 at risk
0 events
0 affected
46 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected153 at risk
EG0060 events0 affected18 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected20 at risk
EG0090 events0 affected21 at risk
EG0101 events1 affected20 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected11 at risk
0 events
0 affected
46 at risk
EG0040 events0 affected78 at risk
EG0051 events1 affected153 at risk
EG0060 events0 affected18 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected20 at risk
EG0090 events0 affected21 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected11 at risk
0 events
0 affected
46 at risk
EG0040 events0 affected78 at risk
EG0051 events1 affected153 at risk
EG0060 events0 affected18 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected20 at risk
EG0090 events0 affected21 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected11 at risk
0 events
0 affected
46 at risk
EG0040 events0 affected78 at risk
EG0051 events1 affected153 at risk
EG0060 events0 affected18 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected20 at risk
EG0090 events0 affected21 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected11 at risk
0 events
0 affected
46 at risk
EG0040 events0 affected78 at risk
EG0051 events1 affected153 at risk
EG0060 events0 affected18 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected20 at risk
EG0091 events1 affected21 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected11 at risk
0 events
0 affected
46 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected153 at risk
EG0060 events0 affected18 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected20 at risk
EG0090 events0 affected21 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected11 at risk
0 events
0 affected
46 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected153 at risk
EG0060 events0 affected18 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected20 at risk
EG0090 events0 affected21 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected10 at risk
EG0121 events1 affected11 at risk
1 events
1 affected
46 at risk
EG0042 events2 affected78 at risk
EG0050 events0 affected153 at risk
EG0060 events0 affected18 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected20 at risk
EG0090 events0 affected21 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected11 at risk
0 events
0 affected
46 at risk
EG0040 events0 affected78 at risk
EG0051 events1 affected153 at risk
EG0060 events0 affected18 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected20 at risk
EG0090 events0 affected21 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected11 at risk
0 events
0 affected
46 at risk
EG0040 events0 affected78 at risk
EG0051 events1 affected153 at risk
EG0060 events0 affected18 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected20 at risk
EG0091 events1 affected21 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected11 at risk
0 events
0 affected
46 at risk
EG0040 events0 affected78 at risk
EG0052 events1 affected153 at risk
EG0060 events0 affected18 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected20 at risk
EG0090 events0 affected21 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected11 at risk
3 events
2 affected
46 at risk
EG0044 events3 affected78 at risk
EG0053 events3 affected153 at risk
EG0060 events0 affected18 at risk
EG0070 events0 affected5 at risk
EG0082 events2 affected20 at risk
EG0090 events0 affected21 at risk
EG0101 events1 affected20 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected11 at risk
0 events
0 affected
46 at risk
EG0041 events1 affected78 at risk
EG0053 events3 affected153 at risk
EG0060 events0 affected18 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected20 at risk
EG0090 events0 affected21 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected11 at risk
0 events
0 affected
46 at risk
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0 affected
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46 at risk
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2 events
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46 at risk
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0 affected
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1 affected
46 at risk
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0 affected
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0 affected
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5 events
5 affected
46 at risk
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11 events
9 affected
46 at risk
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1 events
1 affected
46 at risk
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3 events
3 affected
46 at risk
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5 events
4 affected
46 at risk
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7 events
7 affected
46 at risk
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1 affected
46 at risk
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1 affected
46 at risk
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6 events
6 affected
46 at risk
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14 events
8 affected
46 at risk
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8 events
5 affected
46 at risk
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1 affected
46 at risk
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15 events
11 affected
46 at risk
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5 events
5 affected
46 at risk
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10 events
5 affected
46 at risk
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0 affected
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9 events
6 affected
46 at risk
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3 events
3 affected
46 at risk
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7 events
6 affected
46 at risk
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2 affected
46 at risk
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3 events
3 affected
46 at risk
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1 affected
46 at risk
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0 affected
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10 events
6 affected
46 at risk
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1 events
1 affected
46 at risk
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1 affected
46 at risk
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3 events
3 affected
46 at risk
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41 events
27 affected
46 at risk
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5 affected
46 at risk
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19 events
18 affected
46 at risk
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14 events
10 affected
46 at risk
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4 affected
46 at risk
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4 affected
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21 affected
46 at risk
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16 events
11 affected
46 at risk
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4 affected
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3 affected
46 at risk
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6 affected
46 at risk
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4 affected
46 at risk
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3 affected
46 at risk
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23 events
13 affected
46 at risk
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1 affected
46 at risk
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0 affected
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3 affected
46 at risk
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3 affected
46 at risk
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7 affected
46 at risk
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5 events
3 affected
46 at risk
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1 affected
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1 affected
46 at risk
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5 affected
46 at risk
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28 events
19 affected
46 at risk
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7 events
5 affected
46 at risk
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2 affected
46 at risk
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4 affected
46 at risk
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1 affected
46 at risk
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4 affected
46 at risk
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1 affected
46 at risk
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3 affected
46 at risk
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2 affected
46 at risk
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0 affected
46 at risk
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1 affected
46 at risk
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5 events
5 affected
46 at risk
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2 affected
46 at risk
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22 events
15 affected
46 at risk
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1 events
1 affected
46 at risk
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3 events
3 affected
46 at risk
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1 events
1 affected
46 at risk
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2 events
2 affected
46 at risk
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0 events
0 affected
46 at risk
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15 events
9 affected
46 at risk
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4 events
4 affected
46 at risk
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5 events
5 affected
46 at risk
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8 events
5 affected
46 at risk
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21 events
16 affected
46 at risk
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5 events
5 affected
46 at risk
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5 events
5 affected
46 at risk
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4 events
4 affected
46 at risk
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5 events
5 affected
46 at risk
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2 events
2 affected
46 at risk
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4 events
3 affected
46 at risk
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8 events
7 affected
46 at risk
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1 events
1 affected
46 at risk
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2 events
1 affected
46 at risk
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1 events
1 affected
46 at risk
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6 events
4 affected
46 at risk
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0 affected
46 at risk
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11 events
5 affected
46 at risk
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2 events
2 affected
46 at risk
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1 affected
46 at risk
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1 affected
46 at risk
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2 affected
46 at risk
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1 affected
46 at risk
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4 events
4 affected
46 at risk
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3 affected
46 at risk
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4 affected
46 at risk
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4 events
3 affected
46 at risk
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43 events
32 affected
46 at risk
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41 events
14 affected
46 at risk
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12 events
10 affected
46 at risk
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0 affected
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3 events
3 affected
46 at risk
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8 events
7 affected
46 at risk
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0 affected
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4 events
4 affected
46 at risk
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13 events
8 affected
46 at risk
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3 affected
46 at risk
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5 affected
46 at risk
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2 affected
46 at risk
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1 affected
46 at risk
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2 affected
46 at risk
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7 affected
46 at risk
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1 affected
46 at risk
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81 events
20 affected
46 at risk
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2 affected
46 at risk
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2 affected
46 at risk
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5 affected
46 at risk
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9 events
5 affected
46 at risk
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0 affected
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1 affected
46 at risk
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46 at risk
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8 affected
46 at risk
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0 affected
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11 affected
46 at risk
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4 affected
46 at risk
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29 events
11 affected
46 at risk
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5 affected
46 at risk
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1 affected
46 at risk
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2 affected
46 at risk
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2 affected
46 at risk
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3 affected
46 at risk
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5 affected
46 at risk
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3 affected
46 at risk
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0 affected
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1 affected
46 at risk
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1 affected
46 at risk
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0 affected
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5 affected
46 at risk
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3 affected
46 at risk
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EG0120 events0 affected11 at risk
0 events
0 affected
46 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected153 at risk
EG0060 events0 affected18 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected20 at risk
EG0090 events0 affected21 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected11 at risk
0 events
0 affected
46 at risk
EG0040 events0 affected78 at risk
EG0052 events2 affected153 at risk
EG0061 events1 affected18 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected20 at risk
EG0090 events0 affected21 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected11 at risk
0 events
0 affected
46 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected153 at risk
EG0060 events0 affected18 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected20 at risk
EG0090 events0 affected21 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected10 at risk
EG0121 events1 affected11 at risk
1 events
1 affected
46 at risk
EG0043 events3 affected78 at risk
EG0056 events5 affected153 at risk
EG0060 events0 affected18 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected20 at risk
EG0090 events0 affected21 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected11 at risk
2 events
2 affected
46 at risk
EG0042 events2 affected78 at risk
EG0050 events0 affected153 at risk
EG0060 events0 affected18 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected20 at risk
EG0090 events0 affected21 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected11 at risk
0 events
0 affected
46 at risk
EG0041 events1 affected78 at risk
EG0052 events2 affected153 at risk
EG0060 events0 affected18 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected20 at risk
EG0090 events0 affected21 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected11 at risk
0 events
0 affected
46 at risk
EG0041 events1 affected78 at risk
EG0050 events0 affected153 at risk
EG0060 events0 affected18 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected20 at risk
EG0090 events0 affected21 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected11 at risk
0 events
0 affected
46 at risk
EG0041 events1 affected78 at risk
EG0050 events0 affected153 at risk
EG0060 events0 affected18 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected20 at risk
EG0090 events0 affected21 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected11 at risk
0 events
0 affected
46 at risk
EG0042 events2 affected78 at risk
EG0053 events3 affected153 at risk
EG0060 events0 affected18 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected20 at risk
EG0090 events0 affected21 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected11 at risk
2 events
2 affected
46 at risk
EG0043 events3 affected78 at risk
EG0050 events0 affected153 at risk
EG0060 events0 affected18 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected20 at risk
EG0090 events0 affected21 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected11 at risk
0 events
0 affected
46 at risk
EG0041 events1 affected78 at risk
EG0052 events2 affected153 at risk
EG0060 events0 affected18 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected20 at risk
EG0090 events0 affected21 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected11 at risk
2 events
2 affected
46 at risk
EG0042 events2 affected78 at risk
EG0050 events0 affected153 at risk
EG0060 events0 affected18 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected20 at risk
EG0090 events0 affected21 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected11 at risk
0 events
0 affected
46 at risk
EG0041 events1 affected78 at risk
EG0050 events0 affected153 at risk
EG0060 events0 affected18 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected20 at risk
EG0090 events0 affected21 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected11 at risk
0 events
0 affected
46 at risk
EG0041 events1 affected78 at risk
EG0050 events0 affected153 at risk
EG0060 events0 affected18 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected20 at risk
EG0090 events0 affected21 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected11 at risk
0 events
0 affected
46 at risk
EG0042 events2 affected78 at risk
EG0050 events0 affected153 at risk
EG0060 events0 affected18 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected20 at risk
EG0090 events0 affected21 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected11 at risk
2 events
2 affected
46 at risk
EG0042 events2 affected78 at risk
EG0051 events1 affected153 at risk
EG0060 events0 affected18 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected20 at risk
EG0090 events0 affected21 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected11 at risk
0 events
0 affected
46 at risk
EG0041 events1 affected78 at risk
EG0050 events0 affected153 at risk
EG0060 events0 affected18 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected20 at risk
EG0090 events0 affected21 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected11 at risk
0 events
0 affected
46 at risk
EG0043 events2 affected78 at risk
EG0050 events0 affected153 at risk
EG0060 events0 affected18 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected20 at risk
EG0090 events0 affected21 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected11 at risk
0 events
0 affected
46 at risk
EG0041 events1 affected78 at risk
EG0050 events0 affected153 at risk
EG0060 events0 affected18 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected20 at risk
EG0090 events0 affected21 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected11 at risk
2 events
2 affected
46 at risk
EG0042 events2 affected78 at risk
EG0055 events3 affected153 at risk
EG0060 events0 affected18 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected20 at risk
EG0090 events0 affected21 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected11 at risk
1 events
1 affected
46 at risk
EG0042 events2 affected78 at risk
EG0050 events0 affected153 at risk
EG0060 events0 affected18 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected20 at risk
EG0090 events0 affected21 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected11 at risk
0 events
0 affected
46 at risk
EG0041 events1 affected78 at risk
EG0050 events0 affected153 at risk
EG0060 events0 affected18 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected20 at risk
EG0090 events0 affected21 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected11 at risk
2 events
2 affected
46 at risk
EG0042 events2 affected78 at risk
EG0052 events2 affected153 at risk
EG0060 events0 affected18 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected20 at risk
EG0090 events0 affected21 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected11 at risk
0 events
0 affected
46 at risk
EG0041 events1 affected78 at risk
EG0050 events0 affected153 at risk
EG0060 events0 affected18 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected20 at risk
EG0091 events1 affected21 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected11 at risk
0 events
0 affected
46 at risk
EG0041 events1 affected78 at risk
EG0050 events0 affected153 at risk
EG0060 events0 affected18 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected20 at risk
EG0090 events0 affected21 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected11 at risk
4 events
2 affected
46 at risk
EG0045 events3 affected78 at risk
EG0051 events1 affected153 at risk
EG0060 events0 affected18 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected20 at risk
EG0090 events0 affected21 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected11 at risk
3 events
3 affected
46 at risk
EG0043 events3 affected78 at risk
EG0052 events2 affected153 at risk
EG0060 events0 affected18 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected20 at risk
EG0090 events0 affected21 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected11 at risk
0 events
0 affected
46 at risk
EG0041 events1 affected78 at risk
EG0050 events0 affected153 at risk
EG0060 events0 affected18 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected20 at risk
EG0090 events0 affected21 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected11 at risk
1 events
1 affected
46 at risk
EG0042 events2 affected78 at risk
EG0050 events0 affected153 at risk
EG0060 events0 affected18 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected20 at risk
EG0090 events0 affected21 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected11 at risk
2 events
2 affected
46 at risk
EG0042 events2 affected78 at risk
EG0053 events2 affected153 at risk
EG0060 events0 affected18 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected20 at risk
EG0091 events1 affected21 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected11 at risk
2 events
2 affected
46 at risk
EG0043 events3 affected78 at risk
EG0053 events3 affected153 at risk
EG0060 events0 affected18 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected20 at risk
EG0090 events0 affected21 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected11 at risk
0 events
0 affected
46 at risk
EG0041 events1 affected78 at risk
EG0050 events0 affected153 at risk
EG0060 events0 affected18 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected20 at risk
EG0091 events1 affected21 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected11 at risk
2 events
2 affected
46 at risk
EG0042 events2 affected78 at risk
EG0052 events2 affected153 at risk
EG0060 events0 affected18 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected20 at risk
EG0090 events0 affected21 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected11 at risk
0 events
0 affected
46 at risk
EG0041 events1 affected78 at risk
EG0051 events1 affected153 at risk
EG0060 events0 affected18 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected20 at risk
EG0090 events0 affected21 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected11 at risk
0 events
0 affected
46 at risk
EG0041 events1 affected78 at risk
EG0050 events0 affected153 at risk
EG0060 events0 affected18 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected20 at risk
EG0090 events0 affected21 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected11 at risk
2 events
2 affected
46 at risk
EG0042 events2 affected78 at risk
EG0052 events1 affected153 at risk
EG0060 events0 affected18 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected20 at risk
EG0090 events0 affected21 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected11 at risk
0 events
0 affected
46 at risk
EG0041 events1 affected78 at risk
EG0050 events0 affected153 at risk
EG0060 events0 affected18 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected20 at risk
EG0090 events0 affected21 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected11 at risk
0 events
0 affected
46 at risk
EG0041 events1 affected78 at risk
EG0050 events0 affected153 at risk
EG0060 events0 affected18 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected20 at risk
EG0090 events0 affected21 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected11 at risk
0 events
0 affected
46 at risk
EG0041 events1 affected78 at risk
EG0050 events0 affected153 at risk
EG0060 events0 affected18 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected20 at risk
EG0090 events0 affected21 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected11 at risk
2 events
2 affected
46 at risk
EG0042 events2 affected78 at risk
EG0050 events0 affected153 at risk
EG0060 events0 affected18 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected20 at risk
EG0090 events0 affected21 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected11 at risk
0 events
0 affected
46 at risk
EG0041 events1 affected78 at risk
EG0050 events0 affected153 at risk
EG0060 events0 affected18 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected20 at risk
EG0091 events1 affected21 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected11 at risk
0 events
0 affected
46 at risk
EG0042 events2 affected78 at risk
EG0050 events0 affected153 at risk
EG0060 events0 affected18 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected20 at risk
EG0090 events0 affected21 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected11 at risk
0
1
0
0
0
0
0
10
36
0
36
0
0
3
6
37
43
43
0
0
3
0
3
2
1
4
16
23
39
1
0
0
2
43
45
32
0
12
1
0
1
2
6
14
18
5
23
3
31
11
1
0
1
39
4
0
1
0
1
16
26
1
1
0
1
40
0
0
5
0
5
26
19
0
0
0
0
40
4
2
0
0
0
23
19
0
4
0
4
41
5
0
0
0
0
19
24
0
3
0
3
31
10
0
0
4
4
16
12
16
1
0
1
40
0
0
5
0
5
39
5
1
0
0
0
18
0
0
2
0
2
19
0
0
0
0
0
21
2
1
1
0
1
13
2
4
14
6
2538
± 34.2
OG0048529± 51.1
OG0052288± 71.7
Participants
OG004
6
ParticipantsOG0055
Title
Measurements
OG00013080± 63.5
OG00114130± 124.0
OG00219140± 24.0
OG00326360± 22.3
OG0047468± 92.6
OG00520640± 71.0
495.5
± 37.4
OG004543.3± 39.8
OG005439.9± 56.2
Participants
OG004
6
ParticipantsOG0055
Title
Measurements
OG0001913± 47.9
OG0011998± 112.9
OG0022907± 36.1
OG0033703± 20.8
OG0041101± 75.4
OG0053183± 51.5
5.79
(1.00 to 7.83)
OG0044.02(2.00 to 22.55)
OG0053.13(2.03 to 4.12)
Participants
OG004
6
ParticipantsOG0055
Title
Measurements
OG0002.23(2.13 to 4.00)
OG0012.00(1.00 to 2.12)
OG0021.00(0.00 to 1.08)
OG0033.00(0.00 to 7.50)
OG0042.29(2.00 to 4.00)
OG0051.18(0.00 to 2.07)
12
OG00418
OG00513
OG0068
OG0079
0
OG0041
OG0050
OG0060
OG0070
0
OG0040
OG0050
OG0060
OG0070
0
OG0040
OG0050
OG0060
OG0071
0
OG0040
OG0050
OG0060
OG0070
0
OG0040
OG0050
OG0060
OG0071
0
OG0040
OG0051
OG0060
OG0070
1
OG0040
OG0052
OG0061
OG0070
7
OG0043
OG0055
OG0062
OG0072
11
OG00418
OG00512
OG0067
OG0079
0
OG0040
OG0050
OG0060
OG0070
11
OG00418
OG00512
OG0067
OG0079
0
OG0040
OG0050
OG0061
OG0070
1
OG0040
OG0053
OG0060
OG0070
2
OG0041
OG0051
OG0060
OG0072
3
OG0042
OG0055
OG0062
OG0073
13
OG00418
OG00511
OG0067
OG0076
16
OG00420
OG00516
OG0069
OG0079
18
OG00420
OG00519
OG00610
OG00711
0
OG0040
OG0050
OG0060
OG0070
0
OG0040
OG0050
OG0060
OG0070
1
OG0041
OG0051
OG0060
OG0070
0
OG0040
OG0050
OG0060
OG0070
1
OG0041
OG0051
OG0060
OG0070
0
OG0042
OG0052
OG0063
OG0070
0
OG0041
OG0053
OG0060
OG0070
3
OG0040
OG0050
OG0062
OG0070
4
OG0046
OG0055
OG0063
OG0074
12
OG00412
OG00510
OG0062
OG0077
16
OG00418
OG00515
OG0065
OG00711
1
OG0040
OG0053
OG0061
OG0070
0
OG0041
OG0050
OG0060
OG0070
0
OG0040
OG0050
OG0061
OG0070
1
OG0041
OG0051
OG0062
OG0070
17
OG00419
OG00515
OG0066
OG00710
18
OG00420
OG00516
OG0068
OG00710
14
OG00419
OG00514
OG0068
OG0078
0
OG0040
OG0050
OG0060
OG0070
5
OG0041
OG0054
OG0062
OG0071
0
OG0041
OG0050
OG0060
OG0070
0
OG0040
OG0050
OG0060
OG0070
0
OG0041
OG0050
OG0060
OG0070
1
OG0041
OG0051
OG0061
OG0071
0
OG0041
OG0054
OG0061
OG0070
7
OG0044
OG0054
OG0063
OG0073
7
OG00410
OG0056
OG0064
OG0075
4
OG0045
OG0053
OG0061
OG0070
11
OG00415
OG0059
OG0065
OG0075
0
OG0040
OG0050
OG0061
OG0070
13
OG00410
OG00514
OG0063
OG0078
5
OG00410
OG0056
OG0066
OG0073
1
OG0041
OG0050
OG0060
OG0070
0
OG0040
OG0050
OG0060
OG0070
1
OG0041
OG0050
OG0060
OG0070
14
OG00418
OG00516
OG0067
OG0079
3
OG0041
OG0053
OG0061
OG0072
0
OG0041
OG0051
OG0060
OG0070
0
OG0040
OG0050
OG0060
OG0070
1
OG0041
OG0050
OG0060
OG0070
1
OG0041
OG0050
OG0060
OG0070
14
OG00413
OG00516
OG0064
OG0076
3
OG0047
OG0053
OG0064
OG0074
0
OG0041
OG0050
OG0060
OG0070
0
OG0040
OG0051
OG0060
OG0070
1
OG0040
OG0050
OG0060
OG0071
1
OG0040
OG0051
OG0060
OG0071
15
OG00418
OG00519
OG0069
OG00710
1
OG0043
OG0051
OG0060
OG0071
0
OG0040
OG0050
OG0060
OG0070
2
OG0040
OG0050
OG0061
OG0070
1
OG0040
OG0050
OG0060
OG0070
3
OG0040
OG0050
OG0061
OG0070
11
OG00417
OG00510
OG0067
OG0076
8
OG0044
OG0058
OG0063
OG0075
0
OG0040
OG0052
OG0060
OG0070
0
OG0040
OG0050
OG0060
OG0070
0
OG0040
OG0050
OG0060
OG0070
0
OG0040
OG0050
OG0060
OG0070
17
OG00416
OG00516
OG0067
OG0079
2
OG0044
OG0052
OG0063
OG0072
0
OG0041
OG0052
OG0060
OG0070
0
OG0040
OG0050
OG0060
OG0070
0
OG0040
OG0050
OG0060
OG0070
0
OG0040
OG0050
OG0060
OG0070
7
OG00416
OG00512
OG0066
OG0075
8
OG0044
OG0056
OG0063
OG0075
0
OG0040
OG0050
OG0060
OG0070
4
OG0041
OG0052
OG0061
OG0071
0
OG0040
OG0050
OG0060
OG0070
4
OG0041
OG0052
OG0061
OG0071
18
OG00419
OG00520
OG0069
OG0078
1
OG0042
OG0050
OG0061
OG0073
0
OG0040
OG0050
OG0060
OG0070
0
OG0040
OG0050
OG0060
OG0070
0
OG0040
OG0050
OG0060
OG0070
0
OG0040
OG0050
OG0060
OG0070
13
OG00413
OG00512
OG0065
OG0075
5
OG0048
OG0057
OG0064
OG0076
0
OG0040
OG0050
OG0060
OG0070
0
OG0040
OG0051
OG0061
OG0070
1
OG0040
OG0050
OG0060
OG0070
1
OG0040
OG0051
OG0061
OG0070
11
OG00414
OG0053
OG0065
OG00711
6
OG0045
OG0056
OG0064
OG0070
0
OG0040
OG0050
OG0060
OG0070
0
OG0040
OG0050
OG0060
OG0070
1
OG0041
OG0051
OG0061
OG0070
1
OG0041
OG0051
OG0061
OG0070
7
OG0048
OG0059
OG0063
OG0075
6
OG0047
OG0056
OG0062
OG0072
6
OG0044
OG0054
OG0062
OG0074
0
OG0042
OG0051
OG0063
OG0070
0
OG0040
OG0050
OG0060
OG0070
0
OG0042
OG0051
OG0063
OG0070
17
OG00419
OG00518
OG0069
OG00710
0
OG0040
OG0050
OG0060
OG0070
0
OG0040
OG0050
OG0060
OG0070
2
OG0041
OG0052
OG0061
OG0071
0
OG0040
OG0050
OG0060
OG0070
2
OG0041
OG0052
OG0061
OG0071
17
OG00418
OG00519
OG00610
OG00710
1
OG0040
OG0051
OG0060
OG0071
0
OG0041
OG0050
OG0060
OG0070
0
OG0040
OG0050
OG0060
OG0070
1
OG0041
OG0050
OG0060
OG0070
1
OG0041
OG0050
OG0060
OG0070
12
OG00416
OG00517
OG0068
OG0077
3
OG0045
OG0051
OG0060
OG0073
2
OG0040
OG0051
OG0061
OG0070
0
OG0040
OG0051
OG0061
OG0070
0
OG0040
OG0050
OG0060
OG0071
0
OG0040
OG0051
OG0060
OG0071
13
OG00418
OG00518
OG0069
OG0079
3
OG0042
OG0050
OG0061
OG0071
0
OG0041
OG0050
OG0060
OG0070
0
OG0040
OG0050
OG0060
OG0071
0
OG0040
OG0051
OG0060
OG0070
0
OG0040
OG0051
OG0060
OG0071
13
OG00413
OG0058
OG0064
OG0075
0
OG0043
OG0052
OG0060
OG0073
1
OG0040
OG0050
OG0060
OG0070
0
OG0040
OG0050
OG0060
OG0070
0
OG0040
OG0050
OG0060
OG0070
0
OG0040
OG0050
OG0060
OG0070
6
OG0047
OG0055
OG0060
OG0074
1
OG0042
OG0051
OG0061
OG0071
2
OG0043
OG0053
OG0060
OG0072
3
OG0044
OG0057
OG0063
OG0071
3
OG0041
OG0052
OG0060
OG0075
3051
± 109.7
OG0042031± 69.4
OG0051701± 39.4
OG0064165± 116.5
OG0073898± NAGeometric coefficient of variation could not be calculated due to small number of participants.
Participants
OG004
14
ParticipantsOG0054
ParticipantsOG0061
ParticipantsOG0071
Title
Measurements
OG00020610± 69.7
OG00127710± 14.9
OG00319820± 77.6
OG00419610± 62.1
OG00521810± 45.6
OG00625880± NAGeometric coefficient of variation could not be calculated due to small number of participants.
OG00719940± NAGeometric coefficient of variation could not be calculated due to small number of participants.
623.2
± 75.8
OG004404.1± 58.5
OG005411.2± 9.0
OG006747.5± 107.6
OG007671± NAGeometric coefficient of variation could not be calculated due to small number of participants.
Participants
OG004
14
ParticipantsOG0054
ParticipantsOG0061
ParticipantsOG0071
Title
Measurements
OG0003136± 62.0
OG0013800± 14.7
OG0033239± 68.7
OG0042934± 53.6
OG0053043± 39.3
OG0063500± NAGeometric coefficient of variation could not be calculated due to small number of participants.
OG0073080± NAGeometric coefficient of variation could not be calculated due to small number of participants.