Safety, PD & Efficacy of MT-3724 for the Treatment of Pat... | NCT02361346 | Trialant
NCT02361346
Sponsor
Molecular Templates, Inc.
Status
Terminated
Last Update Posted
Aug 18, 2022Actual
Enrollment
38Actual
Phase
Phase 1Phase 2
Conditions
Non-Hodgkin's B-cell Lymphoma
Leukemia, Lymphocytic, Chronic, B-Cell
Small Lymphocytic Leukemia
Diffuse Large B Cell Lymphoma
Blood Cancer
Hematological Malignancy
Interventions
MT-3724 Phase 1
MT-3724 Phase 2
Countries
United States
Belarus
Canada
Georgia
Israel
Moldova
Poland
Serbia
Spain
Ukraine
Protocol Section
Identification Module
NCT ID
NCT02361346
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
MT-3724_NHL_001
Secondary IDs
Not provided
Brief Title
Safety, PD & Efficacy of MT-3724 for the Treatment of Patients With Relapsed or Refractory DLBCL
Official Title
Safety, Pharmacodynamics and Efficacy of MT-3724 for the Treatment of Patients With Relapsed or Refractory DLBCL
Acronym
MT-3724NHL001
Organization
Molecular Templates, Inc.INDUSTRY
Status Module
Record Verification Date
Jul 2022
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Sponsor decision following clinical hold
Expanded Access Info
No
Start Date
Feb 2015Actual
Primary Completion Date
Mar 22, 2021Actual
Completion Date
Mar 22, 2021Actual
First Submitted Date
Feb 3, 2015
First Submission Date that Met QC Criteria
Feb 6, 2015
First Posted Date
Feb 11, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
May 24, 2022
Results First Submitted that Met QC Criteria
Jul 18, 2022
Results First Posted Date
Aug 18, 2022Actual
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
Jul 18, 2022
Last Update Posted Date
Aug 18, 2022Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Molecular Templates, Inc.INDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of MT-3724 in subjects with relapsed or refractory B-Cell NHL or relapsed and refractory CLL (Part 1 only) and relapsed and refractory DLBCL (Part 2 and Part 3). Part 3 evaluates the efficacy of MT-3724.
Detailed Description
This is a three-part Phase 2 study
Part 1: (MT-3724 Dose Escalation) Define the maximum tolerated dose (MTD) of MT-3724 [Completed]
Part 2: (MTD Expansion Cohort) Confirm the safety and tolerability of the MTD of MT-3724 in the MTD Expansion Cohort.
Part 3: (Phase 2 MTD Expansion Cohort) Determine the efficacy of MT-3724 as monotherapy in subjects with relapsed or refractory DLBCL based on the overall response rate (ORR) by the revised Lugano Classification for Lymphoma adjusted according to LYRIC.
It is anticipated that up to 100 patients will be enrolled in Part 3. Treatment will continue for up to six 21 days cycles. If the subject exhibits SD, CR or PR after the end of Cycle 6 and the investigator determines that the benefit-risk ratio is favorable, then the treatment with MT-3724 may be continued after discussion with the sponsor.
Conditions Module
Conditions
Non-Hodgkin's B-cell Lymphoma
Leukemia, Lymphocytic, Chronic, B-Cell
Small Lymphocytic Leukemia
Diffuse Large B Cell Lymphoma
Blood Cancer
Hematological Malignancy
Keywords
CD20
immunotoxin
NHL
non-Hodgkin's lymphoma
lymphoma
cancer
antibodies
immunotherapy
safety
pharmacokinetics
maximum tolerated dose
MT-3724
relapsed
refractory
leukemia
CLL
SLL
DLBCL
efficacy
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
38Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part 1: Cohort 1 - 5 Micrograms/Kilogram/Dose (mcg/kg/Dose)
Experimental
Part 1: MT-3724 5 mcg/kg/dose IV for 6 doses over 12 days, followed by dose escalations (Part 1) until recommended phase 2 dose of MT-3724 is determined
Drug: MT-3724 Phase 1
Part 1: Cohort 2- 10 mcg/kg/Dose
Experimental
Part 1: MT-3724 10 mcg/kg/dose IV for 6 doses over 12 days, followed by dose escalations (Part) until recommended phase 2 dose of MT-3724 is determined
Drug: MT-3724 Phase 1
Part 1: Cohort 3- 20 mcg/kg/Dose
Experimental
Part 1: MT-3724 20 mcg/kg/dose IV for 6 doses over 12 days, followed by dose escalations (Part 1) until recommended phase 2 dose of MT-3724 is determined
Drug: MT-3724 Phase 1
Part 1: Cohort 4- 50 mcg/kg/Dose
Experimental
Part 1: MT-3724 50 mcg/kg/dose IV for 6 doses over 12 days, followed by dose escalations (Part 1) until recommended phase 2 dose of MT-3724 is determined
Drug: MT-3724 Phase 1
Part 1: Cohort 5- 100 mcg/kg/Dose
Experimental
Part 1: MT-3724 100 mcg/kg/dose IV for 6 doses over 12 days, followed by dose escalations (Phase 1) until recommended phase 2 dose of MT-3724 is determined
Interventions
Name
Type
Description
Arm Group Labels
Other Names
MT-3724 Phase 1
Drug
Intravenous dosing Days 1, 3, 5, 8, 10 and 12; MT-3724 infusion over 2 hours on each dosing day over 28 day initial cycle and then 21 week repeat cycles for up to 5 total cycles.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Part 1: Number of Participants With Dose Limiting Toxicities of a Single Cycle of MT-3724
The MTD is defined to be the dose cohort below which participants experience dose-limiting toxicities during cycle 1. Dose-limiting toxicities were graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Days 1, 3, 5, 8, 10 and 12
Part 1 and 2: Maximum Observed Concentrations (Cmax) of MT-3274
Blood samples were collected at indicated timepoints for the determination of Cmax of MT-3274.
Part 1 and 2 : Days 1, 3 and 12
Part 1 and 2: Time to Achieve Cmax (Tmax) of MT-3724
Blood samples were collected at indicated timepoints for the determination of tmax.
Part 1 and 2: Days 1, 3 and 12
Part 1 and 2: Area Under the Plasma Concentration Time Curve From 0 to 4 Hours (AUC [0-4]), AUC (0-infinity) and AUC From Dosing to Last Measurable Concentration (AUClast) of MT-3724
Blood samples were collected at indicated timepoints for the determination of AUC (0-4), AUC (0-infinity) and AUClast.
Part 1 and 2: Days 1, 3 and 12
Part 1 and 2: Half Life (t1/2) of MT-3724
Blood samples were collected at indicated timepoints for the analysis of t1/2 of MT-3724.
Part 1 and 2: Days 1, 3 and 12
Part 1 and 2: Volume of Distribution (Vz) of MT-3724
Blood samples were collected at indicated timepoints for the analysis of Vz of MT-3724.
Part 1 and 2: Days 1, 3 and 12
Secondary Outcomes
Measure
Description
Time Frame
Part 1 and 2: Number of Participants Reporting Worst Case Serious Treatment Emergent Adverse Events (TEAEs) and Non-serious TEAEs
An adverse event is any untoward medical occurrence or clinical investigation in a participant administered a pharmaceutical product(s) and which does not necessarily have to have a causal relationship with this experimental treatment(s). SAE is any untoward medical occurrence, at any dose; is fatal or life-threatening, is life-threatening, results in permanently disabling; results in unplanned in-patient hospitalization or prolongation of existing hospitalization; results in a congenital abnormality or birth defect; important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when based upon appropriate medical judgment, they may jeopardize the participant or may require medical or surgical intervention.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Participants must be informed about the study and fully consent to participation as demonstrated by signing the written ICF before any screening procedure.
Male and female participants >= 18 years of age at the time of informed consent.
Participants must have relapsed or refractory Diffuse large B cell lymphoma (DLBCL) according to the Revised European American Lymphoma/World Health Organization classification. Participants must have proof of cluster of differentiation 20 plus (CD20+) DLBCL, based on either:
a. historical biopsies (obtained with diagnosis of relapsed or refractory disease), or
b. fresh biopsies
c. bone marrow biopsy, excisional lymph node biopsy, and core biopsy of any involved organ are all acceptable methods; Fine Needle Aspirate is not acceptable.
Participants must have received at least 2 standard of care (SoC) regimens (including anti-CD20 antibody therapy) appropriate for DLBCL treatment.
a. Participants whose prior therapy includes chimeric antigen receptor T-cell (CAR-T-cell) therapy are eligible.
b. Participants who underwent stem cell transplant (SCT) > 100 days for autologous SCT or > 180 days for allogeneic SCT before study drug administration.
c. Participants who have been ineligible for SoC DLBCL treatments may be eligible at the investigator's discretion, upon sponsor approval.
Participants must have at least 1 bi-dimensional tumor lesion at screening that is measurable by computerized tomography (CT) and/or magnetic resonance imaging (MRI) according to the Lugano criteria. Bi-dimensionally measurable tumor lesion by CT and/or MRI is defined as longest diameter of > 1.5 centimeters (cm) for lymph nodes and > 1.0 cm for extranodal disease.
Participants must have life expectancy of > 3 months from the start of treatment.
Participants must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
Participants must have met ALL the following laboratory criteria:
a. absolute neutrophil count (ANC) >= 1.0 × 10^9 cells per liter with no myeloid growth factors (granulocyte colony-stimulating factor [G-CSF] or granulocyte-macrophage colony-stimulating factor preparations) administered within 2 weeks of Cycle 1 Day 1.
b. platelet count >= 50 × 10^9 cells per liter with no Thrombopoietin-receptor agonists agents or platelet transfusions given within 2 weeks of Cycle 1 Day 1.
c. hemoglobin >= 8.0 grams per deciliter (g/dL) with no erythropoietin stimulating agents or peripheral red blood cell (PRBC) transfusions within 2 weeks of Cycle 1 Day 1
d. creatinine clearance (CLcr) to be >= 50 milliliter per minute (ml/min) either measured or estimated using the Cockcroft-Gault formula.
e. total bilirubin (or direct bilirubin for patients with Gilbert's disease < 1.5 × upper limit of normal (ULN)
f. alanine transaminase (ALT) ≤ 3.0 × ULN (or <= 5.0 x ULN if liver involvement).
g. aspartate aminotransferase (AST) <= 3.0 × ULN (or <= 5.0 x ULN if liver involvement).
h. international normalized ratio (INR) or prothrombin time (PT) <= 1.5 x ULN (unless on therapeutic anticoagulants).
i. Activated partial thromboplastin time <= 1.5 x ULN (unless on therapeutic anticoagulants).
Have adequate serum albumin, as determined by: a. albumin >= 3.0 g/dL.
QT interval correction for heart rate using Fridericia's formula (QTcF) <= 480 milliseconds determined as the average of 3 QTcF values from the triplicate electrocardiogram (ECG) obtained at screening.
Women of reproductive potential must have a negative highly sensitive pregnancy test within 72 hours before the start of treatment. Women who are postmenopausal or permanently sterilized (eg, tubal occlusion, hysterectomy, bilateral salpingectomy) may be considered as not of reproductive potential.
Participants of reproductive potential must agree either to abstain continuously from heterosexual intercourse or to use a highly effective birth control method from signing the informed consent until the short term follow-up (STFU) visit for females and until 90 days after the last dose of MT-3724 for males.
Participants must be able to comply with all study-related procedures and medication use.
Exclusion Criteria
Prior or Current Therapies
Received any amount of anti-CD20 monoclonal antibodies (mAbs) within the following periods before the start of treatment:
a. Rituximab (Rituxan®/MabThera® or rituximab biosimilar): within 84 days (12 weeks); if a participant has received rituximab within 37 weeks before the start of treatment, then serum rituximab level must be negative (< 500 nanograms per milliliter [ng/mL]) at screening.
b. Obinutuzumab (Gazyva®/Gazyvaro®): 184 days c. Ofatumumab (Arzerra®): 88 days d. Any other anti-CD20 agents (eg, investigational agents), the washout period is 5 half-lives. The investigator must contact the medical monitor to discuss the most Compound: MT-3724 appropriate washout for non-approved CD20-targeting agents, where the half-life (t1/2) is not known.
Received approved or investigational treatment for DLBCL within 4 weeks before the start of treatment. For small molecules (MW < 0.9 kilodaltons [kDa]), the washout is 5 half-lives or at least 2 weeks. Radioimmunoconjugates are excluded within 12 weeks before the start of treatment.
Received radiation therapy to tumor lesions that would serve as target lesions (measurable disease) within 4 weeks before the start of treatment, unless the lesion exhibited objective progression between radiation therapy and screening according to the Lugano Classification
o a. Palliative radiation therapy to non-target lesions may be permitted at the investigator's discretion after consultation with the medical monitor and sponsor.
Require the use of systemic immune modulators during study treatment:
a. Systemic immune modulators include, but are not limited to, systemic corticosteroids at doses > 20 milligrams per day (mg/day) of prednisone equivalent, cyclosporine and tacrolimus.
b. The use of non-steroidal anti-inflammatory drugs (NSAIDS) is permitted.
Received any live vaccines within 4 weeks before the start of treatment.
Prior treatment with MT-3724.
Medical History
Current evidence of Common Terminology Criteria for Adverse Events (CTCAE) Grade > 1 toxicity (due to prior anticancer therapy) before the start of treatment, except for hair loss and those Grade 2 toxicities listed as permitted in other eligibility criteria.
Current evidence of significant (CTCAE Grade ≥ 2) infection or wound within 4 weeks before the start of treatment. a. Participants with Grade 2 infection that has stabilized or improved with oral anti-infectives before the start of treatment may be eligible at the sponsor's discretion.
Known or suspected hypersensitivity to the study drug or excipients contained in the study drug formulation.
Current evidence of hypersensitivity or other underlying illness requiring systemic corticosteroids at doses > 20 mg/day prednisone equivalent.
Current evidence of uncontrolled human immunodeficiency syndrome (HIV), hepatitis B virus (HBV) or /hepatitis C virus (HCV) at screening. Serology testing is not required if seronegativity is documented in the medical history, and if there are no clinical signs suggestive of HIV or hepatitis infections, or suspected exposure. The following exceptions apply for participants with positive viral serology:
a. Participants with HIV and an undetectable viral load and CD4+ T-cell (CD4+) counts >= 350 cells per milliliter may be enrolled, but must be taking appropriate opportunistic infection prophylaxis, if clinically relevant.
b. Participants with positive HBV serology are eligible if they have an undetectable viral load and the participant will receive antiviral prophylaxis for potential HBV reactivation per institutional guidelines.
c. Participants with positive HCV serology are eligible if quantitative polymerase chain reaction (PCR) for plasma HCV ribonucleic acid (RNA) is below the lower limit of detection. Concurrent antiviral HCV treatment per institutional guidelines is allowed.
Current evidence of incomplete recovery from surgery or radiotherapy before start of treatment, or planned surgery or radiotherapy from the start of treatment until the end of treatment (EoT) visit, except minor elective surgery deemed acceptable by the investigator or palliative radiation therapy to non-target lesions.
History of cardiovascular, renal, hepatic or any other disease within 3 months before the start of treatment that in the investigator's opinion, may increase the risks associated with study participation or require treatments that may interfere with the conduct of the study or the interpretation of study results.
History or current evidence of neoplastic disease that is histologically distinct from NHL, except cervical carcinoma in situ, superficial noninvasive bladder tumors, curatively treated Stage I-II non-melanoma skin cancer. Participants with prior, curatively treated cancer > 2 years ago before the start of treatment can be enrolled.
Current evidence of new or growing brain or spinal metastases during screening. Participants with known brain or spinal metastases may be eligible if they:
a. Had radiotherapy or another appropriate therapy for the brain or spinal metastases; concurrent prophylactic treatment is allowed
b. Neurologic symptoms must be stable and no worse than Grade 2
c. Have evidence of stable brain or spinal disease on CT or MRI scan obtained within 4 weeks before signing the informed consent and compared with prior imaging results
d. Do not require steroid therapy (or, if applicable, have been stable on dose of no more than prednisone 20 mg/day or equivalent by C1D1)
Women who are pregnant or breastfeeding.
History of non-adherence to the schedule of procedures or medication use. 18. Current evidence of Graft vs Host Disease
History or current evidence of significant cardiovascular disease including, but not limited to, the following conditions:
a. Unstable angina (symptoms of angina at rest) or new-onset angina within 3 months before the start of treatment.
b. Arterial thrombosis or pulmonary embolism within 3 months before the start of treatment.
c. Myocardial infarction or stroke within 3 months before the start of treatment.
d. Pericarditis (any CTCAE grade), pericardial effusion (CTCAE Grade >= 2), non-malignant pleural effusion (CTCAE Grade ≥ 2) or malignant pleural effusion (CTCAE Grade >= 3) within 3 months before the start of treatment with MT-3724.
e. Congestive heart failure (New York Heart Association [NYHA] Class III or IV) at screening or left ventricular ejection fraction (LVEF) <= 45 percent (%), assessed by echocardiogram (ECHO) or multigated acquisition (MUGA) scan within 1 month before starting study treatment (inclusion of participants with LVEF between 40% to 45% should be discussed with the medical monitor and approved by the sponsor). (ECHO or MUGA performed within 6 months before screening and at least 28 days after the last cancer therapy is acceptable provided the participant has not received any potentially cardiotoxic agents since then).
f. Cardiac arrhythmia requiring anti-arrhythmic therapy at screening. Participants receiving digoxin, calcium channel blockers, or beta-adrenergic blockers are eligible at the investigator's discretion after consultation with medical monitor and sponsor if the dose has been stable for >= 2 weeks before the start of treatment with MT-3724. Participants with sinus arrhythmia and infrequent premature ventricular contractions are eligible at the investigator's discretion.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Not provided
Locations
Facility
Status
City
State
ZIP
Country
Contacts
University of Arizona
Tucson
Arizona
85724
United States
Innovative Clinical Research Institute, LLC
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
A total of 27 participants were enrolled in Parts 1 and 2 and 11 participants in Part 3. Part 2 was analyzed as a single arm as data was not collected for each dose level separately. The study was terminated as no participants in Part 3 showed a response and the potential risks outweighed potential benefit.
Recruitment Details
This 4-part study evaluated safety, pharmacodynamics and efficacy of MT-3724 in participants with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Part 1 was multiple ascending dose study and Parts 2, 3 and 4 were multi-center, multinational, open-label, single-arm evaluation of MT-3724 administered as monotherapy in repeat doses.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part 1: Cohort 1 - 5 Micrograms/Kilogram/Dose (mcg/kg/Dose)
Participants in this cohort received 5 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.
FG001
Part 1: Cohort 2- 10 mcg/kg/Dose
Periods
Title
Milestones
Reasons Not Completed
Part 1 and 2 ( Up to Day 112)
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Feb 12, 2021
May 24, 2022
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
Non-Randomized
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Drug: MT-3724 Phase 1
Part 1: Cohort 6- 75 mcg/kg/Dose
Experimental
Part 1b: MT-3724 75 mcg/kg/dose IV for 6 doses over 12 days of 21-Day cycle for up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724 (subject will continue with dose that was tolerated in the Part 1 portion of the study)
Drug: MT-3724 Phase 1
Part 2: Cohort 7- MTD Expansion Cohort
Experimental
Part 2: MT-3724 IV for 6 doses administered within 14 days of 21-Day cycle up to 6 Cycles. If the Subject exhibits stable disease or PR after end of Cycle 6 and investigator determines ratio is favorable, treatment with MT- 3724 may be continued for up to additional 6 cycles.
Drug: MT-3724 Phase 1
Drug: MT-3724 Phase 2
Part 3: All MT-3724 Treated Participants
Experimental
Part 3: MT-3724 IV 50 µg/kg/dose administered on Days 1, 3, 5, 8, 10, and 12 of each 21-day cycle. Treatment will continue until death, disease progression, unacceptable toxicity, withdrawal of consent, or another reason for withdrawal, or until study discontinuation
Drug: MT-3724 Phase 2
Part 4: All MT-3724 Treated Participants
Experimental
Part 4: In this arm, subjects were planned to receive all doses of MT-3724 as IV infusion as confirmed in Part 3.
Drug: MT-3724 Phase 2
Part 1: Cohort 1 - 5 Micrograms/Kilogram/Dose (mcg/kg/Dose)
Part 1: Cohort 2- 10 mcg/kg/Dose
Part 1: Cohort 3- 20 mcg/kg/Dose
Part 1: Cohort 4- 50 mcg/kg/Dose
Part 1: Cohort 5- 100 mcg/kg/Dose
Part 1: Cohort 6- 75 mcg/kg/Dose
Part 2: Cohort 7- MTD Expansion Cohort
MT-3724 Phase 2
Drug
Intravenous dosing on Days 1, 3, 5, 8, 10 and 12; MT-3724 infusion over 1 hour on each dosing day over 21 day cycle up to 6 cycles and then can be continued for 6 additional cycles.
Part 2: Cohort 7- MTD Expansion Cohort
Part 3: All MT-3724 Treated Participants
Part 4: All MT-3724 Treated Participants
Part 1 and 2: Clearance (CL) of MT-3724
Blood samples were collected at indicated timepoints for the analysis of CL of MT-3724.
Part 1 and 2: Days 1, 3 and 12
Part 1 and 2: Absolute Values of Cluster of Differentiation 19 Plus (CD19+) for B-cell Lymphocytes
CD19+ cells in the peripheral blood were counted as measures of malignant B-cells and were measured by flow cytometry. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus
Part 1 and 2: Cycle 1: Days 8 and 23; Cycle 3: Day1; Cycle 5: Day 1 and Day 120 (end of study)
Part 1 and 2: Number of Participants With Positive Anti-drug Antibody (ADA) Confirmed
Blood samples were collected to analyze the presence of ADA that bind MT-3724. Number of participants with positive ADA confirmed has been presented.
Part 1 and 2: Cycle 1, Day 23; Cycle 2, Day 1; Cycle 3, Day 1; Cycle 4, Day 1; Cycle 5, Day 1 and Day 120 (end of study)
Part 3: Number of Participants Reporting Serious Treatment-emergent Adverse Events (TEAEs) and Non-serious TEAEs
An adverse event is any untoward medical occurrence or clinical investigation in a participant administered a pharmaceutical product(s) and which does not necessarily have to have a causal relationship with this experimental treatment(s). SAE is any untoward medical occurrence, at any dose; is fatal or life-threatening, is life-threatening, results in permanently disabling; results in unplanned in-patient hospitalization or prolongation of existing hospitalization; results in a congenital abnormality or birth defect; important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when based upon appropriate medical judgment, they may jeopardize the participant or may require medical or surgical intervention.
Up to Day 45
Part 3: Number of Participants With Clinically Significant Laboratory Parameters
Blood samples were collected at indicated timepoints for the analysis of laboratory parameters.
Up to Day 45
Part 3: Number of Participants With Clinically Significant Electrocardiogram (ECG) Values
Standard resting 12-lead ECG assessments was performed after the participant has rested quietly for at least 5 minutes in supine or semi-recumbent position.
Up to Day 26
Part 3: Number Participants With Clinically Significant Vital Signs
Vital signs including systolic and diastolic blood pressure, respiratory rate, heart rate and body temperature were assessed at indicated time points.
Up to Day 45
Part 3: Number of Participants With Clinically Significant Physical Findings
Physical examination was performed by a physician or a qualified delegate at the investigating site.
Up to Day 26
Part 4: Overall Response Rate (ORR) in MT-3724 Treated Participants With Relapsed or Refractory DLBCL
Overall response rate is defined as the percentage of participants with either a CR or a PR as determined by independent, blinded central review.
Up to Day 45
Up to Day 45
Part 3: ORR in MT-3724 Treated Participants With Relapsed or Refractory DLBCL by the Lugano Classification for Lymphoma
Overall response rate is defined as the percentage of participants with either a complete response (CR) or a partial response (PR) as determined by independent, blinded central review board.
Up to Day 45
Part 3: ORR in MT-3724 Treated Participants With Relapsed or Refractory DLBCL
Overall response rate is defined as the percentage of participants with either a CR or a PR as determined by investigator assessment.
Up to Day 45
Part 3: Duration of Tumor Response (DOR) in MT-3724 Treated Participants With Relapsed or Refractory DLBCL
DOR defined as time from initial documentation of tumor response (CR or PR) to disease progression.
Up to Day 45
Part 3: Disease Control Rate (DCR) in MT-3724 Treated Participants With Relapsed or Refractory DLBCL
DCR defined as percentage of participants who have achieved CR, PR and stable disease.
Up to Day 45
Part 3: Cmax of MT-3724 Monotherapy in Participants With Relapsed or Refractory DLBCL
Blood samples were planned to be collected at indicated timepoints for the analysis of Cmax of MT-3724 monotherapy.
Up to Day 45
Part 3: Tmax of MT-3724 Monotherapy in Participants With Relapsed or Refractory DLBCL
Blood samples were planned to be collected at indicated timepoints for the analysis of tmax of MT-3724 monotherapy.
Up to Day 45
Part 3: AUC (0-4), AUC (0-infinity) and AUClast of MT-3724 Monotherapy in Participants With Relapsed or Refractory DLBCL
Blood samples were planned to be collected at indicated timepoints for the analysis of AUC (0-4), AUC (0-infinity) and AUClast of MT-3724 monotherapy.
Up to Day 45
Part 3: t1/2 of MT-3724 Monotherapy in Participants With Relapsed or Refractory DLBCL
Blood samples were planned to be collected at indicated timepoints for the analysis of t1/2 of MT-3724 monotherapy.
Up to Day 45
Part 3: Vz of MT-3724 Monotherapy in Participants With Relapsed or Refractory DLBCL
Blood samples were planned to be collected at indicated timepoints for the analysis of Vz of MT-3724 monotherapy.
Up to Day 45
Part 3: CL of MT-3724 Monotherapy in Participants With Relapsed or Refractory DLBCL
Blood samples were planned to be collected at indicated timepoints for the analysis of CL of MT-3724 monotherapy
Up to Day 45
Part 3: PD of MT-3724 Measured by B-cell Count in Participants With Relapsed or Refractory DCBCL
Pharmacodynamics of MT-3724 was planned to be measured by B-cell count in participants with relapsed of refractory DCBCL using flow cytometry.
Up to Day 45
Part 3: PD of MT-3724 Measured by Immunophenotyping in Participants With Relapsed or Refractory DCBCL
Pharmacodynamics of MT-3724 was planned to be measured by immunophenotyping in participants with relapsed of refractory DCBCL using flow cytometry.
Up to Day 45
Part 3: PD of MT-3724 Measured by Circulating Immunoglobulins in Participants With Relapsed or Refractory DCBCL
Pharmacodynamics of MT-3724 was planned to be measured by circulating immunoglobulins in participants with relapsed of refractory DCBCL.
Up to Day 45
Part 3: Number of Participants With ADA When Treated With MT-3724
Blood samples were planned to be collected to analyze the presence of ADA that bind MT-3724.
Up to Day 45
Part 4: DOR in MT-3724 Treated Participants With Relapsed or Refractory DLBCL
Duration of response was defined as the time from the first occurrence of either complete or partial response to first documented evidence of disease recurrence or progression. Participants without evidence of progression were planned to be censored at time of last disease assessment. Only responders (CR or PR) were planned to be included for this analysis.
Up to Day 45
Part 4: Number of Participants Reporting Serious Treatment-emergent Adverse Events (TEAEs) and Non-serious TEAEs
An adverse event is any untoward medical occurrence or clinical investigation in a participant administered a pharmaceutical product(s) and which does not necessarily have to have a causal relationship with this experimental treatment(s). SAE is any untoward medical occurrence, at any dose; is fatal or life-threatening, is life-threatening, results in permanently disabling; results in unplanned in-patient hospitalization or prolongation of existing hospitalization; results in a congenital abnormality or birth defect; important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when based upon appropriate medical judgment, they may jeopardize the participant or may require medical or surgical intervention.
Up to Day 45
Part 4: Number of Participants With SAEs
A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, any other situation such as important medical events according to medical or scientific judgement or is associated with liver injury and impaired liver function.
Up to Day 45
Part 4: Number of Participants With Clinically Significant Laboratory Parameters
Blood samples were planned to be collected for the analysis of laboratory parameters.
Up to Day 45
Part 4: Number Participants With Clinically Significant Vital Signs
Vital signs parameters including systolic and diastolic blood pressure, heart rate, respiration rate, body temperature and body weight were planned to be analyzed.
Up to Day 45
Part 4: Number of Participants With Clinically Significant ECG Values
Standard resting 12-lead ECG assessments was planned to be performed after the participant has rested quietly for at least 5 minutes in supine or semi-recumbent position.
Up to Day 26
Part 4: Number of Participants With Adverse Events Suggestive of Cardiotoxicity
Number of participants with any adverse events leading to cardiotoxicity when treated with MT-3724 was planned to be analyzed.
Up to Day 26
Part 4: ORR in MT-3724 Treated Participants With Relapsed or Refractory DLBCL
Overall response rate was defined as the percentage of participants with either a CR or a PR as determined by investigator assessment.
Up to Day 45
Part 4: DCR in MT-3724 Treated Participants With Relapsed or Refractory DLBCL
DCR was defined as percentage of participants who has achieved CR, PR and stable disease.
Up to Day 45
Part 4: Progression-free Survival (PFS) in MT-3724 Treated Participants With Relapsed or Refractory DLBCL
Progression-free survival was defined as the time from study enrollment to the earliest date of disease progression or death from any cause.
Up to Day 45
Part 4: Overall Survival (OS) in MT-3724 Treated Participants With Relapsed or Refractory DLBCL
Overall survival was defined as the time from study enrollment to death from any cause.
Up to Day 45
Part 4: Cmax of MT-3724 Monotherapy in Participants With Relapsed or Refractory DLBCL
Blood samples were planned to be collected at indicated timepoints for the analysis of Cmax of MT-3724 monotherapy.
Up to Day 45
Part 4: Tmax of MT-3724 Monotherapy in Participants With Relapsed or Refractory DLBCL
Blood samples were planned to be collected at indicated timepoints for the analysis of Tmax of MT-3724 monotherapy.
Up to Day 45
Part 4: AUC (0-4), AUC (0-infinity) and AUClast of MT-3724 Monotherapy in Participants With Relapsed or Refractory DLBCL
Blood samples were planned to be collected at indicated timepoints for the analysis of AUC (0-4), AUC (0-infinity) and AUClast of MT-3724 monotherapy.
Up to Day 45
Part 4: t1/2 of MT-3724 Monotherapy in Participants With Relapsed or Refractory DLBCL
Blood samples were planned to be collected at indicated timepoints for the analysis of t1/2 of MT-3724 monotherapy.
Up to Day 45
Part 4: Vz of MT-3724 Monotherapy in Participants With Relapsed or Refractory DLBCL
Blood samples were planned to be collected at indicated timepoints for the analysis of Vz of MT-3724 monotherapy.
Up to Day 45
Part 4: CL of MT-3724 Monotherapy in Participants With Relapsed or Refractory DLBCL
Blood samples were planned to be collected at indicated timepoints for the analysis of CL of MT-3724 monotherapy.
Up to Day 45
Part 4: PD of MT-3724 Measured by B-cell Count in Participants With Relapsed or Refractory DCBCL
Pharmacodynamics of MT-3724 was planned to be measured by B-cell count in participants with relapsed of refractory DCBCL using flow cytometry.
Up to Day 45
Part 4: PD of MT-3724 Measured by Immunophenotyping in Participants With Relapsed or Refractory DCBCL
Pharmacodynamics of MT-3724 was planned to be measured by immunophenotyping in participants with relapsed of refractory DCBCL using flow cytometry.
Up to Day 45
Part 4: PD of MT-3724 Measured by Circulating Immunoglobulins in Participants With Relapsed or Refractory DCBCL
Pharmacodynamics of MT-3724 was planned to be measured by circulating immunoglobulins in participants with relapsed of refractory DCBCL.
Up to Day 45
Part 4: Number of Participants With ADA When Treated With MT-3724
Blood samples were planned to be collected to analyze the presence of ADA that bind MT-3724.
Up to Day 45
Whittier
California
90602
United States
21st Century Oncology - Jacksonville
Jacksonville
Florida
32204
United States
Orlando Health, Inc.
Orlando
Florida
32806
United States
Orlando Health, Inc.
Orlando
Florida
United States
BRCR Medical Center
Plantation
Florida
33322
United States
ASCLEPES Research Centers
Weeki Wachee
Florida
34607
United States
Columbus Regional Research Institute
Columbus
Georgia
31904
United States
University of Illinois, Cancer Center
Chicago
Illinois
60612
United States
Healthcare Research Network III, LLC
Tinley Park
Illinois
United States
Carle Foundation Hospital
Urbana
Illinois
United States
Norton Healthcare, Inc
Louisville
Kentucky
United States
New York University Langone Medical Center
New York
New York
10016
United States
Memorial Sloan-Kettering Cancer Center
New York
New York
10065
United States
University of North Carolina
Chapel Hill
North Carolina
27599
United States
MD Anderson Cancer Center
Houston
Texas
77030
United States
UT Health San Antonio Cancer
San Antonio
Texas
78229
United States
Grodno University Hospital
Grodno
Belarus
Minsk City Clinical Oncology Center
Minsk
220013
Belarus
Cross Cancer Institute
Edmonton
Alberta
Canada
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston
Ontario
K7L 2V7
Canada
Princess Margaret Cancer Centre
Toronto
Ontario
M5G 2M9
Canada
Montreal Oncology Research
Québec
H1M 1B1
Canada
LLC ARENSIA Exploratory Medicine
Tbilisi
0112
Georgia
Rabin Medical Center, Davidoff Cancer Center, Hemato-Oncology Institute
Petah Tikva
49100
Israel
Chaim Sheba Medical Center, Department of Hematology
Ramat Gan
Israel
The Tel Aviv Sourasky Medical Center, Department of Hematology and Bone Marrow Transplantation
Tel Aviv
Israel
ARENSIA Exploratory Medicine,
Chisinau
MD-2025
Moldova
Maria Sklodowska-Curie National Institute of Oncology - National Research Institute
Gliwice
Poland
University Hospital in Krakow, Teaching Unit of the Hematology Department
Krakow
Poland
Frederic Chopin Provincial Teaching Hospital, Teaching Department of Hematology
Rzeszów
35-055
Poland
Our Doctor Clinical Trials Center
Torun
Poland
Institute of Hematology and Transfusion Medicine, Department of Hematology
Warsaw
Poland
Jan Mikulicz Radecki University Hospital in Wroclaw, Department and Clinic of Hematology, Blood Neoplasms and Bone Marrow Transplantation
Wroclaw
50-367
Poland
Clinical Center Kragujevac, Clinic of Hematology
Kragujevac
Serbia
Clinical Center of Vojvodina, Clinic of Hematology
Novi Sad
Serbia
Catalan Institute of Oncology (ICO) - Hospital Duran i Reynals, Department of Clinical Hematology
Barcelona
Spain
University Hospital Vall d'Hebron (HUVH), Department of Hematology
Barcelona
Spain
Hospital Universitario QuironSalud Madrid
Madrid
28223
Spain
University Hospital Virgen del Rocio (HUVR), Department of Hematology
Seville
Spain
Medical Center of Limited Liability Company "Medical Centre Named by Academician Yurii Spizhenko
Kyiv
08112
Ukraine
Participants in this cohort received 10 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.
FG002
Part 1: Cohort 3- 20 mcg/kg/Dose
Participants in this cohort received 20 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.
FG003
Part 1: Cohort 4- 50 mcg/kg/Dose
Participants in this cohort received 50 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.
FG004
Part 1: Cohort 5- 100 mcg/kg/Dose
Participants in this cohort received 100 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.
FG005
Part 1: Cohort 6- 75 mcg/kg/Dose
Participants in this cohort received 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 of 21-Day cycle for up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724.
FG006
Part 2: Cohort 7- MTD Expansion Cohort (50 or 75 mcg/kg/Dose)
Participants in this cohort either received 50 or 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 days of 21-Day cycle up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724.
FG007
Part 3
MT-3724 was administered at a dose of 50μg/kg/dose via IV infusion for all participants
FG008
Part 4
Participants in this arm were planned to receive all doses of MT-3724 as IV infusion over 1 hour in a 21-day cycle.
FG0003 subjects
FG0013 subjects
FG0023 subjects
FG0034 subjects
FG0042 subjects
FG0056 subjects
FG0066 subjects
FG0070 subjects
FG0080 subjects
COMPLETED
FG0003 subjects
FG0013 subjects
FG0023 subjects
FG0033 subjects
FG0040 subjects
FG0056 subjects
FG0066 subjects
FG0070 subjects
FG0080 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0042 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
Type
Comment
Reasons
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Part 3 (Up to Day 112)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG00711 subjects
FG0080 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
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Part 4 (Up to Day 112)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Part 2 was analyzed as a single arm as data was not collected for each dose level separately. As no participants from Part 3 had shown a response and as potential risks outweighed benefits, the study was terminated and no participants entered Part 4.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part 1: Cohort 1 - 5 Micrograms/Kilogram/Dose (mcg/kg/Dose)
Participants in this cohort received 5 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.
BG001
Part 1: Cohort 2- 10 mcg/kg/Dose
Participants in this cohort received 10 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.
BG002
Part 1: Cohort 3- 20 mcg/kg/Dose
Participants in this cohort received 20 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.
BG003
Part 1: Cohort 4- 50 mcg/kg/Dose
Participants in this cohort received 50 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.
BG004
Part 1: Cohort 5- 100 mcg/kg/Dose
Participants in this cohort received 100 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.
BG005
Part 1: Cohort 6- 75 mcg/kg/Dose
Participants in this cohort received 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 of 21-Day cycle for up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724.
BG006
Part 2: Cohort 7- MTD Expansion Cohort (50 or 75 mcg/kg/Dose)
Participants in this cohort received 50 or 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 days of 21-Day cycle up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724.
BG007
Part 3: All MT-3724 Treated Participants
MT-3724 was administered at a dose of 50µg/kg/dose via IV infusion for all participants
BG008
Part 4: All MT-3724 Treated Participants
Participants in this arm were planned to receive all doses of MT-3724 as IV infusion over 1 hour in a 21-day cycle
BG009
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0003
BG0013
BG0023
BG0034
BG0042
BG0056
BG0066
BG00711
BG0080
BG00938
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00073.3± 6.43
BG00170.7± 8.74
BG00264.3± 14.01
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0000
BG0012
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
White
Title
Measurements
BG0002
BG0013
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
Part 1: Number of Participants With Dose Limiting Toxicities of a Single Cycle of MT-3724
The MTD is defined to be the dose cohort below which participants experience dose-limiting toxicities during cycle 1. Dose-limiting toxicities were graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Safety Set comprises of all participants who received any amount of MT-3724
Posted
Count of Participants
Participants
Days 1, 3, 5, 8, 10 and 12
ID
Title
Description
OG000
Part 1: Cohort 1 - 5 Micrograms/Kilogram/Dose (mcg/kg/Dose)
Participants in this cohort received 5 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.
OG001
Part 1: Cohort 2- 10 mcg/kg/Dose
Participants in this cohort received 10 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.
OG002
Part 1: Cohort 3- 20 mcg/kg/Dose
Participants in this cohort received 20 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.
OG003
Part 1: Cohort 4- 50 mcg/kg/Dose
Participants in this cohort received 50 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.
OG004
Part 1: Cohort 5- 100 mcg/kg/Dose
Participants in this cohort received 100 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.
OG005
Part 1: Cohort 6- 75 mcg/kg/Dose
Participants in this cohort received 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 of 21-Day cycle for up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Part 1 and 2: Maximum Observed Concentrations (Cmax) of MT-3274
Blood samples were collected at indicated timepoints for the determination of Cmax of MT-3274.
Pharmacokinetic Analysis Set (PAS). All subjects from the Safety Set with sufficient serum concentration data to determine the primary PK parameters. Only those participants with data available at specified timepoints were analyzed. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanograms per milliliter
Part 1 and 2 : Days 1, 3 and 12
ID
Title
Description
OG000
Part 1: Cohort 1 - 5 Micrograms/Kilogram/Dose (mcg/kg/Dose)
Participants in this cohort received 5 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.
OG001
Part 1: Cohort 2- 10 mcg/kg/Dose
Participants in this cohort received 10 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.
OG002
Part 1: Cohort 3- 20 mcg/kg/Dose
Participants in this cohort received 20 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.
Primary
Part 1 and 2: Time to Achieve Cmax (Tmax) of MT-3724
Blood samples were collected at indicated timepoints for the determination of tmax.
Pharmacokinetic Analysis Set. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Posted
Median
Full Range
Hours
Part 1 and 2: Days 1, 3 and 12
ID
Title
Description
OG000
Part 1: Cohort 1 - 5 Micrograms/Kilogram/Dose (mcg/kg/Dose)
Participants in this cohort received 5 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.
OG001
Part 1: Cohort 2- 10 mcg/kg/Dose
Participants in this cohort received 10 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.
OG002
Part 1: Cohort 3- 20 mcg/kg/Dose
Participants in this cohort received 20 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.
Primary
Part 1 and 2: Area Under the Plasma Concentration Time Curve From 0 to 4 Hours (AUC [0-4]), AUC (0-infinity) and AUC From Dosing to Last Measurable Concentration (AUClast) of MT-3724
Blood samples were collected at indicated timepoints for the determination of AUC (0-4), AUC (0-infinity) and AUClast.
Pharmacokinetic Analysis Set. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Posted
Geometric Mean
Geometric Coefficient of Variation
h*ng/ml
Part 1 and 2: Days 1, 3 and 12
ID
Title
Description
OG000
Part 1: Cohort 1 - 5 Micrograms/Kilogram/Dose (mcg/kg/Dose)
Participants in this cohort received 5 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.
OG001
Part 1: Cohort 2 - 10mcg/kg/Dose
Participants in this cohort received 10 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.
OG002
Part 1: Cohort 3 - 20mcg/kg/Dose
Participants in this cohort received 20 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.
Primary
Part 1 and 2: Half Life (t1/2) of MT-3724
Blood samples were collected at indicated timepoints for the analysis of t1/2 of MT-3724.
Pharmacokinetic Analysis Set. Part 2 was analyzed as a single-arm as data was not collected for each dose level separately.
Posted
Geometric Mean
Geometric Coefficient of Variation
Hour
Part 1 and 2: Days 1, 3 and 12
ID
Title
Description
OG000
Part 1: Cohort 1: 5 Micrograms/Kilograms/Dose/Day
Participants in this cohort received 5 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 of 21-Day cycle for up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724.
OG001
Part 1: Cohort 2: 10 mcg/kg/Dose/Day
Participants in this cohort received 10 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 of 21-Day cycle for up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724.
OG002
Part 1: Cohort 3: 20 mcg/kg/Dose/Day
Participants in this cohort received 20 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 of 21-Day cycle for up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724.
Primary
Part 1 and 2: Volume of Distribution (Vz) of MT-3724
Blood samples were collected at indicated timepoints for the analysis of Vz of MT-3724.
Pharmacokinetic Analysis Set. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Posted
Geometric Mean
Geometric Coefficient of Variation
Liters
Part 1 and 2: Days 1, 3 and 12
ID
Title
Description
OG000
Part 1: Cohort 1: 5 Micrograms/Kilograms/Dose/Day
Participants in this cohort received 5 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.
OG001
Part 1: Cohort 2: 10 mcg/kg/Dose/Day
Participants in this cohort received 10 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.
OG002
Part 1: Cohort 3: 20 mcg/kg/Dose/Day
Participants in this cohort received 20 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.
Primary
Part 1 and 2: Clearance (CL) of MT-3724
Blood samples were collected at indicated timepoints for the analysis of CL of MT-3724.
Pharmacokinetic Analysis Set. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Posted
Geometric Mean
Geometric Coefficient of Variation
Liters per hour
Part 1 and 2: Days 1, 3 and 12
ID
Title
Description
OG000
Part 1: Cohort 1: 5 Micrograms/Kilograms/Dose/Day
Participants in this cohort received 5 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.
OG001
Part 1: Cohort 2: 10 mcg/kg/Dose/Day
Participants in this cohort received 10 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.
OG002
Part 1: Cohort 3: 20 mcg/kg/Dose/Day
Participants in this cohort received 20 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.
Primary
Part 1 and 2: Absolute Values of Cluster of Differentiation 19 Plus (CD19+) for B-cell Lymphocytes
CD19+ cells in the peripheral blood were counted as measures of malignant B-cells and were measured by flow cytometry. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus
Pharmacokinetic Analysis Set. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Posted
Mean
Standard Deviation
10^3 cells per microliter
Part 1 and 2: Cycle 1: Days 8 and 23; Cycle 3: Day1; Cycle 5: Day 1 and Day 120 (end of study)
ID
Title
Description
OG000
Part 1: Cohort 1 - 5 Micrograms/Kilogram/Dose (mcg/kg/Dose)
Participants in this cohort received 5 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.
OG001
Part 1: Cohort 2- 10 mcg/kg/Dose
Participants in this cohort received 10 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.
OG002
Part 1: Cohort 3- 20 mcg/kg/Dose
Participants in this cohort received 20 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.
Primary
Part 1 and 2: Number of Participants With Positive Anti-drug Antibody (ADA) Confirmed
Blood samples were collected to analyze the presence of ADA that bind MT-3724. Number of participants with positive ADA confirmed has been presented.
Pharmacokinetic Analysis Set. Only those participants with data available at specified time points has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Posted
Count of Participants
Participants
Part 1 and 2: Cycle 1, Day 23; Cycle 2, Day 1; Cycle 3, Day 1; Cycle 4, Day 1; Cycle 5, Day 1 and Day 120 (end of study)
ID
Title
Description
OG000
Part 1: Cohort 1 - 5 Micrograms/Kilogram/Dose (mcg/kg/Dose)
Participants in this cohort received 5 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.
OG001
Part 1: Cohort 2- 10 mcg/kg/Dose
Participants in this cohort received 10 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.
OG002
Part 1: Cohort 3- 20 mcg/kg/Dose
Participants in this cohort received 20 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.
Primary
Part 3: Number of Participants Reporting Serious Treatment-emergent Adverse Events (TEAEs) and Non-serious TEAEs
An adverse event is any untoward medical occurrence or clinical investigation in a participant administered a pharmaceutical product(s) and which does not necessarily have to have a causal relationship with this experimental treatment(s). SAE is any untoward medical occurrence, at any dose; is fatal or life-threatening, is life-threatening, results in permanently disabling; results in unplanned in-patient hospitalization or prolongation of existing hospitalization; results in a congenital abnormality or birth defect; important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when based upon appropriate medical judgment, they may jeopardize the participant or may require medical or surgical intervention.
Safety Set.
Posted
Count of Participants
Participants
Up to Day 45
ID
Title
Description
OG000
Part 3: All MT-3724 Treated Participants
MT-3724 was administered at a dose of 50µg/kg/dose via IV infusion for all participants
Units
Counts
Participants
OG000
Primary
Part 3: Number of Participants With Clinically Significant Laboratory Parameters
Blood samples were collected at indicated timepoints for the analysis of laboratory parameters.
Safety Set.
Posted
Count of Participants
Participants
Up to Day 45
ID
Title
Description
OG000
Part 3: All MT-3724 Treated Participants
MT-3724 was administered at a dose of 50µg/kg/dose via IV infusion for all participants
Units
Counts
Participants
OG00011
Primary
Part 3: Number of Participants With Clinically Significant Electrocardiogram (ECG) Values
Standard resting 12-lead ECG assessments was performed after the participant has rested quietly for at least 5 minutes in supine or semi-recumbent position.
Safety Set.
Posted
Count of Participants
Participants
Up to Day 26
ID
Title
Description
OG000
Part 3: All MT-3724 Treated Participants
MT-3724 was administered at a dose of 50µg/kg/dose via IV infusion for all participants
Units
Counts
Participants
OG00011
Primary
Part 3: Number Participants With Clinically Significant Vital Signs
Vital signs including systolic and diastolic blood pressure, respiratory rate, heart rate and body temperature were assessed at indicated time points.
Safety Set.
Posted
Count of Participants
Participants
Up to Day 45
ID
Title
Description
OG000
Part 3: All MT-3724 Treated Participants
MT-3724 was administered at a dose of 50µg/kg/dose via IV infusion for all participants
Units
Counts
Participants
OG00011
Primary
Part 3: Number of Participants With Clinically Significant Physical Findings
Physical examination was performed by a physician or a qualified delegate at the investigating site.
Safety Set.
Posted
Count of Participants
Participants
Up to Day 26
ID
Title
Description
OG000
Part 3: All MT-3724 Treated Participants
MT-3724 was administered at a dose of 50µg/kg/dose via IV infusion for all participants
Units
Counts
Participants
OG00011
Primary
Part 4: Overall Response Rate (ORR) in MT-3724 Treated Participants With Relapsed or Refractory DLBCL
Overall response rate is defined as the percentage of participants with either a CR or a PR as determined by independent, blinded central review.
Full Analysis Set. The data was not collected due to early study termination
Posted
Up to Day 45
ID
Title
Description
OG000
Part 4: All MT-3724 Treated Participants
Participants in this arm were planned to receive all doses of MT-3724 as IV infusion over 1 hour in a 21-day cycle
Units
Counts
Participants
OG0000
Secondary
Part 1 and 2: Number of Participants Reporting Worst Case Serious Treatment Emergent Adverse Events (TEAEs) and Non-serious TEAEs
An adverse event is any untoward medical occurrence or clinical investigation in a participant administered a pharmaceutical product(s) and which does not necessarily have to have a causal relationship with this experimental treatment(s). SAE is any untoward medical occurrence, at any dose; is fatal or life-threatening, is life-threatening, results in permanently disabling; results in unplanned in-patient hospitalization or prolongation of existing hospitalization; results in a congenital abnormality or birth defect; important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when based upon appropriate medical judgment, they may jeopardize the participant or may require medical or surgical intervention.
Safety Set comprises of all participants who received any amount of MT-3724. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Posted
Count of Participants
Participants
Up to Day 45
ID
Title
Description
OG000
Part 1: Cohort 1 - 5 Micrograms/Kilogram/Dose (mcg/kg/Dose)
Participants in this cohort received 5 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.
OG001
Part 1: Cohort 2- 10 mcg/kg/Dose
Secondary
Part 3: ORR in MT-3724 Treated Participants With Relapsed or Refractory DLBCL by the Lugano Classification for Lymphoma
Overall response rate is defined as the percentage of participants with either a complete response (CR) or a partial response (PR) as determined by independent, blinded central review board.
Full Analysis Set. The data was not collected due to early study termination.
Posted
Up to Day 45
ID
Title
Description
OG000
Part 3: All MT-3724 Treated Participants
MT-3724 was administered at a dose of 50µg/kg/dose via IV infusion for all participants
Units
Counts
Participants
OG000
Secondary
Part 3: ORR in MT-3724 Treated Participants With Relapsed or Refractory DLBCL
Overall response rate is defined as the percentage of participants with either a CR or a PR as determined by investigator assessment.
Full Analysis Set. The data was not collected due to early study termination
Posted
Up to Day 45
ID
Title
Description
OG000
Part 3: All MT-3724 Treated Participants
MT-3724 was administered at a dose of 50µg/kg/dose via IV infusion for all participants
Units
Counts
Participants
OG0000
Secondary
Part 3: Duration of Tumor Response (DOR) in MT-3724 Treated Participants With Relapsed or Refractory DLBCL
DOR defined as time from initial documentation of tumor response (CR or PR) to disease progression.
Full Analysis Set. The data was not collected due to early study termination
Posted
Up to Day 45
ID
Title
Description
OG000
Part 3: All MT-3724 Treated Participants
MT-3724 was administered at a dose of 50µg/kg/dose via IV infusion for all participants
Units
Counts
Participants
OG0000
Secondary
Part 3: Disease Control Rate (DCR) in MT-3724 Treated Participants With Relapsed or Refractory DLBCL
DCR defined as percentage of participants who have achieved CR, PR and stable disease.
Full Analysis Set. The data was not collected due to early study termination
Posted
Up to Day 45
ID
Title
Description
OG000
Part 3: All MT-3724 Treated Participants
MT-3724 was administered at a dose of 50µg/kg/dose via IV infusion for all participants
Units
Counts
Participants
OG0000
Secondary
Part 3: Cmax of MT-3724 Monotherapy in Participants With Relapsed or Refractory DLBCL
Blood samples were planned to be collected at indicated timepoints for the analysis of Cmax of MT-3724 monotherapy.
Full Analysis Set. The data was not collected due to early study termination
Posted
Up to Day 45
ID
Title
Description
OG000
Part 3: All MT-3724 Treated Participants
MT-3724 was administered at a dose of 50µg/kg/dose via IV infusion for all participants
Units
Counts
Participants
OG0000
Secondary
Part 3: Tmax of MT-3724 Monotherapy in Participants With Relapsed or Refractory DLBCL
Blood samples were planned to be collected at indicated timepoints for the analysis of tmax of MT-3724 monotherapy.
Full Analysis Set. The data was not collected due to early study termination
Posted
Up to Day 45
ID
Title
Description
OG000
Part 3: All MT-3724 Treated Participants
MT-3724 was administered at a dose of 50µg/kg/dose via IV infusion for all participants
Units
Counts
Participants
OG0000
Secondary
Part 3: AUC (0-4), AUC (0-infinity) and AUClast of MT-3724 Monotherapy in Participants With Relapsed or Refractory DLBCL
Blood samples were planned to be collected at indicated timepoints for the analysis of AUC (0-4), AUC (0-infinity) and AUClast of MT-3724 monotherapy.
Full Analysis Set. The data was not collected due to early study termination
Posted
Up to Day 45
ID
Title
Description
OG000
Part 3: All MT-3724 Treated Participants
MT-3724 was administered at a dose of 50µg/kg/dose via IV infusion for all participants
Units
Counts
Participants
OG0000
Secondary
Part 3: t1/2 of MT-3724 Monotherapy in Participants With Relapsed or Refractory DLBCL
Blood samples were planned to be collected at indicated timepoints for the analysis of t1/2 of MT-3724 monotherapy.
Full Analysis Set. The data was not collected due to early study termination
Posted
Up to Day 45
ID
Title
Description
OG000
Part 3: All MT-3724 Treated Participants
MT-3724 was administered at a dose of 50µg/kg/dose via IV infusion for all participants
Units
Counts
Participants
OG0000
Secondary
Part 3: Vz of MT-3724 Monotherapy in Participants With Relapsed or Refractory DLBCL
Blood samples were planned to be collected at indicated timepoints for the analysis of Vz of MT-3724 monotherapy.
Full Analysis Set. The data was not collected due to early study termination
Posted
Up to Day 45
ID
Title
Description
OG000
Part 3: All MT-3724 Treated Participants
MT-3724 was administered at a dose of 50µg/kg/dose via IV infusion for all participants
Units
Counts
Participants
OG0000
Secondary
Part 3: CL of MT-3724 Monotherapy in Participants With Relapsed or Refractory DLBCL
Blood samples were planned to be collected at indicated timepoints for the analysis of CL of MT-3724 monotherapy
Full Analysis Set. The data was not collected due to early study termination
Posted
Up to Day 45
ID
Title
Description
OG000
Part 3: All MT-3724 Treated Participants
MT-3724 was administered at a dose of 50µg/kg/dose via IV infusion for all participants
Units
Counts
Participants
OG0000
Secondary
Part 3: PD of MT-3724 Measured by B-cell Count in Participants With Relapsed or Refractory DCBCL
Pharmacodynamics of MT-3724 was planned to be measured by B-cell count in participants with relapsed of refractory DCBCL using flow cytometry.
Full Analysis Set. The data was not collected due to early study termination
Posted
Up to Day 45
ID
Title
Description
OG000
Part 3: All MT-3724 Treated Participants
MT-3724 was administered at a dose of 50µg/kg/dose via IV infusion for all participants
Units
Counts
Participants
OG0000
Secondary
Part 3: PD of MT-3724 Measured by Immunophenotyping in Participants With Relapsed or Refractory DCBCL
Pharmacodynamics of MT-3724 was planned to be measured by immunophenotyping in participants with relapsed of refractory DCBCL using flow cytometry.
Full Analysis Set. The data was not collected due to early study termination
Posted
Up to Day 45
ID
Title
Description
OG000
Part 3: All MT-3724 Treated Participants
MT-3724 was administered at a dose of 50µg/kg/dose via IV infusion for all participants
Units
Counts
Participants
OG0000
Secondary
Part 3: PD of MT-3724 Measured by Circulating Immunoglobulins in Participants With Relapsed or Refractory DCBCL
Pharmacodynamics of MT-3724 was planned to be measured by circulating immunoglobulins in participants with relapsed of refractory DCBCL.
Full Analysis Set. The data was not collected due to early study termination
Posted
Up to Day 45
ID
Title
Description
OG000
Part 3: All MT-3724 Treated Participants
MT-3724 was administered at a dose of 50µg/kg/dose via IV infusion for all participants
Units
Counts
Participants
OG0000
Secondary
Part 3: Number of Participants With ADA When Treated With MT-3724
Blood samples were planned to be collected to analyze the presence of ADA that bind MT-3724.
Full Analysis Set. The data was not collected due to early study termination
Posted
Up to Day 45
ID
Title
Description
OG000
Part 3: All MT-3724 Treated Participants
MT-3724 was administered at a dose of 50µg/kg/dose via IV infusion for all participants
Units
Counts
Participants
OG0000
Secondary
Part 4: DOR in MT-3724 Treated Participants With Relapsed or Refractory DLBCL
Duration of response was defined as the time from the first occurrence of either complete or partial response to first documented evidence of disease recurrence or progression. Participants without evidence of progression were planned to be censored at time of last disease assessment. Only responders (CR or PR) were planned to be included for this analysis.
Full Analysis Set. The data was not collected due to early study termination
Posted
Up to Day 45
ID
Title
Description
OG000
Part 4: All MT-3724 Treated Participants
Participants in this arm were planned to receive all doses of MT-3724 as IV infusion over 1 hour in a 21-day cycle
Units
Counts
Participants
OG000
Secondary
Part 4: Number of Participants Reporting Serious Treatment-emergent Adverse Events (TEAEs) and Non-serious TEAEs
An adverse event is any untoward medical occurrence or clinical investigation in a participant administered a pharmaceutical product(s) and which does not necessarily have to have a causal relationship with this experimental treatment(s). SAE is any untoward medical occurrence, at any dose; is fatal or life-threatening, is life-threatening, results in permanently disabling; results in unplanned in-patient hospitalization or prolongation of existing hospitalization; results in a congenital abnormality or birth defect; important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when based upon appropriate medical judgment, they may jeopardize the participant or may require medical or surgical intervention.
Safety Set. The data was not collected due to early study termination
Posted
Up to Day 45
ID
Title
Description
OG000
Part 4: All MT-3724 Treated Participants
Participants in this arm were planned to receive all doses of MT-3724 as IV infusion over 1 hour in a 21-day cycle
Units
Counts
Participants
Secondary
Part 4: Number of Participants With SAEs
A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, any other situation such as important medical events according to medical or scientific judgement or is associated with liver injury and impaired liver function.
Safety Set. The data was not collected due to early study termination
Posted
Up to Day 45
ID
Title
Description
OG000
Part 4: All MT-3724 Treated Participants
Participants in this arm were planned to receive all doses of MT-3724 as IV infusion over 1 hour in a 21-day cycle
Units
Counts
Participants
OG000
Secondary
Part 4: Number of Participants With Clinically Significant Laboratory Parameters
Blood samples were planned to be collected for the analysis of laboratory parameters.
Safety Set. The data was not collected due to early study termination
Posted
Up to Day 45
ID
Title
Description
OG000
Part 4: All MT-3724 Treated Participants
Participants in this arm were planned to receive all doses of MT-3724 as IV infusion over 1 hour in a 21-day cycle
Units
Counts
Participants
OG0000
Secondary
Part 4: Number Participants With Clinically Significant Vital Signs
Vital signs parameters including systolic and diastolic blood pressure, heart rate, respiration rate, body temperature and body weight were planned to be analyzed.
Safety Set. The data was not collected due to early study termination
Posted
Up to Day 45
ID
Title
Description
OG000
Part 4: All MT-3724 Treated Participants
Participants in this arm were planned to receive all doses of MT-3724 as IV infusion over 1 hour in a 21-day cycle
Units
Counts
Participants
OG0000
Secondary
Part 4: Number of Participants With Clinically Significant ECG Values
Standard resting 12-lead ECG assessments was planned to be performed after the participant has rested quietly for at least 5 minutes in supine or semi-recumbent position.
Safety Set. The data was not collected due to early study termination
Posted
Up to Day 26
ID
Title
Description
OG000
Part 4: All MT-3724 Treated Participants
Participants in this arm were planned to receive all doses of MT-3724 as IV infusion over 1 hour in a 21-day cycle
Units
Counts
Participants
OG0000
Secondary
Part 4: Number of Participants With Adverse Events Suggestive of Cardiotoxicity
Number of participants with any adverse events leading to cardiotoxicity when treated with MT-3724 was planned to be analyzed.
Safety Set. The data was not collected due to early study termination
Posted
Up to Day 26
ID
Title
Description
OG000
Part 4: All MT-3724 Treated Participants
Participants in this arm were planned to receive all doses of MT-3724 as IV infusion over 1 hour in a 21-day cycle
Units
Counts
Participants
OG0000
Secondary
Part 4: ORR in MT-3724 Treated Participants With Relapsed or Refractory DLBCL
Overall response rate was defined as the percentage of participants with either a CR or a PR as determined by investigator assessment.
Full Analysis Set. The data was not collected due to early study termination
Posted
Up to Day 45
ID
Title
Description
OG000
Part 4: All MT-3724 Treated Participants
Participants in this arm were planned to receive all doses of MT-3724 as IV infusion over 1 hour in a 21-day cycle
Units
Counts
Participants
OG0000
Secondary
Part 4: DCR in MT-3724 Treated Participants With Relapsed or Refractory DLBCL
DCR was defined as percentage of participants who has achieved CR, PR and stable disease.
Full Analysis Set. The data was not collected due to early study termination
Posted
Up to Day 45
ID
Title
Description
OG000
Part 4: All MT-3724 Treated Participants
Participants in this arm were planned to receive all doses of MT-3724 as IV infusion over 1 hour in a 21-day cycle
Units
Counts
Participants
OG0000
Secondary
Part 4: Progression-free Survival (PFS) in MT-3724 Treated Participants With Relapsed or Refractory DLBCL
Progression-free survival was defined as the time from study enrollment to the earliest date of disease progression or death from any cause.
Full Analysis Set. The data was not collected due to early study termination
Posted
Up to Day 45
ID
Title
Description
OG000
Part 4: All MT-3724 Treated Participants
Participants in this arm were planned to receive all doses of MT-3724 as IV infusion over 1 hour in a 21-day cycle
Units
Counts
Participants
OG0000
Secondary
Part 4: Overall Survival (OS) in MT-3724 Treated Participants With Relapsed or Refractory DLBCL
Overall survival was defined as the time from study enrollment to death from any cause.
Full Analysis Set. The data was not collected due to early study termination
Posted
Up to Day 45
ID
Title
Description
OG000
Part 4: All MT-3724 Treated Participants
Participants in this arm were planned to receive all doses of MT-3724 as IV infusion over 1 hour in a 21-day cycle
Units
Counts
Participants
OG0000
Secondary
Part 4: Cmax of MT-3724 Monotherapy in Participants With Relapsed or Refractory DLBCL
Blood samples were planned to be collected at indicated timepoints for the analysis of Cmax of MT-3724 monotherapy.
Pharmacokinetic Analysis Set. The data was not collected due to early study termination
Posted
Up to Day 45
ID
Title
Description
OG000
Part 4: All MT-3724 Treated Participants
Participants in this arm were planned to receive all doses of MT-3724 as IV infusion over 1 hour in a 21-day cycle
Units
Counts
Participants
OG0000
Secondary
Part 4: Tmax of MT-3724 Monotherapy in Participants With Relapsed or Refractory DLBCL
Blood samples were planned to be collected at indicated timepoints for the analysis of Tmax of MT-3724 monotherapy.
Pharmacokinetic Analysis Set. The data was not collected due to early study termination
Posted
Up to Day 45
ID
Title
Description
OG000
Part 4: All MT-3724 Treated Participants
Participants in this arm were planned to receive all doses of MT-3724 as IV infusion over 1 hour in a 21-day cycle
Units
Counts
Participants
OG0000
Secondary
Part 4: AUC (0-4), AUC (0-infinity) and AUClast of MT-3724 Monotherapy in Participants With Relapsed or Refractory DLBCL
Blood samples were planned to be collected at indicated timepoints for the analysis of AUC (0-4), AUC (0-infinity) and AUClast of MT-3724 monotherapy.
Pharmacokinetic Analysis Set. The data was not collected due to early study termination
Posted
Up to Day 45
ID
Title
Description
OG000
Part 4: All MT-3724 Treated Participants
Participants in this arm were planned to receive all doses of MT-3724 as IV infusion over 1 hour in a 21-day cycle
Units
Counts
Participants
OG000
Secondary
Part 4: t1/2 of MT-3724 Monotherapy in Participants With Relapsed or Refractory DLBCL
Blood samples were planned to be collected at indicated timepoints for the analysis of t1/2 of MT-3724 monotherapy.
Pharmacokinetic Analysis Set. The data was not collected due to early study termination
Posted
Up to Day 45
ID
Title
Description
OG000
Part 4: All MT-3724 Treated Participants
Participants in this arm were planned to receive all doses of MT-3724 as IV infusion over 1 hour in a 21-day cycle
Units
Counts
Participants
OG0000
Secondary
Part 4: Vz of MT-3724 Monotherapy in Participants With Relapsed or Refractory DLBCL
Blood samples were planned to be collected at indicated timepoints for the analysis of Vz of MT-3724 monotherapy.
Pharmacokinetic Analysis Set. The data was not collected due to early study termination
Posted
Up to Day 45
ID
Title
Description
OG000
Part 4: All MT-3724 Treated Participants
Participants in this arm were planned to receive all doses of MT-3724 as IV infusion over 1 hour in a 21-day cycle
Units
Counts
Participants
OG0000
Secondary
Part 4: CL of MT-3724 Monotherapy in Participants With Relapsed or Refractory DLBCL
Blood samples were planned to be collected at indicated timepoints for the analysis of CL of MT-3724 monotherapy.
Pharmacokinetic Analysis Set. The data was not collected due to early study termination
Posted
Up to Day 45
ID
Title
Description
OG000
Part 4: All MT-3724 Treated Participants
Participants in this arm were planned to receive all doses of MT-3724 as IV infusion over 1 hour in a 21-day cycle
Units
Counts
Participants
OG0000
Secondary
Part 4: PD of MT-3724 Measured by B-cell Count in Participants With Relapsed or Refractory DCBCL
Pharmacodynamics of MT-3724 was planned to be measured by B-cell count in participants with relapsed of refractory DCBCL using flow cytometry.
Pharmacokinetic Analysis Set. The data was not collected due to early study termination
Posted
Up to Day 45
ID
Title
Description
OG000
Part 4: All MT-3724 Treated Participants
Participants in this arm were planned to receive all doses of MT-3724 as IV infusion over 1 hour in a 21-day cycle
Units
Counts
Participants
OG000
Secondary
Part 4: PD of MT-3724 Measured by Immunophenotyping in Participants With Relapsed or Refractory DCBCL
Pharmacodynamics of MT-3724 was planned to be measured by immunophenotyping in participants with relapsed of refractory DCBCL using flow cytometry.
Pharmacokinetic Analysis Set. The data was not collected due to early study termination
Posted
Up to Day 45
ID
Title
Description
OG000
Part 4: All MT-3724 Treated Participants
Participants in this arm were planned to receive all doses of MT-3724 as IV infusion over 1 hour in a 21-day cycle
Units
Counts
Participants
OG000
Secondary
Part 4: PD of MT-3724 Measured by Circulating Immunoglobulins in Participants With Relapsed or Refractory DCBCL
Pharmacodynamics of MT-3724 was planned to be measured by circulating immunoglobulins in participants with relapsed of refractory DCBCL.
Pharmacokinetic Analysis Set. The data was not collected due to early study termination
Posted
Up to Day 45
ID
Title
Description
OG000
Part 4: All MT-3724 Treated Participants
Participants in this arm were planned to receive all doses of MT-3724 as IV infusion over 1 hour in a 21-day cycle
Units
Counts
Participants
OG000
Secondary
Part 4: Number of Participants With ADA When Treated With MT-3724
Blood samples were planned to be collected to analyze the presence of ADA that bind MT-3724.
Pharmacokinetic Analysis Set. The data was not collected due to early study termination
Posted
Up to Day 45
ID
Title
Description
OG000
Part 4: All MT-3724 Treated Participants
Participants in this arm were planned to receive all doses of MT-3724 as IV infusion over 1 hour in a 21-day cycle
Units
Counts
Participants
OG0000
Time Frame
Non-serious TEAEs and SAEs were collected up to Day 45.
Description
Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade >=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
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
Part 1: Cohort 1: 5 Micrograms/Kilograms/Dose/Day
Participants in this cohort received 5 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.
0
3
1
3
3
3
EG001
Part 1: Cohort 2: 10 mcg/kg/Dose/Day
Participants in this cohort received 10 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.
0
3
0
3
3
3
EG002
Part 1: Cohort 3: 20 mcg/kg/Dose/Day
Participants in this cohort received 20 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.
0
3
2
3
3
3
EG003
Part 1: Cohort 4: 50 mcg/kg/Dose/Day
Participants in this cohort received 50 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.
1
4
4
4
4
4
EG004
Part 1: Cohort 5: 100 mcg/kg/Dose/Day
Participants in this cohort received 100 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.
0
2
2
2
2
2
EG005
Part 1: Cohort 6: 75 mcg/kg/Dose/Day
Participants in this cohort received 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.
0
6
3
6
6
6
EG006
Part 2: Cohort 7- MTD Expansion Cohort (50 or 75 mcg/kg/Dose)
Participants in this cohort received either 50 or 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 days of 21-Day cycle up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724.
0
6
2
6
6
6
EG007
Part 3: All MT-3724 Treated Participants
Participants in this arm received all doses of MT-3724 as IV infusion over 1 hour in a 21-day cycle
1
11
3
11
11
11
EG008
Part 4: All MT-3724 Treated Participants
Participants in this arm were planned to receive all doses of MT-3724 as IV infusion over 1 hour in a 21-day cycle
0
0
0
0
0
0
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0030 affected4 at risk
EG0040 affected2 at risk
EG0050 affected6 at risk
EG0060 affected6 at risk
EG0070 affected11 at risk
EG0080 affected0 at risk
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Acute coronary syndrome
Cardiac disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Gastric haemorrhage
Gastrointestinal disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Fatigue
General disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Oedema
General disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Oedema peripheral
General disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Superinfection
Infections and infestations
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Viral infection
Infections and infestations
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 17
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 17
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Aphasia
Nervous system disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Renal failure acute
Renal and urinary disorders
MedDRA 17
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypertension
Vascular disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Fever
General disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Capillary leak syndrome
Vascular disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 17
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0032 affected4 at risk
EG0041 affected2 at risk
EG0051 affected6 at risk
EG0060 affected6 at risk
EG0070 affected11 at risk
EG0080 affected0 at risk
Leukocytosis
Blood and lymphatic system disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 17
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Lymph node pain
Blood and lymphatic system disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 17
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Pancytopenia
Blood and lymphatic system disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Granulocytopenia
Blood and lymphatic system disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Iron deficiency anemia
Blood and lymphatic system disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Cardiomyopathy
Cardiac disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Myocardial ischaemia
Cardiac disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Ear disorder
Ear and labyrinth disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Diplopia
Eye disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Eye irritation
Eye disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Eye swelling
Eye disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Dry eye
Eye disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0021 affected3 at risk
EG003
Retinal exudates
Eye disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Retinal haemorrhage
Eye disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Vision blurred
Eye disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0021 affected3 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Anal haemorrhage
Gastrointestinal disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Asthenia
Gastrointestinal disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0021 affected3 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 17
Systematic Assessment
EG0002 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 17
Systematic Assessment
EG0001 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 17
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Gastric ulcer
Gastrointestinal disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Melaena
Gastrointestinal disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Mouth haemorrhage
Gastrointestinal disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 17
Systematic Assessment
EG0001 affected3 at risk
EG0013 affected3 at risk
EG0020 affected3 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected3 at risk
EG0020 affected3 at risk
EG003
Reflux gastritis
Gastrointestinal disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 17
Systematic Assessment
EG0001 affected3 at risk
EG0012 affected3 at risk
EG0020 affected3 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Anemia
General disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Asthenia
General disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Chills
General disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Face oedema
General disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Fatigue
General disorders
MedDRA 17
Systematic Assessment
EG0003 affected3 at risk
EG0011 affected3 at risk
EG0022 affected3 at risk
EG003
Infusion site irritation
General disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Injection site extravasation
General disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Injection site reaction
General disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Local swelling
General disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Malaise
General disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Muscular weakness
General disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 17
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Oedema
General disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Oedema peripheral
General disorders
MedDRA 17
Systematic Assessment
EG0001 affected3 at risk
EG0013 affected3 at risk
EG0020 affected3 at risk
EG003
Pain
General disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pyrexia
General disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Swelling face
General disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Folliculitis
Infections and infestations
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Oropharyngeal candidiasis
Infections and infestations
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Otitis media
Infections and infestations
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 17
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pyoderma
Infections and infestations
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Respiratory syncytial virus infection
Infections and infestations
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0022 affected3 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Scratch
Injury, poisoning and procedural complications
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Wound
Injury, poisoning and procedural complications
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Blood chloride increased
Investigations
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Blood lactic acid increased
Investigations
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Heart rate increased
Investigations
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Lipase increased
Investigations
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Platelet count decreased
Investigations
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Troponin increased
Investigations
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Weight increased
Investigations
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 17
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 17
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 17
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 17
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 17
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypoproteinaemia
Metabolism and nutrition disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 17
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA 17
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 17
Systematic Assessment
EG0001 affected3 at risk
EG0012 affected3 at risk
EG0021 affected3 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 17
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Tumor pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Participants in this cohort received 50 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.
OG004
Part 1: Cohort 5- 100 mcg/kg/Dose
Participants in this cohort received 100 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.
OG005
Part 1: Cohort 6- 75 mcg/kg/Dose
Participants in this cohort received 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 of 21-Day cycle for up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724.
OG006
Part 2: Cohort 7- MTD Expansion Cohort (50 or 75 mcg/kg/Dose)
Participants in this cohort received either 50 or 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 days of 21-Day cycle up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724.
Units
Counts
Participants
OG0001
OG0013
OG0023
OG0037
OG0049
OG0052
OG0066
Title
Denominators
Categories
Title
Measurements
OG000NA± NAGeometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)
OG001NA± NAGeometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)
OG002NA± NAGeometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)
OG003NA± NAGeometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)
OG004NA± NAGeometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)
OG005NA± NAGeometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)
OG006NA± NAGeometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)
OG003
Part 1: Cohort 4- 50 mcg/kg/Dose
Participants in this cohort received 50 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles
OG004
Part 1: Cohort 5- 100 mcg/kg/Dose
Participants in this cohort received 100 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.
OG005
Part 1: Cohort 6- 75 mcg/kg/Dose
Participants in this cohort received 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 of 21-Day cycle for up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724.
OG006
Part 2: Cohort 7- MTD Expansion Cohort (50 or 75 mcg/kg/Dose)
Participants in this cohort received either 50 or 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 days of 21-Day cycle up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0034
OG0042
OG0056
OG0066
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Median and Full Range could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)
OG001NA(NA to NA)Median and Full Range could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)
OG002NA(NA to NA)Median and Full Range could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)
OG003NA(NA to NA)Median and Full Range could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)
OG004NA(NA to NA)Median and Full Range could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)
OG005NA(NA to NA)Median and Full Range could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)
OG006NA(NA to NA)Median and Full Range could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)
OG003
Part 1: Cohort 4 - 50mcg/kg/Dose
Participants in this cohort received 50 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.
OG004
Part 1: Cohort 5 - 100mcg/kg/Dose
Participants in this cohort received 100 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.
OG005
Part 1: Cohort 6 - 75 mcg/kg/Dose
Participants in this cohort received 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 of 21-Day cycle for up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724.
OG006
Part 2: Cohort 7- MTD Expansion Cohort (50 or 75 mcg/kg/Dose)
Participants in this cohort received either 50 or 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 days of 21-Day cycle up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0034
OG0042
OG0056
OG0066
Title
Denominators
Categories
AUC (0-4)
Title
Measurements
OG000NA± NAGeometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)
OG001NA± NAGeometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)
OG002NA± NAGeometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)
OG003NA± NAGeometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)
OG004NA± NAGeometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)
OG005NA± NAGeometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)
OG006NA± NAGeometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)
AUC (0-infinity)
Title
Measurements
OG000NA± NAGeometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)
OG001NA± NAGeometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)
OG002NA± NAGeometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)
AUClast
Title
Measurements
OG000NA± NAGeometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)
OG001NA± NAGeometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)
OG002NA± NAGeometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)
OG003
Part 1: Cohort 4: 50 mcg/kg/Dose/Day
Participants in this cohort received 50 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 of 21-Day cycle for up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724.
OG004
Part 1: Cohort 5: 100 mcg/kg/Dose/Day
Participants in this cohort received 100 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 of 21-Day cycle for up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724.
OG005
Part 1: Cohort 6: 75 mcg/kg/Dose/Day
Participants in this cohort received 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 of 21-Day cycle for up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724.
OG006
Part 2: Cohort 7- MTD Expansion Cohort (50 or 75 mcg/kg/Dose)
Participants in this cohort received either 50 or 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 days of 21-Day cycle up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0034
OG0042
OG0056
OG0066
Title
Denominators
Categories
Title
Measurements
OG000NA± NAGeometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)
OG001NA± NAGeometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)
OG002NA± NAGeometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)
OG003NA± NAGeometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)
OG004NA± NAGeometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)
OG005NA± NAGeometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)
OG006NA± NAGeometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)
OG003
Part 1: Cohort 4: 50 mcg/kg/Dose/Day
Participants in this cohort received 50 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.
OG004
Part 1: Cohort 5: 100 mcg/kg/Dose/Day
Participants in this cohort received 100 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.
OG005
Part 1: Cohort 6: 75 mcg/kg/Dose/Day
Participants in this cohort received 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.
OG006
Part 2: Cohort 7- MTD Expansion Cohort (50 or 75 mcg/kg/Dose)
Participants in this cohort received either 50 or 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 days of 21-Day cycle up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0034
OG0042
OG0056
OG0066
Title
Denominators
Categories
Title
Measurements
OG000NA± NAGeometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)
OG001NA± NAGeometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)
OG002NA± NAGeometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)
OG003NA± NAGeometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)
OG004NA± NAGeometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)
OG005NA± NAGeometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)
OG006NA± NAGeometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)
OG003
Part 1: Cohort 4: 50 mcg/kg/Dose/Day
Participants in this cohort received 50 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.
OG004
Part 1: Cohort 5: 100 mcg/kg/Dose/Day
Participants in this cohort received 100 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.
OG005
Part 1: Cohort 6: 75 mcg/kg/Dose/Day
Participants in this cohort received 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.
OG006
Part 2: Cohort 7- MTD Expansion Cohort (50 or 75 mcg/kg/Dose)
Participants in this cohort received 50 or 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 days of 21-Day cycle up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0034
OG0042
OG0056
OG0066
Title
Denominators
Categories
Title
Measurements
OG000NA± NAGeometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)
OG001NA± NAGeometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)
OG002NA± NAGeometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)
OG003NA± NAGeometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)
OG004NA± NAGeometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)
OG005NA± NAGeometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)
OG006NA± NAGeometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)
OG003
Part 1: Cohort 4- 50 mcg/kg/Dose
Participants in this cohort received 50 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.
OG004
Part 1: Cohort 5- 100 mcg/kg/Dose
Participants in this cohort received 100 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.
OG005
Part 1: Cohort 6- 75 mcg/kg/Dose
Participants in this cohort received 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.
OG006
Part 2: Cohort 7- MTD Expansion Cohort (50 or 75 mcg/kg/Dose)
Participants in this cohort received either 50 or 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0034
OG0040
OG0056
OG0060
Title
Denominators
Categories
Cycle 1 Day 8
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0021
ParticipantsOG0033
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0060
Title
Measurements
OG000114± NAMean and Standard Deviation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)
OG001325± NAMean and Standard Deviation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)
OG002244± NAMean and Standard Deviation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)
OG003
Cycle 1 Day 23
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0021
ParticipantsOG0030
Cycle 3 Day 1
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0021
ParticipantsOG0033
Cycle 5 Day 1
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0021
ParticipantsOG0032
Day 120 (End of study)
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0021
ParticipantsOG0033
OG003
Part 1: Cohort 4- 50 mcg/kg/Dose
Participants in this cohort received 50 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.
OG004
Part 1: Cohort 5- 100 mcg/kg/Dose
Participants in this cohort received 100 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.
OG005
Part 1: Cohort 6- 75 mcg/kg/Dose
Participants in this cohort received 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.
OG006
Part 2: Cohort 7- MTD Expansion Cohort (50 or 75 mcg/kg/Dose)
Participants in this cohort received either 50 or 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0034
OG0042
OG0056
OG0060
Title
Denominators
Categories
Cycle 1 Day 23
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0033
ParticipantsOG0041
ParticipantsOG0055
ParticipantsOG0060
Title
Measurements
OG0000
OG0013
OG0021
OG003
Cycle 2 Day 1
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0034
Cycle 3 Day 1
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0021
ParticipantsOG0033
Cycle 4 Day 1
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0021
ParticipantsOG0033
Cycle 5 Day 1
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0021
ParticipantsOG0032
Day 120 (end of study)
ParticipantsOG0003
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0034
11
Title
Denominators
Categories
Serious TEAEs
Title
Measurements
OG0003
Non-serious TEAEs
Title
Measurements
OG00011
Title
Denominators
Categories
Title
Measurements
OG0000
Title
Denominators
Categories
Title
Measurements
OG0000
Title
Denominators
Categories
Title
Measurements
OG0000
Title
Denominators
Categories
Title
Measurements
OG0002
Participants in this cohort received 10 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.
OG002
Part 1: Cohort 3- 20 mcg/kg/Dose
Participants in this cohort received 20 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.
OG003
Part 1: Cohort 4- 50 mcg/kg/Dose
Participants in this cohort received 50 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.
OG004
Part 1: Cohort 5- 100 mcg/kg/Dose
Participants in this cohort received 100 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.
OG005
Part 1: Cohort 6- 75 mcg/kg/Dose
Participants in this cohort received 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.
OG006
Part 2: Cohort 7- MTD Expansion Cohort (50 or 75 mcg/kg/Dose)
Participants in this cohort received either 50 or 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0034
OG0042
OG0056
OG0066
Title
Denominators
Categories
Serious TEAEs
Title
Measurements
OG0001
OG0010
OG0022
OG0034
OG0042
OG0053
OG0062
Non-serious TEAEs
Title
Measurements
OG0003
OG0013
OG0023
OG003
0
Title
Denominators
Categories
AUC (0-4)
AUC (0-infinity)
AUClast
0
OG000
0
Title
Denominators
Categories
TEAEs
Severe TEAEs
0
0
Title
Denominators
Categories
AUC (0-4)
AUC (0-infinity)
AUClast
0
0
0
1 affected
4 at risk
EG0040 affected2 at risk
EG0050 affected6 at risk
EG0060 affected6 at risk
EG0070 affected11 at risk
EG0080 affected0 at risk
1 affected
4 at risk
EG0040 affected2 at risk
EG0050 affected6 at risk
EG0060 affected6 at risk
EG0070 affected11 at risk
EG0080 affected0 at risk
1 affected
4 at risk
EG0040 affected2 at risk
EG0050 affected6 at risk
EG0060 affected6 at risk
EG0070 affected11 at risk
EG0080 affected0 at risk
1 affected
4 at risk
EG0040 affected2 at risk
EG0050 affected6 at risk
EG0060 affected6 at risk
EG0070 affected11 at risk
EG0080 affected0 at risk
1 affected
4 at risk
EG0040 affected2 at risk
EG0050 affected6 at risk
EG0060 affected6 at risk
EG0070 affected11 at risk
EG0080 affected0 at risk
1 affected
4 at risk
EG0040 affected2 at risk
EG0050 affected6 at risk
EG0060 affected6 at risk
EG0070 affected11 at risk
EG0080 affected0 at risk
1 affected
4 at risk
EG0040 affected2 at risk
EG0050 affected6 at risk
EG0060 affected6 at risk
EG0070 affected11 at risk
EG0080 affected0 at risk
1 affected
4 at risk
EG0040 affected2 at risk
EG0050 affected6 at risk
EG0060 affected6 at risk
EG0070 affected11 at risk
EG0080 affected0 at risk
1 affected
4 at risk
EG0040 affected2 at risk
EG0050 affected6 at risk
EG0060 affected6 at risk
EG0070 affected11 at risk
EG0080 affected0 at risk
0 affected
4 at risk
EG0041 affected2 at risk
EG0050 affected6 at risk
EG0060 affected6 at risk
EG0070 affected11 at risk
EG0080 affected0 at risk
0 affected
4 at risk
EG0040 affected2 at risk
EG0051 affected6 at risk
EG0061 affected6 at risk
EG0070 affected11 at risk
EG0080 affected0 at risk
0 affected
4 at risk
EG0040 affected2 at risk
EG0050 affected6 at risk
EG0061 affected6 at risk
EG0071 affected11 at risk
EG0080 affected0 at risk
0 affected
4 at risk
EG0040 affected2 at risk
EG0051 affected6 at risk
EG0060 affected6 at risk
EG0070 affected11 at risk
EG0080 affected0 at risk
1 affected
4 at risk
EG0041 affected2 at risk
EG0052 affected6 at risk
EG0062 affected6 at risk
EG0070 affected11 at risk
EG0080 affected0 at risk
0 affected
4 at risk
EG0041 affected2 at risk
EG0051 affected6 at risk
EG0062 affected6 at risk
EG0070 affected11 at risk
EG0080 affected0 at risk
1 affected
4 at risk
EG0040 affected2 at risk
EG0050 affected6 at risk
EG0060 affected6 at risk
EG0070 affected11 at risk
EG0080 affected0 at risk
0 affected
4 at risk
EG0040 affected2 at risk
EG0051 affected6 at risk
EG0060 affected6 at risk
EG0070 affected11 at risk
EG0080 affected0 at risk
1 affected
4 at risk
EG0040 affected2 at risk
EG0051 affected6 at risk
EG0060 affected6 at risk
EG0070 affected11 at risk
EG0080 affected0 at risk
1 affected
4 at risk
EG0040 affected2 at risk
EG0050 affected6 at risk
EG0060 affected6 at risk
EG0070 affected11 at risk
EG0080 affected0 at risk
1 affected
4 at risk
EG0041 affected2 at risk
EG0050 affected6 at risk
EG0060 affected6 at risk
EG0070 affected11 at risk
EG0080 affected0 at risk
1 affected
4 at risk
EG0040 affected2 at risk
EG0050 affected6 at risk
EG0060 affected6 at risk
EG0070 affected11 at risk
EG0080 affected0 at risk
0 affected
4 at risk
EG0041 affected2 at risk
EG0050 affected6 at risk
EG0060 affected6 at risk
EG0070 affected11 at risk
EG0080 affected0 at risk
0 affected
4 at risk
EG0040 affected2 at risk
EG0050 affected6 at risk
EG0060 affected6 at risk
EG0070 affected11 at risk
EG0080 affected0 at risk
1 affected
4 at risk
EG0040 affected2 at risk
EG0050 affected6 at risk
EG0060 affected6 at risk
EG0070 affected11 at risk
EG0080 affected0 at risk
1 affected
4 at risk
EG0040 affected2 at risk
EG0051 affected6 at risk
EG0060 affected6 at risk
EG0070 affected11 at risk
EG0080 affected0 at risk
1 affected
4 at risk
EG0040 affected2 at risk
EG0050 affected6 at risk
EG0060 affected6 at risk
EG0070 affected11 at risk
EG0080 affected0 at risk
0 affected
4 at risk
EG0040 affected2 at risk
EG0050 affected6 at risk
EG0060 affected6 at risk
EG0071 affected11 at risk
EG0080 affected0 at risk
0 affected
4 at risk
EG0040 affected2 at risk
EG0050 affected6 at risk
EG0060 affected6 at risk
EG0071 affected11 at risk
EG0080 affected0 at risk
0 affected
4 at risk
EG0040 affected2 at risk
EG0050 affected6 at risk
EG0060 affected6 at risk
EG0072 affected11 at risk
EG0080 affected0 at risk
1 affected
4 at risk
EG0040 affected2 at risk
EG0051 affected6 at risk
EG0060 affected6 at risk
EG0070 affected11 at risk
EG0080 affected0 at risk
0 affected
4 at risk
EG0040 affected2 at risk
EG0050 affected6 at risk
EG0060 affected6 at risk
EG0071 affected11 at risk
EG0080 affected0 at risk
0 affected
4 at risk
EG0040 affected2 at risk
EG0050 affected6 at risk
EG0060 affected6 at risk
EG0070 affected11 at risk
EG0080 affected0 at risk
1 affected
4 at risk
EG0040 affected2 at risk
EG0050 affected6 at risk
EG0060 affected6 at risk
EG0071 affected11 at risk
EG0080 affected0 at risk
0 affected
4 at risk
EG0041 affected2 at risk
EG0050 affected6 at risk
EG0060 affected6 at risk
EG0070 affected11 at risk
EG0080 affected0 at risk
0 affected
4 at risk
EG0040 affected2 at risk
EG0050 affected6 at risk
EG0060 affected6 at risk
EG0071 affected11 at risk
EG0080 affected0 at risk
0 affected
4 at risk
EG0040 affected2 at risk
EG0050 affected6 at risk
EG0060 affected6 at risk
EG0071 affected11 at risk
EG0080 affected0 at risk
0 affected
4 at risk
EG0040 affected2 at risk
EG0050 affected6 at risk
EG0060 affected6 at risk
EG0071 affected11 at risk
EG0080 affected0 at risk
0 affected
4 at risk
EG0040 affected2 at risk
EG0050 affected6 at risk
EG0060 affected6 at risk
EG0071 affected11 at risk
EG0080 affected0 at risk
1 affected
4 at risk
EG0040 affected2 at risk
EG0050 affected6 at risk
EG0060 affected6 at risk
EG0070 affected11 at risk
EG0080 affected0 at risk
1 affected
4 at risk
EG0040 affected2 at risk
EG0050 affected6 at risk
EG0060 affected6 at risk
EG0070 affected11 at risk
EG0080 affected0 at risk
0 affected
4 at risk
EG0040 affected2 at risk
EG0050 affected6 at risk
EG0060 affected6 at risk
EG0071 affected11 at risk
EG0080 affected0 at risk
1 affected
4 at risk
EG0040 affected2 at risk
EG0050 affected6 at risk
EG0060 affected6 at risk
EG0070 affected11 at risk
EG0080 affected0 at risk
0 affected
4 at risk
EG0040 affected2 at risk
EG0050 affected6 at risk
EG0061 affected6 at risk
EG0070 affected11 at risk
EG0080 affected0 at risk
1 affected
4 at risk
EG0040 affected2 at risk
EG0050 affected6 at risk
EG0062 affected6 at risk
EG0070 affected11 at risk
EG0080 affected0 at risk
0 affected
4 at risk
EG0040 affected2 at risk
EG0051 affected6 at risk
EG0060 affected6 at risk
EG0070 affected11 at risk
EG0080 affected0 at risk
0 affected
4 at risk
EG0040 affected2 at risk
EG0051 affected6 at risk
EG0060 affected6 at risk
EG0070 affected11 at risk
EG0080 affected0 at risk
0 affected
4 at risk
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EG0040 affected2 at risk
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EG0072 affected11 at risk
EG0080 affected0 at risk
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EG0040 affected2 at risk
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EG0040 affected2 at risk
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EG0070 affected11 at risk
EG0080 affected0 at risk
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4 at risk
EG0040 affected2 at risk
EG0050 affected6 at risk
EG0061 affected6 at risk
EG0070 affected11 at risk
EG0080 affected0 at risk
1 affected
4 at risk
EG0040 affected2 at risk
EG0052 affected6 at risk
EG0063 affected6 at risk
EG0071 affected11 at risk
EG0080 affected0 at risk
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EG0040 affected2 at risk
EG0050 affected6 at risk
EG0061 affected6 at risk
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4 at risk
EG0040 affected2 at risk
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EG0062 affected6 at risk
EG0070 affected11 at risk
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EG0040 affected2 at risk
EG0051 affected6 at risk
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OG003NA± NAGeometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)
OG004NA± NAGeometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)
OG005NA± NAGeometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)
OG006NA± NAGeometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)
OG003NA± NAGeometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)
OG004NA± NAGeometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)
OG005NA± NAGeometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)
OG006NA± NAGeometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)
57.7
± 91.166
OG005126± NANA indicates standard deviation could not be calculated for a single participant
Participants
OG004
0
ParticipantsOG0051
ParticipantsOG0060
Title
Measurements
OG000143± NAMean and Standard Deviation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)
OG001104± NAMean and Standard Deviation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)
OG002131± NAMean and Standard Deviation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)
OG00567.0± NANA indicates standard deviation could not be calculated for a single participant
Participants
OG004
0
ParticipantsOG0051
ParticipantsOG0060
Title
Measurements
OG00067.0± NAMean and Standard Deviation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)
OG001134± NAMean and Standard Deviation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)
OG00260.0± NAMean and Standard Deviation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)
OG0031170± 1965.6
OG00534.0± NANA indicates standard deviation could not be calculated for a single participant
Participants
OG004
0
ParticipantsOG0051
ParticipantsOG0060
Title
Measurements
OG000132± NAMean and Standard Deviation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)
OG001180± NAMean and Standard Deviation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)
OG00253.0± NAMean and Standard Deviation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)
OG00326.0± 31.1127
OG00539.0± NANA indicates standard deviation could not be calculated for a single participant
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0060
Title
Measurements
OG00079.0± NAMean and Standard Deviation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)
OG001184± NAMean and Standard Deviation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)
OG00249.0± NAMean and Standard Deviation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)
OG00322.87± 18.17
OG00544.0± NANA indicates standard deviation could not be calculated for a single participant