Study of ADCT-402 in Patients With Relapsed or Refractory... | NCT02669017 | Trialant
NCT02669017
Sponsor
ADC Therapeutics S.A.
Status
Completed
Last Update Posted
May 19, 2021Actual
Enrollment
183Actual
Phase
Phase 1
Conditions
Non-Hodgkin Lymphoma
Burkitt's Lymphoma
Chronic Lymphocytic Leukemia
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Follicular
Lymphoma, Mantle-Cell
Lymphoma, Marginal Zone
Waldenstrom Macroglobulinemia
Primary Mediastinal B-cell Lymphoma
Interventions
ADCT-402
Countries
United States
Italy
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT02669017
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
ADCT-402-101
Secondary IDs
ID
Type
Description
Link
2016-000952-92
EudraCT Number
Brief Title
Study of ADCT-402 in Patients With Relapsed or Refractory B-cell Lineage Non Hodgkin Lymphoma (B-NHL)
Official Title
A Phase 1 Dose-escalation Study to Evaluate the Tolerability, Safety, Pharmacokinetics, and Antitumor Activity of ADCT-402 in Patients With Relapsed or Refractory B-cell Lineage Non Hodgkin Lymphoma (B-NHL)
Acronym
Not provided
Organization
ADC Therapeutics S.A.INDUSTRY
Status Module
Record Verification Date
Apr 2021
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Mar 2016
Primary Completion Date
Feb 21, 2019Actual
Completion Date
Feb 21, 2019Actual
First Submitted Date
Jan 21, 2016
First Submission Date that Met QC Criteria
Jan 27, 2016
First Posted Date
Jan 29, 2016Estimated
Results Waived
Not provided
Results First Submitted Date
Feb 19, 2020
Results First Submitted that Met QC Criteria
Mar 31, 2020
Results First Posted Date
Apr 13, 2020Actual
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
Apr 27, 2021
Last Update Posted Date
May 19, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
ADC Therapeutics S.A.INDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This study evaluates ADCT-402 in participants with Relapsed or Refractory B-cell Lineage Non Hodgkin Lymphoma (B-NHL). Participants will participate in a dose escalation phase (Part 1) and dose expansion (Part 2). In Part 2, participants will receive the dose level identified in Part 1.
Detailed Description
Study ADCT-402-101 is the first clinical study with ADCT-402 in participants with B-cell Non Hodgkin Lymphoma (NHL).
ADCT-402 is an antibody drug conjugate (ADC) composed of a humanized antibody directed against human cluster of differentiation 19 (CD19), stochastically conjugated via a valine-alanine cleavable, maleimide linker to a pyrrolobenzodiazepine (PBD) dimer cytotoxin.
The study will be conducted in 2 parts. In Part 1 (dose escalation) participants will receive infusions of ADCT-402, at escalating doses. Part 1 will continue until the maximum tolerated dose is determined. In Part 2 (expansion), participants will be assigned to the recommended dose level(s) and schedule(s) of ADCT-402 identified in Part 1 by the Dose Escalation Steering Committee.
For each participant, the study will include a screening period (up to 28 days), a treatment period (until withdrawal), and a follow-up period to assess disease progression and survival for up to 12 months after the last dose of study drug. The total study duration will be dependent on overall participant tolerability to the study drug and response to treatment. It is anticipated that the duration of the entire study (Parts 1 and 2) could be approximately 3 years from first participant treated to last participant completed.
Conditions Module
Conditions
Non-Hodgkin Lymphoma
Burkitt's Lymphoma
Chronic Lymphocytic Leukemia
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Follicular
Lymphoma, Mantle-Cell
Lymphoma, Marginal Zone
Waldenstrom Macroglobulinemia
Primary Mediastinal B-cell Lymphoma
Keywords
Loncastuximab tesirine
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 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
183Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part 1: ADCT-402 dose escalation
Experimental
In Part 1 (dose escalation) participants will receive intravenous (IV) infusions of ADCT-402 at escalating doses, according to a 3+3 study design. Doses will be escalated from 15 µg/kg to 200 µg/kg on Day 1 of each cycle, with cycle lengths of 3 or 6 weeks.
Drug: ADCT-402
Part 2: ADCT-402 dose expansion
Experimental
In Part 2 (expansion), participants will be assigned to the recommended dose level(s) and schedule(s) of ADCT-402 identified in Part 1 by the Dose Escalation Steering Committee.
Participants will receive intravenous (IV) infusions of ADCT-402 at either 120 μg/kg or 150 μg/kg on Day 1 of each 3 week cycle (Q3W).
Drug: ADCT-402
Interventions
Name
Type
Description
Arm Group Labels
Other Names
ADCT-402
Drug
intravenous infusion
Part 1: ADCT-402 dose escalation
Part 2: ADCT-402 dose expansion
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
A DLT is defined as any of the following events, except those that are clearly due to underlying disease or extraneous causes:
A hematologic DLT is defined as:
CTCAE Grade 3 or 4 febrile neutropenia or neutropenic infection.
CTCAE Grade 4 neutropenia lasting >7 days.
CTCAE Grade 4 thrombocytopenia.
CTCAE Grade 3 thrombocytopenia with clinically significant bleeding, or Grade 3 thrombocytopenia requiring a platelet transfusion.
CTCAE Grade 4 anemia.
A non-hematologic DLT is defined as:
CTCAE Grade 4 tumor lysis syndrome (TLS). Grade 3 TLS will not constitute DLT unless it leads to irreversible end-organ damage.
CTCAE Grade 3 or higher AE (including nausea, vomiting, diarrhea, and electrolyte imbalances lasting more than 48 hours despite optimal therapy; excluding all grades of alopecia).
CTCAE Grade 3 or higher hypersensitivity reaction (regardless of premedication).
CTCAE Grade 2 or higher skin ulceration.
Q3W schedule: Day 1 to End of Cycle 1 (3 weeks); Q6W schedule: Day 1 to End of Cycle 1 (6 weeks)
Recommended Dose of ADCT-402 for Part 2
The recommended dose was established by the dose escalation steering committee and based on safety findings during Part 1 of the study.
Q3W schedule: Day 1 to End of Cycle 1 (3 weeks); Q6W schedule: Day 1 to End of Cycle 1 (6 weeks)
Number of Participants Reporting at Least One Treatment Emergent Adverse Event (TEAE)
An adverse event (AE) is defined as any untoward medical occurrence in a participants enrolled into this study regardless of its causal relationship to study drug. A TEAE is defined as any event not present before exposure to study drug or any event already present that worsens in either intensity or frequency after exposure to study drug.
Day 1 to End of Study (a maximum of 18 months)
Number of Participants Reporting at Least One Treatment Emergent Serious Adverse Event (SAE)
An adverse event (AE) is defined as any untoward medical occurrence in a participant enrolled into this study regardless of its causal relationship to study drug. A treatment emergent AE (TEAE) is defined as any event not present before exposure to study drug or any event already present that worsens in either intensity or frequency after exposure to study drug. An SAE is defined as any event that results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.
Secondary Outcomes
Measure
Description
Time Frame
Overall Response Rate (ORR)
ORR was defined as the number of participants with a best overall response of complete response (CR) or partial response (PR) at the time each participant discontinued treatment with ADCT-402, before the start of subsequent anticancer therapy or procedure. Tumor response was assessed using the 2014 Lugano Classification for response.
CR is defined as achieving either of the following:
Complete metabolic response.
Complete radiologic response (target node regress to <1.5 cm, no nonmeasured lesions, no organ enlargement, no new lesions and normal bone marrow morphology).
PR is defined as achieving either of the following:
Partial remission (>50% decrease in target measurable nodes, regression/ absence/ no increase of nonmeasured lesions, spleen regressed by >50% in length and no new lesions).
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Male or female participants, ages 18 years or older with pathologically confirmed relapsed or refractory B-cell lineage NHL who have failed or are intolerant to established therapy, or for whom no other treatment options are available.
Refractory or relapsed B-cell NHL (per World health Organization [WHO] Classification system).
Availability of formalin-fixed paraffin-embedded (FFPE) tumor tissue block.
Measurable disease, as defined by the 2014 Lugano Classification.
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
Absolute neutrophil count (ANC) ≥1000/μL.
Platelet count of ≥75000/μL.
Hemoglobin ≥9.0 g/dL without transfusion within the 2 weeks prior to Day 1.
Serum/plasma creatinine ≤1.5 mg/dL.
Serum/plasma alkaline phosphatase, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) ≤2 times the upper limit of normal (ULN); ≤ 5 times ULN if there is liver or bone involvement.
Total serum/plasma bilirubin ≤1.5 times ULN.
Negative blood or urine beta-human chorionic gonadotropin (β-HCG) pregnancy test within 7 days prior to Day 1 for women of childbearing potential.
Males, and female participants who are biologically capable of having children, must agree to use a medically acceptable method of birth control.
Exclusion Criteria:
Participants who have any option for other treatment for B-cell NHL at the current state of disease.
Active graft-versus-host disease.
Autologous or allogenic transplant within the 60 days prior to the Screening visit.
Known history of immunogenicity or hypersensitivity to a CD19 antibody.
Evidence of myelodysplasia or myeloid leukemia by morphology, immunostains, flow cytometry, or cytogenetics on a bone marrow aspirate or biopsy.
Known history of positive serum human ADA.
Active autoimmune disease, motor neuropathy considered of autoimmune origin, and other central nervous system (CNS) autoimmune disease.
Known seropositive for human immunodeficiency (HIV) virus, hepatitis B surface antigen (HbsAg), or antibody to hepatitis C virus (anti-HCV).
History of Steven's Johnson's syndrome or toxic epidermal necrolysis syndrome.
Pregnant or breastfeeding women.
Significant medical comorbidities, including uncontrolled hypertension (diastolic blood pressure greater than 115 mm Hg), unstable angina, congestive heart failure (greater than New York Heart Association class II), severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia, poorly controlled diabetes, severe chronic pulmonary disease, coronary angioplasty, or myocardial infarction within 6 months prior to screening, or uncontrolled atrial or ventricular cardiac arrhythmias.
Use of any other experimental medication(s) within 14 days or 5 half-lives but in no case less than 14 days prior to start of study treatment on Cycle 1, Day 1, except if approved by Sponsor.
Steroid use equivalent to greater than 20 mg of prednisone within 4 weeks (28 days) prior to Day 1.
Major surgery, chemotherapy, systemic therapy (excluding steroids hydroxyurea steroids, and any targeted small molecules or biologics), or radiotherapy, within 14 days or 5 half-lives (whichever is shorter) prior to Cycle 1, Day 1 treatment, except if approved by the Sponsor.
Failure to recover (to Common Terminology Criteria for Adverse Events [CTCAE] Grade 0 or Grade 1) from acute non hematologic toxicity (except all grades alopecia or Grade 2 or lower neuropathy), due to previous therapy, prior to Screening.
Congenital long QT syndrome or a corrected QTc interval ≥450 ms at the Screening visit.
Active second primary malignancy other than non-melanoma skin cancers, non-metastatic prostate cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast, or other malignancy determined not be exclusionary.
Any other significant medical illness, abnormality, or condition that would make the participant inappropriate for study participation or put the participant at risk.
Hess B, Townsend W, Ai W, Stathis A, Solh M, Alderuccio JP, Ungar D, Liao S, Liao L, Khouri L, Zhang X, Boni J. Efficacy and Safety Exposure-Response Analysis of Loncastuximab Tesirine in Patients with B cell non-Hodgkin Lymphoma. AAPS J. 2021 Dec 10;24(1):11. doi: 10.1208/s12248-021-00660-3.
Participants were screened at 11 sites in 3 countries.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part 1: 15 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (15 μg/kg) on Day 1 of each 3 week cycle (Q3W).
FG001
Part 1: 30 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (30 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
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
Oct 16, 2017
Feb 19, 2020
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
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
Loncastuximab tesirine
Zynlonta
Day 1 to End of Study (a maximum of 18 months)
Baseline to End of Study (a maximum of 18 months)
Duration of Response (DoR)
DoR is defined among responders (complete response [CR] and partial response [PR]) as the time from the earliest date of first response until the first date of either disease progression or death due to any cause. Tumor response was assessed using the 2014 Lugano Classification for response.
Disease progression is defined as progressive metabolic disease or one of the follow:
Target node progression.
An individual extranodal lesion must be abnormal with length >1.5cm and/or increase of length >50%.
New or clear progression of nonmeasured lesions.
Regrowth of previously resolved lesions or new nodes >1.5 cm in length.
New or recurrent bone marrow involvement.
DoR is presented overall for all participants who received ADCT-402, as specified in protocol section 7.4.
Baseline to End of Study (a maximum of 18 months)
Overall Survival (OS)
OS is defined as the time from the first dose of study drug treatment until the date of death due to any cause.
OS is presented overall for all participants who received ADCT-402, as specified in protocol section 7.4.
Baseline to End of Study (a maximum of 18 months)
Progression-free Survival (PFS)
PFS is defined among the efficacy population as the time from first dose of study drug until either disease progression or death due to any cause. Tumor response was assessed using the 2014 Lugano Classification for response.
Disease progression is defined as progressive metabolic disease or one of the follow:
Target node progression.
An individual extranodal lesion must be abnormal with length >1.5cm and/or increase of length >50%.
New or clear progression of nonmeasured lesions.
Regrowth of previously resolved lesions or new nodes >1.5 cm in length.
New or recurrent bone marrow involvement.
PFS is presented overall for all participants who received ADCT-402, as specified in protocol section 7.4.
Baseline to End of Study (a maximum of 18 months)
Maximum Observed Serum Concentration (Cmax) for ADCT-402
Cmax for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199).
Results for Part 1 and Part 2 have been pooled for the same dosage and schedule, as specified in the protocol.
Q3W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (3 weeks cycle); Q6W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (6 week cycle)
Time to Reach the Maximum Serum Concentration (Tmax) for ADCT-402
Tmax for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199).
Results for Part 1 and Part 2 have been pooled for the same dosage and schedule, as specified in the protocol.
Q3W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (3 weeks cycle); Q6W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (6 week cycle)
Area Under the Serum Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for ADCT-402
AUClast for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199).
Results for Part 1 and Part 2 have been pooled for the same dosage and schedule, as specified in the protocol.
Q3W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (3 weeks cycle); Q6W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (6 week cycle)
Area Under the Serum Concentration-Time Curve From Time 0 to the End of the Dosing Interval (AUCtau) for ADCT-402
AUCtau for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199).
Results for Part 1 and Part 2 have been pooled for the same dosage and schedule, as specified in the protocol.
Q3W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (3 weeks cycle); Q6W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (6 week cycle)
Area Under the Serum Concentration-time Curve From Time 0 to Infinity (AUCinf) for ADCT-402
AUCinf for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199).
Results for Part 1 and Part 2 have been pooled for the same dosage and schedule, as specified in the protocol.
Q3W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (3 weeks cycle); Q6W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (6 week cycle)
Terminal Half-life (Thalf) of ADCT-402
Thalf of Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199).
Results for Part 1 and Part 2 have been pooled for the same dosage and schedule, as specified in the protocol.
Q3W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (3 weeks cycle); Q6W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (6 week cycle)
Apparent Clearance (CL) at Steady State for ADCT-402
CL of Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199).
Results for Part 1 and Part 2 have been pooled for the same dosage and schedule, as specified in the protocol.
Q3W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (3 weeks cycle); Q6W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (6 week cycle)
Volume of Distribution at Steady State (Vss) for ADCT-402
Vss for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199).
Results for Part 1 and Part 2 have been pooled for the same dosage and schedule, as specified in the protocol.
Q3W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (3 weeks cycle); Q6W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (6 week cycle)
Accumulation Index (AI) for ADCT-402
AI for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199). AI is the ratio of area under the serum concentration-time curve (AUC) from 0 to 21 days for Cycle 2 divided by AUC from 0 to 21 days for Cycle 1 (Q3W schedule: 3 week cycle length; Q6W schedule: 6 week cycle length). It is the increase in drug plasma concentration after multiple dosing until a steady state is reached.
Results for Part 1 and Part 2 have been pooled for the same dosage and schedule, as specified in the protocol.
Q3W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (3 weeks cycle); Q6W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (6 week cycle)
Number of Participants With Anti-drug Antibody Response (ADA) Against ADCT-402
Blood serum samples were collected and analysed to determine the presence or absence of ADA.
ADA is presented overall for all participants who received ADCT-402, as specified in protocol section 7.4.
Q3W schedule: Day 1 to End of Cycle 1 (3 weeks); Q6W schedule: Day 1 to End of Cycle 1 (6 weeks)
Atlanta
Georgia
30322
United States
Blood and Marrow Transplant Group of Georgia
Atlanta
Georgia
30342
United States
Washington University School of Medicine
St Louis
Missouri
63110
United States
Columbia University Medical Center Herbert Irving Pavilion
New York
New York
10032
United States
University Hospitals of Cleveland
Cleveland
Ohio
44106
United States
Greenville Health System, Institute for Translational Oncology Research, Clinical Research Unit
Greenville
South Carolina
29605
United States
Froedtert Hospital & the Medical College of Wisconsin
Milwaukee
Wisconsin
53226
United States
U.O Oncologia e Ematologia - Istituto Clinico Humanitas
Milan
Italy
University College London Hospitals
London
NW1 2BU
United Kingdom
The Christie NHS Foundation Trust
Manchester
M20 4BX
United Kingdom
Hamadani M, Radford J, Carlo-Stella C, Caimi PF, Reid E, O'Connor OA, Feingold JM, Ardeshna KM, Townsend W, Solh M, Heffner LT, Ungar D, Wang L, Boni J, Havenith K, Qin Y, Kahl BS. Final results of a phase 1 study of loncastuximab tesirine in relapsed/refractory B-cell non-Hodgkin lymphoma. Blood. 2021 May 13;137(19):2634-2645. doi: 10.1182/blood.2020007512.
Kahl BS, Hamadani M, Radford J, Carlo-Stella C, Caimi P, Reid E, Feingold JM, Ardeshna KM, Solh M, Heffner LT, Ungar D, He S, Boni J, Havenith K, O'Connor OA. A Phase I Study of ADCT-402 (Loncastuximab Tesirine), a Novel Pyrrolobenzodiazepine-Based Antibody-Drug Conjugate, in Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma. Clin Cancer Res. 2019 Dec 1;25(23):6986-6994. doi: 10.1158/1078-0432.CCR-19-0711. Epub 2019 Nov 4.
FG002
Part 1: 60 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (60 μg/kg) on Day 1 of each 3 week cycle (Q3W).
FG003
Part 1: 90 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (90 μg/kg) on Day 1 of each 3 week cycle (Q3W).
FG004
Part 1: 120 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (120 μg/kg) on Day 1 of each 3 week cycle (Q3W).
FG005
Part 2: 120 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (120 μg/kg) on Day 1 of each 3 week cycle (Q3W).
FG006
Part 1: 150 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (150 μg/kg) on Day 1 of each 3 week cycle (Q3W).
FG007
Part 2: 150 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (150 μg/kg) on Day 1 of each 3 week cycle (Q3W).
FG008
Part 1: 200 μg/kg Q3W and Q6W
Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 3 week cycle (Q3W). Following protocol amendment 5, treatment cycle length was increased to 6 weeks (Q6W).
FG0004 subjects
FG0014 subjects
FG0024 subjects
FG0035 subjects
FG00416 subjects
FG00526 subjects
FG00619 subjects
FG00769 subjects
FG00836 subjects
COMPLETED
FG0003 subjects
FG0012 subjects
FG0022 subjects
FG0031 subjects
FG0044 subjects
FG0057 subjects
FG0068 subjects
FG0077 subjects
FG00811 subjects
NOT COMPLETED
FG0001 subjects
FG0012 subjects
FG0022 subjects
FG0034 subjects
FG00412 subjects
FG00519 subjects
FG00611 subjects
FG00762 subjects
FG00825 subjects
Type
Comment
Reasons
Death
FG0001 subjects
FG0012 subjects
FG0022 subjects
FG0033 subjects
FG0048 subjects
FG00518 subjects
FG00610 subjects
FG00747 subjects
FG00820 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Miscellaneous
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
All participants who received at least one dose of study treatment.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part 1: 15 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (15 μg/kg) on Day 1 of each 3 week cycle (Q3W).
BG001
Part 1: 30 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (30 μg/kg) on Day 1 of each 3 week cycle (Q3W).
BG002
Part 1: 60 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (60 μg/kg) on Day 1 of each 3 week cycle (Q3W).
BG003
Part 1: 90 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (90 μg/kg) on Day 1 of each 3 week cycle (Q3W).
BG004
Part 1: 120 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (120 μg/kg) on Day 1 of each 3 week cycle (Q3W).
BG005
Part 2: 120 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (120 μg/kg) on Day 1 of each 3 week cycle (Q3W).
BG006
Part 1: 150 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (150 μg/kg) on Day 1 of each 3 week cycle (Q3W).
BG007
Part 2: 150 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (150 μg/kg) on Day 1 of each 3 week cycle (Q3W).
BG008
Part 1: 200 μg/kg Q3W and Q6W
Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 3 week cycle (Q3W). Following protocol amendment 5, treatment cycle length was increased to 6 weeks (Q6W).
BG009
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0004
BG0014
BG0024
BG0035
BG00416
BG00526
BG00619
BG00769
BG00836
BG009183
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG0004
ParticipantsBG0014
ParticipantsBG0024
ParticipantsBG003
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
ParticipantsBG0004
ParticipantsBG0014
ParticipantsBG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG0004
ParticipantsBG0014
ParticipantsBG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG0004
ParticipantsBG0014
ParticipantsBG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Race
ParticipantsBG0004
ParticipantsBG0014
ParticipantsBG002
Height
Height data was not collected for 2 participants because of complications during the collection of baseline measurements.
Mean
Standard Deviation
cm
Title
Denominators
Categories
ParticipantsBG0004
ParticipantsBG0014
ParticipantsBG002
Weight
Mean
Standard Deviation
kg
Title
Denominators
Categories
ParticipantsBG0004
ParticipantsBG0014
ParticipantsBG002
Body Mass Index (BMI)
BMI could not be calculated for 2 participants due to missing height information.
Mean
Standard Deviation
kg/m^2
Title
Denominators
Categories
ParticipantsBG0004
ParticipantsBG0014
ParticipantsBG002
Eastern Cooperative Oncology Group (ECOG) Performance Status
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG0004
ParticipantsBG0014
ParticipantsBG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
A DLT is defined as any of the following events, except those that are clearly due to underlying disease or extraneous causes:
A hematologic DLT is defined as:
CTCAE Grade 3 or 4 febrile neutropenia or neutropenic infection.
CTCAE Grade 4 neutropenia lasting >7 days.
CTCAE Grade 4 thrombocytopenia.
CTCAE Grade 3 thrombocytopenia with clinically significant bleeding, or Grade 3 thrombocytopenia requiring a platelet transfusion.
CTCAE Grade 4 anemia.
A non-hematologic DLT is defined as:
CTCAE Grade 4 tumor lysis syndrome (TLS). Grade 3 TLS will not constitute DLT unless it leads to irreversible end-organ damage.
CTCAE Grade 3 or higher AE (including nausea, vomiting, diarrhea, and electrolyte imbalances lasting more than 48 hours despite optimal therapy; excluding all grades of alopecia).
CTCAE Grade 3 or higher hypersensitivity reaction (regardless of premedication).
CTCAE Grade 2 or higher skin ulceration.
All participants in Part 1 who completed at least one cycle of treatment.
Posted
Count of Participants
Participants
Q3W schedule: Day 1 to End of Cycle 1 (3 weeks); Q6W schedule: Day 1 to End of Cycle 1 (6 weeks)
ID
Title
Description
OG000
Part 1: 15 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (15 μg/kg) on Day 1 of each 3 week cycle (Q3W).
OG001
Part 1: 30 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (30 μg/kg) on Day 1 of each 3 week cycle (Q3W).
OG002
Part 1: 60 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (60 μg/kg) on Day 1 of each 3 week cycle (Q3W).
OG003
Part 1: 90 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (90 μg/kg) on Day 1 of each 3 week cycle (Q3W).
OG004
Part 1: 120 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (120 μg/kg) on Day 1 of each 3 week cycle (Q3W).
OG005
Part 1: 150 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (150 μg/kg) on Day 1 of each 3 week cycle (Q3W).
OG006
Part 1: 200 μg/kg Q3W and Q6W
Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 3 week cycle (Q3W). Following protocol amendment 5, treatment cycle length was increased to 6 weeks (Q6W).
Units
Counts
Participants
OG0004
OG0014
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Recommended Dose of ADCT-402 for Part 2
The recommended dose was established by the dose escalation steering committee and based on safety findings during Part 1 of the study.
All participants in Part 1 who completed at least one cycle of treatment.
Posted
Number
μg/kg
Q3W schedule: Day 1 to End of Cycle 1 (3 weeks); Q6W schedule: Day 1 to End of Cycle 1 (6 weeks)
ID
Title
Description
OG000
Part 1: ADCT-402 Dose Escalation
In Part 1 (dose escalation) participants received intravenous (IV) infusions of ADCT-402, at escalating doses according to a 3+3 study design. Doses assessed:
Dose Level 1: 15 μg/kg on Day 1 of each 3 week cycle (Q3W)
Dose Level 2: 30 μg/kg Day 1 Q3W
Dose Level 3: 60 μg/kg Day 1 Q3W
Dose Level 4: 90 μg/kg Day 1 Q3W
Dose Level 5: 120 μg/kg Day 1 Q3W
Dose Level 6: 150 μg/kg Day 1 Q3W
Dose Level 7: 200 μg/kg Day 1 Q3W and on Day 1 of each 6 week cycle (Q6W).
Units
Counts
Participants
OG000
Primary
Number of Participants Reporting at Least One Treatment Emergent Adverse Event (TEAE)
An adverse event (AE) is defined as any untoward medical occurrence in a participants enrolled into this study regardless of its causal relationship to study drug. A TEAE is defined as any event not present before exposure to study drug or any event already present that worsens in either intensity or frequency after exposure to study drug.
All participants who received at least one dose of study treatment.
Posted
Count of Participants
Participants
Day 1 to End of Study (a maximum of 18 months)
ID
Title
Description
OG000
Part 1: 15 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (15 μg/kg) on Day 1 of each 3 week cycle (Q3W).
OG001
Part 1: 30 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (30 μg/kg) on Day 1 of each 3 week cycle (Q3W).
OG002
Part 1: 60 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (60 μg/kg) on Day 1 of each 3 week cycle (Q3W).
OG003
Part 1: 90 μg/kg Q3W
Primary
Number of Participants Reporting at Least One Treatment Emergent Serious Adverse Event (SAE)
An adverse event (AE) is defined as any untoward medical occurrence in a participant enrolled into this study regardless of its causal relationship to study drug. A treatment emergent AE (TEAE) is defined as any event not present before exposure to study drug or any event already present that worsens in either intensity or frequency after exposure to study drug. An SAE is defined as any event that results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.
All participants who received at least one dose of study treatment.
Posted
Count of Participants
Participants
Day 1 to End of Study (a maximum of 18 months)
ID
Title
Description
OG000
Part 1: 15 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (15 μg/kg) on Day 1 of each 3 week cycle (Q3W).
OG001
Part 1: 30 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (30 μg/kg) on Day 1 of each 3 week cycle (Q3W).
OG002
Part 1: 60 μg/kg Q3W
Secondary
Overall Response Rate (ORR)
ORR was defined as the number of participants with a best overall response of complete response (CR) or partial response (PR) at the time each participant discontinued treatment with ADCT-402, before the start of subsequent anticancer therapy or procedure. Tumor response was assessed using the 2014 Lugano Classification for response.
CR is defined as achieving either of the following:
Complete metabolic response.
Complete radiologic response (target node regress to <1.5 cm, no nonmeasured lesions, no organ enlargement, no new lesions and normal bone marrow morphology).
PR is defined as achieving either of the following:
Partial remission (>50% decrease in target measurable nodes, regression/ absence/ no increase of nonmeasured lesions, spleen regressed by >50% in length and no new lesions).
All participants who received at least one dose of study treatment with a valid baseline disease assessment and at least one valid post-baseline disease assessment.
Posted
Count of Participants
Participants
Baseline to End of Study (a maximum of 18 months)
ID
Title
Description
OG000
Part 1: 15 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (15 μg/kg) on Day 1 of each 3 week cycle (Q3W).
OG001
Part 1: 30 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (30 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Secondary
Duration of Response (DoR)
DoR is defined among responders (complete response [CR] and partial response [PR]) as the time from the earliest date of first response until the first date of either disease progression or death due to any cause. Tumor response was assessed using the 2014 Lugano Classification for response.
Disease progression is defined as progressive metabolic disease or one of the follow:
Target node progression.
An individual extranodal lesion must be abnormal with length >1.5cm and/or increase of length >50%.
New or clear progression of nonmeasured lesions.
Regrowth of previously resolved lesions or new nodes >1.5 cm in length.
New or recurrent bone marrow involvement.
DoR is presented overall for all participants who received ADCT-402, as specified in protocol section 7.4.
All participants who received at least one dose of study treatment with a valid baseline disease assessment and at least one valid post-baseline disease assessment. Results are pooled for all arms as specified in the protocol.
Posted
Median
95% Confidence Interval
months
Baseline to End of Study (a maximum of 18 months)
ID
Title
Description
OG000
Parts 1 and 2: ADCT-402
In Part 1 (dose escalation) participants received intravenous (IV) infusions of ADCT-402, at escalating doses according to a 3+3 study design. Doses assessed:
Dose Level 1: 15 μg/kg on Day 1 of each 3 week cycle (Q3W)
Dose Level 2: 30 μg/kg Day 1 Q3W
Dose Level 3: 60 μg/kg Day 1 Q3W
Dose Level 4: 90 μg/kg Day 1 Q3W
Dose Level 5: 120 μg/kg Day 1 Q3W
Dose Level 6: 150 μg/kg Day 1 Q3W
Dose Level 7: 200 μg/kg Day 1 Q3W and on Day 1 of each 6 week cycle (Q6W).
In Part 2 (expansion), participants received intravenous (IV) infusions of ADCT-402 at either 120 μg/kg or 150 μg/kg on Day 1 of each 3 week cycle (Q3W).
Secondary
Overall Survival (OS)
OS is defined as the time from the first dose of study drug treatment until the date of death due to any cause.
OS is presented overall for all participants who received ADCT-402, as specified in protocol section 7.4.
All participants who received at least one dose of study treatment with a valid baseline disease assessment and at least one valid post-baseline disease assessment. Results are pooled for all arms as specified in the protocol.
Posted
Median
95% Confidence Interval
months
Baseline to End of Study (a maximum of 18 months)
ID
Title
Description
OG000
Parts 1 and 2: ADCT-402
In Part 1 (dose escalation) participants received intravenous (IV) infusions of ADCT-402, at escalating doses according to a 3+3 study design. Doses assessed:
Dose Level 1: 15 μg/kg on Day 1 of each 3 week cycle (Q3W)
Dose Level 2: 30 μg/kg Day 1 Q3W
Dose Level 3: 60 μg/kg Day 1 Q3W
Dose Level 4: 90 μg/kg Day 1 Q3W
Dose Level 5: 120 μg/kg Day 1 Q3W
Dose Level 6: 150 μg/kg Day 1 Q3W
Dose Level 7: 200 μg/kg Day 1 Q3W and on Day 1 of each 6 week cycle (Q6W).
In Part 2 (expansion), participants received intravenous (IV) infusions of ADCT-402 at either 120 μg/kg or 150 μg/kg on Day 1 of each 3 week cycle (Q3W).
Units
Counts
Participants
Secondary
Progression-free Survival (PFS)
PFS is defined among the efficacy population as the time from first dose of study drug until either disease progression or death due to any cause. Tumor response was assessed using the 2014 Lugano Classification for response.
Disease progression is defined as progressive metabolic disease or one of the follow:
Target node progression.
An individual extranodal lesion must be abnormal with length >1.5cm and/or increase of length >50%.
New or clear progression of nonmeasured lesions.
Regrowth of previously resolved lesions or new nodes >1.5 cm in length.
New or recurrent bone marrow involvement.
PFS is presented overall for all participants who received ADCT-402, as specified in protocol section 7.4.
All participants who received at least one dose of study treatment with a valid baseline disease assessment and at least one valid post-baseline disease assessment. Results are pooled for all arms as specified in the protocol.
Posted
Median
95% Confidence Interval
months
Baseline to End of Study (a maximum of 18 months)
ID
Title
Description
OG000
Parts 1 and 2: ADCT-402
In Part 1 (dose escalation) participants received intravenous (IV) infusions of ADCT-402, at escalating doses according to a 3+3 study design. Doses assessed:
Dose Level 1: 15 μg/kg on Day 1 of each 3 week cycle (Q3W)
Dose Level 2: 30 μg/kg Day 1 Q3W
Dose Level 3: 60 μg/kg Day 1 Q3W
Dose Level 4: 90 μg/kg Day 1 Q3W
Dose Level 5: 120 μg/kg Day 1 Q3W
Dose Level 6: 150 μg/kg Day 1 Q3W
Dose Level 7: 200 μg/kg Day 1 Q3W and on Day 1 of each 6 week cycle (Q6W).
In Part 2 (expansion), participants received intravenous (IV) infusions of ADCT-402 at either 120 μg/kg or 150 μg/kg on Day 1 of each 3 week cycle (Q3W).
Secondary
Maximum Observed Serum Concentration (Cmax) for ADCT-402
Cmax for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199).
Results for Part 1 and Part 2 have been pooled for the same dosage and schedule, as specified in the protocol.
Only participants with evaluable pharmacokinetic (PK) results were included in the analysis. Where data is not presented, the PK profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed.
Posted
Mean
Standard Deviation
ng/mL
Q3W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (3 weeks cycle); Q6W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (6 week cycle)
ID
Title
Description
OG000
Part 1: 15 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (15 μg/kg) on Day 1 of each 3 week cycle (Q3W).
OG001
Part 1: 30 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (30 μg/kg) on Day 1 of each 3 week cycle (Q3W).
OG002
Part 1: 60 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (60 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Secondary
Time to Reach the Maximum Serum Concentration (Tmax) for ADCT-402
Tmax for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199).
Results for Part 1 and Part 2 have been pooled for the same dosage and schedule, as specified in the protocol.
Only participants with evaluable pharmacokinetic (PK) results were included in the analysis. Where data is not presented, the PK profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed.
Posted
Median
Full Range
days
Q3W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (3 weeks cycle); Q6W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (6 week cycle)
ID
Title
Description
OG000
Part 1: 15 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (15 μg/kg) on Day 1 of each 3 week cycle (Q3W).
OG001
Part 1: 30 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (30 μg/kg) on Day 1 of each 3 week cycle (Q3W).
OG002
Part 1: 60 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (60 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Secondary
Area Under the Serum Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for ADCT-402
AUClast for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199).
Results for Part 1 and Part 2 have been pooled for the same dosage and schedule, as specified in the protocol.
Only participants with evaluable pharmacokinetic (PK) results were included in the analysis. Where data is not presented, the PK profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed.
Posted
Mean
Standard Deviation
day*ng/mL
Q3W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (3 weeks cycle); Q6W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (6 week cycle)
ID
Title
Description
OG000
Part 1: 15 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (15 μg/kg) on Day 1 of each 3 week cycle (Q3W).
OG001
Part 1: 30 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (30 μg/kg) on Day 1 of each 3 week cycle (Q3W).
OG002
Part 1: 60 μg/kg Q3W
Secondary
Area Under the Serum Concentration-Time Curve From Time 0 to the End of the Dosing Interval (AUCtau) for ADCT-402
AUCtau for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199).
Results for Part 1 and Part 2 have been pooled for the same dosage and schedule, as specified in the protocol.
Only participants with evaluable pharmacokinetic (PK) results were included in the analysis. Where data is not presented, the PK profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed.
Posted
Mean
Standard Deviation
day*ng/mL
Q3W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (3 weeks cycle); Q6W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (6 week cycle)
ID
Title
Description
OG000
Part 1: 15 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (15 μg/kg) on Day 1 of each 3 week cycle (Q3W).
OG001
Part 1: 30 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (30 μg/kg) on Day 1 of each 3 week cycle (Q3W).
OG002
Part 1: 60 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (60 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Secondary
Area Under the Serum Concentration-time Curve From Time 0 to Infinity (AUCinf) for ADCT-402
AUCinf for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199).
Results for Part 1 and Part 2 have been pooled for the same dosage and schedule, as specified in the protocol.
Only participants with evaluable pharmacokinetic (PK) results were included in the analysis. Where data is not presented, the PK profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed.
Posted
Mean
Standard Deviation
day*ng/mL
Q3W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (3 weeks cycle); Q6W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (6 week cycle)
ID
Title
Description
OG000
Part 1: 15 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (15 μg/kg) on Day 1 of each 3 week cycle (Q3W).
OG001
Part 1: 30 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (30 μg/kg) on Day 1 of each 3 week cycle (Q3W).
OG002
Part 1: 60 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (60 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Secondary
Terminal Half-life (Thalf) of ADCT-402
Thalf of Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199).
Results for Part 1 and Part 2 have been pooled for the same dosage and schedule, as specified in the protocol.
Only participants with evaluable pharmacokinetic (PK) results were included in the analysis. Where data is not presented, the PK profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed.
Posted
Median
Full Range
days
Q3W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (3 weeks cycle); Q6W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (6 week cycle)
ID
Title
Description
OG000
Part 1: 15 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (15 μg/kg) on Day 1 of each 3 week cycle (Q3W).
OG001
Part 1: 30 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (30 μg/kg) on Day 1 of each 3 week cycle (Q3W).
OG002
Part 1: 60 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (60 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Secondary
Apparent Clearance (CL) at Steady State for ADCT-402
CL of Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199).
Results for Part 1 and Part 2 have been pooled for the same dosage and schedule, as specified in the protocol.
Only participants with evaluable pharmacokinetic (PK) results were included in the analysis. Where data is not presented, the PK profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed.
Posted
Mean
Standard Deviation
liters/day
Q3W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (3 weeks cycle); Q6W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (6 week cycle)
ID
Title
Description
OG000
Part 1: 15 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (15 μg/kg) on Day 1 of each 3 week cycle (Q3W).
OG001
Part 1: 30 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (30 μg/kg) on Day 1 of each 3 week cycle (Q3W).
OG002
Part 1: 60 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (60 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Secondary
Volume of Distribution at Steady State (Vss) for ADCT-402
Vss for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199).
Results for Part 1 and Part 2 have been pooled for the same dosage and schedule, as specified in the protocol.
Only participants with evaluable pharmacokinetic (PK) results were included in the analysis. Where data is not presented, the PK profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed.
Posted
Mean
Standard Deviation
liters
Q3W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (3 weeks cycle); Q6W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (6 week cycle)
ID
Title
Description
OG000
Part 1: 15 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (15 μg/kg) on Day 1 of each 3 week cycle (Q3W).
OG001
Part 1: 30 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (30 μg/kg) on Day 1 of each 3 week cycle (Q3W).
OG002
Part 1: 60 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (60 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Secondary
Accumulation Index (AI) for ADCT-402
AI for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199). AI is the ratio of area under the serum concentration-time curve (AUC) from 0 to 21 days for Cycle 2 divided by AUC from 0 to 21 days for Cycle 1 (Q3W schedule: 3 week cycle length; Q6W schedule: 6 week cycle length). It is the increase in drug plasma concentration after multiple dosing until a steady state is reached.
Results for Part 1 and Part 2 have been pooled for the same dosage and schedule, as specified in the protocol.
Only participants with evaluable pharmacokinetic (PK) results were included in the analysis. Where data is not presented, the PK profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed.
Posted
Mean
Standard Deviation
ratio
Q3W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (3 weeks cycle); Q6W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (6 week cycle)
ID
Title
Description
OG000
Part 1: 15 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (15 μg/kg) on Day 1 of each 3 week cycle (Q3W).
OG001
Part 1: 30 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (30 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Secondary
Number of Participants With Anti-drug Antibody Response (ADA) Against ADCT-402
Blood serum samples were collected and analysed to determine the presence or absence of ADA.
ADA is presented overall for all participants who received ADCT-402, as specified in protocol section 7.4.
All participants who were tested for ADA.
Posted
Count of Participants
Participants
Q3W schedule: Day 1 to End of Cycle 1 (3 weeks); Q6W schedule: Day 1 to End of Cycle 1 (6 weeks)
ID
Title
Description
OG000
Parts 1 and 2: ADCT-402
In Part 1 (dose escalation) participants received intravenous (IV) infusions of ADCT-402, at escalating doses according to a 3+3 study design. Doses assessed:
Dose Level 1: 15 μg/kg on Day 1 of each 3 week cycle (Q3W)
Dose Level 2: 30 μg/kg Day 1 Q3W
Dose Level 3: 60 μg/kg Day 1 Q3W
Dose Level 4: 90 μg/kg Day 1 Q3W
Dose Level 5: 120 μg/kg Day 1 Q3W
Dose Level 6: 150 μg/kg Day 1 Q3W
Dose Level 7: 200 μg/kg Day 1 Q3W and on Day 1 of each 6 week cycle (Q6W).
In Part 2 (expansion), participants received intravenous (IV) infusions of ADCT-402 at either 120 μg/kg or 150 μg/kg on Day 1 of each 3 week cycle (Q3W).
Units
Counts
Participants
OG000
Time Frame
Day 1 to End of Study (a maximum of 18 months)
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Part 1: 15 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (15 μg/kg) on Day 1 of each 3 week cycle (Q3W).
1
4
1
4
4
4
EG001
Part 1: 30 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (30 μg/kg) on Day 1 of each 3 week cycle (Q3W).
2
4
1
4
3
4
EG002
Part 1: 60 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (60 μg/kg) on Day 1 of each 3 week cycle (Q3W).
2
4
0
4
4
4
EG003
Part 1: 90 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (90 μg/kg) on Day 1 of each 3 week cycle (Q3W).
3
5
4
5
5
5
EG004
Part 1: 120 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (120 μg/kg) on Day 1 of each 3 week cycle (Q3W).
8
16
4
16
16
16
EG005
Part 2: 120 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (120 μg/kg) on Day 1 of each 3 week cycle (Q3W).
18
26
4
26
25
26
EG006
Part 1: 150 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (150 μg/kg) on Day 1 of each 3 week cycle (Q3W).
10
19
6
19
19
19
EG007
Part 2: 150 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (150 μg/kg) on Day 1 of each 3 week cycle (Q3W).
47
69
40
69
65
69
EG008
Part 1: 200 μg/kg Q3W and Q6W
Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 3 week cycle (Q3W). Following protocol amendment 5, treatment cycle length was increased to 6 weeks (Q6W).
20
36
15
36
36
36
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG0031 affected5 at risk
EG004
Anaemia
Blood and lymphatic system disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected4 at risk
EG0020 affected4 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Abdominal compartment syndrome
Gastrointestinal disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Anal fissure
Gastrointestinal disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Intestinal perforation
Gastrointestinal disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Lower gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Melaena
Gastrointestinal disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Disease progression
General disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Pyrexia
General disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
General physical health deterioration
General disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Fatigue
General disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Generalised oedema
General disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Gait disturbance
General disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Injection site extravasation
General disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Oedema peripheral
General disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Hepatic failure
Hepatobiliary disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Sepsis
Infections and infestations
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Lung infection
Infections and infestations
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Clostridium difficile infection
Infections and infestations
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Cytomegalovirus infection
Infections and infestations
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Enterocolitis infectious
Infections and infestations
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Influenza
Infections and infestations
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Oesophageal candidiasis
Infections and infestations
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Oropharyngeal candidiasis
Infections and infestations
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Parainfluenzae virus infection
Infections and infestations
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Pneumonia haemophilus
Infections and infestations
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Pneumonia influenzal
Infections and infestations
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Pneumonia staphylococcal
Infections and infestations
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Progressive multifocal leukoencephalopathy
Infections and infestations
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Rhinovirus infection
Infections and infestations
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Septic shock
Infections and infestations
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Staphylococcal sepsis
Infections and infestations
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Wound
Injury, poisoning and procedural complications
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Platelet count decreased
Investigations
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Fluid overload
Metabolism and nutrition disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Neck mass
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Diffuse large B-cell lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Burkitt's lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Mantle cell lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Aphasia
Nervous system disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Depressed level of consciousness
Nervous system disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Headache
Nervous system disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Syncope
Nervous system disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Disorientation
Psychiatric disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Oedema genital
Reproductive system and breast disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Perineal pain
Reproductive system and breast disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Scrotal pain
Reproductive system and breast disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Pneumomediastinum
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Embolism
Vascular disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Lymphoedema
Vascular disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0021 affected4 at risk
EG0033 affected5 at risk
EG0041 affected16 at risk
EG0059 affected26 at risk
EG0067 affected19 at risk
EG00725 affected69 at risk
EG00814 affected36 at risk
Neutropenia
Blood and lymphatic system disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0021 affected4 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0021 affected4 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0021 affected4 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Periorbital oedema
Eye disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Dry eye
Eye disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Visual impairment
Eye disorders
MedDRA 22.0
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 22.0
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0021 affected4 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0021 affected4 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 22.0
Non-systematic Assessment
EG0001 affected4 at risk
EG0011 affected4 at risk
EG0020 affected4 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 22.0
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0021 affected4 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Anal incontinence
Gastrointestinal disorders
MedDRA 22.0
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Salivary hypersecretion
Gastrointestinal disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Fatigue
General disorders
MedDRA 22.0
Non-systematic Assessment
EG0001 affected4 at risk
EG0011 affected4 at risk
EG0022 affected4 at risk
EG003
Oedema peripheral
General disorders
MedDRA 22.0
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Pyrexia
General disorders
MedDRA 22.0
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Asthenia
General disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Face oedema
General disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0021 affected4 at risk
EG003
Chills
General disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Localised oedema
General disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Pain
General disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Malaise
General disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0021 affected4 at risk
EG003
Axillary pain
General disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Food allergy
Immune system disorders
MedDRA 22.0
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 22.0
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Clostridium difficile infection
Infections and infestations
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0021 affected4 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Influenza
Infections and infestations
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Corona virus infection
Infections and infestations
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Pyelonephritis acute
Infections and infestations
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 22.0
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected4 at risk
EG0020 affected4 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0021 affected4 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0021 affected4 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0021 affected4 at risk
EG003
Platelet count decreased
Investigations
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0021 affected4 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 22.0
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Weight decreased
Investigations
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Amylase increased
Investigations
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0021 affected4 at risk
EG003
Blood cholesterol increased
Investigations
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Lipase increased
Investigations
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0021 affected4 at risk
EG003
International normalised ratio increased
Investigations
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Blood bicarbonate increased
Investigations
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0021 affected4 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 22.0
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Limb mass
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected4 at risk
EG0020 affected4 at risk
EG003
Muscle twitching
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 22.0
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Headache
Nervous system disorders
MedDRA 22.0
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected4 at risk
EG0020 affected4 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0021 affected4 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Breast oedema
Reproductive system and breast disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0021 affected4 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Organising pneumonia
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0021 affected4 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 22.0
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0021 affected4 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 22.0
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0022 affected4 at risk
EG003
Skin hyperpigmentation
Skin and subcutaneous tissue disorders
MedDRA 22.0
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Photosensitivity reaction
Skin and subcutaneous tissue disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 22.0
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0021 affected4 at risk
EG003
Dermatitis bullous
Skin and subcutaneous tissue disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Decubitus ulcer
Skin and subcutaneous tissue disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Pruritus generalised
Skin and subcutaneous tissue disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected4 at risk
EG0020 affected4 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA 22.0
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Drug eruption
Skin and subcutaneous tissue disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Hypertension
Vascular disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0021 affected4 at risk
EG003
Hypotension
Vascular disorders
MedDRA 22.0
Non-systematic Assessment
EG0002 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Flushing
Vascular disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Bladder spasm
Renal and urinary disorders
MedDRA 22.0
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 22.0
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0020 affected4 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
PI can publish after first multi-site publication, or if no multi-site publication is made within 18 months of study completion/termination. The only disclosure restriction on the PI is the sponsor can review results comms. prior to public release and can embargo comms. regarding trial results for a period that is more than 60 but less than or equal to 180 days from the time submitted to sponsor for review. The sponsor can't require changes to the communication and can't extend the embargo.
Participants received an intravenous (IV) infusion of ADCT-402 (90 μg/kg) on Day 1 of each 3 week cycle (Q3W).
OG004
Part 1: 120 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (120 μg/kg) on Day 1 of each 3 week cycle (Q3W).
OG005
Part 2: 120 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (120 μg/kg) on Day 1 of each 3 week cycle (Q3W).
OG006
Part 1: 150 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (150 μg/kg) on Day 1 of each 3 week cycle (Q3W).
OG007
Part 2: 150 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (150 μg/kg) on Day 1 of each 3 week cycle (Q3W).
OG008
Part 1: 200 μg/kg Q3W and Q6W
Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 3 week cycle (Q3W). Following protocol amendment 5, treatment cycle length was increased to 6 weeks (Q6W).
Units
Counts
Participants
OG0004
OG0014
OG0024
OG0035
OG00416
OG00526
OG00619
OG00769
OG00836
Title
Denominators
Categories
Title
Measurements
OG0004
OG0013
OG0024
OG0035
OG00416
OG00526
OG00619
OG00768
OG00836
Participants received an intravenous (IV) infusion of ADCT-402 (60 μg/kg) on Day 1 of each 3 week cycle (Q3W).
OG003
Part 1: 90 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (90 μg/kg) on Day 1 of each 3 week cycle (Q3W).
OG004
Part 1: 120 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (120 μg/kg) on Day 1 of each 3 week cycle (Q3W).
OG005
Part 2: 120 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (120 μg/kg) on Day 1 of each 3 week cycle (Q3W).
OG006
Part 1: 150 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (150 μg/kg) on Day 1 of each 3 week cycle (Q3W).
OG007
Part 2: 150 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (150 μg/kg) on Day 1 of each 3 week cycle (Q3W).
OG008
Part 1: 200 μg/kg Q3W and Q6W
Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 3 week cycle (Q3W). Following protocol amendment 5, treatment cycle length was increased to 6 weeks (Q6W).
Units
Counts
Participants
OG0004
OG0014
OG0024
OG0035
OG00416
OG00526
OG00619
OG00769
OG00836
Title
Denominators
Categories
Title
Measurements
OG0001
OG0011
OG0020
OG0034
OG0044
OG00514
OG0066
OG00740
OG00815
OG002
Part 1: 60 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (60 μg/kg) on Day 1 of each 3 week cycle (Q3W).
OG003
Part 1: 90 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (90 μg/kg) on Day 1 of each 3 week cycle (Q3W).
OG004
Part 1: 120 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (120 μg/kg) on Day 1 of each 3 week cycle (Q3W).
OG005
Part 2: 120 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (120 μg/kg) on Day 1 of each 3 week cycle (Q3W).
OG006
Part 1: 150 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (150 μg/kg) on Day 1 of each 3 week cycle (Q3W).
OG007
Part 2: 150 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (150 μg/kg) on Day 1 of each 3 week cycle (Q3W).
OG008
Part 1: 200 μg/kg Q3W and Q6W
Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 3 week cycle (Q3W). Following protocol amendment 5, treatment cycle length was increased to 6 weeks (Q6W).
Units
Counts
Participants
OG0004
OG0014
OG0024
OG0035
OG00416
OG00526
OG00619
OG00768
OG00834
Title
Denominators
Categories
Title
Measurements
OG0001
OG0011
OG0021
OG0032
OG0049
OG00511
OG00612
OG00725
OG00820
Units
Counts
Participants
OG000180
Title
Denominators
Categories
Title
Measurements
OG0005.36(4.04 to NA)Upper limit of the confidence interval was not reached.
OG000180
Title
Denominators
Categories
Title
Measurements
OG0008.25(6.74 to 10.68)
Units
Counts
Participants
OG000180
Title
Denominators
Categories
Title
Measurements
OG0003.09(2.66 to 4.24)
OG003
Part 1: 90 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (90 μg/kg) on Day 1 of each 3 week cycle (Q3W).
OG004
Parts 1 and 2: 120 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (120 μg/kg) on Day 1 of each 3 week cycle (Q3W). Parts 1 and 2 are pooled for PK analysis as specified in the protocol.
OG005
Parts 1 and 2: 150 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (150 μg/kg) on Day 1 of each 3 week cycle (Q3W). Parts 1 and 2 are pooled for PK analysis as specified in the protocol.
OG006
Part 1: 200 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 3 week cycle (Q3W). Analysis was performed separately for Q3W and Q6W treatment cycles as specified in the protocol.
OG007
Part 1: 200 μg/kg Q6W
Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 6 week cycle (Q6W). Analysis was performed separately for Q3W and Q6W treatment cycles as specified in the protocol.
Units
Counts
Participants
OG0004
OG0014
OG0024
OG0035
OG00442
OG00588
OG00614
OG00722
Title
Denominators
Categories
PBD conjugated Ab: Cycle 1
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG0024
ParticipantsOG0035
ParticipantsOG00442
ParticipantsOG00588
ParticipantsOG00614
ParticipantsOG00722
Title
Measurements
OG000260± 85.5
OG001404± 161
OG002721± 481
OG003
PBD conjugated Ab: Cycle 2
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG0023
ParticipantsOG0035
total Ab: Cycle 1
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG0024
ParticipantsOG0035
total Ab: Cycle 2
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG0023
ParticipantsOG0035
SG3199: Cycle 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
SG3199: Cycle 2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0032
OG003
Part 1: 90 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (90 μg/kg) on Day 1 of each 3 week cycle (Q3W).
OG004
Parts 1 and 2: 120 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (120 μg/kg) on Day 1 of each 3 week cycle (Q3W). Parts 1 and 2 are pooled for PK analysis as specified in the protocol.
OG005
Parts 1 and 2: 150 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (150 μg/kg) on Day 1 of each 3 week cycle (Q3W). Parts 1 and 2 are pooled for PK analysis as specified in the protocol.
OG006
Part 1: 200 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 3 week cycle (Q3W). Analysis was performed separately for Q3W and Q6W treatment cycles as specified in the protocol.
OG007
Part 1: 200 μg/kg Q6W
Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 6 week cycle (Q6W). Analysis was performed separately for Q3W and Q6W treatment cycles as specified in the protocol.
Units
Counts
Participants
OG0004
OG0014
OG0024
OG0035
OG00442
OG00588
OG00614
OG00722
Title
Denominators
Categories
PBD conjugated Ab: Cycle 1
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG0024
ParticipantsOG0035
ParticipantsOG00442
ParticipantsOG00588
ParticipantsOG00614
ParticipantsOG00722
Title
Measurements
OG0000.0837(0.0833 to 0.0854)
OG0010.0833(0.0431 to 0.319)
OG0020.0819(0.0417 to 0.0847)
OG003
PBD conjugated Ab: Cycle 2
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG0023
ParticipantsOG0035
total Ab: Cycle 1
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG0024
ParticipantsOG0035
total Ab: Cycle 2
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG0023
ParticipantsOG0035
SG3199: Cycle 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
SG3199: Cycle 2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0032
Participants received an intravenous (IV) infusion of ADCT-402 (60 μg/kg) on Day 1 of each 3 week cycle (Q3W).
OG003
Part 1: 90 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (90 μg/kg) on Day 1 of each 3 week cycle (Q3W).
OG004
Parts 1 and 2: 120 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (120 μg/kg) on Day 1 of each 3 week cycle (Q3W). Parts 1 and 2 are pooled for PK analysis as specified in the protocol.
OG005
Parts 1 and 2: 150 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (150 μg/kg) on Day 1 of each 3 week cycle (Q3W). Parts 1 and 2 are pooled for PK analysis as specified in the protocol.
OG006
Part 1: 200 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 3 week cycle (Q3W). Analysis was performed separately for Q3W and Q6W treatment cycles as specified in the protocol.
OG007
Part 1: 200 μg/kg Q6W
Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 6 week cycle (Q6W). Analysis was performed separately for Q3W and Q6W treatment cycles as specified in the protocol.
Units
Counts
Participants
OG0004
OG0014
OG0024
OG0035
OG00442
OG00588
OG00614
OG00722
Title
Denominators
Categories
PBD conjugated Ab: Cycle 1
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG0024
ParticipantsOG0035
ParticipantsOG00442
ParticipantsOG00588
ParticipantsOG00614
ParticipantsOG00722
Title
Measurements
OG0001063± 1340
OG0012390± 826
OG0023875± 3228
OG003
PBD conjugated Ab: Cycle 2
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG0023
ParticipantsOG0035
total Ab: Cycle 1
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG0024
ParticipantsOG0035
total Ab: Cycle 2
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG0023
ParticipantsOG0035
SG3199: Cycle 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
SG3199: Cycle 2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0032
OG003
Part 1: 90 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (90 μg/kg) on Day 1 of each 3 week cycle (Q3W).
OG004
Parts 1 and 2: 120 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (120 μg/kg) on Day 1 of each 3 week cycle (Q3W). Parts 1 and 2 are pooled for PK analysis as specified in the protocol.
OG005
Parts 1 and 2: 150 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (150 μg/kg) on Day 1 of each 3 week cycle (Q3W). Parts 1 and 2 are pooled for PK analysis as specified in the protocol.
OG006
Part 1: 200 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 3 week cycle (Q3W). Analysis was performed separately for Q3W and Q6W treatment cycles as specified in the protocol.
OG007
Part 1: 200 μg/kg Q6W
Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 6 week cycle (Q6W). Analysis was performed separately for Q3W and Q6W treatment cycles as specified in the protocol.
Units
Counts
Participants
OG0004
OG0014
OG0023
OG0035
OG00440
OG00572
OG00611
OG00712
Title
Denominators
Categories
PBD conjugated Ab: Cycle 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
PBD conjugated Ab: Cycle 2
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG0022
ParticipantsOG0035
total Ab: Cycle 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
total Ab: Cycle 2
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG0023
ParticipantsOG0034
SG3199: Cycle 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
SG3199: Cycle 2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG003
Part 1: 90 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (90 μg/kg) on Day 1 of each 3 week cycle (Q3W).
OG004
Parts 1 and 2: 120 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (120 μg/kg) on Day 1 of each 3 week cycle (Q3W). Parts 1 and 2 are pooled for PK analysis as specified in the protocol.
OG005
Parts 1 and 2: 150 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (150 μg/kg) on Day 1 of each 3 week cycle (Q3W). Parts 1 and 2 are pooled for PK analysis as specified in the protocol.
OG006
Part 1: 200 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 3 week cycle (Q3W). Analysis was performed separately for Q3W and Q6W treatment cycles as specified in the protocol.
OG007
Part 1: 200 μg/kg Q6W
Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 6 week cycle (Q6W). Analysis was performed separately for Q3W and Q6W treatment cycles as specified in the protocol.
Units
Counts
Participants
OG0003
OG0012
OG0022
OG0032
OG00415
OG00547
OG0064
OG00713
Title
Denominators
Categories
PBD conjugated Ab: Cycle 1
ParticipantsOG0003
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0032
ParticipantsOG00415
ParticipantsOG00547
ParticipantsOG0064
ParticipantsOG00713
Title
Measurements
OG000432± 173
OG0012001± 663
OG0025333± 4002
OG003
PBD conjugated Ab: Cycle 2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
total Ab: Cycle 1
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
total Ab: Cycle 2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
SG3199: Cycle 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
SG3199: Cycle 2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG003
Part 1: 90 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (90 μg/kg) on Day 1 of each 3 week cycle (Q3W).
OG004
Parts 1 and 2: 120 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (120 μg/kg) on Day 1 of each 3 week cycle (Q3W). Parts 1 and 2 are pooled for PK analysis as specified in the protocol.
OG005
Parts 1 and 2: 150 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (150 μg/kg) on Day 1 of each 3 week cycle (Q3W). Parts 1 and 2 are pooled for PK analysis as specified in the protocol.
OG006
Part 1: 200 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 3 week cycle (Q3W). Analysis was performed separately for Q3W and Q6W treatment cycles as specified in the protocol.
OG007
Part 1: 200 μg/kg Q6W
Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 6 week cycle (Q6W). Analysis was performed separately for Q3W and Q6W treatment cycles as specified in the protocol.
Units
Counts
Participants
OG0004
OG0014
OG0022
OG0034
OG00438
OG00569
OG00611
OG00713
Title
Denominators
Categories
PBD conjugated Ab: Cycle 1
ParticipantsOG0003
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0032
ParticipantsOG00415
ParticipantsOG00547
ParticipantsOG0064
ParticipantsOG00713
Title
Measurements
OG0001.15(1.04 to 2.56)
OG0016.84(5.74 to 7.94)
OG0026.30(4.30 to 8.30)
OG003
PBD conjugated Ab: Cycle 2
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG0022
ParticipantsOG0034
total Ab: Cycle 1
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
total Ab: Cycle 2
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0034
SG3199: Cycle 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
SG3199: Cycle 2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG003
Part 1: 90 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (90 μg/kg) on Day 1 of each 3 week cycle (Q3W).
OG004
Parts 1 and 2: 120 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (120 μg/kg) on Day 1 of each 3 week cycle (Q3W). Parts 1 and 2 are pooled for PK analysis as specified in the protocol.
OG005
Parts 1 and 2: 150 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (150 μg/kg) on Day 1 of each 3 week cycle (Q3W). Parts 1 and 2 are pooled for PK analysis as specified in the protocol.
OG006
Part 1: 200 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 3 week cycle (Q3W). Analysis was performed separately for Q3W and Q6W treatment cycles as specified in the protocol.
OG007
Part 1: 200 μg/kg Q6W
Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 6 week cycle (Q6W). Analysis was performed separately for Q3W and Q6W treatment cycles as specified in the protocol.
Units
Counts
Participants
OG0004
OG0014
OG0023
OG0035
OG00440
OG00572
OG00611
OG00713
Title
Denominators
Categories
PBD conjugated Ab: Cycle 1
ParticipantsOG0003
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0032
ParticipantsOG00415
ParticipantsOG00547
ParticipantsOG0064
ParticipantsOG00713
Title
Measurements
OG0002.49± 0.978
OG0011.08± 0.164
OG0020.696± 0.444
OG003
PBD conjugated Ab: Cycle 2
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG0022
ParticipantsOG0035
total Ab: Cycle 1
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
total Ab: Cycle 2
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG0023
ParticipantsOG0034
SG3199: Cycle 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
SG3199: Cycle 2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG003
Part 1: 90 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (90 μg/kg) on Day 1 of each 3 week cycle (Q3W).
OG004
Parts 1 and 2: 120 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (120 μg/kg) on Day 1 of each 3 week cycle (Q3W). Parts 1 and 2 are pooled for PK analysis as specified in the protocol.
OG005
Parts 1 and 2: 150 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (150 μg/kg) on Day 1 of each 3 week cycle (Q3W). Parts 1 and 2 are pooled for PK analysis as specified in the protocol.
OG006
Part 1: 200 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 3 week cycle (Q3W). Analysis was performed separately for Q3W and Q6W treatment cycles as specified in the protocol.
OG007
Part 1: 200 μg/kg Q6W
Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 6 week cycle (Q6W). Analysis was performed separately for Q3W and Q6W treatment cycles as specified in the protocol.
Units
Counts
Participants
OG0004
OG0014
OG0022
OG0034
OG00438
OG00569
OG00611
OG00713
Title
Denominators
Categories
PBD conjugated Ab: Cycle 1
ParticipantsOG0003
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0032
ParticipantsOG00415
ParticipantsOG00547
ParticipantsOG0064
ParticipantsOG00713
Title
Measurements
OG0004.47± 0.759
OG00110.3± 4.83
OG0024.96± 0.318
OG003
PBD conjugated Ab: Cycle 2
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG0022
ParticipantsOG0034
total Ab: Cycle 1
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
total Ab: Cycle 2
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0034
SG3199: Cycle 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
SG3199: Cycle 2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG002
Part 1: 60 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (60 μg/kg) on Day 1 of each 3 week cycle (Q3W).
OG003
Part 1: 90 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (90 μg/kg) on Day 1 of each 3 week cycle (Q3W).
OG004
Parts 1 and 2: 120 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (120 μg/kg) on Day 1 of each 3 week cycle (Q3W). Parts 1 and 2 are pooled for PK analysis as specified in the protocol.
OG005
Parts 1 and 2: 150 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (150 μg/kg) on Day 1 of each 3 week cycle (Q3W). Parts 1 and 2 are pooled for PK analysis as specified in the protocol.
OG006
Part 1: 200 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 3 week cycle (Q3W). Analysis was performed separately for Q3W and Q6W treatment cycles as specified in the protocol.
OG007
Part 1: 200 μg/kg Q6W
Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 6 week cycle (Q6W). Analysis was performed separately for Q3W and Q6W treatment cycles as specified in the protocol.
Units
Counts
Participants
OG0004
OG0014
OG0022
OG0034
OG00438
OG00569
OG00611
OG00712
Title
Denominators
Categories
PBD conjugated Ab: Cycle 2
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG0022
ParticipantsOG0034
ParticipantsOG00438
ParticipantsOG00569
ParticipantsOG00611
ParticipantsOG00712
Title
Measurements
OG0001.12± 0.173
OG0011.37± 0.264
OG0021.70± 0.467
OG003
total Ab: Cycle 2
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0034
SG3199: Cycle 2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
183
Title
Denominators
Categories
Confirmed positive ADA pre-dose
Title
Measurements
OG0005
Confirmed positive ADA post-dose only
Title
Measurements
OG0001
Confirmed positive ADA at anytime
Title
Measurements
OG0006
1 affected
16 at risk
EG0051 affected26 at risk
EG0061 affected19 at risk
EG0075 affected69 at risk
EG0081 affected36 at risk
0 affected
5 at risk
EG0040 affected16 at risk
EG0051 affected26 at risk
EG0060 affected19 at risk
EG0070 affected69 at risk
EG0080 affected36 at risk
1 affected
5 at risk
EG0040 affected16 at risk
EG0050 affected26 at risk
EG0060 affected19 at risk
EG0070 affected69 at risk
EG0080 affected36 at risk
0 affected
5 at risk
EG0040 affected16 at risk
EG0051 affected26 at risk
EG0060 affected19 at risk
EG0071 affected69 at risk
EG0081 affected36 at risk
0 affected
5 at risk
EG0040 affected16 at risk
EG0050 affected26 at risk
EG0060 affected19 at risk
EG0071 affected69 at risk
EG0080 affected36 at risk
0 affected
5 at risk
EG0040 affected16 at risk
EG0050 affected26 at risk
EG0060 affected19 at risk
EG0070 affected69 at risk
EG0081 affected36 at risk
0 affected
5 at risk
EG0040 affected16 at risk
EG0050 affected26 at risk
EG0060 affected19 at risk
EG0071 affected69 at risk
EG0080 affected36 at risk
0 affected
5 at risk
EG0040 affected16 at risk
EG0052 affected26 at risk
EG0060 affected19 at risk
EG0071 affected69 at risk
EG0081 affected36 at risk
0 affected
5 at risk
EG0040 affected16 at risk
EG0051 affected26 at risk
EG0060 affected19 at risk
EG0071 affected69 at risk
EG0080 affected36 at risk
0 affected
5 at risk
EG0040 affected16 at risk
EG0050 affected26 at risk
EG0060 affected19 at risk
EG0072 affected69 at risk
EG0080 affected36 at risk
0 affected
5 at risk
EG0040 affected16 at risk
EG0051 affected26 at risk
EG0060 affected19 at risk
EG0070 affected69 at risk
EG0081 affected36 at risk
0 affected
5 at risk
EG0040 affected16 at risk
EG0050 affected26 at risk
EG0060 affected19 at risk
EG0071 affected69 at risk
EG0080 affected36 at risk
1 affected
5 at risk
EG0040 affected16 at risk
EG0050 affected26 at risk
EG0060 affected19 at risk
EG0070 affected69 at risk
EG0080 affected36 at risk
0 affected
5 at risk
EG0040 affected16 at risk
EG0050 affected26 at risk
EG0060 affected19 at risk
EG0071 affected69 at risk
EG0080 affected36 at risk
0 affected
5 at risk
EG0041 affected16 at risk
EG0050 affected26 at risk
EG0060 affected19 at risk
EG0070 affected69 at risk
EG0080 affected36 at risk
0 affected
5 at risk
EG0040 affected16 at risk
EG0050 affected26 at risk
EG0060 affected19 at risk
EG0071 affected69 at risk
EG0080 affected36 at risk
0 affected
5 at risk
EG0040 affected16 at risk
EG0050 affected26 at risk
EG0060 affected19 at risk
EG0071 affected69 at risk
EG0080 affected36 at risk
0 affected
5 at risk
EG0040 affected16 at risk
EG0051 affected26 at risk
EG0060 affected19 at risk
EG0070 affected69 at risk
EG0080 affected36 at risk
0 affected
5 at risk
EG0040 affected16 at risk
EG0050 affected26 at risk
EG0060 affected19 at risk
EG0071 affected69 at risk
EG0080 affected36 at risk
0 affected
5 at risk
EG0040 affected16 at risk
EG0050 affected26 at risk
EG0060 affected19 at risk
EG0070 affected69 at risk
EG0081 affected36 at risk
0 affected
5 at risk
EG0040 affected16 at risk
EG0050 affected26 at risk
EG0061 affected19 at risk
EG0070 affected69 at risk
EG0080 affected36 at risk
0 affected
5 at risk
EG0040 affected16 at risk
EG0052 affected26 at risk
EG0061 affected19 at risk
EG0078 affected69 at risk
EG0080 affected36 at risk
0 affected
5 at risk
EG0040 affected16 at risk
EG0054 affected26 at risk
EG0061 affected19 at risk
EG0072 affected69 at risk
EG0080 affected36 at risk
0 affected
5 at risk
EG0040 affected16 at risk
EG0051 affected26 at risk
EG0060 affected19 at risk
EG0070 affected69 at risk
EG0082 affected36 at risk
1 affected
5 at risk
EG0040 affected16 at risk
EG0050 affected26 at risk
EG0060 affected19 at risk
EG0071 affected69 at risk
EG0080 affected36 at risk
0 affected
5 at risk
EG0040 affected16 at risk
EG0050 affected26 at risk
EG0061 affected19 at risk
EG0071 affected69 at risk
EG0080 affected36 at risk
1 affected
5 at risk
EG0040 affected16 at risk
EG0050 affected26 at risk
EG0060 affected19 at risk
EG0070 affected69 at risk
EG0080 affected36 at risk
0 affected
5 at risk
EG0040 affected16 at risk
EG0050 affected26 at risk
EG0060 affected19 at risk
EG0070 affected69 at risk
EG0081 affected36 at risk
0 affected
5 at risk
EG0041 affected16 at risk
EG0050 affected26 at risk
EG0060 affected19 at risk
EG0070 affected69 at risk
EG0080 affected36 at risk
0 affected
5 at risk
EG0040 affected16 at risk
EG0050 affected26 at risk
EG0061 affected19 at risk
EG0070 affected69 at risk
EG0080 affected36 at risk
0 affected
5 at risk
EG0040 affected16 at risk
EG0050 affected26 at risk
EG0060 affected19 at risk
EG0071 affected69 at risk
EG0080 affected36 at risk
0 affected
5 at risk
EG0040 affected16 at risk
EG0051 affected26 at risk
EG0060 affected19 at risk
EG0074 affected69 at risk
EG0080 affected36 at risk
0 affected
5 at risk
EG0040 affected16 at risk
EG0051 affected26 at risk
EG0060 affected19 at risk
EG0072 affected69 at risk
EG0080 affected36 at risk
0 affected
5 at risk
EG0040 affected16 at risk
EG0050 affected26 at risk
EG0060 affected19 at risk
EG0072 affected69 at risk
EG0080 affected36 at risk
0 affected
5 at risk
EG0040 affected16 at risk
EG0051 affected26 at risk
EG0060 affected19 at risk
EG0070 affected69 at risk
EG0081 affected36 at risk
0 affected
5 at risk
EG0040 affected16 at risk
EG0050 affected26 at risk
EG0060 affected19 at risk
EG0070 affected69 at risk
EG0081 affected36 at risk
0 affected
5 at risk
EG0040 affected16 at risk
EG0050 affected26 at risk
EG0060 affected19 at risk
EG0071 affected69 at risk
EG0080 affected36 at risk
0 affected
5 at risk
EG0040 affected16 at risk
EG0050 affected26 at risk
EG0060 affected19 at risk
EG0071 affected69 at risk
EG0080 affected36 at risk
0 affected
5 at risk
EG0040 affected16 at risk
EG0050 affected26 at risk
EG0060 affected19 at risk
EG0071 affected69 at risk
EG0080 affected36 at risk
0 affected
5 at risk
EG0040 affected16 at risk
EG0050 affected26 at risk
EG0060 affected19 at risk
EG0071 affected69 at risk
EG0080 affected36 at risk
0 affected
5 at risk
EG0040 affected16 at risk
EG0050 affected26 at risk
EG0060 affected19 at risk
EG0071 affected69 at risk
EG0080 affected36 at risk
0 affected
5 at risk
EG0040 affected16 at risk
EG0050 affected26 at risk
EG0061 affected19 at risk
EG0070 affected69 at risk
EG0080 affected36 at risk
0 affected
5 at risk
EG0040 affected16 at risk
EG0050 affected26 at risk
EG0061 affected19 at risk
EG0070 affected69 at risk
EG0080 affected36 at risk
0 affected
5 at risk
EG0040 affected16 at risk
EG0050 affected26 at risk
EG0060 affected19 at risk
EG0071 affected69 at risk
EG0080 affected36 at risk
0 affected
5 at risk
EG0040 affected16 at risk
EG0051 affected26 at risk
EG0060 affected19 at risk
EG0070 affected69 at risk
EG0080 affected36 at risk
0 affected
5 at risk
EG0040 affected16 at risk
EG0050 affected26 at risk
EG0060 affected19 at risk
EG0071 affected69 at risk
EG0080 affected36 at risk
1 affected
5 at risk
EG0040 affected16 at risk
EG0050 affected26 at risk
EG0060 affected19 at risk
EG0070 affected69 at risk
EG0080 affected36 at risk
0 affected
5 at risk
EG0040 affected16 at risk
EG0050 affected26 at risk
EG0060 affected19 at risk
EG0070 affected69 at risk
EG0081 affected36 at risk
0 affected
5 at risk
EG0040 affected16 at risk
EG0050 affected26 at risk
EG0060 affected19 at risk
EG0071 affected69 at risk
EG0080 affected36 at risk
0 affected
5 at risk
EG0040 affected16 at risk
EG0051 affected26 at risk
EG0060 affected19 at risk
EG0070 affected69 at risk
EG0080 affected36 at risk
0 affected
5 at risk
EG0040 affected16 at risk
EG0050 affected26 at risk
EG0060 affected19 at risk
EG0071 affected69 at risk
EG0080 affected36 at risk
0 affected
5 at risk
EG0040 affected16 at risk
EG0050 affected26 at risk
EG0060 affected19 at risk
EG0071 affected69 at risk
EG0080 affected36 at risk
0 affected
5 at risk
EG0040 affected16 at risk
EG0050 affected26 at risk
EG0060 affected19 at risk
EG0071 affected69 at risk
EG0080 affected36 at risk
0 affected
5 at risk
EG0040 affected16 at risk
EG0050 affected26 at risk
EG0060 affected19 at risk
EG0071 affected69 at risk
EG0080 affected36 at risk
0 affected
5 at risk
EG0040 affected16 at risk
EG0050 affected26 at risk
EG0061 affected19 at risk
EG0070 affected69 at risk
EG0080 affected36 at risk
0 affected
5 at risk
EG0040 affected16 at risk
EG0050 affected26 at risk
EG0060 affected19 at risk
EG0070 affected69 at risk
EG0081 affected36 at risk
0 affected
5 at risk
EG0040 affected16 at risk
EG0050 affected26 at risk
EG0060 affected19 at risk
EG0070 affected69 at risk
EG0081 affected36 at risk
1 affected
5 at risk
EG0040 affected16 at risk
EG0050 affected26 at risk
EG0060 affected19 at risk
EG0070 affected69 at risk
EG0080 affected36 at risk
0 affected
5 at risk
EG0040 affected16 at risk
EG0050 affected26 at risk
EG0061 affected19 at risk
EG0070 affected69 at risk
EG0080 affected36 at risk
0 affected
5 at risk
EG0040 affected16 at risk
EG0050 affected26 at risk
EG0060 affected19 at risk
EG0071 affected69 at risk
EG0081 affected36 at risk
0 affected
5 at risk
EG0040 affected16 at risk
EG0050 affected26 at risk
EG0060 affected19 at risk
EG0071 affected69 at risk
EG0080 affected36 at risk
0 affected
5 at risk
EG0040 affected16 at risk
EG0050 affected26 at risk
EG0060 affected19 at risk
EG0071 affected69 at risk
EG0080 affected36 at risk
0 affected
5 at risk
EG0040 affected16 at risk
EG0050 affected26 at risk
EG0061 affected19 at risk
EG0070 affected69 at risk
EG0080 affected36 at risk
0 affected
5 at risk
EG0040 affected16 at risk
EG0050 affected26 at risk
EG0061 affected19 at risk
EG0071 affected69 at risk
EG0080 affected36 at risk
0 affected
5 at risk
EG0040 affected16 at risk
EG0050 affected26 at risk
EG0060 affected19 at risk
EG0071 affected69 at risk
EG0080 affected36 at risk
0 affected
5 at risk
EG0040 affected16 at risk
EG0050 affected26 at risk
EG0060 affected19 at risk
EG0070 affected69 at risk
EG0081 affected36 at risk
0 affected
5 at risk
EG0041 affected16 at risk
EG0052 affected26 at risk
EG0060 affected19 at risk
EG0072 affected69 at risk
EG0080 affected36 at risk
0 affected
5 at risk
EG0040 affected16 at risk
EG0050 affected26 at risk
EG0060 affected19 at risk
EG0071 affected69 at risk
EG0081 affected36 at risk
0 affected
5 at risk
EG0040 affected16 at risk
EG0050 affected26 at risk
EG0060 affected19 at risk
EG0071 affected69 at risk
EG0080 affected36 at risk
0 affected
5 at risk
EG0040 affected16 at risk
EG0050 affected26 at risk
EG0060 affected19 at risk
EG0070 affected69 at risk
EG0081 affected36 at risk
0 affected
5 at risk
EG0040 affected16 at risk
EG0050 affected26 at risk
EG0060 affected19 at risk
EG0071 affected69 at risk
EG0080 affected36 at risk
0 affected
5 at risk
EG0040 affected16 at risk
EG0051 affected26 at risk
EG0060 affected19 at risk
EG0070 affected69 at risk
EG0080 affected36 at risk
0 affected
5 at risk
EG0040 affected16 at risk
EG0051 affected26 at risk
EG0060 affected19 at risk
EG0070 affected69 at risk
EG0080 affected36 at risk
0 affected
5 at risk
EG0040 affected16 at risk
EG0050 affected26 at risk
EG0060 affected19 at risk
EG0071 affected69 at risk
EG0080 affected36 at risk
0 affected
5 at risk
EG0041 affected16 at risk
EG0050 affected26 at risk
EG0060 affected19 at risk
EG0070 affected69 at risk
EG0080 affected36 at risk
0 affected
5 at risk
EG0040 affected16 at risk
EG0050 affected26 at risk
EG0060 affected19 at risk
EG0071 affected69 at risk
EG0080 affected36 at risk
0 affected
5 at risk
EG0040 affected16 at risk
EG0050 affected26 at risk
EG0060 affected19 at risk
EG0070 affected69 at risk
EG0081 affected36 at risk
1 affected
5 at risk
EG0040 affected16 at risk
EG0050 affected26 at risk
EG0060 affected19 at risk
EG0070 affected69 at risk
EG0080 affected36 at risk
0 affected
5 at risk
EG0040 affected16 at risk
EG0050 affected26 at risk
EG0061 affected19 at risk
EG0071 affected69 at risk
EG0081 affected36 at risk
0 affected
5 at risk
EG0040 affected16 at risk
EG0050 affected26 at risk
EG0060 affected19 at risk
EG0071 affected69 at risk
EG0080 affected36 at risk
0 affected
5 at risk
EG0041 affected16 at risk
EG0050 affected26 at risk
EG0060 affected19 at risk
EG0070 affected69 at risk
EG0080 affected36 at risk
0 affected
5 at risk
EG0040 affected16 at risk
EG0050 affected26 at risk
EG0061 affected19 at risk
EG0070 affected69 at risk
EG0080 affected36 at risk
0 affected
5 at risk
EG0040 affected16 at risk
EG0050 affected26 at risk
EG0060 affected19 at risk
EG0070 affected69 at risk
EG0081 affected36 at risk
0 affected
5 at risk
EG0040 affected16 at risk
EG0050 affected26 at risk
EG0060 affected19 at risk
EG0070 affected69 at risk
EG0081 affected36 at risk
0 affected
5 at risk
EG0040 affected16 at risk
EG0052 affected26 at risk
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EG0072 affected69 at risk
EG0083 affected36 at risk
0 affected
5 at risk
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5 at risk
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5 at risk
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5 at risk
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5 at risk
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2 affected
5 at risk
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5 at risk
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5 at risk
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5 at risk
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5 at risk
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5 at risk
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EG0050 affected26 at risk
EG0060 affected19 at risk
EG0070 affected69 at risk
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5 at risk
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EG0051 affected26 at risk
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5 at risk
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EG0060 affected19 at risk
EG0075 affected69 at risk
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1 affected
5 at risk
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1 affected
5 at risk
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1 affected
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4 affected
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3 affected
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2 affected
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2 affected
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1 affected
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EG0065 affected19 at risk
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EG0072 affected69 at risk
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1 affected
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1 affected
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1 affected
5 at risk
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1 affected
5 at risk
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1 affected
5 at risk
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EG0077 affected69 at risk
EG0085 affected36 at risk
0 affected
5 at risk
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5 at risk
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1 affected
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5 at risk
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1 affected
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1 affected
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5 at risk
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1 affected
5 at risk
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1 affected
5 at risk
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EG0051 affected26 at risk
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EG0073 affected69 at risk
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5 at risk
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5 at risk
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1 affected
5 at risk
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5 at risk
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5 at risk
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1 affected
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5 at risk
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5 at risk
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EG0084 affected36 at risk
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5 at risk
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EG0071 affected69 at risk
EG0083 affected36 at risk
1 affected
5 at risk
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EG0050 affected26 at risk
EG0060 affected19 at risk
EG0070 affected69 at risk
EG0080 affected36 at risk
1 affected
5 at risk
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EG0057 affected26 at risk
EG0064 affected19 at risk
EG00715 affected69 at risk
EG0087 affected36 at risk
2 affected
5 at risk
EG0044 affected16 at risk
EG0054 affected26 at risk
EG0063 affected19 at risk
EG00715 affected69 at risk
EG0088 affected36 at risk
0 affected
5 at risk
EG0043 affected16 at risk
EG0057 affected26 at risk
EG0062 affected19 at risk
EG00714 affected69 at risk
EG0088 affected36 at risk
0 affected
5 at risk
EG0041 affected16 at risk
EG0052 affected26 at risk
EG0061 affected19 at risk
EG0072 affected69 at risk
EG0083 affected36 at risk
0 affected
5 at risk
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EG0051 affected26 at risk
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EG0073 affected69 at risk
EG0081 affected36 at risk
0 affected
5 at risk
EG0041 affected16 at risk
EG0052 affected26 at risk
EG0062 affected19 at risk
EG0071 affected69 at risk
EG0080 affected36 at risk
1 affected
5 at risk
EG0040 affected16 at risk
EG0050 affected26 at risk
EG0060 affected19 at risk
EG0070 affected69 at risk
EG0080 affected36 at risk
1 affected
5 at risk
EG0040 affected16 at risk
EG0050 affected26 at risk
EG0060 affected19 at risk
EG0070 affected69 at risk
EG0080 affected36 at risk
1 affected
5 at risk
EG0040 affected16 at risk
EG0050 affected26 at risk
EG0060 affected19 at risk
EG0070 affected69 at risk
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1 affected
5 at risk
EG0040 affected16 at risk
EG0050 affected26 at risk
EG0060 affected19 at risk
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EG0080 affected36 at risk
1 affected
5 at risk
EG0043 affected16 at risk
EG0054 affected26 at risk
EG0068 affected19 at risk
EG00719 affected69 at risk
EG0089 affected36 at risk
1 affected
5 at risk
EG0042 affected16 at risk
EG0053 affected26 at risk
EG0062 affected19 at risk
EG0079 affected69 at risk
EG0084 affected36 at risk
0 affected
5 at risk
EG0042 affected16 at risk
EG0052 affected26 at risk
EG0062 affected19 at risk
EG0075 affected69 at risk
EG0087 affected36 at risk
0 affected
5 at risk
EG0043 affected16 at risk
EG0051 affected26 at risk
EG0062 affected19 at risk
EG0075 affected69 at risk
EG0085 affected36 at risk
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5 at risk
EG0043 affected16 at risk
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EG0062 affected19 at risk
EG0073 affected69 at risk
EG0084 affected36 at risk
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5 at risk
EG0043 affected16 at risk
EG0051 affected26 at risk
EG0061 affected19 at risk
EG0072 affected69 at risk
EG0083 affected36 at risk
1 affected
5 at risk
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EG0052 affected26 at risk
EG0060 affected19 at risk
EG0071 affected69 at risk
EG0082 affected36 at risk
0 affected
5 at risk
EG0040 affected16 at risk
EG0051 affected26 at risk
EG0062 affected19 at risk
EG0071 affected69 at risk
EG0084 affected36 at risk
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5 at risk
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EG0051 affected26 at risk
EG0062 affected19 at risk
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EG0083 affected36 at risk
1 affected
5 at risk
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EG0061 affected19 at risk
EG0072 affected69 at risk
EG0081 affected36 at risk
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5 at risk
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EG0060 affected19 at risk
EG0071 affected69 at risk
EG0082 affected36 at risk
1 affected
5 at risk
EG0040 affected16 at risk
EG0050 affected26 at risk
EG0060 affected19 at risk
EG0070 affected69 at risk
EG0081 affected36 at risk
1 affected
5 at risk
EG0040 affected16 at risk
EG0051 affected26 at risk
EG0060 affected19 at risk
EG0070 affected69 at risk
EG0080 affected36 at risk
1 affected
5 at risk
EG0040 affected16 at risk
EG0050 affected26 at risk
EG0061 affected19 at risk
EG0070 affected69 at risk
EG0080 affected36 at risk
0 affected
5 at risk
EG0040 affected16 at risk
EG0050 affected26 at risk
EG0060 affected19 at risk
EG0071 affected69 at risk
EG0080 affected36 at risk
0 affected
5 at risk
EG0040 affected16 at risk
EG0050 affected26 at risk
EG0060 affected19 at risk
EG0070 affected69 at risk
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1 affected
5 at risk
EG0040 affected16 at risk
EG0050 affected26 at risk
EG0060 affected19 at risk
EG0070 affected69 at risk
EG0080 affected36 at risk
0 affected
5 at risk
EG0042 affected16 at risk
EG0053 affected26 at risk
EG0060 affected19 at risk
EG0074 affected69 at risk
EG0084 affected36 at risk
0 affected
5 at risk
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EG0053 affected26 at risk
EG0061 affected19 at risk
EG0073 affected69 at risk
EG0084 affected36 at risk
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5 at risk
EG0040 affected16 at risk
EG0053 affected26 at risk
EG0061 affected19 at risk
EG0073 affected69 at risk
EG0080 affected36 at risk
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5 at risk
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EG0060 affected19 at risk
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5 at risk
EG0040 affected16 at risk
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EG0060 affected19 at risk
EG0070 affected69 at risk
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3
BG00514
BG00613
BG00743
BG00819
BG00999
13
BG00512
BG0066
BG00726
BG00817
BG00984
13
BG00519
BG00613
BG00735
BG00826
BG009114
16
BG00525
BG00618
BG00765
BG00835
BG009176
0
BG0050
BG0060
BG0071
BG0080
BG0091
1
BG0054
BG0060
BG0075
BG0080
BG00911
1
BG0052
BG0060
BG0070
BG0080
BG0093
0
BG0050
BG0060
BG0070
BG0080
BG0090
0
BG0050
BG0060
BG0070
BG0080
BG0090
0
BG0051
BG0060
BG0071
BG0081
BG0093
0
BG0050
BG0060
BG0072
BG0080
BG0092
8
BG00519
BG00612
BG00736
BG00821
BG009106
1
BG0050
BG0062
BG00712
BG0083
BG00921
0
BG0050
BG0061
BG0071
BG0080
BG0092
0
BG0050
BG0060
BG0070
BG0080
BG0090
0
BG0050
BG0060
BG0070
BG0080
BG0090
1088
± 748
OG0042374± 1040
OG0053416± 3093
OG0063619± 688
OG0073798± 1332
ParticipantsOG00440
ParticipantsOG00572
ParticipantsOG00611
ParticipantsOG00712
Title
Measurements
OG000398± 284
OG0011971± 2566
OG002864± 686
OG0031416± 799
OG0042573± 655
OG0053776± 2738
OG0064293± 1021
OG0073178± 1733
ParticipantsOG00441
ParticipantsOG00588
ParticipantsOG00614
ParticipantsOG00722
Title
Measurements
OG000298± 83.7
OG001542± 192
OG002856± 475
OG0031560± 1102
OG0042829± 1257
OG0054383± 4460
OG0064185± 1308
OG0074543± 1805
ParticipantsOG00439
ParticipantsOG00572
ParticipantsOG00611
ParticipantsOG00712
Title
Measurements
OG000447± 283
OG0012906± 4034
OG0021275± 1025
OG0032422± 983
OG0043142± 888
OG0054798± 3334
OG0065059± 1027
OG0073834± 1913
Participants
OG004
4
ParticipantsOG00528
ParticipantsOG0064
ParticipantsOG00716
Title
Measurements
OG0030.102± NAStandard deviation could not be determined as only one participant had evaluable data.
OG0040.0372± 0.0208
OG0050.0570± 0.0454
OG0060.0479± 0.0381
OG0070.0468± 0.0333
Participants
OG004
4
ParticipantsOG00515
ParticipantsOG0063
ParticipantsOG0074
Title
Measurements
OG0030.0704± 0.0152
OG0040.0403± 0.0116
OG0050.0485± 0.0449
OG0060.0293± 0.00329
OG0070.0516± 0.0325
0.0500
(0.0417 to 0.0875)
OG0040.0833(0.0403 to 0.296)
OG0050.0840(0.0417 to 0.305)
OG0060.0858(0.0417 to 0.285)
OG0070.0840(0.0417 to 0.276)
ParticipantsOG00440
ParticipantsOG00572
ParticipantsOG00611
ParticipantsOG00712
Title
Measurements
OG0000.122(0.0660 to 0.170)
OG0010.0618(0.0417 to 0.0875)
OG0020.0417(0.0222 to 0.165)
OG0030.0833(0.0229 to 0.0882)
OG0040.0830(0.0208 to 0.278)
OG0050.0642(0.0208 to 1.00)
OG0060.0854(0.0208 to 1.00)
OG0070.0826(0.0257 to 0.172)
ParticipantsOG00441
ParticipantsOG00588
ParticipantsOG00614
ParticipantsOG00722
Title
Measurements
OG0000.0844(0.0438 to 0.292)
OG0010.0833(0.0431 to 0.0896)
OG0020.0833(0.0806 to 0.0847)
OG0030.0500(0.0417 to 0.169)
OG0040.0833(0.0403 to 0.294)
OG0050.0837(0.0403 to 0.299)
OG0060.0840(0.0417 to 0.285)
OG0070.0837(0.0417 to 0.271)
ParticipantsOG00439
ParticipantsOG00572
ParticipantsOG00611
ParticipantsOG00712
Title
Measurements
OG0000.0649(0.0431 to 0.0868)
OG0010.0618(0.0417 to 0.0875)
OG0020.0417(0.0222 to 0.0854)
OG0030.0833(0.0229 to 0.159)
OG0040.0632(0.0208 to 0.275)
OG0050.0639(0 to 2.11)
OG0060.132(0.0208 to 4.00)
OG0070.0858(0.0257 to 0.172)
Participants
OG004
4
ParticipantsOG00528
ParticipantsOG0064
ParticipantsOG00716
Title
Measurements
OG0030.0833(0.0833 to 0.0833)
OG0040.0854(0.0458 to 0.172)
OG0050.0844(0.0417 to 0.294)
OG0060.128(0.0833 to 0.285)
OG0070.165(0.0417 to 6.81)
Participants
OG004
4
ParticipantsOG00515
ParticipantsOG0063
ParticipantsOG0074
Title
Measurements
OG0031.05(0.0417 to 2.06)
OG0040.120(0.0840 to 0.153)
OG0050.0632(0.0222 to 13.8)
OG0060.165(0.0299 to 0.992)
OG0070.162(0.0833 to 0.280)
6587
± 6842
OG00413544± 7503
OG00514258± 8248
OG00630571± 12425
OG00730386± 16960
ParticipantsOG00440
ParticipantsOG00572
ParticipantsOG00611
ParticipantsOG00712
Title
Measurements
OG0001933± 2289
OG0012955± 1132
OG0025573± 4827
OG00310369± 11656
OG00418707± 10505
OG00523109± 15370
OG00648183± 20288
OG00739609± 24852
ParticipantsOG00441
ParticipantsOG00588
ParticipantsOG00614
ParticipantsOG00722
Title
Measurements
OG0001185± 1540
OG0013194± 1136
OG0025032± 4334
OG0038869± 9108
OG00415980± 7649
OG00516973± 9745
OG00633834± 14888
OG00736099± 20829
ParticipantsOG00439
ParticipantsOG00572
ParticipantsOG00611
ParticipantsOG00712
Title
Measurements
OG0001924± 2576
OG0013986± 1725
OG0027958± 6882
OG00314025± 15704
OG00423428± 13513
OG00528657± 19457
OG00657450± 26899
OG00749892± 31012
Participants
OG004
4
ParticipantsOG00528
ParticipantsOG0064
ParticipantsOG00716
Title
Measurements
OG0030.00213± NAStandard deviation could not be determined as only one participant had evaluable data.
OG0040.00462± 0.00671
OG0050.0222± 0.0423
OG0060.0174± 0.0303
OG0070.0436± 0.0959
Participants
OG004
4
ParticipantsOG00515
ParticipantsOG0063
ParticipantsOG0074
Title
Measurements
OG0030.0242± 0.0234
OG0040.154± 0.286
OG0050.0108± 0.0248
OG0060.00425± 0.00461
OG0070.00332± 0.00215
ParticipantsOG00440
ParticipantsOG00572
ParticipantsOG00611
ParticipantsOG00712
Title
Measurements
OG0002285± 2928
OG0013458± 1426
OG00210575± 1121
OG00310171± 11244
OG00419890± 8968
OG00522859± 12080
OG00639362± 9800
OG00738466± 23514
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG00439
ParticipantsOG00572
ParticipantsOG00611
ParticipantsOG00712
Title
Measurements
OG0002636± 3387
OG0014662± 2096
OG00210211± 8827
OG00317141± 15029
OG00424247± 10902
OG00528041± 15312
OG00646469± 12675
OG00748524± 28858
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
5622
± 7170
OG00410232± 6220
OG00511498± 8175
OG00629174± 25838
OG00732629± 19488
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG00412
ParticipantsOG00537
ParticipantsOG0062
ParticipantsOG00712
Title
Measurements
OG000869± NAStandard deviation could not be determined as only one participant had evaluable data.
OG00316409± NAStandard deviation could not be determined as only one participant had evaluable data.
OG00413292± 8495
OG00512692± 8968
OG00638991± 53597
OG00743952± 24032
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
Participants
OG004
0
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0070
Title
Measurements
OG0050.154± NAStandard deviation could not be determined as only one participant had evaluable data.
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
3.97
(0.923 to 7.01)
OG0046.33(0.515 to 9.50)
OG0056.43(0.146 to 13.1)
OG0067.96(6.43 to 16.6)
OG00710.4(0.0560 to 19.6)
ParticipantsOG00438
ParticipantsOG00569
ParticipantsOG00611
ParticipantsOG00712
Title
Measurements
OG0003.98(0.909 to 11.1)
OG00110.1(6.72 to 17.1)
OG00216.3(11.1 to 21.4)
OG00311.4(1.78 to 19.2)
OG00412.5(1.74 to 28.7)
OG00511.6(1.50 to 33.0)
OG00616.3(8.14 to 28.8)
OG00715.5(4.82 to 25.0)
ParticipantsOG00412
ParticipantsOG00537
ParticipantsOG0062
ParticipantsOG00712
Title
Measurements
OG0002.75(2.75 to 2.75)
OG0038.82(8.82 to 8.82)
OG0047.00(0.325 to 10.6)
OG0056.58(0.0759 to 17.7)
OG0069.39(0.661 to 18.1)
OG00712.7(0.248 to 19.0)
ParticipantsOG00434
ParticipantsOG00566
ParticipantsOG00610
ParticipantsOG00712
Title
Measurements
OG0003.71(0.860 to 13.0)
OG0019.58(7.11 to 15.4)
OG00216.5(12.9 to 20.0)
OG00313.4(1.27 to 38.5)
OG00414.9(2.07 to 33.5)
OG00514.3(0.269 to 36.0)
OG00614.7(8.47 to 27.8)
OG00718.4(6.18 to 39.9)
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
7.13
± 8.91
OG0042.09± 4.07
OG0053.84± 8.53
OG0063.11± 5.30
OG00712.6± 39.4
ParticipantsOG00440
ParticipantsOG00572
ParticipantsOG00611
ParticipantsOG00712
Title
Measurements
OG0001.78± 1.80
OG0010.646± 0.348
OG0020.415± 0.205
OG00319.6± 40.6
OG00417.8± 109
OG0050.986± 2.48
OG0060.407± 0.143
OG0070.349± 0.210
ParticipantsOG00412
ParticipantsOG00537
ParticipantsOG0062
ParticipantsOG00712
Title
Measurements
OG0001.28± NAStandard deviation could not be determined as only one participant had evaluable data.
OG0030.640± NAStandard deviation could not be determined as only one participant had evaluable data.
OG0042.47± 5.00
OG0053.87± 8.95
OG0067.12± 9.62
OG0072.02± 5.11
ParticipantsOG00439
ParticipantsOG00572
ParticipantsOG00611
ParticipantsOG00712
Title
Measurements
OG0001.76± 1.71
OG0010.577± 0.309
OG00238.1± 65.5
OG0031.42± 2.06
OG0040.581± 0.660
OG0051.05± 2.91
OG0060.417± 0.161
OG0070.323± 0.187
Participants
OG004
0
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0070
Title
Measurements
OG005627± NAStandard deviation could not be determined as only one participant had evaluable data.
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
9.68
± 2.68
OG0045.95± 1.86
OG0057.59± 6.18
OG00611.5± 11.1
OG0077.18± 2.52
ParticipantsOG00438
ParticipantsOG00569
ParticipantsOG00611
ParticipantsOG00712
Title
Measurements
OG0003.82± 1.25
OG00110.1± 8.57
OG0028.29± 0.540
OG0037.62± 1.09
OG0046.71± 3.13
OG0057.48± 4.29
OG0069.18± 3.43
OG0076.21± 1.70
ParticipantsOG00412
ParticipantsOG00537
ParticipantsOG0062
ParticipantsOG00712
Title
Measurements
OG0004.71± NAStandard deviation could not be determined as only one participant had evaluable data.
OG0037.84± NAStandard deviation could not be determined as only one participant had evaluable data.
OG0045.51± 1.29
OG0056.60± 3.16
OG0067.91± 0.0252
OG0077.20± 2.03
ParticipantsOG00434
ParticipantsOG00566
ParticipantsOG00610
ParticipantsOG00712
Title
Measurements
OG0003.83± 0.854
OG0019.62± 8.54
OG0027.30± 1.38
OG0038.52± 1.34
OG0048.11± 4.57
OG0058.21± 3.64
OG0069.46± 5.26
OG0076.86± 2.27
Participants
OG004
0
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0070
Title
Measurements
OG005335± NAStandard deviation could not be determined as only one participant had evaluable data.