CAT-8015 in Children, Adolescents and Young Adults With A... | NCT00659425 | Trialant
NCT00659425
Sponsor
MedImmune LLC
Status
Completed
Last Update Posted
Oct 2, 2017Actual
Enrollment
57Actual
Phase
Phase 1
Conditions
Acute Lymphoblastic Leukemia
Non-Hodgkin's Lymphoma
Interventions
CAT-8015 (Moxetumomab Pasudotox)
CAT-8015 (Moxetumomab Pasudotox)
CAT-8015 (Moxetumomab Pasudotox)
CAT-8015 (Moxetumomab Pasudotox)
CAT-8015 (Moxetumomab Pasudotox)
CAT-8015 (Moxetumomab Pasudotox)
CAT-8015 (Moxetumomab Pasudotox)
CAT-8015 (Moxetumomab Pasudotox)
CAT-8015 (Moxetumomab Pasudotox)
CAT-8015 (Moxetumomab Pasudotox)
Countries
United States
Canada
Protocol Section
Identification Module
NCT ID
NCT00659425
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CAT-8015-1004
Secondary IDs
Not provided
Brief Title
CAT-8015 in Children, Adolescents and Young Adults With Acute Lymphoblastic Leukemia or Non-Hodgkin's Lymphoma
Official Title
A Phase 1, Multicenter, Dose Escalation Study of CAT-8015 in Children, Adolescents and Young Adults With Refractory CD22+ Acute Lymphoblastic Leukemia (ALL) or Non-Hodgkin Lymphoma (NHL)
Acronym
Not provided
Organization
MedImmune LLCINDUSTRY
Status Module
Record Verification Date
Aug 2017
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
Sep 2008
Primary Completion Date
Dec 2014Actual
Completion Date
Dec 2014Actual
First Submitted Date
Apr 10, 2008
First Submission Date that Met QC Criteria
Apr 11, 2008
First Posted Date
Apr 16, 2008Estimated
Results Waived
Not provided
Results First Submitted Date
Feb 24, 2017
Results First Submitted that Met QC Criteria
Aug 28, 2017
Results First Posted Date
Oct 2, 2017Actual
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
Aug 28, 2017
Last Update Posted Date
Oct 2, 2017Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
MedImmune LLCINDUSTRY
Collaborators
Name
Class
National Cancer Institute (NCI)
NIH
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
A dose-escalation study to estimate maximum cummulative dose (MTCD) of CAT-8015 that can be safely administered to a participant.
Detailed Description
A Phase 1, Multicenter, Dose Escalation Study of CAT-8015 in Children, Adolescents and Young Adults with Refractory CD22+ Acute Lymphoblastic Leukemia (ALL) or Non-Hodgkin Lymphoma (NHL) to estimate the maximum tolerated cummulative dose (MTCD), defined as the highest dose and number of doses that can be safely administered to a participant, and to establish a safe dose, based on the MTCD, for subsequent clinical testing.
Conditions Module
Conditions
Acute Lymphoblastic Leukemia
Non-Hodgkin's Lymphoma
Keywords
Moxetumomab pasudotox
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
57Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
5 microgram per kilogram (mcg/kg)
Experimental
Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
Drug: CAT-8015 (Moxetumomab Pasudotox)
10 microgram per kilogram (mcg/kg)
Experimental
Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
Drug: CAT-8015 (Moxetumomab Pasudotox)
20 microgram per kilogram (mcg/kg): Schema A
Experimental
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
Drug: CAT-8015 (Moxetumomab Pasudotox)
20 microgram per kilogram (mcg/kg): Schema B
Experimental
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
Drug: CAT-8015 (Moxetumomab Pasudotox)
30 microgram per kilogram (mcg/kg): Schema A
Interventions
Name
Type
Description
Arm Group Labels
Other Names
CAT-8015 (Moxetumomab Pasudotox)
Drug
Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Dose Limiting Toxicities (DLTs)
Adverse events that were suspected of a relationship to moxetumomab pasudotox and were greater than or equal to (>=) Grade 3 in severity were considered DLTs with the following additional criteria or exceptions: Participants with hematologic abnormalities of any grade, Grade 2 allergic reactions of bronchospasm or urticaria, or any Grade ≥ 3 allergic reaction, in the presence of premedication.
Day 1 up to 21 days of Cycle 1 (each cycle duration was of 21 days)
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received investigational product. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of investigational product and 30 days after the last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state.
From start of study drug administration until 30 days after the last dose of study drug
Number of Participants With Vital Signs Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)
Vital signs included parameters as heart rate, blood pressure, temperature, weight, pulse oximetry and respiratory rate. TEAEs were events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug, for the period extending to 30 days after the last dose of study drug.
From start of study drug administration until 30 days after the last dose of study drug
Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)
Secondary Outcomes
Measure
Description
Time Frame
Number of Participants With Positive Anti-Drug Antibody (ADA) and Neutralizing Antibody
Participants tested for immunogenicity to CAT-8015 (moxetumomab pasudotox) prior to enrollment, before each cycle and at end of study. The neutralization assay measures the capacity of participant's plasma (antibodies) to inhibit the binding of moxetumomab pasudotox to its target, cluster of differentiation 22 (CD22), coated onto enzyme linked immunosorbent assay (ELISA) plates. It was used as a direct surrogate for biological activity based on the mechanism of action of this drug. Significant level of neutralizing antibody activity defined as the capacity of test plasma to inhibit greater than (>)50 percentage (%) of the binding of CAT-8015 to CD22 using an ELISA-based method.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed diagnosis of acute lymphoblastic leukemia (ALL) or non-Hodgkin's lymphoma (NHL) including lymphoblastic lymphoma, Burkitt's lymphoma, and large cell lymphoma; - Measurable or evaluable disease. - Evidence of CD22-positive malignancy by one of the following criteria: - greater than or equal to (>=) 30 % of malignant cells from a disease site cluster of differentiation 22+ (CD22+) by fluorescence-activated cell sorter (FACS) analysis or; ≥ 15 % of malignant cells from a disease site CD22+ by immunohistochemistry (IHC). Stage of disease: - Participants must have relapsed or refractory disease and have received at least one standard chemotherapy and one salvage regimen or allogeneic stem cell transplant; - Relapse after prior autologous or allogeneic HSCT is allowed. In the event of relapse after prior allogeneic HSCT, the participant must be at least 100 days post-transplant and have no evidence of ongoing active graft-vs-host disease; - Recovered from the acute toxic effects of all prior therapy before entry. Performance status: - Participants greater than or equal to (>=) 12 years of age: Eastern Cooperative Oncology Group (ECOG) score of 0, 1, 2, or 3; - Participants < 12 years of age: Lansky scale >= 50%; - Participants who are unable to walk because of paralysis, but who are up in a wheel chair will be considered ambulatory for the purpose of calculating the performance score. Participants with the following central nervous system (CNS) status, are eligible only in the absence of neurologic symptoms suggestive of CNS leukemia, such as cranial nerve palsy. - Female and male participants with childbearing potential and their sexual partners must agree to use an approved method of contraception during the study.
Exclusion Criteria:
- Participants meeting any of the following criteria are not eligible for participation in the study: - Isolated testicular or CNS ALL; Hepatic function: - Inadequate liver function defined as total bilirubin > 2 × upper limit of normal (ULN) (except in the case of participants with documented Gilbert's disease > 5 × ULN) or transaminases (ALT and aspartate aminotransferase [AST]) > 5 × ULN based on age- and laboratory-specific normal ranges; Renal function: - With greater than age-adjusted normal serum creatinine (see Table below) and a creatinine clearance > 60 millilitre per minute mL/min/1.73 m2. - Age(Years)- Maximum Serum Creatinine (mg/dl)[≤5,0.8] [5 < age less than or equal to 10,1.0] [10 < age less than or equal to 15,1.2 [> 15, 1.5] Hematologic function: - For non-leukemic subjects only, absolute neutrophil count (ANC) < 1000/cmm, or platelet count < 50,000/cmm, if these cytopenias are not judged by the investigator to be due to underlying disease (ie potentially reversible with anti-neoplastic therapy); - Participants with CNS 3 disease; - Hyperleukocytosis (≥ 50,000 blasts/µL) or rapidly progressive disease (PD) that in the estimation of the investigator and sponsor would compromise ability to complete study therapy; - Prior treatment with CAT-3888 (BL22) or any pseudomonas-exotoxin-containing compound; - HIV positive serology (due to increased risk of severe infection and unknown interaction of CAT-8015 with antiretroviral drugs); - Active hepatitis B or C infection.](streamdown:incomplete-link)
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
6 Months
Maximum Age
25 Years
Standard Ages
ChildAdult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Medimmune LLC Medimmune LLC
MedImmune LLC
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Research Site
Los Angeles
California
United States
Research Site
References Module
Citations
PubMed Identifier
Type
Citation
Retractions
Result
Wayne AS, Shah NN, Bhojwani D, Silverman LB, Whitlock JA, Stetler-Stevenson M, et al. Pediatric phase 1 trial of moxetumomab pasudotox: activity in chemotherapy refractory acute lymphoblastic leukemia (ALL) . http://cancerres.aacrjournals.org/content/74/19_Supplement/CT230.short
Wayne AS, Shah NN, Bhojwani D, Silverman LB, Whitlock JA, Stetler-Stevenson M, Sun W, Liang M, Yang J, Kreitman RJ, Lanasa MC, Pastan I. Phase 1 study of the anti-CD22 immunotoxin moxetumomab pasudotox for childhood acute lymphoblastic leukemia. Blood. 2017 Oct 5;130(14):1620-1627. doi: 10.1182/blood-2017-02-749101. Epub 2017 Aug 9.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
A total of 57 participants were enrolled of which 55 participants received treatment.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
5 Microgram Per Kilogram (mcg/kg)
Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
FG001
10 Microgram Per Kilogram (mcg/kg)
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
No data available
No data is available for this block.
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
N/A
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
Experimental
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
Drug: CAT-8015 (Moxetumomab Pasudotox)
30 microgram per kilogram (mcg/kg): Schema B
Experimental
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
Drug: CAT-8015 (Moxetumomab Pasudotox)
40 microgram per kilogram (mcg/kg): Schema B
Experimental
Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
Drug: CAT-8015 (Moxetumomab Pasudotox)
32 microgram per kilogram (mcg/kg): Schema C
Experimental
Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
Drug: CAT-8015 (Moxetumomab Pasudotox)
50 microgram per kilogram (mcg/kg): Schema B
Experimental
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
Drug: CAT-8015 (Moxetumomab Pasudotox)
50 microgram per kilogram (mcg/kg): Schema C
Experimental
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
Drug: CAT-8015 (Moxetumomab Pasudotox)
5 microgram per kilogram (mcg/kg)
CAT-8015 (Moxetumomab Pasudotox)
Drug
Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
10 microgram per kilogram (mcg/kg)
CAT-8015 (Moxetumomab Pasudotox)
Drug
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
20 microgram per kilogram (mcg/kg): Schema A
CAT-8015 (Moxetumomab Pasudotox)
Drug
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
20 microgram per kilogram (mcg/kg): Schema B
CAT-8015 (Moxetumomab Pasudotox)
Drug
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
30 microgram per kilogram (mcg/kg): Schema A
CAT-8015 (Moxetumomab Pasudotox)
Drug
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
30 microgram per kilogram (mcg/kg): Schema B
CAT-8015 (Moxetumomab Pasudotox)
Drug
Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
40 microgram per kilogram (mcg/kg): Schema B
CAT-8015 (Moxetumomab Pasudotox)
Drug
Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
32 microgram per kilogram (mcg/kg): Schema C
CAT-8015 (Moxetumomab Pasudotox)
Drug
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
50 microgram per kilogram (mcg/kg): Schema B
CAT-8015 (Moxetumomab Pasudotox)
Drug
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
50 microgram per kilogram (mcg/kg): Schema C
An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as an adverse event. Treatment-emergent were events between first dose of study drug and 30 days after the last dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with grade 3 or higher treatment-emergent adverse events (5% cut off) for laboratory abnormalities were reported as clinically relevant laboratory changes.
From start of study drug administration up to 30 days after the last dose of study drug
Treatment-Emergent Adverse Events (TEAEs) Related to Chemistry Abnormalities Occurring in Greater Than (>) 5 Percent of Participants
An abnormal chemistry finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as an adverse event. Treatment-emergent were events between first dose of study drug and 30 days after the last dose that were absent before treatment or that worsened relative to pretreatment state.
From start of study drug administration up to 30 days after the last dose of study drug
Number of Participants With Abnormalities in Ophthalmologic Examination at End of Treatment That Were Not Present at Baseline
Ophthalmologic examination included evaluation of retinal, corneal and lens abnormalities at baseline and end of treatment that were not present at screening. Participants who experienced abnormalitities during ophthalmologic examination recorded and reported.
Baseline and end of treatment (up to 1 year after the last participants begins study drug treatment)
Number of Participants With Change From Baseline in Normal Sinus Rhythm Findings in ECG
Number of participants with abnormal ECG changes (compared with baseline) as assessed by study cardiologist
Baseline and end of treatment (up to 1 year after the last participant begins study drug treatment)
Change From Baseline to End of Treatment in Clinical Findings in Electrocardiogram (ECG) QT, QTC Interval and Ventricular Rate
The 12-lead ECG data were summarized and evaluated for the following parameters: ,QT, QTC intervals and ventricular rate. Change from baseline in these parameters were reported.
Baseline and end of treatment (up to 1 year after the last participants begins study drug treatment)
Best Overall Tumor Response
Antitumor activity was assessed by best overall tumor response.
Baseline and end of treatment (up to 1 year after the last participant begins study drug treatment)
Objective Response Rate (ORR)
Objective response based on assessment of confirmed composite complete response (CRc) or partial response (PR) according to disease specific criteria [modified criteria for response in acute lymphoblastic leukemia (ALL)].
Baseline until end of treatment (up to 1 year after the last participant begins study drug treatment)
Percentage of Participants With Relapse of Disease
Relapse is defined as progressive disease (PD) following complete response (CR). Rate of relapse was only calculated for the subgroup of participants with complete response.
Baseline until end of treatment (up to 1 year after the last participant begins study drug treatment)
Time to Disease Response
Time to disease response was measured from the start of moxetumomab pasudotox administration to the first documentation of response (CR or PR) and was assessed in participants who achieved objective response.
Baseline and end of treatment (up to 1 year after the last participant begins study drug treatment)
Duration of Response (DR)
Duration of response was defined as the duration from the first documentation of objective response to the first documented disease progression.
Baseline and end of treatment (up to 1 year after the last participant begins study drug treatment
Time to Disease Progression (TDP)
Time to disease progression was measured from the start of treatment with moxetumomab pasudotox until the documentation of disease progression. Number of progressions were reported here.
Baseline and end of treatment (up to 1 year after the last participant begins study drug treatment
Progression-Free Survival (PFS)
Progression-free survival was measured from the start of treatment with moxetumomab pasudotox until the documentation of disease progression or death due to any cause, whichever occurs first. Number of progressions/deaths were reported here.
Baseline and end of treatment (up to 1 year after the last participant begins study drug treatment)
Overall Survival (OS)
Overall survival was determined as the time from the start of treatment with Moxetumomab Pasudotox until death. Number of deaths were reported here.
Baseline and end of treatment (up to 1 year after the last participant begins study drug treatment)
Maximum Observed Serum Concentration (Cmax) for Moxetumomab Pasudotox
The Cmax is the maximum observed plasma concentration of Moxetumomab Pasudotox.
Cycles 1, 2 and every 4th cycle: pre-dose, end of infusion (EOI), 1, 1.5, 2.5, 4 and 8 hours post-dose of Dose 1; pre-dose and end of infusion after Dose 6
Area Under the Serum Concentration Time Curve From Time Zero to Infinity (AUC [0 to Infinity]) for Moxetumomab Pasudotox
The AUC (0 to infinity) is the area under the plasma concentration-time curve from time zero to infinity hours.
Cycles 1, 2 and every 4th cycle: pre-dose, end of infusion (EOI), 1, 1.5, 2.5, 4 and 8 hours post-dose of Dose 1; pre-dose and end of infusion after Dose 6
Systemic Clearance (CL) for Moxetumomab Pasudotox
The CL is a quantitative measure of the rate at which a drug substance is removed from the body. The total systemic clearance after intravenous dose was estimated by dividing the total administered dose by the plasma area under the plasma concentration-time curve from time zone to infinite time (AUC[0-infinity]).
Cycles 1, 2 and every 4th cycle: pre-dose, end of infusion (EOI), 1, 1.5, 2.5, 4 and 8 hours post-dose of Dose 1; pre-dose and end of infusion after Dose 6
Terminal Phase Elimination Half Life (t1/2) for Moxetumomab Pasudotox
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Cycles 1, 2 and every 4th cycle: pre-dose, end of infusion (EOI), 1, 1.5, 2.5, 4 and 8 hours post-dose of Dose 1; pre-dose and end of infusion after Dose 6
Baseline until end of treatment (up to 1 year after the last participant begins study drug treatment)
CD22 Expression Cells in Peripheral Blood by Best Response
Participants malignant cells (peripheral blood) was tested for cluster of differentiation 22 (CD22) expression by fluorescence-activated cell sorter (FACS) analysis.
Baseline until end of treatment (up to 1 year after the last participant begins study drug treatment)
Number of Participants With Potential Biomarkers of Predicting Capillary Leak Syndrome (CLS)
Potential biomarkers include orthostatic blood pressure, albumin levels, weight change, edema and hypoxia were evaluated.
Baseline and end of treatment (up to 1 year after the last participant begins study drug treatment)
Bethesda
Maryland
United States
Research Site
Boston
Massachusetts
United States
Research Site
Memphis
Tennessee
United States
Research Site
Toronto
Ontario
Canada
Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
FG002
20 Microgram Per Kilogram (mcg/kg): Schema A
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
FG003
20 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
FG004
30 Microgram Per Kilogram (mcg/kg): Schema A
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
FG005
30 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
FG006
40 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
FG007
32 Microgram Per Kilogram (mcg/kg): Schema C
Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
FG008
50 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
FG009
50 Microgram Per Kilogram (mcg/kg): Schema C
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
FG0001 subjects
FG0011 subjects
FG0021 subjects
FG0034 subjects
FG0044 subjects
FG0055 subjects
FG0068 subjects
FG00711 subjects
FG0086 subjects
FG00914 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0091 subjects
NOT COMPLETED
FG0001 subjects
FG0011 subjects
FG0021 subjects
FG0034 subjects
FG0044 subjects
FG0054 subjects
FG0068 subjects
FG00711 subjects
FG0086 subjects
FG00913 subjects
Type
Comment
Reasons
Disease progression
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0052 subjects
FG0064 subjects
FG0073 subjects
FG0085 subjects
FG0093 subjects
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Investigator Discretion
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Other
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0032 subjects
FG004
Safety Population includes all participants who received any treatment of study drug.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
5 Microgram Per Kilogram (mcg/kg)
Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
BG001
10 Microgram Per Kilogram (mcg/kg)
Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
BG002
20 Microgram Per Kilogram (mcg/kg): Schema A
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
BG003
20 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
BG004
30 Microgram Per Kilogram (mcg/kg): Schema A
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
BG005
30 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
BG006
40 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
BG007
32 Microgram Per Kilogram (mcg/kg): Schema C
Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
BG008
50 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
BG009
50 Microgram Per Kilogram (mcg/kg): Schema C
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
BG010
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0001
BG0011
BG0021
BG0034
BG0044
BG0055
BG0068
BG00711
BG0086
BG00914
BG01055
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00017± NAStandard Deviation is not evaluable for single participant.
BG0018± NAStandard Deviation is not evaluable for single participant.
BG00217
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0001
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants With Dose Limiting Toxicities (DLTs)
Adverse events that were suspected of a relationship to moxetumomab pasudotox and were greater than or equal to (>=) Grade 3 in severity were considered DLTs with the following additional criteria or exceptions: Participants with hematologic abnormalities of any grade, Grade 2 allergic reactions of bronchospasm or urticaria, or any Grade ≥ 3 allergic reaction, in the presence of premedication.
Evaluable Population for DLT included all participants who received any treatment of moxetumomab pasudotox (CAT-8015) and completed the DLT period without a DLT, or did not complete the DLT period due to a DLT. Here, "N" is number of participants evaluated for this outcome measure.
Posted
Number
participants
Day 1 up to 21 days of Cycle 1 (each cycle duration was of 21 days)
ID
Title
Description
OG000
10 Microgram Per Kilogram (mcg/kg)
Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG001
20 Microgram Per Kilogram (mcg/kg): Schema A
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG002
20 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG003
30 Microgram Per Kilogram (mcg/kg): Schema A
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG004
30 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG005
40 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG006
32 Microgram Per Kilogram (mcg/kg): Schema C
Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
OG007
50 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG008
50 Microgram Per Kilogram (mcg/kg): Schema C
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
Units
Counts
Participants
OG0001
OG0011
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received investigational product. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of investigational product and 30 days after the last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state.
Safety Population included all participants who received any treatment of study drug.
Posted
Number
Participants
From start of study drug administration until 30 days after the last dose of study drug
ID
Title
Description
OG000
5 Microgram Per Kilogram (mcg/kg)
Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG001
10 Microgram Per Kilogram (mcg/kg)
Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
Primary
Number of Participants With Vital Signs Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)
Vital signs included parameters as heart rate, blood pressure, temperature, weight, pulse oximetry and respiratory rate. TEAEs were events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug, for the period extending to 30 days after the last dose of study drug.
Safety Population included all participants who received any treatment of study drug.
Posted
Number
Participants
From start of study drug administration until 30 days after the last dose of study drug
ID
Title
Description
OG000
5 Microgram Per Kilogram (mcg/kg)
Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG001
10 Microgram Per Kilogram (mcg/kg)
Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG002
20 Microgram Per Kilogram (mcg/kg): Schema A
Primary
Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)
An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as an adverse event. Treatment-emergent were events between first dose of study drug and 30 days after the last dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with grade 3 or higher treatment-emergent adverse events (5% cut off) for laboratory abnormalities were reported as clinically relevant laboratory changes.
Safety population included all participants who received any treatment of study drug.
Posted
Number
Participants
From start of study drug administration up to 30 days after the last dose of study drug
ID
Title
Description
OG000
5 Microgram Per Kilogram (mcg/kg)
Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG001
10 Microgram Per Kilogram (mcg/kg)
Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
Primary
Treatment-Emergent Adverse Events (TEAEs) Related to Chemistry Abnormalities Occurring in Greater Than (>) 5 Percent of Participants
An abnormal chemistry finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as an adverse event. Treatment-emergent were events between first dose of study drug and 30 days after the last dose that were absent before treatment or that worsened relative to pretreatment state.
Safety population included all participants who received any treatment of study drug.
Posted
Number
Participants
From start of study drug administration up to 30 days after the last dose of study drug
ID
Title
Description
OG000
5 Microgram Per Kilogram (mcg/kg)
Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG001
10 Microgram Per Kilogram (mcg/kg)
Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG002
20 Microgram Per Kilogram (mcg/kg): Schema A
Primary
Number of Participants With Abnormalities in Ophthalmologic Examination at End of Treatment That Were Not Present at Baseline
Ophthalmologic examination included evaluation of retinal, corneal and lens abnormalities at baseline and end of treatment that were not present at screening. Participants who experienced abnormalitities during ophthalmologic examination recorded and reported.
Safety population included all participants who received any treatment of study drug.
Posted
Number
Participants
Baseline and end of treatment (up to 1 year after the last participants begins study drug treatment)
ID
Title
Description
OG000
5 Microgram Per Kilogram (mcg/kg)
Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG001
10 Microgram Per Kilogram (mcg/kg)
Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG002
20 Microgram Per Kilogram (mcg/kg): Schema A
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
Primary
Number of Participants With Change From Baseline in Normal Sinus Rhythm Findings in ECG
Number of participants with abnormal ECG changes (compared with baseline) as assessed by study cardiologist
Safety population included all participants who received any treatment of study drug.
Posted
Number
participants
Baseline and end of treatment (up to 1 year after the last participant begins study drug treatment)
ID
Title
Description
OG000
5 Microgram Per Kilogram (mcg/kg)
Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG001
10 Microgram Per Kilogram (mcg/kg)
Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG002
20 Microgram Per Kilogram (mcg/kg): Schema A
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
Primary
Change From Baseline to End of Treatment in Clinical Findings in Electrocardiogram (ECG) QT, QTC Interval and Ventricular Rate
The 12-lead ECG data were summarized and evaluated for the following parameters: ,QT, QTC intervals and ventricular rate. Change from baseline in these parameters were reported.
Safety population included all participants who received any treatment of study drug.
Posted
Mean
Standard Deviation
milli seconds (msec)
Baseline and end of treatment (up to 1 year after the last participants begins study drug treatment)
ID
Title
Description
OG000
5 Microgram Per Kilogram (mcg/kg)
Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG001
10 Microgram Per Kilogram (mcg/kg)
Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG002
20 Microgram Per Kilogram (mcg/kg): Schema A
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
Primary
Best Overall Tumor Response
Antitumor activity was assessed by best overall tumor response.
Evaluable Population for Efficacy included all participants who received any treatment of moxetumomab pasudotox and had at least 1 disease assessment after the initiation of moxetumomab pasudotox. Here, "N" is number of participants analyzed for this outcome measure.
Posted
Number
Participants
Baseline and end of treatment (up to 1 year after the last participant begins study drug treatment)
ID
Title
Description
OG000
5 Microgram Per Kilogram (mcg/kg)
Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG001
10 Microgram Per Kilogram (mcg/kg)
Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG002
20 Microgram Per Kilogram (mcg/kg): Schema A
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
Primary
Objective Response Rate (ORR)
Objective response based on assessment of confirmed composite complete response (CRc) or partial response (PR) according to disease specific criteria [modified criteria for response in acute lymphoblastic leukemia (ALL)].
Efficacy population included all participants who received any treatment of study drug and had at least 1 disease assessment after the initiation of study drug. Here, "N" is number of participants analyzed for this outcome measure.
Posted
Number
percentage of participants
Baseline until end of treatment (up to 1 year after the last participant begins study drug treatment)
ID
Title
Description
OG000
5 Microgram Per Kilogram (mcg/kg)
Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG001
10 Microgram Per Kilogram (mcg/kg)
Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG002
20 Microgram Per Kilogram (mcg/kg): Schema A
Primary
Percentage of Participants With Relapse of Disease
Relapse is defined as progressive disease (PD) following complete response (CR). Rate of relapse was only calculated for the subgroup of participants with complete response.
Efficacy population. Here, "N" is number of participants with CR in the respective cohort. Rate of relapse could not be estimated as none of the participants experienced CR in the 5 mcg/kg, 20 mcg/kg (Schema A) and 30 mcg/kg (schema A) cohort of the study.
Posted
Number
percentage of participants
Baseline until end of treatment (up to 1 year after the last participant begins study drug treatment)
ID
Title
Description
OG000
5 Microgram Per Kilogram (mcg/kg)
Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG001
10 Microgram Per Kilogram (mcg/kg)
Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG002
20 Microgram Per Kilogram (mcg/kg): Schema A
Primary
Time to Disease Response
Time to disease response was measured from the start of moxetumomab pasudotox administration to the first documentation of response (CR or PR) and was assessed in participants who achieved objective response.
Evaluable Population for Efficacy. Here, "N" is number of participants with objective disease response in the respective cohort. Time to disease response could not be estimated as none of the participants experienced OR in the 5 mcg/kg, 20 mcg/kg (schema A) and 30 mcg/kg (schema A).
Posted
Median
Full Range
months
Baseline and end of treatment (up to 1 year after the last participant begins study drug treatment)
ID
Title
Description
OG000
5 Microgram Per Kilogram (mcg/kg)
Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG001
10 Microgram Per Kilogram (mcg/kg)
Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG002
20 Microgram Per Kilogram (mcg/kg): Schema A
Primary
Duration of Response (DR)
Duration of response was defined as the duration from the first documentation of objective response to the first documented disease progression.
Evaluable Population for Efficacy. Here, "N" is number of participants with objective disease response in the respective cohort. DR could not be estimated as none of the participants experienced OR in the 5 mcg/kg, 20 mcg/kg (schema A) and 30 mcg/kg (schema A).
Posted
Median
Full Range
months
Baseline and end of treatment (up to 1 year after the last participant begins study drug treatment
ID
Title
Description
OG000
5 Microgram Per Kilogram (mcg/kg)
Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG001
10 Microgram Per Kilogram (mcg/kg)
Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG002
20 Microgram Per Kilogram (mcg/kg): Schema A
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
Primary
Time to Disease Progression (TDP)
Time to disease progression was measured from the start of treatment with moxetumomab pasudotox until the documentation of disease progression. Number of progressions were reported here.
Evaluable Population for Efficacy included all participants who received any treatment of moxetumomab pasudotox and had at least 1 disease assessment after the initiation of moxetumomab pasudotox. Here, "N" is number of participants analyzed for this outcome measure.
Posted
Median
Full Range
months
Baseline and end of treatment (up to 1 year after the last participant begins study drug treatment
ID
Title
Description
OG000
5 Microgram Per Kilogram (mcg/kg)
Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG001
10 Microgram Per Kilogram (mcg/kg)
Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG002
20 Microgram Per Kilogram (mcg/kg): Schema A
Primary
Progression-Free Survival (PFS)
Progression-free survival was measured from the start of treatment with moxetumomab pasudotox until the documentation of disease progression or death due to any cause, whichever occurs first. Number of progressions/deaths were reported here.
Evaluable Population for Efficacy included all participants who received any treatment of moxetumomab pasudotox and had at least 1 disease assessment after the initiation of moxetumomab pasudotox. Here, "N" is number of participants analyzed for this outcome measure.
Posted
Median
Full Range
months
Baseline and end of treatment (up to 1 year after the last participant begins study drug treatment)
ID
Title
Description
OG000
5 Microgram Per Kilogram (mcg/kg)
Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG001
10 Microgram Per Kilogram (mcg/kg)
Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG002
20 Microgram Per Kilogram (mcg/kg): Schema A
Primary
Overall Survival (OS)
Overall survival was determined as the time from the start of treatment with Moxetumomab Pasudotox until death. Number of deaths were reported here.
Evaluable Population for Efficacy included all participants who received any treatment of moxetumomab pasudotox and had at least 1 disease assessment after the initiation of moxetumomab pasudotox. Here, "N" is number of participants analyzed for this outcome measure.
Posted
Median
Full Range
months
Baseline and end of treatment (up to 1 year after the last participant begins study drug treatment)
ID
Title
Description
OG000
5 Microgram Per Kilogram (mcg/kg)
Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG001
10 Microgram Per Kilogram (mcg/kg)
Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG002
20 Microgram Per Kilogram (mcg/kg): Schema A
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
Primary
Maximum Observed Serum Concentration (Cmax) for Moxetumomab Pasudotox
The Cmax is the maximum observed plasma concentration of Moxetumomab Pasudotox.
Evaluable Population for efficacy included all participants who received any treatment of study drug and had at least 1 disease assessment after the initiation of study drug.
Posted
Mean
Standard Deviation
nanogram per milliliter (ng/mL)
Cycles 1, 2 and every 4th cycle: pre-dose, end of infusion (EOI), 1, 1.5, 2.5, 4 and 8 hours post-dose of Dose 1; pre-dose and end of infusion after Dose 6
ID
Title
Description
OG000
5 Microgram Per Kilogram (mcg/kg)
Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG001
10 Microgram Per Kilogram (mcg/kg)
Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG002
20 Microgram Per Kilogram (mcg/kg)
Participants received intravenous infusion of 20 mcg/kg CAT-8015 with/without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
Primary
Area Under the Serum Concentration Time Curve From Time Zero to Infinity (AUC [0 to Infinity]) for Moxetumomab Pasudotox
The AUC (0 to infinity) is the area under the plasma concentration-time curve from time zero to infinity hours.
Evaluable Population for Efficacy included all participants who received any treatment of study drug and had at least 1 disease assessment after the initiation of study drug.
Posted
Mean
Standard Deviation
hour*nanogram per milliliter (h.ng/mL)
Cycles 1, 2 and every 4th cycle: pre-dose, end of infusion (EOI), 1, 1.5, 2.5, 4 and 8 hours post-dose of Dose 1; pre-dose and end of infusion after Dose 6
ID
Title
Description
OG000
5 Microgram Per Kilogram (mcg/kg)
Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG001
10 Microgram Per Kilogram (mcg/kg)
Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG002
20 Microgram Per Kilogram (mcg/kg)
Primary
Systemic Clearance (CL) for Moxetumomab Pasudotox
The CL is a quantitative measure of the rate at which a drug substance is removed from the body. The total systemic clearance after intravenous dose was estimated by dividing the total administered dose by the plasma area under the plasma concentration-time curve from time zone to infinite time (AUC[0-infinity]).
Evaluable Population for Efficacy included all participants who received any treatment of study drug and had at least 1 disease assessment after the initiation of study drug.
Posted
Mean
Standard Deviation
milliliter per hour per kilogram
Cycles 1, 2 and every 4th cycle: pre-dose, end of infusion (EOI), 1, 1.5, 2.5, 4 and 8 hours post-dose of Dose 1; pre-dose and end of infusion after Dose 6
ID
Title
Description
OG000
5 Microgram Per Kilogram (mcg/kg)
Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG001
10 Microgram Per Kilogram (mcg/kg)
Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG002
20 Microgram Per Kilogram (mcg/kg)
Primary
Terminal Phase Elimination Half Life (t1/2) for Moxetumomab Pasudotox
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Evaluable Population for Efficacy included all participants who received any treatment of study drug and had at least 1 disease assessment after the initiation of study drug.
Posted
Mean
Standard Deviation
hour (h)
Cycles 1, 2 and every 4th cycle: pre-dose, end of infusion (EOI), 1, 1.5, 2.5, 4 and 8 hours post-dose of Dose 1; pre-dose and end of infusion after Dose 6
ID
Title
Description
OG000
5 Microgram Per Kilogram (mcg/kg)
Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG001
10 Microgram Per Kilogram (mcg/kg)
Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG002
20 Microgram Per Kilogram (mcg/kg)
Participants received intravenous infusion of 20 mcg/kg CAT-8015 with/without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
Secondary
Number of Participants With Positive Anti-Drug Antibody (ADA) and Neutralizing Antibody
Participants tested for immunogenicity to CAT-8015 (moxetumomab pasudotox) prior to enrollment, before each cycle and at end of study. The neutralization assay measures the capacity of participant's plasma (antibodies) to inhibit the binding of moxetumomab pasudotox to its target, cluster of differentiation 22 (CD22), coated onto enzyme linked immunosorbent assay (ELISA) plates. It was used as a direct surrogate for biological activity based on the mechanism of action of this drug. Significant level of neutralizing antibody activity defined as the capacity of test plasma to inhibit greater than (>)50 percentage (%) of the binding of CAT-8015 to CD22 using an ELISA-based method.
Safety population included all participants who received any treatment of study drug.
Posted
Number
Participants
Baseline until end of treatment (up to 1 year after the last participant begins study drug treatment)
ID
Title
Description
OG000
5 Microgram Per Kilogram (mcg/kg)
Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG001
10 Microgram Per Kilogram (mcg/kg)
Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
Secondary
CD22 Expression Cells in Peripheral Blood by Best Response
Participants malignant cells (peripheral blood) was tested for cluster of differentiation 22 (CD22) expression by fluorescence-activated cell sorter (FACS) analysis.
Safety population included all participants who received any treatment of study drug. Here, n = participants evaluable for specified category for each arm, respectively
Posted
Median
Full Range
sites per cell
Baseline until end of treatment (up to 1 year after the last participant begins study drug treatment)
ID
Title
Description
OG000
5 Microgram Per Kilogram (mcg/kg)
Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG001
10 Microgram Per Kilogram (mcg/kg)
Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG002
20 Microgram Per Kilogram (mcg/kg): Schema A
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
Secondary
Number of Participants With Potential Biomarkers of Predicting Capillary Leak Syndrome (CLS)
Potential biomarkers include orthostatic blood pressure, albumin levels, weight change, edema and hypoxia were evaluated.
Safety population included all participants who received any treatment of study drug.
Posted
Number
participants
Baseline and end of treatment (up to 1 year after the last participant begins study drug treatment)
ID
Title
Description
OG000
5 Microgram Per Kilogram (mcg/kg)
Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG001
10 Microgram Per Kilogram (mcg/kg)
Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG002
20 Microgram Per Kilogram (mcg/kg): Schema A
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
Time Frame
From start of study drug administration up to 30 days after the last dose of study drug
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
5 UG/KG SCHEMA A
Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
1
1
1
1
EG001
10 UG/KG SCHEMA A
Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
1
1
1
1
EG002
20 UG/KG SCHEMA A
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
1
1
1
1
EG003
20 UG/KG SCHEMA B
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
4
4
4
4
EG004
30 UG/KG SCHEMA A
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
3
4
4
4
EG005
30 UG/KG SCHEMA B
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
2
5
5
5
EG006
40 UG/KG SCHEMA B
Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
5
8
8
8
EG007
32 UG/KG SCHEMA C
Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
7
11
11
11
EG008
50 UG/KG SCHEMA B
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
4
6
6
6
EG009
50 UG/KG SCHEMA C
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
9
14
14
14
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0012 events1 affected1 at risk
EG0022 events1 affected1 at risk
EG0031 events1 affected4 at risk
EG0040 events0 affected4 at risk
EG0052 events1 affected5 at risk
EG0063 events2 affected8 at risk
EG0072 events1 affected11 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected14 at risk
Haemolytic uraemic syndrome
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Choroidal detachment
Eye disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Brain death
General disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Multi-organ failure
General disorders
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Pyrexia
General disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Hepatobiliary disease
Hepatobiliary disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Venoocclusive liver disease
Hepatobiliary disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Bacterial infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Geotrichum infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Opportunistic infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Pneumonia fungal
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Sepsis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Staphylococcal sepsis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Acute lymphocytic leukaemia recurrent
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Central nervous system haemorrhage
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Coma
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Seizure
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Haemoglobinuria
Renal and urinary disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected1 at risk
EG003
Lung infiltration
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Pulmonary haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Disease progression
General disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Neutropenic infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Septic shock
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Systemic mycosis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected1 at risk
EG003
Tooth infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Troponin
Investigations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Acute respiratory distress syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Respiratory distress
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected1 at risk
EG003
Capillary leak syndrome
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Haemorrhage
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Hypotension
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Thrombosis
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Venoocclusive disease
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG00119 events1 affected1 at risk
EG00212 events1 affected1 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG00612 events2 affected8 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected6 at risk
EG00917 events3 affected14 at risk
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG00113 events1 affected1 at risk
EG0024 events1 affected1 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0017 events1 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG00138 events1 affected1 at risk
EG0028 events1 affected1 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Vision blurred
Eye disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0014 events1 affected1 at risk
EG0021 events1 affected1 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected1 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0012 events1 affected1 at risk
EG0023 events1 affected1 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0024 events1 affected1 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0014 events1 affected1 at risk
EG0023 events1 affected1 at risk
EG003
Catheter site pain
General disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Fatigue
General disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Activated partial thromboplastin time prolonged
Investigations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0013 events1 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0012 events1 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected1 at risk
EG0012 events1 affected1 at risk
EG0021 events1 affected1 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Blood urea increased
Investigations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Electrocardiogram qt prolonged
Investigations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0012 events1 affected1 at risk
EG0021 events1 affected1 at risk
EG003
Platelet count decreased
Investigations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0012 events1 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Weight increased
Investigations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0012 events1 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Hyperphosphataemia
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0024 events1 affected1 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected1 at risk
EG0013 events1 affected1 at risk
EG0022 events1 affected1 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Headache
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Oedema
General disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Oedema peripheral
General disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Pyrexia
General disorders
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0022 events1 affected1 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 18.0
Systematic Assessment
EG0002 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected1 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA 18.0
Systematic Assessment
EG0002 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected1 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected1 at risk
EG0012 events1 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0021 events1 affected1 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Haemoglobinuria
Renal and urinary disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected1 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Tachypnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Petechiae
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0022 events1 affected1 at risk
EG003
Hypertension
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Hypotension
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0013 events1 affected1 at risk
EG0020 events0 affected1 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
MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
Point of Contact
Title
Organization
Phone
Extension
Email
Mark Lanasa, MD Associate Director, Clinical Development, Oncology
MedImmune, LLC
301-398-0000
information.center@AstraZeneca.com
ID
Term
D054198
Precursor Cell Lymphoblastic Leukemia-Lymphoma
D008228
Lymphoma, Non-Hodgkin
Ancestor Terms
ID
Term
D007945
Leukemia, Lymphoid
D007938
Leukemia
D009370
Neoplasms by Histologic Type
D009369
Neoplasms
D006402
Hematologic Diseases
D006425
Hemic and Lymphatic Diseases
D008232
Lymphoproliferative Disorders
D008206
Lymphatic Diseases
D007160
Immunoproliferative Disorders
D007154
Immune System Diseases
D008223
Lymphoma
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C541974
immunotoxin HA22
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG0051 subjects
FG0060 subjects
FG0073 subjects
FG0081 subjects
FG0094 subjects
0 subjects
FG0051 subjects
FG0060 subjects
FG0073 subjects
FG0080 subjects
FG0090 subjects
4 subjects
FG0050 subjects
FG0063 subjects
FG0072 subjects
FG0080 subjects
FG0096 subjects
± NA
Standard Deviation is not evaluable for single participant.
BG00312.8± 6.8
BG0049± 2.7
BG00514± 4.7
BG0068.6± 5.3
BG00713.8± 6.3
BG00812.8± 8.3
BG00914.3± 5.5
BG01012.7± 5.9
0
BG0033
BG0040
BG0050
BG0063
BG0076
BG0082
BG0096
BG01021
Male
BG0000
BG0011
BG0021
BG0031
BG0044
BG0055
BG0065
BG0075
BG0084
BG0098
BG01034
4
OG0043
OG0057
OG0067
OG0073
OG00811
2
OG0040
OG0051
OG0061
OG0070
OG0081
OG002
20 Microgram Per Kilogram (mcg/kg): Schema A
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG003
20 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG004
30 Microgram Per Kilogram (mcg/kg): Schema A
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG005
30 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG006
40 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG007
32 Microgram Per Kilogram (mcg/kg): Schema C
Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
OG008
50 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG009
50 Microgram Per Kilogram (mcg/kg): Schema C
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
Units
Counts
Participants
OG0001
OG0011
OG0021
OG0034
OG0044
OG0055
OG0068
OG00711
OG0086
OG00914
Title
Denominators
Categories
TEAEs
Title
Measurements
OG0001
OG0011
OG0021
OG0034
OG0044
OG0055
OG0068
OG00711
OG0086
OG00914
TESAEs
Title
Measurements
OG0001
OG0011
OG0021
OG003
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG003
20 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG004
30 Microgram Per Kilogram (mcg/kg): Schema A
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG005
30 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG006
40 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG007
32 Microgram Per Kilogram (mcg/kg): Schema C
Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
OG008
50 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG009
50 Microgram Per Kilogram (mcg/kg): Schema C
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
Units
Counts
Participants
OG0001
OG0011
OG0021
OG0034
OG0044
OG0055
OG0068
OG00711
OG0086
OG00914
Title
Denominators
Categories
Tachycardia
Title
Measurements
OG0000
OG0010
OG0020
OG0032
OG0043
OG0053
OG0062
OG0072
OG0080
OG0093
Arrhythmia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Bradycardia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Sinus bradycardia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Sinus tachycardia
Title
Measurements
OG0001
OG0010
OG0020
OG003
Pyrexia
Title
Measurements
OG0001
OG0010
OG0020
OG003
Dyspnoea
Title
Measurements
OG0000
OG0010
OG0020
OG003
Respiratory distress
Title
Measurements
OG0000
OG0010
OG0021
OG003
Tachypnoea
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hypertension
Title
Measurements
OG0000
OG0011
OG0020
OG003
Hypotension
Title
Measurements
OG0000
OG0011
OG0020
OG003
OG002
20 Microgram Per Kilogram (mcg/kg): Schema A
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG003
20 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG004
30 Microgram Per Kilogram (mcg/kg): Schema A
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG005
30 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG006
40 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG007
32 Microgram Per Kilogram (mcg/kg): Schema C
Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
OG008
50 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG009
50 Microgram Per Kilogram (mcg/kg): Schema C
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
Units
Counts
Participants
OG0001
OG0011
OG0021
OG0034
OG0044
OG0055
OG0068
OG00711
OG0086
OG00914
Title
Denominators
Categories
Febrile neutropenia
Title
Measurements
OG0000
OG0011
OG0021
OG0031
OG0042
OG0051
OG0063
OG0075
OG0080
OG0091
Anemia
Title
Measurements
OG0000
OG0011
OG0021
OG003
Leukopenia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Lymphopenia
Title
Measurements
OG0000
OG0011
OG0021
OG003
Neutropenia
Title
Measurements
OG0000
OG0011
OG0020
OG003
Thrombocytopenia
Title
Measurements
OG0000
OG0011
OG0021
OG003
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG003
20 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG004
30 Microgram Per Kilogram (mcg/kg): Schema A
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG005
30 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG006
40 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG007
32 Microgram Per Kilogram (mcg/kg): Schema C
Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
OG008
50 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG009
50 Microgram Per Kilogram (mcg/kg): Schema C
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
Units
Counts
Participants
OG0001
OG0011
OG0021
OG0034
OG0044
OG0055
OG0068
OG00711
OG0086
OG00914
Title
Denominators
Categories
Alanine aminotransferase increased
Title
Measurements
OG0000
OG0011
OG0020
OG0032
OG0040
OG0054
OG0062
OG0072
OG0082
OG0093
Aspartate aminotransferase increased
Title
Measurements
OG0001
OG0011
OG0021
OG003
Blood creatinine increased
Title
Measurements
OG0001
OG0010
OG0021
OG003
Blood lactate dehydrogenase increased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Blood urea increased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hyperglycaemia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hyperphosphataemia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hypoalbuminaemia
Title
Measurements
OG0000
OG0011
OG0021
OG003
Hypocalcaemia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hypokalaemia
Title
Measurements
OG0001
OG0011
OG0021
OG003
Hypomagnesaemia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hyponatraemia
Title
Measurements
OG0000
OG0010
OG0021
OG003
Hypophosphataemia
Title
Measurements
OG0001
OG0011
OG0020
OG003
OG003
20 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG004
30 Microgram Per Kilogram (mcg/kg): Schema A
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG005
30 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG006
40 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG007
32 Microgram Per Kilogram (mcg/kg): Schema C
Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
OG008
50 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG009
50 Microgram Per Kilogram (mcg/kg): Schema C
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
Units
Counts
Participants
OG0001
OG0011
OG0021
OG0034
OG0044
OG0055
OG0068
OG00711
OG0086
OG00914
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG003
20 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG004
30 Microgram Per Kilogram (mcg/kg): Schema A
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG005
30 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG006
40 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG007
32 Microgram Per Kilogram (mcg/kg): Schema C
Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
OG008
50 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG009
50 Microgram Per Kilogram (mcg/kg): Schema C
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
Units
Counts
Participants
OG0001
OG0011
OG0021
OG0034
OG0044
OG0054
OG0067
OG0077
OG0086
OG00912
Title
Denominators
Categories
Title
Measurements
OG0000(0.2 to 0.2)
OG0010(3.6 to 3.6)
OG0020(1.7 to 1.7)
OG0030(0.6 to 31.3)
OG0040(0.7 to 1.4)
OG0050(1.6 to 9.0)
OG0060(1.8 to 42.0)
OG0070(1.7 to 13.7)
OG0080(0.9 to 7.9)
OG0090(1.9 to 26.1)
OG003
20 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG004
30 Microgram Per Kilogram (mcg/kg): Schema A
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG005
30 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG006
40 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG007
32 Microgram Per Kilogram (mcg/kg): Schema C
Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
OG008
50 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG009
50 Microgram Per Kilogram (mcg/kg): Schema C
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
Units
Counts
Participants
OG0001
OG0011
OG0021
OG0034
OG0044
OG0055
OG0068
OG00711
OG0086
OG00914
Title
Denominators
Categories
QT interval
Title
Measurements
OG000-107± NAOnly 1 subject analyzed at baseline and end of treatment so SD is not applicable
OG001NA± NANo data available at end of treatment so change from baseline to end of treatment cannot be calculated
OG002NA± NANo data available at end of treatment so change from baseline to end of treatment cannot be calculated
OG003NA± NANo data available at end of treatment so change from baseline to end of treatment cannot be calculated
OG004-52.0± NAOf the 4 subjects with data, only 1 subject had analyzable data at baseline and end of treatment so SD is not applicable
OG005NA± NANo data available at end of treatment so change from baseline to end of treatment cannot be calculated
OG006NA± NANo data available at end of treatment so change from baseline to end of treatment cannot be calculated
OG007NA± NANo data available at end of treatment so change from baseline to end of treatment cannot be calculated
OG008NA± NANo data available at end of treatment so change from baseline to end of treatment cannot be calculated
OG009NA± NANo data available at end of treatment so change from baseline to end of treatment cannot be calculated
QTC interval
Title
Measurements
OG00020.0± NAOnly 1 subject analyzed at baseline and end of treatment so SD is not applicable
OG001NA± NANo data available at end of treatment so change from baseline to end of treatment cannot be calculated
OG002NA± NANo data available at end of treatment so change from baseline to end of treatment cannot be calculated
OG003
Ventricluar rate
Title
Measurements
OG00069.0± NAOnly 1 subject analyzed at baseline and end of treatment so SD is not applicable
OG001NA± NANo data available at end of treatment so change from baseline to end of treatment cannot be calculated
OG002NA± NANo data available at end of treatment so change from baseline to end of treatment cannot be calculated
OG003
OG003
20 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG004
30 Microgram Per Kilogram (mcg/kg): Schema A
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG005
30 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG006
40 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG007
32 Microgram Per Kilogram (mcg/kg): Schema C
Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
OG008
50 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG009
50 Microgram Per Kilogram (mcg/kg): Schema C
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
Units
Counts
Participants
OG0001
OG0011
OG0021
OG0034
OG0044
OG0054
OG0067
OG0077
OG0086
OG00912
Title
Denominators
Categories
Composite complete response
Title
Measurements
OG0000
OG0011
OG0020
OG0031
OG0040
OG0051
OG0061
OG0072
OG0082
OG0093
Complete response
Title
Measurements
OG0000
OG0011
OG0020
OG003
complete response with incomplete count recovery
Title
Measurements
OG0000
OG0010
OG0020
OG003
Partial response
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hematological activity
Title
Measurements
OG0000
OG0010
OG0020
OG003
Stable disease
Title
Measurements
OG0000
OG0010
OG0021
OG003
Progressive disease
Title
Measurements
OG0001
OG0010
OG0020
OG003
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG003
20 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG004
30 Microgram Per Kilogram (mcg/kg): Schema A
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG005
30 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG006
40 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG007
32 Microgram Per Kilogram (mcg/kg): Schema C
Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
OG008
50 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG009
50 Microgram Per Kilogram (mcg/kg): Schema C
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
Units
Counts
Participants
OG0001
OG0011
OG0021
OG0034
OG0044
OG0054
OG0067
OG0077
OG0086
OG00912
Title
Denominators
Categories
Title
Measurements
OG0000
OG001100
OG0020
OG00325.0
OG0040
OG00550.0
OG00614.3
OG00742.9
OG00833.3
OG00941.7
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG003
20 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG004
30 Microgram Per Kilogram (mcg/kg): Schema A
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG005
30 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG006
40 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG007
32 Microgram Per Kilogram (mcg/kg): Schema C
Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
OG008
50 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG009
50 Microgram Per Kilogram (mcg/kg): Schema C
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
Units
Counts
Participants
OG0000
OG0011
OG0020
OG0031
OG0040
OG0051
OG0061
OG0071
OG0082
OG0093
Title
Denominators
Categories
Title
Measurements
OG0010
OG003100
OG0050
OG0060
OG0070
OG00850
OG0090
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG003
20 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG004
30 Microgram Per Kilogram (mcg/kg): Schema A
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG005
30 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG006
40 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG007
32 Microgram Per Kilogram (mcg/kg): Schema C
Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
OG008
50 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG009
50 Microgram Per Kilogram (mcg/kg): Schema C
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
Units
Counts
Participants
OG0000
OG0011
OG0020
OG0031
OG0040
OG0052
OG0061
OG0073
OG0082
OG0095
Title
Denominators
Categories
Title
Measurements
OG0010.69(0.69 to 0.69)
OG0030.49(0.49 to 0.49)
OG0050.66(0.59 to 0.72)
OG0060.49(0.49 to 0.49)
OG0070.72(0.72 to 0.76)
OG0080.62(0.59 to 0.66)
OG0090.66(0.59 to 0.72)
OG003
20 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG004
30 Microgram Per Kilogram (mcg/kg): Schema A
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG005
30 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG006
40 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG007
32 Microgram Per Kilogram (mcg/kg): Schema C
Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
OG008
50 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG009
50 Microgram Per Kilogram (mcg/kg): Schema C
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
Units
Counts
Participants
OG0000
OG0011
OG0020
OG0031
OG0040
OG0052
OG0061
OG0073
OG0082
OG0095
Title
Denominators
Categories
Title
Measurements
OG001NA(1.9 to 1.9)Median DR was estimated using the Kaplan-Meier survival analysis. Where median DR = NA, it could not be estimated using this method (range is calculated using simple summary statistics)
OG0032.3(2.3 to 2.3)
OG005NA(0.7 to 1.4)Median DR was estimated using the Kaplan-Meier survival analysis. Where median DR = NA, it could not be estimated using this method (range is calculated using simple summary statistics)
OG006NA(0.8 to 0.8)Median DR was estimated using the Kaplan-Meier survival analysis. Where median DR = NA, it could not be estimated using this method (range is calculated using simple summary statistics)
OG007NA(0.0 to 0.9)Median DR was estimated using the Kaplan-Meier survival analysis. Where median DR = NA, it could not be estimated using this method (range is calculated using simple summary statistics)
OG008NA(0.4 to 1.4)Median DR was estimated using the Kaplan-Meier survival analysis. Where median DR = NA, it could not be estimated using this method (range is calculated using simple summary statistics)
OG009NA(0.0 to 2.0)Median DR was estimated using the Kaplan-Meier survival analysis. Where median DR = NA, it could not be estimated using this method (range is calculated using simple summary statistics)
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG003
20 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG004
30 Microgram Per Kilogram (mcg/kg): Schema A
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG005
30 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG006
40 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG007
32 Microgram Per Kilogram (mcg/kg): Schema C
Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
OG008
50 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG009
50 Microgram Per Kilogram (mcg/kg): Schema C
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
Units
Counts
Participants
OG0001
OG0011
OG0021
OG0034
OG0044
OG0054
OG0067
OG0077
OG0086
OG00912
Title
Denominators
Categories
Title
Measurements
OG0000.2(0.2 to 0.2)
OG001NA(2.6 to 2.6)Median TDP was estimated using the Kaplan-Meier survival analysis. Where median TDP = NA, it could not be estimated using this method (range is calculated using simple summary statistics)
OG002NA(0.6 to 0.6)Median TDP was estimated using the Kaplan-Meier survival analysis. Where median TDP = NA, it could not be estimated using this method (range is calculated using simple summary statistics)
OG0032(0.5 to 2.8)
OG004NA(0.2 to 1.4)Median TDP was estimated using the Kaplan-Meier survival analysis. Where median TDP = NA, it could not be estimated using this method (range is calculated using simple summary statistics)
OG005NA(0.5 to 2.2)Median TDP was estimated using the Kaplan-Meier survival analysis. Where median TDP = NA, it could not be estimated using this method (range is calculated using simple summary statistics)
OG0061.2(0.5 to 1.2)
OG0071.5(0.5 to 1.6)
OG0080.8(0.4 to 2.0)
OG009NA(0.5 to 2.7)Median TDP was estimated using the Kaplan-Meier survival analysis. Where median TDP = NA, it could not be estimated using this method (range is calculated using simple summary statistics)
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG003
20 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG004
30 Microgram Per Kilogram (mcg/kg): Schema A
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG005
30 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG006
40 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG007
32 Microgram Per Kilogram (mcg/kg): Schema C
Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
OG008
50 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG009
50 Microgram Per Kilogram (mcg/kg): Schema C
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
Units
Counts
Participants
OG0001
OG0011
OG0021
OG0034
OG0044
OG0054
OG0067
OG0077
OG0086
OG00912
Title
Denominators
Categories
Title
Measurements
OG0000.2(0.2 to 0.2)
OG0013.6(3.6 to 3.6)
OG0021.7(1.7 to 1.7)
OG0031.8(0.6 to 2.8)
OG004NA(0.2 to 1.4)Median PFS was estimated using the Kaplan-Meier survival analysis. Where median PFS = NA, it could not be estimated using this method (range is calculated using simple summary statistics)
OG0053.1(0.5 to 9.0)
OG0061.2(0.6 to 14.0)
OG0071.5(0.5 to 5.6)
OG0080.8(0.4 to 5.9)
OG0095.8(0.5 to 17.3)
OG003
20 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG004
30 Microgram Per Kilogram (mcg/kg): Schema A
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG005
30 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG006
40 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG007
32 Microgram Per Kilogram (mcg/kg): Schema C
Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
OG008
50 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG009
50 Microgram Per Kilogram (mcg/kg): Schema C
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
Units
Counts
Participants
OG0001
OG0011
OG0021
OG0034
OG0044
OG0054
OG0067
OG0077
OG0086
OG00912
Title
Denominators
Categories
Title
Measurements
OG0000.2(0.2 to 0.2)
OG0013.6(3.6 to 3.6)
OG0021.7(1.7 to 1.7)
OG0032.1(0.6 to 31.3)
OG004NA(0.7 to 1.4)Median OS was estimated using the Kaplan-Meier survival analysis. Where median OS = NA, it could not be estimated using this method (range is calculated using simple summary statistics)
OG0054.6(1.6 to 9.0)
OG0069.4(1.8 to 42.0)
OG007NA(1.7 to 13.7)Median OS was estimated using the Kaplan-Meier survival analysis. Where median OS = NA, it could not be estimated using this method (range is calculated using simple summary statistics)
OG0084.1(0.9 to 7.9)
OG00912.7(1.9 to 26.1)
OG003
30 Microgram Per Kilogram (mcg/kg)
Participants received intravenous infusion of 30 mcg/kg CAT-8015 with/without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG004
32 Microgram Per Kilogram (mcg/kg): Schema C
Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
OG005
40 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG006
50 Microgram Per Kilogram (mcg/kg)
Participants received intravenous infusion of 50 mcg/kg CAT-8015 without concomitant corticosteroid administration/continuous every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
Units
Counts
Participants
OG0001
OG0011
OG0025
OG0039
OG00410
OG0056
OG00620
Title
Denominators
Categories
Title
Measurements
OG000NA± NACmax below lower limit of quantification
OG001126± NAStandard deviation was not evaluable since only 1 participant was evaluated.
OG002274± 135
OG003446± 126
OG004446± 156
OG005555± 196
OG006755± 188
Participants received intravenous infusion of 20 mcg/kg CAT-8015 with/without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG003
30 Microgram Per Kilogram (mcg/kg)
Participants received intravenous infusion of 30 mcg/kg CAT-8015 with/without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG004
32 Microgram Per Kilogram (mcg/kg): Schema C
Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
OG005
40 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG006
50 Microgram Per Kilogram (mcg/kg)
Participants received intravenous infusion of 50 mcg/kg CAT-8015 without concomitant corticosteroid administration/continuous every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
Units
Counts
Participants
OG0001
OG0011
OG0023
OG0038
OG00410
OG0055
OG00620
Title
Denominators
Categories
Title
Measurements
OG000NA± NAAUC cannot be estimated due to insufficient samples from subject to be able to calculate AUC
OG001NA± NAAUC cannot be estimated due to insufficient samples from subject to be able to calculate AUC
OG002744± 514
OG0031060± 508
OG004844± 385
OG0051320± 554
OG0061690± 689
Participants received intravenous infusion of 20 mcg/kg CAT-8015 with/without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG003
30 Microgram Per Kilogram (mcg/kg)
Participants received intravenous infusion of 30 mcg/kg CAT-8015 with/without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG004
32 Microgram Per Kilogram (mcg/kg): Schema C
Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
OG005
40 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG006
50 Microgram Per Kilogram (mcg/kg)
Participants received intravenous infusion of 50 mcg/kg CAT-8015 without concomitant corticosteroid administration/continuous every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
Units
Counts
Participants
OG0001
OG0011
OG0023
OG0038
OG00410
OG0055
OG00620
Title
Denominators
Categories
Title
Measurements
OG000NA± NACL below lower limit of quantification
OG001NA± NACL below lower limit of quantification
OG00240.5± 32.3
OG00335.4± 18.2
OG00447.5± 28.2
OG00534.6± 13.2
OG00635.3± 14.7
OG003
30 Microgram Per Kilogram (mcg/kg)
Participants received intravenous infusion of 30 mcg/kg CAT-8015 with/without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG004
32 Microgram Per Kilogram (mcg/kg): Schema C
Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
OG005
40 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG006
50 Microgram Per Kilogram (mcg/kg)
Participants received intravenous infusion of 50 mcg/kg CAT-8015 without concomitant corticosteroid administration/continuous every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
Units
Counts
Participants
OG0001
OG0011
OG0023
OG0038
OG00410
OG0055
OG00620
Title
Denominators
Categories
Title
Measurements
OG000NA± NAplasma concentration of moxetumomab pasudotox below the lower limit of quantification therefore t1/2 cannot be estimated
OG001NA± NAplasma concentration of moxetumomab pasudotox below the lower limit of quantification therefore t1/2 cannot be estimated
OG0020.906± 0.545
OG0031.32± 0.893
OG0040.997± 0.557
OG0050.880± 0.522
OG0061.38± 0.753
OG002
20 Microgram Per Kilogram (mcg/kg): Schema A
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG003
20 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG004
30 Microgram Per Kilogram (mcg/kg): Schema A
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG005
30 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG006
40 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG007
32 Microgram Per Kilogram (mcg/kg): Schema C
Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
OG008
50 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG009
50 Microgram Per Kilogram (mcg/kg): Schema C
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
Units
Counts
Participants
OG0001
OG0011
OG0021
OG0034
OG0044
OG0055
OG0068
OG00711
OG0086
OG00914
Title
Denominators
Categories
ADA present by screening assay
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0041
OG0051
OG0061
OG0071
OG0081
OG0091
Neutralizing ADA present by functional assay
Title
Measurements
OG0001
OG0010
OG0020
OG003
OG003
20 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG004
30 Microgram Per Kilogram (mcg/kg): Schema A
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG005
30 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG006
40 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG007
32 Microgram Per Kilogram (mcg/kg): Schema C
Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
OG008
50 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG009
50 Microgram Per Kilogram (mcg/kg): Schema C
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG004
30 Microgram Per Kilogram (mcg/kg): Schema A
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG005
30 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG006
40 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG007
32 Microgram Per Kilogram (mcg/kg): Schema C
Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
OG008
50 Microgram Per Kilogram (mcg/kg): Schema B
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
OG009
50 Microgram Per Kilogram (mcg/kg): Schema C
Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
Units
Counts
Participants
OG0001
OG0011
OG0021
OG0034
OG0044
OG0055
OG0068
OG00711
OG0086
OG00914
Title
Denominators
Categories
Hypertension; Event; Developed no later than CLS
Title
Measurements
OG0000(NA to NA)
OG0010(14519 to 14519)
OG0020(NA to NA)
OG0030(749 to 749)
OG0040(NA to NA)
OG0050(3058 to 3058)
OG0060(NA to NA)
OG0070(1650 to 3895)
OG0080(3968 to 7272)
OG0090(3085 to 10393)
Hypertension; Event; Developed after CLS
Title
Measurements
OG0000(NA to NA)
OG0010(14519 to 14519)
OG0020(NA to NA)
OG003
Hypertension; Event; No CLS
Title
Measurements
OG0000(NA to NA)
OG0010(NA to NA)
OG0020(NA to NA)
OG003
Hypertension; No Event; No CLS
Title
Measurements
OG0001(NA to NA)
OG0011(NA to NA)
OG0021(NA to NA)
OG003
Hypertension; No Event; CLS
Title
Measurements
OG0000(NA to NA)
OG0010(NA to NA)
OG0020(5050 to 5050)
OG003
Weight change; Event; Developed no later than CLS
Title
Measurements
OG0000(13210 to 13210)
OG0010(NA to NA)
OG0020(NA to NA)
OG003
Weight change; Event; Developed after CLS
Title
Measurements
OG0000
OG0010
OG0020
OG003
Weight change; Event; No CLS
Title
Measurements
OG0000
OG0010
OG0020
OG003
Weight change; No Event; No CLS
Title
Measurements
OG0001
OG0011
OG0021
OG003
Weight change; No Event; CLS
Title
Measurements
OG0000
OG0010
OG0020
OG003
Change in Albumin; Event; Developed no later CLS
Title
Measurements
OG0000
OG0010
OG0020
OG003
Change in Albumin; Event; Developed after CLS
Title
Measurements
OG0000
OG0010
OG0020
OG003
Change in Albumin; Event; No CLS
Title
Measurements
OG0000
OG0010
OG0020
OG003
Change in Albumin; No Event; No CLS
Title
Measurements
OG0001
OG0011
OG0021
OG003
Change in Albumin; No Event; CLS
Title
Measurements
OG0000
OG0010
OG0020
OG003
Edema; Event; Developed no later than CLS
Title
Measurements
OG0000
OG0010
OG0020
OG003
Edema; Event; Developed after CLS
Title
Measurements
OG0000
OG0010
OG0020
OG003
Edema; Event; No CLS
Title
Measurements
OG0000
OG0010
OG0020
OG003
Edema; No Event; No CLS
Title
Measurements
OG0001
OG0011
OG0021
OG003
Edema; No Event; CLS
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hypoxia; Event; Developed no later than CLS
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hypoxia; Event; Developed after CLS
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hypoxia; Event; No CLS
Title
Measurements
OG0001
OG0010
OG0021
OG003
Hypoxia; No Event; No CLS
Title
Measurements
OG0000
OG0011
OG0020
OG003
Hypoxia; No Event; CLS
Title
Measurements
OG0000
OG0010
OG0020
OG003
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0071 events1 affected11 at risk
EG0080 events0 affected6 at risk
EG0093 events3 affected14 at risk
0 events
0 affected
4 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected14 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected14 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected6 at risk
EG0091 events1 affected14 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0071 events1 affected11 at risk
EG0081 events1 affected6 at risk
EG0090 events0 affected14 at risk
1 events
1 affected
4 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected5 at risk
EG0062 events2 affected8 at risk
EG0071 events1 affected11 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected14 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0071 events1 affected11 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected14 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected6 at risk
EG0091 events1 affected14 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected5 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected14 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0052 events1 affected5 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected14 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected6 at risk
EG0091 events1 affected14 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected6 at risk
EG0091 events1 affected14 at risk
1 events
1 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected14 at risk
1 events
1 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected14 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected11 at risk
EG0081 events1 affected6 at risk
EG0090 events0 affected14 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0071 events1 affected11 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected14 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected6 at risk
EG0092 events2 affected14 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected6 at risk
EG0091 events1 affected14 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected11 at risk
EG0081 events1 affected6 at risk
EG0090 events0 affected14 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected6 at risk
EG0091 events1 affected14 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected14 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected5 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected11 at risk
EG0081 events1 affected6 at risk
EG0090 events0 affected14 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0071 events1 affected11 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected14 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0071 events1 affected11 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected14 at risk
0 events
0 affected
4 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected11 at risk
EG0081 events1 affected6 at risk
EG0090 events0 affected14 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected11 at risk
EG0081 events1 affected6 at risk
EG0090 events0 affected14 at risk
0 events
0 affected
4 at risk
EG0043 events2 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected14 at risk
0 events
0 affected
4 at risk
EG0043 events1 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected14 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0071 events1 affected11 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected14 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0071 events1 affected11 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected14 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected14 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0071 events1 affected11 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected14 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected14 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected8 at risk
EG0071 events1 affected11 at risk
EG0080 events0 affected6 at risk
EG0092 events2 affected14 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0052 events1 affected5 at risk
EG0060 events0 affected8 at risk
EG0071 events1 affected11 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected14 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected14 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected14 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected14 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected14 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0062 events1 affected8 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected14 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0071 events1 affected11 at risk
EG0080 events0 affected6 at risk
EG0092 events2 affected14 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected6 at risk
EG0091 events1 affected14 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0071 events1 affected11 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected14 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0071 events1 affected11 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected14 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected14 at risk
0 events
0 affected
4 at risk
EG0042 events2 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected6 at risk
EG0091 events1 affected14 at risk
1 events
1 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected14 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0071 events1 affected11 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected14 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected11 at risk
EG0081 events1 affected6 at risk
EG0090 events0 affected14 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected11 at risk
EG0081 events1 affected6 at risk
EG0090 events0 affected14 at risk
0 events
0 affected
4 at risk
EG0042 events2 affected4 at risk
EG0050 events0 affected5 at risk
EG0062 events2 affected8 at risk
EG0074 events4 affected11 at risk
EG0080 events0 affected6 at risk
EG0092 events2 affected14 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0053 events1 affected5 at risk
EG0067 events3 affected8 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected6 at risk
EG00912 events1 affected14 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0054 events1 affected5 at risk
EG0067 events3 affected8 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected6 at risk
EG00910 events1 affected14 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected5 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected6 at risk
EG0097 events1 affected14 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG00512 events1 affected5 at risk
EG00624 events3 affected8 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected6 at risk
EG00915 events1 affected14 at risk
0 events
0 affected
4 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected6 at risk
EG0092 events1 affected14 at risk
3 events
2 affected
4 at risk
EG0043 events3 affected4 at risk
EG0054 events3 affected5 at risk
EG0062 events2 affected8 at risk
EG0072 events2 affected11 at risk
EG0080 events0 affected6 at risk
EG0094 events3 affected14 at risk
1 events
1 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0073 events3 affected11 at risk
EG0080 events0 affected6 at risk
EG0093 events3 affected14 at risk
1 events
1 affected
4 at risk
EG0041 events1 affected4 at risk
EG0053 events3 affected5 at risk
EG0062 events2 affected8 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected14 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected11 at risk
EG0081 events1 affected6 at risk
EG0090 events0 affected14 at risk
1 events
1 affected
4 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected5 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected6 at risk
EG0093 events3 affected14 at risk
0 events
0 affected
4 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected5 at risk
EG0065 events3 affected8 at risk
EG0074 events4 affected11 at risk
EG0081 events1 affected6 at risk
EG0092 events2 affected14 at risk
1 events
1 affected
4 at risk
EG0047 events2 affected4 at risk
EG0050 events0 affected5 at risk
EG0067 events4 affected8 at risk
EG0072 events2 affected11 at risk
EG0080 events0 affected6 at risk
EG0096 events5 affected14 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected5 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected6 at risk
EG0092 events2 affected14 at risk
1 events
1 affected
4 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected5 at risk
EG0065 events2 affected8 at risk
EG0072 events2 affected11 at risk
EG0080 events0 affected6 at risk
EG0094 events3 affected14 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0073 events3 affected11 at risk
EG0080 events0 affected6 at risk
EG0092 events2 affected14 at risk
1 events
1 affected
4 at risk
EG0040 events0 affected4 at risk
EG0053 events3 affected5 at risk
EG0060 events0 affected8 at risk
EG0074 events4 affected11 at risk
EG0082 events1 affected6 at risk
EG0095 events5 affected14 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected8 at risk
EG0071 events1 affected11 at risk
EG0080 events0 affected6 at risk
EG0092 events2 affected14 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0062 events2 affected8 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected14 at risk
2 events
2 affected
4 at risk
EG0040 events0 affected4 at risk
EG0058 events4 affected5 at risk
EG00610 events2 affected8 at risk
EG0073 events2 affected11 at risk
EG0086 events2 affected6 at risk
EG0098 events3 affected14 at risk
0 events
0 affected
4 at risk
EG0041 events1 affected4 at risk
EG0055 events3 affected5 at risk
EG00610 events5 affected8 at risk
EG0072 events2 affected11 at risk
EG0087 events4 affected6 at risk
EG0095 events2 affected14 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0062 events2 affected8 at risk
EG0070 events0 affected11 at risk
EG0085 events3 affected6 at risk
EG0090 events0 affected14 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected5 at risk
EG0064 events2 affected8 at risk
EG0070 events0 affected11 at risk
EG0083 events2 affected6 at risk
EG0090 events0 affected14 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected5 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected11 at risk
EG0081 events1 affected6 at risk
EG0091 events1 affected14 at risk
3 events
1 affected
4 at risk
EG00420 events3 affected4 at risk
EG00511 events2 affected5 at risk
EG0063 events2 affected8 at risk
EG0075 events3 affected11 at risk
EG0083 events1 affected6 at risk
EG00917 events8 affected14 at risk
2 events
1 affected
4 at risk
EG00423 events4 affected4 at risk
EG00533 events4 affected5 at risk
EG00625 events3 affected8 at risk
EG00739 events6 affected11 at risk
EG00817 events4 affected6 at risk
EG00937 events7 affected14 at risk
8 events
4 affected
4 at risk
EG0046 events2 affected4 at risk
EG0054 events2 affected5 at risk
EG0060 events0 affected8 at risk
EG00715 events7 affected11 at risk
EG0084 events3 affected6 at risk
EG00915 events4 affected14 at risk
16 events
3 affected
4 at risk
EG00410 events2 affected4 at risk
EG0055 events3 affected5 at risk
EG0068 events1 affected8 at risk
EG0078 events4 affected11 at risk
EG00811 events2 affected6 at risk
EG00943 events8 affected14 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0062 events2 affected8 at risk
EG0071 events1 affected11 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected14 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0053 events1 affected5 at risk
EG0065 events3 affected8 at risk
EG0070 events0 affected11 at risk
EG0081 events1 affected6 at risk
EG00913 events2 affected14 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0063 events1 affected8 at risk
EG0071 events1 affected11 at risk
EG0081 events1 affected6 at risk
EG0090 events0 affected14 at risk
0 events
0 affected
4 at risk
EG0047 events3 affected4 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected8 at risk
EG0072 events2 affected11 at risk
EG0082 events1 affected6 at risk
EG0094 events2 affected14 at risk
0 events
0 affected
4 at risk
EG0041 events1 affected4 at risk
EG0052 events1 affected5 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected11 at risk
EG0081 events1 affected6 at risk
EG0096 events1 affected14 at risk
3 events
1 affected
4 at risk
EG0040 events0 affected4 at risk
EG0053 events2 affected5 at risk
EG0065 events4 affected8 at risk
EG0073 events1 affected11 at risk
EG0080 events0 affected6 at risk
EG0094 events1 affected14 at risk
1 events
1 affected
4 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected5 at risk
EG0063 events3 affected8 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected14 at risk
0 events
0 affected
4 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0073 events3 affected11 at risk
EG0080 events0 affected6 at risk
EG0093 events3 affected14 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0073 events3 affected11 at risk
EG0080 events0 affected6 at risk
EG0091 events1 affected14 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0062 events1 affected8 at risk
EG0072 events2 affected11 at risk
EG0080 events0 affected6 at risk
EG0091 events1 affected14 at risk
1 events
1 affected
4 at risk
EG0042 events1 affected4 at risk
EG0055 events2 affected5 at risk
EG0063 events1 affected8 at risk
EG0076 events4 affected11 at risk
EG0082 events2 affected6 at risk
EG00910 events7 affected14 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected8 at risk
EG0071 events1 affected11 at risk
EG0081 events1 affected6 at risk
EG0092 events2 affected14 at risk
0 events
0 affected
4 at risk
EG0042 events2 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0071 events1 affected11 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected14 at risk
0 events
0 affected
4 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected6 at risk
EG0097 events4 affected14 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected11 at risk
EG0081 events1 affected6 at risk
EG0092 events2 affected14 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0071 events1 affected11 at risk
EG0080 events0 affected6 at risk
EG0093 events2 affected14 at risk
0 events
0 affected
4 at risk
EG0041 events1 affected4 at risk
EG0051 events1 affected5 at risk
EG0060 events0 affected8 at risk
EG0071 events1 affected11 at risk
EG0080 events0 affected6 at risk
EG0091 events1 affected14 at risk
0 events
0 affected
4 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected6 at risk
EG0091 events1 affected14 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0052 events1 affected5 at risk
EG0062 events1 affected8 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected6 at risk
EG0092 events2 affected14 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0071 events1 affected11 at risk
EG0080 events0 affected6 at risk
EG0093 events2 affected14 at risk
1 events
1 affected
4 at risk
EG0041 events1 affected4 at risk
EG0053 events2 affected5 at risk
EG0061 events1 affected8 at risk
EG0072 events2 affected11 at risk
EG0082 events1 affected6 at risk
EG0097 events4 affected14 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0075 events4 affected11 at risk
EG0081 events1 affected6 at risk
EG0096 events4 affected14 at risk
1 events
1 affected
4 at risk
EG0043 events3 affected4 at risk
EG0052 events2 affected5 at risk
EG0060 events0 affected8 at risk
EG0073 events2 affected11 at risk
EG0085 events2 affected6 at risk
EG00915 events7 affected14 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected6 at risk
EG0096 events1 affected14 at risk
0 events
0 affected
4 at risk
EG0042 events2 affected4 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected8 at risk
EG0071 events1 affected11 at risk
EG0083 events1 affected6 at risk
EG00913 events6 affected14 at risk
8 events
3 affected
4 at risk
EG00411 events4 affected4 at risk
EG0057 events3 affected5 at risk
EG00610 events2 affected8 at risk
EG0079 events4 affected11 at risk
EG00812 events2 affected6 at risk
EG00938 events8 affected14 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected8 at risk
EG0071 events1 affected11 at risk
EG0080 events0 affected6 at risk
EG0095 events1 affected14 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0063 events2 affected8 at risk
EG0070 events0 affected11 at risk
EG0082 events2 affected6 at risk
EG0091 events1 affected14 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0064 events4 affected8 at risk
EG0070 events0 affected11 at risk
EG0081 events1 affected6 at risk
EG0098 events1 affected14 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected5 at risk
EG0063 events2 affected8 at risk
EG0071 events1 affected11 at risk
EG0081 events1 affected6 at risk
EG0092 events2 affected14 at risk
0 events
0 affected
4 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected8 at risk
EG0071 events1 affected11 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected14 at risk
0 events
0 affected
4 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected11 at risk
EG0082 events2 affected6 at risk
EG0091 events1 affected14 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected5 at risk
EG0061 events1 affected8 at risk
EG0071 events1 affected11 at risk
EG0081 events1 affected6 at risk
EG0090 events0 affected14 at risk
0 events
0 affected
4 at risk
EG0043 events2 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0071 events1 affected11 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected14 at risk
0 events
0 affected
4 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0073 events2 affected11 at risk
EG0081 events1 affected6 at risk
EG0094 events1 affected14 at risk
0 events
0 affected
4 at risk
EG0041 events1 affected4 at risk
EG0051 events1 affected5 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected11 at risk
EG0081 events1 affected6 at risk
EG0094 events2 affected14 at risk
1 events
1 affected
4 at risk
EG0042 events2 affected4 at risk
EG0053 events1 affected5 at risk
EG0060 events0 affected8 at risk
EG0072 events2 affected11 at risk
EG0081 events1 affected6 at risk
EG0092 events1 affected14 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0071 events1 affected11 at risk
EG0080 events0 affected6 at risk
EG0092 events2 affected14 at risk
1 events
1 affected
4 at risk
EG0042 events1 affected4 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected8 at risk
EG0071 events1 affected11 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected14 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected5 at risk
EG0061 events1 affected8 at risk
EG0071 events1 affected11 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected14 at risk
1 events
1 affected
4 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected6 at risk
EG0092 events2 affected14 at risk
0 events
0 affected
4 at risk
EG0041 events1 affected4 at risk
EG0051 events1 affected5 at risk
EG0061 events1 affected8 at risk
EG0071 events1 affected11 at risk
EG0080 events0 affected6 at risk
EG0092 events2 affected14 at risk
1 events
1 affected
4 at risk
EG0040 events0 affected4 at risk
EG0054 events2 affected5 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected11 at risk
EG0082 events1 affected6 at risk
EG0091 events1 affected14 at risk
0 events
0 affected
4 at risk
EG0042 events2 affected4 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected8 at risk
EG0073 events3 affected11 at risk
EG0081 events1 affected6 at risk
EG0099 events5 affected14 at risk
0 events
0 affected
4 at risk
EG0041 events1 affected4 at risk
EG0053 events2 affected5 at risk
EG0062 events2 affected8 at risk
EG0071 events1 affected11 at risk
EG0081 events1 affected6 at risk
EG0091 events1 affected14 at risk
4
OG0043
OG0052
OG0065
OG0077
OG0084
OG0099
0
OG0040
OG0050
OG0061
OG0070
OG0080
OG0090
0
OG0041
OG0051
OG0060
OG0071
OG0080
OG0091
0
OG0040
OG0050
OG0060
OG0071
OG0080
OG0090
0
OG0041
OG0050
OG0060
OG0070
OG0080
OG0091
2
OG0044
OG0052
OG0062
OG0072
OG0082
OG0097
0
OG0041
OG0050
OG0060
OG0071
OG0080
OG0094
0
OG0040
OG0051
OG0060
OG0070
OG0080
OG0092
1
OG0041
OG0050
OG0061
OG0071
OG0080
OG0090
0
OG0042
OG0050
OG0061
OG0073
OG0081
OG0095
0
OG0041
OG0052
OG0062
OG0072
OG0081
OG0091
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0093
0
OG0040
OG0051
OG0063
OG0070
OG0080
OG0091
0
OG0040
OG0051
OG0063
OG0070
OG0080
OG0091
0
OG0040
OG0051
OG0060
OG0070
OG0080
OG0091
0
OG0040
OG0051
OG0063
OG0071
OG0080
OG0091
0
OG0041
OG0053
OG0065
OG0072
OG0084
OG0092
0
OG0042
OG0050
OG0061
OG0071
OG0081
OG0096
0
OG0040
OG0050
OG0062
OG0070
OG0083
OG0090
0
OG0040
OG0051
OG0062
OG0070
OG0082
OG0090
0
OG0040
OG0051
OG0063
OG0070
OG0081
OG0092
0
OG0040
OG0050
OG0061
OG0071
OG0081
OG0090
0
OG0043
OG0050
OG0061
OG0072
OG0081
OG0092
0
OG0041
OG0051
OG0060
OG0070
OG0081
OG0091
1
OG0040
OG0052
OG0064
OG0071
OG0080
OG0091
0
OG0040
OG0050
OG0061
OG0071
OG0080
OG0091
0
OG0040
OG0050
OG0062
OG0070
OG0082
OG0091
0
OG0040
OG0050
OG0064
OG0070
OG0081
OG0091
NA
± NA
No data available at end of treatment so change from baseline to end of treatment cannot be calculated
OG004-26.0± NAOf the 4 subjects with data, only 1 subject had analyzable data at baseline and end of treatment so SD is not applicable
OG005NA± NANo data available at end of treatment so change from baseline to end of treatment cannot be calculated
OG006NA± NANo data available at end of treatment so change from baseline to end of treatment cannot be calculated
OG007NA± NANo data available at end of treatment so change from baseline to end of treatment cannot be calculated
OG008NA± NANo data available at end of treatment so change from baseline to end of treatment cannot be calculated
OG009NA± NANo data available at end of treatment so change from baseline to end of treatment cannot be calculated
NA
± NA
No data available at end of treatment so change from baseline to end of treatment cannot be calculated
OG00429.0± NAOf the 4 subjects with data, only 1 subject had analyzable data at baseline and end of treatment so SD is not applicable
OG005NA± NANo data available at end of treatment so change from baseline to end of treatment cannot be calculated
OG006NA± NANo data available at end of treatment so change from baseline to end of treatment cannot be calculated
OG007NA± NANo data available at end of treatment so change from baseline to end of treatment cannot be calculated
OG008NA± NANo data available at end of treatment so change from baseline to end of treatment cannot be calculated
OG009NA± NANo data available at end of treatment so change from baseline to end of treatment cannot be calculated