A Dose-escalation Study to Evaluate the Safety, Tolerabil... | NCT00816361 | Trialant
NCT00816361
Sponsor
MedImmune LLC
Status
Completed
Last Update Posted
Mar 4, 2019Actual
Enrollment
43Actual
Phase
Phase 1
Conditions
Cancer
Interventions
MEDI-573
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT00816361
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
MI-CP184
Secondary IDs
Not provided
Brief Title
A Dose-escalation Study to Evaluate the Safety, Tolerability, and Antitumor Activity of MEDI-573 in Subjects With Advanced Solid Tumors
Official Title
A Phase 1, Multicenter, Open-label, Single-arm, Dose-escalation Study to Evaluate the Safety, Tolerability, and Antitumor Activity of MEDI-573, a Fully Human Monoclonal Antibody Directed Against Insulin-like Growth Factors I and II, in Subjects With Advanced Solid Tumors Refractory to Standard Therapy or for Which No Standard Therapy Exists
Acronym
Not provided
Organization
MedImmune LLCINDUSTRY
Status Module
Record Verification Date
Oct 2018
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Mar 9, 2009Actual
Primary Completion Date
Sep 11, 2012Actual
Completion Date
Sep 11, 2012Actual
First Submitted Date
Dec 23, 2008
First Submission Date that Met QC Criteria
Dec 30, 2008
First Posted Date
Jan 1, 2009Estimated
Results Waived
Not provided
Results First Submitted Date
Feb 5, 2018
Results First Submitted that Met QC Criteria
Oct 31, 2018
Results First Posted Date
Mar 4, 2019Actual
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
Oct 31, 2018
Last Update Posted Date
Mar 4, 2019Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
MedImmune LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
Evaluate the safety and tolerability of MEDI-573 in adult subjects with advanced solid tumors refractory to standard therapy or for which no standard therapy exists.
Detailed Description
Not provided
Conditions Module
Conditions
Cancer
Keywords
Not provided
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
43Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
MEDI-573 0.5 mg/Kg QWk Dose Escalation
Experimental
Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) as a 60-minute intravenous (IV) infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
Drug: MEDI-573
MEDI-573 1.5 mg/Kg QWk Dose Escalation
Experimental
Participants received MEDI-573 1.5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
Drug: MEDI-573
MEDI-573 5 mg/Kg QWk Dose Escalation
Experimental
Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
Drug: MEDI-573
MEDI-573 10 mg/Kg QWk Dose Escalation
Experimental
Participants received MEDI-573 10 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
Drug: MEDI-573
MEDI-573 15 mg/Kg QWk Dose Escalation
Experimental
Interventions
Name
Type
Description
Arm Group Labels
Other Names
MEDI-573
Drug
Administered at a dose determined by the subject's enrollment cohort as an IV infusion as part of a 21 day treatment cycle.
MEDI-573 0.5 mg/Kg QWk Dose Escalation
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs)
AEs were any unfavorable and unintended signs (including abnormal laboratory findings), symptoms, or diseases temporally associated with the use of MEDI-573, whether or not considered related to MEDI-573. A SAE was any AE that resulted in: death; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability or incapacity; was life-threatening; was a congenital anomaly/birth defect in the offspring of a study participant; or was an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgment, may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes above. TEAEs were defined as AEs present at baseline that worsened in intensity after administration of MEDI-573, or events absent at baseline that emerged after administration of MEDI-573, up to 30 days after the last dose.
From the start of study treatment through 30 days after the last dose of MEDI-573, up to 3.5 years
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
An abnormal laboratory finding that was judged by the investigator to be medically significant was reported as an AE. TEAEs were defined as events present at baseline that worsened in intensity after administration of MEDI-573, or events absent at baseline that emerged after administration of MEDI-573, for the period extending to 30 days after the last dose.
From the start of study treatment through 30 days after the last dose of MEDI-573, up to 3.5 years
Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as TEAEs
Vital signs and physical findings included parameters such as heart rate, blood pressure, temperature, and respiratory rate. TEAEs were defined as events present at baseline that worsened in intensity after administration of MEDI-573 or events absent at baseline that emerged after administration of MEDI-573, for the period extending to 30 days after the last dose.
Secondary Outcomes
Measure
Description
Time Frame
Maximum Observed Serum Concentration (Cmax) After the First Dose
The Cmax was the maximum observed serum concentration of MEDI-573.
For weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); For 3 weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); and on Days 8 and 15
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed advanced solid tumor for which no curative or standard therapies exist.
Karnofsky Performance Status ≥60.
Adequate hematological function.
Adequate organ function.
Women of non-child-bearing potential (defined as being >1 year post-menopausal) or using effective contraception, e.g., use of oral contraceptives with an additional barrier method (since the investigational product may impair the effectiveness of oral contraceptives), double barrier methods (diaphragm with spermicidal gel or condoms with contraceptive foam), Depo-Provera, partner vasectomy, or total abstinence, from the time the informed consent is signed through 30 days after the last dose of MEDI-573. Male subjects with partners of child-bearing potential must be surgically sterile or use contraceptive method as described above from the time of the initiation of MEDI-573 through 30 days after the last dose of MEDI-573.
Exclusion Criteria:
No prior treatment within 4 weeks of study drug administration.
No concurrent therapy for treatment of cancer.
No uncontrolled diabetes.
New York Heart Association Grade ≥ 2 congestive heart failure.
History of myocardial infarction, unstable angina, transient ischemic attack or stroke within the previous 6 months prior to study entry.
Documented brain metastasis.
Pregnancy or lactation or plans to become pregnant while on study.
A total of 43 participants ((23 participants in dose-escalation phase and 20 participants in dose-expansion phase) were entered in the study and received the study treatment.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
MEDI-573 0.5 mg/Kg QWk Dose Escalation
Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) as a 60-minute intravenous (IV) infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
FG001
MEDI-573 1.5 mg/Kg QWk Dose Escalation
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
0
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
Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
Drug: MEDI-573
MEDI-573 30 mg/Kg Q3Wk Dose Escalation
Experimental
Participants received MEDI-573 30 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
Drug: MEDI-573
MEDI-573 45 mg/Kg Q3Wk Dose Escalation
Experimental
Participants received MEDI-573 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
Drug: MEDI-573
MEDI-573 5 mg/Kg QWk Dose Expansion
Experimental
Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
Drug: MEDI-573
MEDI-573 15 mg/Kg QWk Dose Expansion
Experimental
Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
Drug: MEDI-573
MEDI-573 1.5 mg/Kg QWk Dose Escalation
MEDI-573 10 mg/Kg QWk Dose Escalation
MEDI-573 15 mg/Kg QWk Dose Escalation
MEDI-573 15 mg/Kg QWk Dose Expansion
MEDI-573 30 mg/Kg Q3Wk Dose Escalation
MEDI-573 45 mg/Kg Q3Wk Dose Escalation
MEDI-573 5 mg/Kg QWk Dose Escalation
MEDI-573 5 mg/Kg QWk Dose Expansion
From the start of study treatment through 30 days after the last dose of MEDI-573, up to 3.5 years
Maximum Tolerated Dose (MTD) of MEDI-573
The MTD was defined as the highest dose that can be safely administered to participants and was determined by the number of participants in each cohort with a dose-limiting toxicity (DLT). The number and proportion of participants in each dose cohort and the number of participants with a DLT was presented using the total number of participants in the MTD Evaluable Population as the denominator. 2 participants from Cohorts 0.5 and 5 mg/kg QWk (1 in each cohort) did not complete the DLT period and therefore not evaluable for MTD.
Cycle 1 Day 1 through Cycle 1 Day 21
Number of Participants With Dose-Limiting Toxicities (DLTs)
A DLT was defined as any grade greater than or equal to (>=) 3 treatment-related non-hematologic toxicity that occurred during the DLT assessment period with the following exceptions: Grade less than (<) 4 serum-high glucose (fasting) with duration of < 24 hours; Grade 3 fever (in the absence of neutropenia) defined as > 40.0 degree centigrade (°C) [greater than (>) 104.0°F] that resolved to normal or baseline within 24 hours of treatment and was not considered an SAE; or Grade 3 rigors/chills that responded to optimal therapy; any Grade >= 3 treatment-related hematologic toxicity that occurred during the DLT assessment period.
Cycle 1 Day 1 through Cycle 1 Day 21
Optimal Biologically Effective Dose (OBED) of MEDI-573
The OBED was defined as the dose at which all circulating insulin-like growth factor (IGF)-1 and IGF-2 ligand was sequestered by MEDI-573.
From the start of study treatment through 30 days after the last dose of MEDI-573, up to 3.5 years
Time to Reach Maximum Observed Concentration (Tmax) After the First Dose
The tmax was defined as actual sampling time to reach the maximum observed serum concentration of MEDI-573.
For weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); For 3 weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); and on Days 8 and 15
Trough Serum Concentration (Ctrough) After the First Dose
The Ctrough was the lowest serum concentration of MEDI-573 within a dosing interval.
For weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); For 3 weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); and on Days 8 and 15
Dose Normalized Cmax (Cmax/Dose) After the First Dose
The Cmax/dose was the dose-normalized maximum serum concentration of MEDI-573.
For weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); For 3 weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); and on Days 8 and 15
Area Under the Serum Concentration-time Curve Over the First Dosing Interval (AUCτ)
Area under the serum concentration-time curve over the first dosing interval.
For weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); For 3 weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); and on Days 8 and 15
Dose-normalized Area Under the Serum Concentration Time Curve Over the First Dosing Interval (AUCτ/Dose)
The AUCtau/dose was a measure of dose-normalized area under the serum concentration-time curve over the first dosing interval.
For weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); For 3 weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); and on Days 8 and 15
Number of Participants With Positive Anti-Drug Antibodies (ADA) to MEDI-573
Two methods were used to assess the immunogenicity data: an ECL-based method and measurement of neutralizing ADA. The titer was calculated by multiplying the minimum assay dilution factor by the reciprocal of the highest dilution factor which yielded an ECL multiple equal to or greater than the screening assay cut-point factor.
Pre-infusion on Day 1 of each cycle, end of treatment, and 90 days after last dose MEDI-573 (up to 3.5 years)
Objective Response Rate (ORR)
The ORR was defined as the proportion of participants with confirmed complete response (CR) or partial response (PR) according to the RECIST criteria The CR was defined as disappearance of all target and nontarget lesions and no new lesions; and PR was definded as >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline [screening]) and no new lesions.
From study entry through the end of the study, up to 3.5 years
Progression-free Survival (PFS)
Progression-free survival (PFS) was defined as the duration from the start of treatment with MEDI-573 until the documentation of disease progression or death due to any cause, whichever occurred first.
From study entry through the end of the study, up to 3.5 years
Time to Progression
Time to disease progression (TTP) was defined as the duration from the start of treatment with MEDI-573 until the documentation of disease progression.
From study entry through the end of the study, up to 3.5 years
Overall Survival
Overall survival (OS) was defined as the time from the start of treatment with MEDI-573 until death.
From study entry through the end of the study, up to 3.5 years
Time to Response (TTR)
Time to response was defined as the duration from the start of treatment with MEDI-573 to the first documentation of objective response (confirmed CR or PR) and was only assessed in participants who had achieved objective response.
From study entry through the end of the study, up to 3.5 years
Duration of Response
Duration of response was defined as the duration from the first documentation of objective response (confirmed CR or PR) to the first documented disease progression.
From study entry through the end of the study, up to 3.5 years
Suppression Profiles of IGF-I and IGF-II Post-Administration of MEDI-573
The suppression profiles of both IGF-1 and IGF-2 post administration of MEDI-573 in relation to time course of antibody concentrations in serum were evaluated during treatment.
From the start of study treatment through 30 days after the last dose of MEDI-573, up to 3.5 years
Jacksonville
Florida
32224
United States
Research Site
Boston
Massachusetts
02115
United States
Research Site
Detroit
Michigan
48201
United States
Research Site
Rochester
Minnesota
55905
United States
Research Site
Philadelphia
Pennsylvania
19111
United States
Participants received MEDI-573 1.5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
FG002
MEDI-573 5 mg/Kg QWk Dose Escalation
Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
FG003
MEDI-573 10 mg/Kg QWk Dose Escalation
Participants received MEDI-573 10 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
FG004
MEDI-573 15 mg/Kg QWk Dose Escalation
Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
FG005
MEDI-573 30 mg/Kg Q3Wk Dose Escalation
Participants received MEDI-573 30 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
FG006
MEDI-573 45 mg/Kg Q3Wk Dose Escalation
Participants received MEDI-573 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
FG007
MEDI-573 5 mg/Kg QWk Dose Expansion
Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
FG008
MEDI-573 15 mg/Kg QWk Dose Expansion
Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
FG0004 subjects
FG0013 subjects
FG0024 subjects
FG0033 subjects
FG0043 subjects
FG0053 subjects
FG0063 subjects
FG00710 subjects
FG00810 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
NOT COMPLETED
FG0004 subjects
FG0013 subjects
FG0023 subjects
FG0033 subjects
FG0042 subjects
FG0053 subjects
FG0063 subjects
FG0079 subjects
FG00810 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0052 subjects
FG0060 subjects
FG0072 subjects
FG0081 subjects
Death
FG0004 subjects
FG0013 subjects
FG0023 subjects
FG0033 subjects
FG004
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Safety Population included all participants who had received any MEDI-573 treatment.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
MEDI-573 0.5 mg/Kg QWk Dose Escalation
Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) as a 60-minute intravenous (IV) infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
BG001
MEDI-573 1.5 mg/Kg QWk Dose Escalation
Participants received MEDI-573 1.5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
BG002
MEDI-573 5 mg/Kg QWk Dose Escalation and Expansion
Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
BG003
MEDI-573 10 mg/Kg QWk Dose Escalation
Participants received MEDI-573 10 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
BG004
MEDI-573 15 mg/Kg QWk Dose Escalation and Expansion
Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
BG005
MEDI-573 30 mg/Kg Q3Wk Dose Escalation
Participants received MEDI-573 30 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
BG006
MEDI-573 45 mg/Kg Q3Wk Dose Escalation
Participants received MEDI-573 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
BG007
TOTAL
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0004
BG0013
BG00214
BG0033
BG00413
BG0053
BG0063
BG00743
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
BG00053.8± 12.2
BG00167.0± 8.7
BG00264.5± 13.7
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0004
BG0011
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs)
AEs were any unfavorable and unintended signs (including abnormal laboratory findings), symptoms, or diseases temporally associated with the use of MEDI-573, whether or not considered related to MEDI-573. A SAE was any AE that resulted in: death; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability or incapacity; was life-threatening; was a congenital anomaly/birth defect in the offspring of a study participant; or was an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgment, may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes above. TEAEs were defined as AEs present at baseline that worsened in intensity after administration of MEDI-573, or events absent at baseline that emerged after administration of MEDI-573, up to 30 days after the last dose.
The Safety Population included all participants who had received any MEDI-573 treatment.
Posted
Count of Participants
Participants
From the start of study treatment through 30 days after the last dose of MEDI-573, up to 3.5 years
ID
Title
Description
OG000
MEDI-573 0.5 mg/Kg QWk Dose Escalation
Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) as a 60-minute intravenous (IV) infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG001
MEDI-573 1.5 mg/Kg QWk Dose Escalation
Participants received MEDI-573 1.5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG002
MEDI-573 5 mg/Kg QWk Dose Escalation and Expansion
Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG003
MEDI-573 10 mg/Kg QWk Dose Escalation
Participants received MEDI-573 10 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG004
MEDI-573 15 mg/Kg QWk Dose Escalation and Expansion
Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG005
MEDI-573 30 mg/Kg Q3Wk Dose Escalation
Participants received MEDI-573 30 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
Units
Counts
Participants
OG0004
OG0013
OG00214
OG003
Title
Denominators
Categories
TEAEs
Title
Measurements
OG0004
OG0013
OG00213
OG003
Primary
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
An abnormal laboratory finding that was judged by the investigator to be medically significant was reported as an AE. TEAEs were defined as events present at baseline that worsened in intensity after administration of MEDI-573, or events absent at baseline that emerged after administration of MEDI-573, for the period extending to 30 days after the last dose.
The Safety Population included all participants who had received any MEDI-573 treatment.
Posted
Count of Participants
Participants
From the start of study treatment through 30 days after the last dose of MEDI-573, up to 3.5 years
ID
Title
Description
OG000
MEDI-573 0.5 mg/Kg QWk Dose Escalation
Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) as a 60-minute intravenous (IV) infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG001
MEDI-573 1.5 mg/Kg QWk Dose Escalation
Participants received MEDI-573 1.5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG002
MEDI-573 5 mg/Kg QWk Dose Escalation and Expansion
Primary
Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as TEAEs
Vital signs and physical findings included parameters such as heart rate, blood pressure, temperature, and respiratory rate. TEAEs were defined as events present at baseline that worsened in intensity after administration of MEDI-573 or events absent at baseline that emerged after administration of MEDI-573, for the period extending to 30 days after the last dose.
The Safety Population included all participants who had received any MEDI-573 treatment.
Posted
Count of Participants
Participants
From the start of study treatment through 30 days after the last dose of MEDI-573, up to 3.5 years
ID
Title
Description
OG000
MEDI-573 0.5 mg/Kg QWk Dose Escalation
Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) as a 60-minute intravenous (IV) infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG001
MEDI-573 1.5 mg/Kg QWk Dose Escalation
Participants received MEDI-573 1.5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG002
MEDI-573 5 mg/Kg QWk Dose Escalation and Expansion
Primary
Maximum Tolerated Dose (MTD) of MEDI-573
The MTD was defined as the highest dose that can be safely administered to participants and was determined by the number of participants in each cohort with a dose-limiting toxicity (DLT). The number and proportion of participants in each dose cohort and the number of participants with a DLT was presented using the total number of participants in the MTD Evaluable Population as the denominator. 2 participants from Cohorts 0.5 and 5 mg/kg QWk (1 in each cohort) did not complete the DLT period and therefore not evaluable for MTD.
MTD Evaluable Population included all participants in dose-escalation phase who had received at least 1 full cycle of MEDI-573 and completed safety follow-up through DLT period (Cycle 1 Day 1 through Cycle 1 Day 21), or who experienced a DLT. Two participants did not receive a full cycle of MEDI-573 and therefore excluded from MTD population.
Posted
Number
mg/kg
Cycle 1 Day 1 through Cycle 1 Day 21
ID
Title
Description
OG000
MEDI-573 Dose Escalation
Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) up to 15 mg/kg as a 60-minute intravenous (IV) infusion once every 7 days or up to 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
Units
Counts
Participants
Primary
Number of Participants With Dose-Limiting Toxicities (DLTs)
A DLT was defined as any grade greater than or equal to (>=) 3 treatment-related non-hematologic toxicity that occurred during the DLT assessment period with the following exceptions: Grade less than (<) 4 serum-high glucose (fasting) with duration of < 24 hours; Grade 3 fever (in the absence of neutropenia) defined as > 40.0 degree centigrade (°C) [greater than (>) 104.0°F] that resolved to normal or baseline within 24 hours of treatment and was not considered an SAE; or Grade 3 rigors/chills that responded to optimal therapy; any Grade >= 3 treatment-related hematologic toxicity that occurred during the DLT assessment period.
The Safety Population included all participants who had received any MEDI-573 treatment.
Posted
Number
Participants
Cycle 1 Day 1 through Cycle 1 Day 21
ID
Title
Description
OG000
MEDI-573 0.5 mg/Kg QWk Dose Escalation
Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) as a 60-minute intravenous (IV) infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG001
MEDI-573 1.5 mg/Kg QWk Dose Escalation
Participants received MEDI-573 1.5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
Primary
Optimal Biologically Effective Dose (OBED) of MEDI-573
The OBED was defined as the dose at which all circulating insulin-like growth factor (IGF)-1 and IGF-2 ligand was sequestered by MEDI-573.
Safety population: Participants in the dose-escalation phase were analyzed for this outcome measure.
Posted
Number
mg/kg
From the start of study treatment through 30 days after the last dose of MEDI-573, up to 3.5 years
ID
Title
Description
OG000
MEDI-573 Dose Escalation
Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) up to 15 mg/kg as a 60-minute intravenous (IV) infusion once every 7 days or up to 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
Units
Counts
Participants
OG000
Secondary
Maximum Observed Serum Concentration (Cmax) After the First Dose
The Cmax was the maximum observed serum concentration of MEDI-573.
The Safety Population included all participants who had received any MEDI-573 treatment. Here, "N" is number of participants analyzed for this outcome measure.
Posted
Mean
Standard Deviation
microgram per milliliter (mcg/mL)
For weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); For 3 weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); and on Days 8 and 15
ID
Title
Description
OG000
MEDI-573 0.5 mg/Kg QWk Dose Escalation
Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) as a 60-minute intravenous (IV) infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG001
MEDI-573 1.5 mg/Kg QWk Dose Escalation
Participants received MEDI-573 1.5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG002
MEDI-573 5 mg/Kg QWk Dose Escalation
Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
Secondary
Time to Reach Maximum Observed Concentration (Tmax) After the First Dose
The tmax was defined as actual sampling time to reach the maximum observed serum concentration of MEDI-573.
The Safety Population included all participants who had received any MEDI-573 treatment. Here, "N" is number of participants analyzed for this outcome measure.
Posted
Median
Full Range
Day
For weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); For 3 weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); and on Days 8 and 15
ID
Title
Description
OG000
MEDI-573 0.5 mg/Kg QWk Dose Escalation
Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) as a 60-minute intravenous (IV) infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG001
MEDI-573 1.5 mg/Kg QWk Dose Escalation
Participants received MEDI-573 1.5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG002
MEDI-573 5 mg/Kg QWk Dose Escalation
Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
Secondary
Trough Serum Concentration (Ctrough) After the First Dose
The Ctrough was the lowest serum concentration of MEDI-573 within a dosing interval.
The Safety Population included all participants who had received any MEDI-573 treatment. Here, "N" is number of participants analyzed for this outcome measure.
Posted
Mean
Standard Deviation
mcg/mL
For weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); For 3 weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); and on Days 8 and 15
ID
Title
Description
OG000
MEDI-573 0.5 mg/Kg QWk Dose Escalation
Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) as a 60-minute intravenous (IV) infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG001
MEDI-573 1.5 mg/Kg QWk Dose Escalation
Participants received MEDI-573 1.5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG002
MEDI-573 5 mg/Kg QWk Dose Escalation
Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
Secondary
Dose Normalized Cmax (Cmax/Dose) After the First Dose
The Cmax/dose was the dose-normalized maximum serum concentration of MEDI-573.
The Safety Population included all participants who had received any MEDI-573 treatment. Here, "N" is number of participants analyzed for this outcome measure.
Posted
Mean
Standard Deviation
mcg/mL/mg
For weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); For 3 weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); and on Days 8 and 15
ID
Title
Description
OG000
MEDI-573 0.5 mg/Kg QWk Dose Escalation
Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) as a 60-minute intravenous (IV) infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG001
MEDI-573 1.5 mg/Kg QWk Dose Escalation
Participants received MEDI-573 1.5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG002
MEDI-573 5 mg/Kg QWk Dose Escalation
Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
Secondary
Area Under the Serum Concentration-time Curve Over the First Dosing Interval (AUCτ)
Area under the serum concentration-time curve over the first dosing interval.
The Safety Population included all participants who had received any MEDI-573 treatment. Here, "N" is number of participants analyzed for this outcome measure.
Posted
Mean
Standard Deviation
mcg*day/mL
For weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); For 3 weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); and on Days 8 and 15
ID
Title
Description
OG000
MEDI-573 0.5 mg/Kg QWk Dose Escalation
Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) as a 60-minute intravenous (IV) infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG001
MEDI-573 1.5 mg/Kg QWk Dose Escalation
Participants received MEDI-573 1.5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG002
MEDI-573 5 mg/Kg QWk Dose Escalation
Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
Secondary
Dose-normalized Area Under the Serum Concentration Time Curve Over the First Dosing Interval (AUCτ/Dose)
The AUCtau/dose was a measure of dose-normalized area under the serum concentration-time curve over the first dosing interval.
The Safety Population included all participants who had received any MEDI-573 treatment. Here, "N" is number of participants analyzed for this outcome measure.
Posted
Mean
Standard Deviation
mcg*day/mL/mg
For weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); For 3 weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); and on Days 8 and 15
ID
Title
Description
OG000
MEDI-573 0.5 mg/Kg QWk Dose Escalation
Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) as a 60-minute intravenous (IV) infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG001
MEDI-573 1.5 mg/Kg QWk Dose Escalation
Participants received MEDI-573 1.5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG002
MEDI-573 5 mg/Kg QWk Dose Escalation
Secondary
Number of Participants With Positive Anti-Drug Antibodies (ADA) to MEDI-573
Two methods were used to assess the immunogenicity data: an ECL-based method and measurement of neutralizing ADA. The titer was calculated by multiplying the minimum assay dilution factor by the reciprocal of the highest dilution factor which yielded an ECL multiple equal to or greater than the screening assay cut-point factor.
The Safety Population included all participants who had received any MEDI-573 treatment. Here, "N" is number of participants analyzed for this outcome measure.
Posted
Count of Participants
Participants
Pre-infusion on Day 1 of each cycle, end of treatment, and 90 days after last dose MEDI-573 (up to 3.5 years)
ID
Title
Description
OG000
MEDI-573 0.5 mg/Kg QWk Dose Escalation
Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) as a 60-minute intravenous (IV) infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG001
MEDI-573 1.5 mg/Kg QWk Dose Escalation
Participants received MEDI-573 1.5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG002
MEDI-573 5 mg/Kg QWk Dose Escalation
Secondary
Objective Response Rate (ORR)
The ORR was defined as the proportion of participants with confirmed complete response (CR) or partial response (PR) according to the RECIST criteria The CR was defined as disappearance of all target and nontarget lesions and no new lesions; and PR was definded as >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline [screening]) and no new lesions.
The Efficacy Evaluable Population included all participants who received MEDI-573 and had at least one tumor assessment after the initiation of treatment. Participants in the dose-expansion phase were to have at least 1 lesion that was measurable using RECIST criteria, and a histologically confirmed diagnosis of advanced urothelial carcinoma.
Posted
Number
Percentage of Participants
From study entry through the end of the study, up to 3.5 years
ID
Title
Description
OG000
MEDI-573 0.5 mg/Kg QWk Dose Escalation
Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) as a 60-minute intravenous (IV) infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG001
MEDI-573 1.5 mg/Kg QWk Dose Escalation
Participants received MEDI-573 1.5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
Secondary
Progression-free Survival (PFS)
Progression-free survival (PFS) was defined as the duration from the start of treatment with MEDI-573 until the documentation of disease progression or death due to any cause, whichever occurred first.
Efficacy Evaluable Population included all participants who received MEDI-573 and had at least 1 tumor assessment after initiation of treatment. Participants in dose-expansion phase had at least 1 measurable lesion and histologically diagnosis of advanced urothelial carcinoma. Here, "N" is number of participants analyzed for this outcome measure.
Posted
Median
95% Confidence Interval
Months
From study entry through the end of the study, up to 3.5 years
ID
Title
Description
OG000
MEDI-573 0.5 mg/Kg QWk Dose Escalation
Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) as a 60-minute intravenous (IV) infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG001
MEDI-573 1.5 mg/Kg QWk Dose Escalation
Participants received MEDI-573 1.5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG002
MEDI-573 5 mg/Kg QWk Dose Escalation and Expansion
Secondary
Time to Progression
Time to disease progression (TTP) was defined as the duration from the start of treatment with MEDI-573 until the documentation of disease progression.
Efficacy Evaluable Population included all participants who received MEDI-573 and had at least 1 tumor assessment after initiation of treatment. Participants in dose-expansion phase had at least 1 measurable lesion and histologically diagnosis of advanced urothelial carcinoma. Here, "N" is number of participants analyzed for this outcome measure.
Posted
Median
95% Confidence Interval
Months
From study entry through the end of the study, up to 3.5 years
ID
Title
Description
OG000
MEDI-573 0.5 mg/Kg QWk Dose Escalation
Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) as a 60-minute intravenous (IV) infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG001
MEDI-573 1.5 mg/Kg QWk Dose Escalation
Participants received MEDI-573 1.5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG002
MEDI-573 5 mg/Kg QWk Dose Escalation and Expansion
Secondary
Overall Survival
Overall survival (OS) was defined as the time from the start of treatment with MEDI-573 until death.
Efficacy Evaluable Population included all participants who received MEDI-573 and had at least 1 tumor assessment after initiation of treatment. Participants in dose-expansion phase had at least 1 measurable lesion and histologically diagnosis of advanced urothelial carcinoma. Here, "N" is number of participants analyzed for this outcome measure.
Posted
Median
Full Range
Months
From study entry through the end of the study, up to 3.5 years
ID
Title
Description
OG000
MEDI-573 0.5 mg/Kg QWk Dose Escalation
Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) as a 60-minute intravenous (IV) infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG001
MEDI-573 1.5 mg/Kg QWk Dose Escalation
Participants received MEDI-573 1.5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG002
MEDI-573 5 mg/Kg QWk Dose Escalation and Expansion
Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
Secondary
Time to Response (TTR)
Time to response was defined as the duration from the start of treatment with MEDI-573 to the first documentation of objective response (confirmed CR or PR) and was only assessed in participants who had achieved objective response.
Participants in efficacy evaluable population and who achieved objective response were analyzed. As no participants achieved objective response in this study, number of participants analyzed for this outcome measure were zero.
Posted
From study entry through the end of the study, up to 3.5 years
ID
Title
Description
OG000
MEDI-573 0.5 mg/Kg QWk Dose Escalation
Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) as a 60-minute intravenous (IV) infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG001
MEDI-573 1.5 mg/Kg QWk Dose Escalation
Participants received MEDI-573 1.5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG002
MEDI-573 5 mg/Kg QWk Dose Escalation and Expansion
Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
Secondary
Duration of Response
Duration of response was defined as the duration from the first documentation of objective response (confirmed CR or PR) to the first documented disease progression.
Participants in efficacy evaluable population and who achieved objective response were analyzed. As no participants achieved objective response in this study, number of participants analyzed for this outcome measure were zero.
Posted
From study entry through the end of the study, up to 3.5 years
ID
Title
Description
OG000
MEDI-573 0.5 mg/Kg QWk Dose Escalation
Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) as a 60-minute intravenous (IV) infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG001
MEDI-573 1.5 mg/Kg QWk Dose Escalation
Participants received MEDI-573 1.5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG002
MEDI-573 5 mg/Kg QWk Dose Escalation and Expansion
Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
Secondary
Suppression Profiles of IGF-I and IGF-II Post-Administration of MEDI-573
The suppression profiles of both IGF-1 and IGF-2 post administration of MEDI-573 in relation to time course of antibody concentrations in serum were evaluated during treatment.
The Safety Population included all participants who had received any MEDI-573 treatment. Here, "N" and "n" represent number of participants analyzed for this outcome measure and at specific time points, respectively.
Posted
Mean
Standard Deviation
nanogram per milliliter (ng/ml)
From the start of study treatment through 30 days after the last dose of MEDI-573, up to 3.5 years
ID
Title
Description
OG000
MEDI-573 0.5 mg/Kg QWk Dose Escalation
Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) as a 60-minute intravenous (IV) infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG001
MEDI-573 1.5 mg/Kg QWk Dose Escalation
Participants received MEDI-573 1.5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG002
MEDI-573 5 mg/Kg QWk Dose Escalation
Time Frame
From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
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
MEDI-573 0.5 mg/Kg QWk Dose Escalation
Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) as a 60-minute intravenous (IV) infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
4
4
2
4
4
4
EG001
MEDI-573 1.5 mg/Kg QWk Dose Escalation
Participants received MEDI-573 1.5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
3
3
1
3
3
3
EG002
MEDI-573 5 mg/Kg QWk Dose Escalation and Expansion
Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
10
14
4
14
13
14
EG003
MEDI-573 10 mg/Kg QWk Dose Escalation
Participants received MEDI-573 10 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
3
3
1
3
3
3
EG004
MEDI-573 15 mg/Kg QWk Dose Escalation and Expansion
Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
9
13
6
13
13
13
EG005
MEDI-573 30 mg/Kg Q3Wk Dose Escalation
Participants received MEDI-573 30 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
1
3
0
3
3
3
EG006
MEDI-573 45 mg/Kg Q3Wk Dose Escalation
Participants received MEDI-573 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
3
3
3
3
3
3
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal distension
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected3 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Disease progression
General disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Fatigue
General disorders
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Device related infection
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Urosepsis
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Glomerular filtration rate decreased
Investigations
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Weight decreased
Investigations
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 15.0
Systematic Assessment
EG0002 events1 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Colon cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Renal failure acute
Renal and urinary disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Urinary tract obstruction
Renal and urinary disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 15.0
Systematic Assessment
EG0004 events2 affected4 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected14 at risk
EG0034 events2 affected3 at risk
EG0042 events2 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
Leukopenia
Blood and lymphatic system disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Cerumen impaction
Ear and labyrinth disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Ear discomfort
Ear and labyrinth disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Conjunctivitis
Eye disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Dry eye
Eye disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Vision blurred
Eye disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected3 at risk
EG0023 events2 affected14 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Abdominal tenderness
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Cheilitis
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0002 events1 affected4 at risk
EG0011 events1 affected3 at risk
EG0022 events2 affected14 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Faecaloma
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Gingival pain
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Glossitis
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected3 at risk
EG0022 events2 affected14 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected3 at risk
EG0022 events2 affected14 at risk
EG003
Asthenia
General disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Chills
General disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Early satiety
General disorders
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Fatigue
General disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected3 at risk
EG0023 events3 affected14 at risk
EG003
Implant site pain
General disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Local swelling
General disorders
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Oedema
General disorders
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Oedema peripheral
General disorders
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Pyrexia
General disorders
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Thirst
General disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Hepatomegaly
Hepatobiliary disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 15.0
Systematic Assessment
EG0002 events1 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Candidiasis
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Herpes simplex
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 15.0
Systematic Assessment
EG0002 events2 affected4 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Excoriation
Injury, poisoning and procedural complications
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Post procedural discomfort
Injury, poisoning and procedural complications
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Post procedural haematoma
Injury, poisoning and procedural complications
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Post procedural haemorrhage
Injury, poisoning and procedural complications
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Tooth fracture
Injury, poisoning and procedural complications
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0022 events2 affected14 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected3 at risk
EG0025 events2 affected14 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Blood creatine increased
Investigations
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0023 events2 affected14 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0022 events1 affected14 at risk
EG003
Blood growth hormone increased
Investigations
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Blood insulin increased
Investigations
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA 15.0
Systematic Assessment
EG0002 events1 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Breath sounds abnormal
Investigations
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Cardiac enzymes increased
Investigations
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Electrocardiogram qt prolonged
Investigations
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Heart rate increased
Investigations
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Lipase increased
Investigations
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Protein total increased
Investigations
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Red blood cell count decreased
Investigations
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Weight decreased
Investigations
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Weight increased
Investigations
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
White blood cell count increased
Investigations
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 15.0
Systematic Assessment
EG0004 events3 affected4 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0022 events2 affected14 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0022 events2 affected14 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Encephalopathy
Nervous system disorders
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Extrapyramidal disorder
Nervous system disorders
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Headache
Nervous system disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Depression
Psychiatric disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Micturition urgency
Renal and urinary disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Scrotal oedema
Reproductive system and breast disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Testicular pain
Reproductive system and breast disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0022 events2 affected14 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Stridor
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0022 events2 affected14 at risk
EG003
Swelling face
Skin and subcutaneous tissue disorders
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Hypertension
Vascular disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Hypotension
Vascular disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Pallor
Vascular disorders
MedDRA 15.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Systolic hypertension
Vascular disorders
MedDRA 15.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 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
Susan Perez MD, MSc
MedImmune LLC
+1 301-398-2827
information.center@astrazeneca.com
ID
Term
D009369
Neoplasms
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C000601324
dusigitumab
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
1 subjects
FG0051 subjects
FG0063 subjects
FG0077 subjects
FG0088 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
68.0
± 13.2
BG00461.2± 8.6
BG00558.3± 18.5
BG00665.7± 4.5
BG00762.6± 11.5
4
BG0032
BG0043
BG0052
BG0062
BG00718
Male
BG0000
BG0012
BG00210
BG0031
BG00410
BG0051
BG0061
BG00725
0
BG0030
BG0041
BG0050
BG0060
BG0071
Not Hispanic or Latino
BG0004
BG0013
BG00214
BG0033
BG00412
BG0053
BG0063
BG00742
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
0
BG0030
BG0040
BG0050
BG0060
BG0070
Asian
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
Black or African American
BG0000
BG0010
BG0020
BG0030
BG0043
BG0050
BG0061
BG0074
White
BG0004
BG0013
BG00214
BG0033
BG00410
BG0053
BG0062
BG00739
More than one race
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
OG006
MEDI-573 45 mg/Kg Q3Wk Dose Escalation
Participants received MEDI-573 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
3
OG00413
OG0053
OG0063
3
OG00413
OG0053
OG0063
Treatment emergent SAEs
Title
Measurements
OG0002
OG0011
OG0024
OG0031
OG0046
OG0050
OG0063
Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG003
MEDI-573 10 mg/Kg QWk Dose Escalation
Participants received MEDI-573 10 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG004
MEDI-573 15 mg/Kg QWk Dose Escalation and Expansion
Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG005
MEDI-573 30 mg/Kg Q3Wk Dose Escalation
Participants received MEDI-573 30 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG006
MEDI-573 45 mg/Kg Q3Wk Dose Escalation
Participants received MEDI-573 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
Units
Counts
Participants
OG0004
OG0013
OG00214
OG0033
OG00413
OG0053
OG0063
Title
Denominators
Categories
Anemia
Title
Measurements
OG0002
OG0011
OG0021
OG0032
OG0042
OG0050
OG0060
Thrombocytopenia
Title
Measurements
OG0000
OG0010
OG0021
OG003
Leukopenia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Lymphopenia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Red blood cell count decreased
Title
Measurements
OG0000
OG0010
OG0020
OG003
White blood cell count decreased
Title
Measurements
OG0000
OG0010
OG0020
OG003
White blood cell count increased
Title
Measurements
OG0000
OG0011
OG0020
OG003
Blood alkaline phosphatase increased
Title
Measurements
OG0001
OG0010
OG0021
OG003
Aspartate aminotransferase increased
Title
Measurements
OG0000
OG0011
OG0022
OG003
Alanine aminotransferase increased
Title
Measurements
OG0000
OG0010
OG0022
OG003
Blood creatinine increased
Title
Measurements
OG0001
OG0010
OG0021
OG003
Weight decreased
Title
Measurements
OG0000
OG0010
OG0021
OG003
Blood insulin increased
Title
Measurements
OG0000
OG0011
OG0020
OG003
Blood creatine increased
Title
Measurements
OG0000
OG0010
OG0022
OG003
Blood growth hormone increased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Blood bilirubin increased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Blood lactate dehydrogenase increased
Title
Measurements
OG0001
OG0010
OG0020
OG003
Breath sounds abnormal
Title
Measurements
OG0000
OG0010
OG0020
OG003
Cardiac enzymes increased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Electrocardiogram QT prolonged
Title
Measurements
OG0000
OG0010
OG0020
OG003
Glomerular filtration rate decreased
Title
Measurements
OG0001
OG0010
OG0020
OG003
Heart rate increased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Lipase increased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Protein total increased
Title
Measurements
OG0000
OG0011
OG0020
OG003
Weight increased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hematuria
Title
Measurements
OG0000
OG0010
OG0020
OG003
Renal failure
Title
Measurements
OG0000
OG0010
OG0020
OG003
Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG003
MEDI-573 10 mg/Kg QWk Dose Escalation
Participants received MEDI-573 10 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG004
MEDI-573 15 mg/Kg QWk Dose Escalation and Expansion
Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG005
MEDI-573 30 mg/Kg Q3Wk Dose Escalation
Participants received MEDI-573 30 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG006
MEDI-573 45 mg/Kg Q3Wk Dose Escalation
Participants received MEDI-573 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
Units
Counts
Participants
OG0004
OG0013
OG00214
OG0033
OG00413
OG0053
OG0063
Title
Denominators
Categories
Pyrexia
Title
Measurements
OG0001
OG0011
OG0021
OG0030
OG0041
OG0050
OG0060
Tachycardia
Title
Measurements
OG0000
OG0011
OG0020
OG003
Breath sounds abnormal
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hypotension
Title
Measurements
OG0000
OG0010
OG0020
OG003
Heart rate increased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hypertension
Title
Measurements
OG0000
OG0010
OG0020
OG003
Orthostatic hypotension
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG00021
Title
Denominators
Categories
Title
Measurements
OG000NAThe MTD was not established in the study.
OG002
MEDI-573 5 mg/Kg QWk Dose Escalation and Expansion
Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG003
MEDI-573 10 mg/Kg QWk Dose Escalation
Participants received MEDI-573 10 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG004
MEDI-573 15 mg/Kg QWk Dose Escalation and Expansion
Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG005
MEDI-573 30 mg/Kg Q3Wk Dose Escalation
Participants received MEDI-573 30 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG006
MEDI-573 45 mg/Kg Q3Wk Dose Escalation
Participants received MEDI-573 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
Units
Counts
Participants
OG0004
OG0013
OG00214
OG0033
OG00413
OG0053
OG0063
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
23
Title
Denominators
Categories
Title
Measurements
OG0005
OG003
MEDI-573 10 mg/Kg QWk Dose Escalation
Participants received MEDI-573 10 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG004
MEDI-573 15 mg/Kg QWk Dose Escalation
Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG005
MEDI-573 30 mg/Kg Q3Wk Dose Escalation
Participants received MEDI-573 30 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG006
MEDI-573 45 mg/Kg Q3Wk Dose Escalation
Participants received MEDI-573 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG007
MEDI-573 5 mg/Kg QWk Dose Expansion
Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG008
MEDI-573 15 mg/Kg QWk Dose Expansion
Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
Units
Counts
Participants
OG0004
OG0013
OG0024
OG0033
OG0043
OG0053
OG0063
OG00710
OG0089
Title
Denominators
Categories
Title
Measurements
OG00011.6± 5.54
OG00171.8± 12.5
OG002166± 37.7
OG003264± 121
OG004560± 251
OG005588± 213
OG0061200± 621
OG007115± 42.6
OG008412± 141
OG003
MEDI-573 10 mg/Kg QWk Dose Escalation
Participants received MEDI-573 10 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG004
MEDI-573 15 mg/Kg QWk Dose Escalation
Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG005
MEDI-573 30 mg/Kg Q3Wk Dose Escalation
Participants received MEDI-573 30 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG006
MEDI-573 45 mg/Kg Q3Wk Dose Escalation
Participants received MEDI-573 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG007
MEDI-573 5 mg/Kg QWk Dose Expansion
Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG008
MEDI-573 15 mg/Kg QWk Dose Expansion
Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
Units
Counts
Participants
OG0004
OG0013
OG0024
OG0033
OG0043
OG0053
OG0063
OG00710
OG0089
Title
Denominators
Categories
Title
Measurements
OG0000.04(0.04 to 0.04)
OG0010.04(0.04 to 0.06)
OG0020.04(0.04 to 0.12)
OG0030.04(0.04 to 0.14)
OG0040.28(0.12 to 0.30)
OG0050.06(0.06 to 0.06)
OG0060.06(0.06 to 0.06)
OG0070.04(0.04 to 0.30)
OG0080.06(0.04 to 0.30)
OG003
MEDI-573 10 mg/Kg QWk Dose Escalation
Participants received MEDI-573 10 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG004
MEDI-573 15 mg/Kg QWk Dose Escalation
Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG005
MEDI-573 30 mg/Kg Q3Wk Dose Escalation
Participants received MEDI-573 30 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG006
MEDI-573 45 mg/Kg Q3Wk Dose Escalation
Participants received MEDI-573 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG007
MEDI-573 5 mg/Kg QWk Dose Expansion
Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG008
MEDI-573 15 mg/Kg QWk Dose Expansion
Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
Units
Counts
Participants
OG0002
OG0013
OG0023
OG0033
OG0043
OG0053
OG0063
OG00710
OG0089
Title
Denominators
Categories
Title
Measurements
OG0001.04± 0.919
OG0011.98± 0.377
OG00217.3± 10.2
OG00334.6± 26.8
OG004138± 77.8
OG00532.9± 28.2
OG00663.5± 59.5
OG0075.27± 4.80
OG00877.8± 33.5
OG003
MEDI-573 10 mg/Kg QWk Dose Escalation
Participants received MEDI-573 10 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG004
MEDI-573 15 mg/Kg QWk Dose Escalation
Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG005
MEDI-573 30 mg/Kg Q3Wk Dose Escalation
Participants received MEDI-573 30 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG006
MEDI-573 45 mg/Kg Q3Wk Dose Escalation
Participants received MEDI-573 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG007
MEDI-573 5 mg/Kg QWk Dose Expansion
Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG008
MEDI-573 15 mg/Kg QWk Dose Expansion
Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
Units
Counts
Participants
OG0004
OG0013
OG0024
OG0033
OG0043
OG0053
OG0063
OG00710
OG0089
Title
Denominators
Categories
Title
Measurements
OG0000.319± 0.154
OG0010.593± 0.122
OG0020.401± 0.054
OG0030.393± 0.129
OG0040.422± 0.168
OG0050.240± 0.072
OG0060.352± 0.178
OG0070.267± 0.110
OG0080.314± 0.095
OG003
MEDI-573 10 mg/Kg QWk Dose Escalation
Participants received MEDI-573 10 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG004
MEDI-573 15 mg/Kg QWk Dose Escalation
Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG005
MEDI-573 30 mg/Kg Q3Wk Dose Escalation
Participants received MEDI-573 30 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG006
MEDI-573 45 mg/Kg Q3Wk Dose Escalation
Participants received MEDI-573 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG007
MEDI-573 5 mg/Kg QWk Dose Expansion
Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG008
MEDI-573 15 mg/Kg QWk Dose Expansion
Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
Units
Counts
Participants
OG0002
OG0013
OG0023
OG0033
OG0043
OG0053
OG0063
OG00710
OG0089
Title
Denominators
Categories
Title
Measurements
OG0009.59± 5.12
OG00190.8± 18.6
OG002431± 135
OG003631± 288
OG0041950± 917
OG0053510± 1230
OG0065790± 3390
OG007227± 99.8
OG0081280± 392
Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG003
MEDI-573 10 mg/Kg QWk Dose Escalation
Participants received MEDI-573 10 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG004
MEDI-573 15 mg/Kg QWk Dose Escalation
Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG005
MEDI-573 30 mg/Kg Q3Wk Dose Escalation
Participants received MEDI-573 30 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG006
MEDI-573 45 mg/Kg Q3Wk Dose Escalation
Participants received MEDI-573 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG007
MEDI-573 5 mg/Kg QWk Dose Expansion
Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG008
MEDI-573 15 mg/Kg QWk Dose Expansion
Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
Units
Counts
Participants
OG0002
OG0013
OG0023
OG0033
OG0043
OG0053
OG0063
OG00710
OG0089
Title
Denominators
Categories
Title
Measurements
OG0000.245± 0.145
OG0010.749± 0.176
OG0020.962± 0.041
OG0030.955± 0.401
OG0041.47± 0.624
OG0051.46± 0.526
OG0061.70± 0.976
OG0070.53± 0.233
OG0080.981± 0.275
Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG003
MEDI-573 10 mg/Kg QWk Dose Escalation
Participants received MEDI-573 10 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG004
MEDI-573 15 mg/Kg QWk Dose Escalation
Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG005
MEDI-573 30 mg/Kg Q3Wk Dose Escalation
Participants received MEDI-573 30 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG006
MEDI-573 45 mg/Kg Q3Wk Dose Escalation
Participants received MEDI-573 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG007
MEDI-573 5 mg/Kg QWk Dose Expansion
Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG008
MEDI-573 15 mg/Kg QWk Dose Expansion
Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
Units
Counts
Participants
OG0004
OG0013
OG0024
OG0033
OG0043
OG0053
OG0063
OG00710
OG0089
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG002
MEDI-573 5 mg/Kg QWk Dose Escalation and Expansion
Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG003
MEDI-573 10 mg/Kg QWk Dose Escalation
Participants received MEDI-573 10 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG004
MEDI-573 15 mg/Kg QWk Dose Escalation and Expansion
Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG005
MEDI-573 30 mg/Kg Q3Wk Dose Escalation
Participants received MEDI-573 30 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG006
MEDI-573 45 mg/Kg Q3Wk Dose Escalation
Participants received MEDI-573 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
Units
Counts
Participants
OG0004
OG0013
OG00213
OG0033
OG00412
OG0053
OG0061
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG003
MEDI-573 10 mg/Kg QWk Dose Escalation
Participants received MEDI-573 10 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG004
MEDI-573 15 mg/Kg QWk Dose Escalation and Expansion
Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG005
MEDI-573 30 mg/Kg Q3Wk Dose Escalation
Participants received MEDI-573 30 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG006
MEDI-573 45 mg/Kg Q3Wk Dose Escalation
Participants received MEDI-573 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
Units
Counts
Participants
OG0004
OG0013
OG00212
OG0033
OG00411
OG0051
OG0060
Title
Denominators
Categories
Title
Measurements
OG0001.0(0.5 to 1.5)
OG0012.6(1.3 to 2.8)
OG0021.4(1.2 to 2.8)
OG0031.5(0.7 to 4.7)
OG0041.3(0.7 to 4.2)
OG005NA(1.2 to NA)Median and upper limit of 95 % confidence interval was not applicable, as only 1 participant was evaluable.
Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG003
MEDI-573 10 mg/Kg QWk Dose Escalation
Participants received MEDI-573 10 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG004
MEDI-573 15 mg/Kg QWk Dose Escalation and Expansion
Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG005
MEDI-573 30 mg/Kg Q3Wk Dose Escalation
Participants received MEDI-573 30 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG006
MEDI-573 45 mg/Kg Q3Wk Dose Escalation
Participants received MEDI-573 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
Units
Counts
Participants
OG0004
OG0013
OG00212
OG0033
OG00411
OG0051
OG0060
Title
Denominators
Categories
Title
Measurements
OG0001.0(0.5 to 1.5)
OG0012.6(1.3 to 2.8)
OG0021.4(1.2 to 2.8)
OG0031.5(0.7 to 4.7)
OG0041.3(0.7 to 4.2)
OG005NA(1.2 to NA)Median and upper limit of 95 % confidence interval was not applicable, as only 1 participant was evaluable.
OG003
MEDI-573 10 mg/Kg QWk Dose Escalation
Participants received MEDI-573 10 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG004
MEDI-573 15 mg/Kg QWk Dose Escalation and Expansion
Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG005
MEDI-573 30 mg/Kg Q3Wk Dose Escalation
Participants received MEDI-573 30 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG006
MEDI-573 45 mg/Kg Q3Wk Dose Escalation
Participants received MEDI-573 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
Units
Counts
Participants
OG0004
OG0013
OG0029
OG0033
OG0049
OG0051
OG0061
Title
Denominators
Categories
Title
Measurements
OG0005.3(2.1 to 8.7)
OG00113.6(1.9 to 20.2)
OG00212.3(1.4 to 37.3)
OG0032.5(1.3 to 8.6)
OG0044.0(1.1 to 33.0)
OG0057.9(1.4 to 7.9)
OG0064.7(4.7 to 4.7)
OG003
MEDI-573 10 mg/Kg QWk Dose Escalation
Participants received MEDI-573 10 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG004
MEDI-573 15 mg/Kg QWk Dose Escalation and Expansion
Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG005
MEDI-573 30 mg/Kg Q3Wk Dose Escalation
Participants received MEDI-573 30 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG006
MEDI-573 45 mg/Kg Q3Wk Dose Escalation
Participants received MEDI-573 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG003
MEDI-573 10 mg/Kg QWk Dose Escalation
Participants received MEDI-573 10 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG004
MEDI-573 15 mg/Kg QWk Dose Escalation and Expansion
Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG005
MEDI-573 30 mg/Kg Q3Wk Dose Escalation
Participants received MEDI-573 30 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG006
MEDI-573 45 mg/Kg Q3Wk Dose Escalation
Participants received MEDI-573 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG003
MEDI-573 10 mg/Kg QWk Dose Escalation
Participants received MEDI-573 10 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG004
MEDI-573 15 mg/Kg QWk Dose Escalation
Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG005
MEDI-573 30 mg/Kg Q3Wk Dose Escalation
Participants received MEDI-573 30 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG006
MEDI-573 45 mg/Kg Q3Wk Dose Escalation
Participants received MEDI-573 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG007
MEDI-573 5 mg/Kg QWk Dose Expansion
Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
OG008
MEDI-573 15 mg/Kg QWk Dose Expansion
Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
Units
Counts
Participants
OG0004
OG0013
OG0024
OG0033
OG0043
OG0053
OG0063
OG00710
OG0089
Title
Denominators
Categories
IGF-I at 0.000
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG0063
ParticipantsOG00710
ParticipantsOG0089
Title
Measurements
OG0004.014± 2.177
OG0019.264± 7.401
OG0024.655± 3.437
OG003
IGF-I at 0.042
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0033
IGF-I at 0.063
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
IGF-I at 0.125
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0033
IGF-I at 0.292
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0033
IGF-I at 1.000
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0033
IGF-I at 7.000
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0033
IGF-I at 7.042
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
IGF-I at 14.000
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0033
IGF-I at 14.042
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
IGF-I at 21.000
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
IGF-II at 0.000
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0033
IGF-II at 0.042
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0033
IGF-II at 0.063
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
IGF-II at 0.125
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0033
IGF-II at 0.292
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0033
IGF-II at 1.000
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0033
IGF-II at 7.000
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0033
IGF-II at 7.042
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
IGF-II at 14.000
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0033
IGF-II at 14.042
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
IGF-II at 21.000
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
0 events
0 affected
3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected3 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected3 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected3 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected3 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected3 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected3 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
9 events
2 affected
3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
3 events
1 affected
3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
7 events
2 affected
3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected13 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected3 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected3 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0045 events3 affected13 at risk
EG0052 events2 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected3 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0043 events3 affected13 at risk
EG0051 events1 affected3 at risk
EG0061 events1 affected3 at risk
0 events
0 affected
3 at risk
EG0043 events3 affected13 at risk
EG0051 events1 affected3 at risk
EG0063 events2 affected3 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected13 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected3 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected13 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected3 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
3 events
2 affected
3 at risk
EG0047 events6 affected13 at risk
EG0053 events2 affected3 at risk
EG0061 events1 affected3 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected3 at risk
EG0062 events2 affected3 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
2 events
2 affected
3 at risk
EG0042 events1 affected13 at risk
EG0053 events2 affected3 at risk
EG0062 events1 affected3 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected13 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected3 at risk
2 events
2 affected
3 at risk
EG00410 events8 affected13 at risk
EG0052 events1 affected3 at risk
EG0063 events2 affected3 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected3 at risk
0 events
0 affected
3 at risk
EG0042 events2 affected13 at risk
EG0050 events0 affected3 at risk
EG0062 events2 affected3 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected3 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0042 events2 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected3 at risk
EG0063 events1 affected3 at risk
0 events
0 affected
3 at risk
EG0045 events4 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected3 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected13 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0043 events3 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected13 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0042 events2 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0043 events2 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
1 events
1 affected
3 at risk
EG0043 events3 affected13 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected3 at risk
0 events
0 affected
3 at risk
EG0042 events1 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0042 events2 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
3 events
1 affected
3 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
2 events
1 affected
3 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected3 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected13 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected13 at risk
EG0052 events1 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected3 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
3 events
2 affected
3 at risk
EG0049 events8 affected13 at risk
EG0051 events1 affected3 at risk
EG0063 events3 affected3 at risk
1 events
1 affected
3 at risk
EG0042 events2 affected13 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0042 events2 affected13 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected3 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected3 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected3 at risk
EG0062 events2 affected3 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected3 at risk
EG0062 events1 affected3 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected13 at risk
EG0051 events1 affected3 at risk
EG0062 events2 affected3 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected13 at risk
EG0051 events1 affected3 at risk
EG0061 events1 affected3 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected3 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected3 at risk
EG0062 events2 affected3 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected3 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected13 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected3 at risk
0 events
0 affected
3 at risk
EG0042 events1 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected13 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected13 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected13 at risk
EG0051 events1 affected3 at risk
EG0061 events1 affected3 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected13 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected3 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected13 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected3 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected3 at risk
1 events
1 affected
3 at risk
EG0042 events2 affected13 at risk
EG0050 events0 affected3 at risk
EG0062 events2 affected3 at risk
2 events
1 affected
3 at risk
EG0042 events2 affected13 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
2 events
1 affected
3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected13 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected3 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
3 events
1 affected
3 at risk
EG0042 events2 affected13 at risk
EG0052 events1 affected3 at risk
EG0061 events1 affected3 at risk
1 events
1 affected
3 at risk
EG0042 events2 affected13 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected13 at risk
EG0052 events1 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0042 events2 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected13 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected3 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected3 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
2
OG0040
OG0050
OG0060
2
OG0040
OG0050
OG0060
1
OG0040
OG0050
OG0060
1
OG0040
OG0050
OG0060
0
OG0041
OG0050
OG0060
0
OG0040
OG0050
OG0060
1
OG0043
OG0050
OG0061
0
OG0042
OG0050
OG0060
0
OG0042
OG0050
OG0060
0
OG0042
OG0050
OG0060
0
OG0042
OG0051
OG0060
1
OG0041
OG0050
OG0060
0
OG0040
OG0050
OG0060
1
OG0041
OG0050
OG0060
0
OG0041
OG0050
OG0060
0
OG0040
OG0050
OG0060
1
OG0040
OG0050
OG0060
0
OG0040
OG0050
OG0061
0
OG0040
OG0051
OG0060
0
OG0040
OG0050
OG0060
0
OG0041
OG0050
OG0060
0
OG0041
OG0050
OG0060
0
OG0040
OG0050
OG0060
0
OG0040
OG0050
OG0061
0
OG0041
OG0050
OG0060
0
OG0041
OG0050
OG0061
1
OG0040
OG0050
OG0060
1
OG0040
OG0050
OG0060
0
OG0042
OG0050
OG0060
0
OG0041
OG0050
OG0060
0
OG0040
OG0051
OG0060
0
OG0040
OG0051
OG0060
1.721
± 2.710
OG0041.440± 0.812
OG0052.693± 2.855
OG0061.925± 1.374
OG0071.749± 0.643
OG0082.099± 1.128
Participants
OG004
3
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG00710
ParticipantsOG0089
Title
Measurements
OG000NA± 0.000Below the limit of quantitation (0.313 ng/mL).
OG001NA± 0.000Below the limit of quantitation (0.313 ng/mL).
OG002NA± 0.000Below the limit of quantitation (0.313 ng/mL).
OG003NA± 0.000Below the limit of quantitation (0.313 ng/mL).
OG004NA± 0.000Below the limit of quantitation (0.313 ng/mL).
OG007NA± 0.000Below the limit of quantitation (0.313 ng/mL).
OG008NA± 0.000Below the limit of quantitation (0.313 ng/mL).
Participants
OG004
0
ParticipantsOG0053
ParticipantsOG0063
ParticipantsOG0070
ParticipantsOG0080
Title
Measurements
OG005NA± 0.000Below the limit of quantitation (0.313 ng/mL).
OG006NA± 0.000Below the limit of quantitation (0.313 ng/mL).
Participants
OG004
3
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG00710
ParticipantsOG0089
Title
Measurements
OG0000.252± 0.111
OG001NA± 0.000Below the limit of quantitation (0.313 ng/mL).
OG002NA± 0.000Below the limit of quantitation (0.313 ng/mL).
OG003NA± 0.000Below the limit of quantitation (0.313 ng/mL).
OG004NA± 0.000Below the limit of quantitation (0.313 ng/mL).
OG007NA± 0.000Below the limit of quantitation (0.313 ng/mL).
OG008NA± 0.000Below the limit of quantitation (0.313 ng/mL).
Participants
OG004
3
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0079
ParticipantsOG0088
Title
Measurements
OG0000.345± 0.227
OG001NA± 0.000Below the limit of quantitation (0.313 ng/mL).
OG002NA± 0.000Below the limit of quantitation (0.313 ng/mL).
OG003NA± 0.000Below the limit of quantitation (0.313 ng/mL).
OG004NA± 0.000Below the limit of quantitation (0.313 ng/mL).
OG007NA± 0.000Below the limit of quantitation (0.313 ng/mL).
OG008NA± 0.000Below the limit of quantitation (0.313 ng/mL).
Participants
OG004
3
ParticipantsOG0053
ParticipantsOG0063
ParticipantsOG00710
ParticipantsOG0089
Title
Measurements
OG0002.088± 0.964
OG001NA± 0.000Below the limit of quantitation (0.313 ng/mL).
OG0020.215± 0.117
OG003NA± 0.000Below the limit of quantitation (0.313 ng/mL).
OG004NA± 0.000Below the limit of quantitation (0.313 ng/mL).
OG005NA± 0.000Below the limit of quantitation (0.313 ng/mL).
OG006NA± 0.000Below the limit of quantitation (0.313 ng/mL).
OG007NA± 0.000Below the limit of quantitation (0.313 ng/mL).
OG008NA± 0.000Below the limit of quantitation (0.313 ng/mL).
Participants
OG004
3
ParticipantsOG0053
ParticipantsOG0063
ParticipantsOG00710
ParticipantsOG0089
Title
Measurements
OG0030.223± 0.115
OG004NA± 0.000Below the limit of quantitation (0.313 ng/mL).
OG005NA± 0.000Below the limit of quantitation (0.313 ng/mL).
OG006NA± 0.000Below the limit of quantitation (0.313 ng/mL).
OG0070.641± 0.546
OG0080.196± 0.078
Participants
OG004
3
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG00710
ParticipantsOG0089
Title
Measurements
OG0000.201± 0.087
OG001NA± 0.000Below the limit of quantitation (0.313 ng/mL).
OG002NA± 0.000Below the limit of quantitation (0.313 ng/mL).
OG003NA± 0.000Below the limit of quantitation (0.313 ng/mL).
OG004NA± 0.000Below the limit of quantitation (0.313 ng/mL).
OG007NA± 0.000Below the limit of quantitation (0.313 ng/mL).
OG008NA± 0.000Below the limit of quantitation (0.313 ng/mL).
Participants
OG004
3
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG00710
ParticipantsOG0089
Title
Measurements
OG0030.232± 0.130
OG004NA± 0.000Below the limit of quantitation (0.313 ng/mL).
OG0070.360± 0.166
OG008NA± 0.000Below the limit of quantitation (0.313 ng/mL).
Participants
OG004
3
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG00710
ParticipantsOG0089
Title
Measurements
OG000NA± 0.000Below the limit of quantitation (0.313 ng/mL).
OG001NA± 0.000Below the limit of quantitation (0.313 ng/mL).
OG002NA± 0.000Below the limit of quantitation (0.313 ng/mL).
OG003NA± 0.000Below the limit of quantitation (0.313 ng/mL).
OG004NA± 0.000Below the limit of quantitation (0.313 ng/mL).
OG007NA± 0.000Below the limit of quantitation (0.313 ng/mL).
OG008NA± 0.000Below the limit of quantitation (0.313 ng/mL).
Participants
OG004
3
ParticipantsOG0053
ParticipantsOG0063
ParticipantsOG00710
ParticipantsOG0088
Title
Measurements
OG0030.334± NAStandard deviation can not be calculated as only one participant evaluated.
OG004NA± 0.000Below the limit of quantitation (0.313 ng/mL).
OG0050.265± 0.189
OG0060.241± 0.147
OG0070.336± 0.177
OG008NA± 0.000Below the limit of quantitation (0.313 ng/mL).
Participants
OG004
3
ParticipantsOG0053
ParticipantsOG0063
ParticipantsOG00710
ParticipantsOG0089
Title
Measurements
OG0002.773± 0.320
OG0012.984± 1.753
OG0022.431± 0.139
OG0031.879± 1.020
OG0041.872± 0.862
OG0052.780± 0.694
OG0064.093± 1.039
OG0072.689± 0.882
OG0082.213± 0.752
Participants
OG004
3
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG00710
ParticipantsOG0089
Title
Measurements
OG000NA± 0.000Below the limit of quantitation (0.626 ng/mL).
OG001NA± 0.000Below the limit of quantitation (0.626 ng/mL).
OG002NA± 0.000Below the limit of quantitation (0.626 ng/mL).
OG003NA± 0.000Below the limit of quantitation (0.626 ng/mL).
OG004NA± 0.000Below the limit of quantitation (0.626 ng/mL).
OG007NA± 0.000Below the limit of quantitation (0.626 ng/mL).
OG008NA± 0.000Below the limit of quantitation (0.626 ng/mL).
Participants
OG004
0
ParticipantsOG0053
ParticipantsOG0063
ParticipantsOG0070
ParticipantsOG0080
Title
Measurements
OG005NA± 0.000Below the limit of quantitation (0.626 ng/mL)
OG006NA± 0.000Below the limit of quantitation (0.626 ng/mL)
Participants
OG004
3
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG00710
ParticipantsOG0089
Title
Measurements
OG000NA± 0.000Below the limit of quantitation (0.626 ng/mL)
OG001NA± 0.000Below the limit of quantitation (0.626 ng/mL)
OG002NA± 0.000Below the limit of quantitation (0.626 ng/mL)
OG003NA± 0.000Below the limit of quantitation (0.626 ng/mL)
OG004NA± 0.000Below the limit of quantitation (0.626 ng/mL)
OG007NA± 0.000Below the limit of quantitation (0.626 ng/mL)
OG008NA± 0.000Below the limit of quantitation (0.626 ng/mL)
Participants
OG004
3
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0079
ParticipantsOG0088
Title
Measurements
OG000NA± 0.000Below the limit of quantitation (0.626 ng/mL).
OG001NA± 0.000Below the limit of quantitation (0.626 ng/mL).
OG002NA± 0.000Below the limit of quantitation (0.626 ng/mL).
OG003NA± 0.000Below the limit of quantitation (0.626 ng/mL).
OG004NA± 0.000Below the limit of quantitation (0.626 ng/mL).
OG007NA± 0.000Below the limit of quantitation (0.626 ng/mL).
OG008NA± 0.000Below the limit of quantitation (0.626 ng/mL).
Participants
OG004
3
ParticipantsOG0053
ParticipantsOG0063
ParticipantsOG00710
ParticipantsOG0089
Title
Measurements
OG0001.060± 0.828
OG001NA± 0.000Below the limit of quantitation (0.626 ng/mL).
OG002NA± 0.000Below the limit of quantitation (0.626 ng/mL).
OG003NA± 0.000Below the limit of quantitation (0.626 ng/mL).
OG004NA± 0.000Below the limit of quantitation (0.626 ng/mL).
OG005NA± 0.000Below the limit of quantitation (0.626 ng/mL).
OG006NA± 0.000Below the limit of quantitation (0.626 ng/mL).
OG007NA± 0.000Below the limit of quantitation (0.626 ng/mL).
OG008NA± 0.000Below the limit of quantitation (0.626 ng/mL).
Participants
OG004
3
ParticipantsOG0053
ParticipantsOG0063
ParticipantsOG00710
ParticipantsOG0089
Title
Measurements
OG003NA± 0.000Below the limit of quantitation (0.626 ng/mL).
OG004NA± 0.000Below the limit of quantitation (0.626 ng/mL).
OG005NA± 0.000Below the limit of quantitation (0.626 ng/mL).
OG006NA± 0.000Below the limit of quantitation (0.626 ng/mL).
OG007NA± 0.000Below the limit of quantitation (0.626 ng/mL).
OG008NA± 0.000Below the limit of quantitation (0.626 ng/mL).
Participants
OG004
3
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG00710
ParticipantsOG0089
Title
Measurements
OG000NA± 0.000Below the limit of quantitation (0.626 ng/mL).
OG001NA± 0.000Below the limit of quantitation (0.626 ng/mL).
OG002NA± 0.000Below the limit of quantitation (0.626 ng/mL).
OG003NA± 0.000Below the limit of quantitation (0.626 ng/mL).
OG004NA± 0.000Below the limit of quantitation (0.626 ng/mL).
OG007NA± 0.000Below the limit of quantitation (0.626 ng/mL).
OG008NA± 0.000Below the limit of quantitation (0.626 ng/mL).
ParticipantsOG0043
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG00710
ParticipantsOG0089
Title
Measurements
OG003NA± 0.000Below the limit of quantitation (0.626 ng/mL).
OG004NA± 0.000Below the limit of quantitation (0.626 ng/mL).
OG007NA± 0.000Below the limit of quantitation (0.626 ng/mL).
OG008NA± 0.000Below the limit of quantitation (0.626 ng/mL).
ParticipantsOG0043
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG00710
ParticipantsOG0089
Title
Measurements
OG000NA± 0.000Below the limit of quantitation (0.626 ng/mL).
OG001NA± 0.000Below the limit of quantitation (0.626 ng/mL).
OG002NA± 0.000Below the limit of quantitation (0.626 ng/mL).
OG003NA± 0.000Below the limit of quantitation (0.626 ng/mL).
OG004NA± 0.000Below the limit of quantitation (0.626 ng/mL).
OG007NA± 0.000Below the limit of quantitation (0.626 ng/mL).
OG008NA± 0.000Below the limit of quantitation (0.626 ng/mL).
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG0063
ParticipantsOG00710
ParticipantsOG0088
Title
Measurements
OG003NA± NAMean was below the limit of quantitation (0.626 ng/mL). Standard deviation can not be calculated as only one participant evaluated.
OG004NA± 0.000Below the limit of quantitation (0.626 ng/mL).
OG005NA± 0.000Below the limit of quantitation (0.626 ng/mL).
OG006NA± 0.000Below the limit of quantitation (0.626 ng/mL).
OG007NA± 0.000Below the limit of quantitation (0.626 ng/mL).
OG008NA± 0.000Below the limit of quantitation (0.626 ng/mL).