A Phase 1, Randomized, Placebo-controlled, Dose-escalatio... | NCT01544348 | Trialant
NCT01544348
Sponsor
MedImmune LLC
Status
Completed
Last Update Posted
Dec 30, 2014Estimated
Enrollment
295Actual
Phase
Phase 1
Conditions
Allergic Asthma
Atopic Dermatitis
Allergic Rhinitis
Healthy Volunteers
Interventions
Placebo
Omalizumab
MEDI4212 5 mg Subcutaneous
MEDI4212 15 mg Subcutaneous
MEDI4212 60 mg Subcutaneous
MEDI4212 150 mg Subcutaneous
MEDI4212 300 mg Subcutaneous
MEDI4212 300 mg Intravenous
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT01544348
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CD-RI-MEDI4212-1085
Secondary IDs
Not provided
Brief Title
A Phase 1, Randomized, Placebo-controlled, Dose-escalation Safety Study of MEDI4212 in Subjects With IgE >= 30 IU/mL
Official Title
A Phase 1 Randomized, Placebo-controlled, Dose-escalation Study to Evaluate the Safety of MEDI4212 in Subjects With IgE >= 30 IU/mL
Acronym
Not provided
Organization
MedImmune LLCINDUSTRY
Status Module
Record Verification Date
Dec 2014
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
Jan 2012
Primary Completion Date
Jun 2013Actual
Completion Date
Jun 2013Actual
First Submitted Date
Jan 31, 2012
First Submission Date that Met QC Criteria
Mar 2, 2012
First Posted Date
Mar 5, 2012Estimated
Results Waived
Not provided
Results First Submitted Date
Dec 18, 2014
Results First Submitted that Met QC Criteria
Dec 18, 2014
Results First Posted Date
Dec 30, 2014Estimated
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
Dec 18, 2014
Last Update Posted Date
Dec 30, 2014Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
MedImmune LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
Phase 1 study to evaluate the safety of MEDI4212.
Detailed Description
A Phase 1, randomized, placebo-controlled, dose-escalation study to evaluate the safety and tolerability of ascending single subcutaneous and intravenous doses of MEDI4212 in subjects with immunoglobulin E (IgE) greater than or equal to (>=) 30 international units per milliliters (IU/mL).
Conditions Module
Conditions
Allergic Asthma
Atopic Dermatitis
Allergic Rhinitis
Healthy Volunteers
Keywords
Allergic
Atopic Dermatitis
MEDI4212
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
295Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Placebo
Placebo Comparator
A single dose of placebo matched to MEDI4212 subcutaneous injection or intravenous infusion on Day 1.
Other: Placebo
Omalizumab
Active Comparator
A single flexible dose of omalizumab between 150 to 375 milligram (mg) injection based upon participant's Immunoglobulin E (IgE) levels and body weight subcutaneously on Day 1.
Biological: Omalizumab
MEDI4212 5 mg Subcutaneous
Experimental
A single dose of MEDI4212 5 mg injection subcutaneously on Day 1.
Biological: MEDI4212 5 mg Subcutaneous
MEDI4212 15 mg Subcutaneous
Experimental
A single dose of MEDI4212 15 mg injection subcutaneously on Day 1.
Biological: MEDI4212 15 mg Subcutaneous
MEDI4212 60 mg Subcutaneous
Experimental
A single dose of MEDI4212 60 mg injection subcutaneously on Day 1.
Biological: MEDI4212 60 mg Subcutaneous
MEDI4212 150 mg Subcutaneous
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Placebo
Other
A single dose of placebo matched to MEDI4212 subcutaneous injection or intravenous infusion on Day 1.
Placebo
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of study drug and up to Day 85 that were absent before treatment or that worsened relative to pre-treatment state.
Day 1 to 85
Secondary Outcomes
Measure
Description
Time Frame
Observed Serum Concentration
Serum concentration of omalizumab and MEDI4212 were measured for participants who received omalizumab and MEDI4212, respectively.
Pre-dose and post-dose on Day 1; Day 2, 3, 5, 8, 15, 22, 29, 43, 57 and 85
Number of Participants Exhibiting Anti-Drug Antibodies for MEDI4212 at Any Visit
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Age 18 through 60 years
Written informed consent and any locally required authorization
Body weight 45-150 kilogram (kg) for Cohorts 1-3, 4b, and 5-9. Body weight 45-90 kg for Cohort 4a
Females must have been surgically sterilized or postmenopausal
Non-sterilized males who are sexually active with a female partner of childbearing potential must use a highly effective method of contraception from Day 1 through Day 85; Both partners to use contraception
Sterilized males must be at least 1-year post vasectomy or use a highly effective contraceptive method
Healthy Japanese population as determined by a responsible physician
Current diagnosis of allergic rhinitis, allergic asthma, or atopic dermatitis (cohorts 1-6) with a diagnostic immunoglobulin E (IgE) of 30 international units per milliliter (IU/mL) at Screening. Diagnostic IgE levels are further restricted for subjects enrolling into each cohort, with the following levels required at Screening: Cohorts 1 and 2: 30-700 IU/mL; Cohort 3: 30-700 IU/mL (4 subjects), greater than (>) 700-1,200 IU/mL (4 subjects), and >1,200 IU/mL (4 subjects); Cohort 4a: 30-500 IU/mL; Cohort 4b: >700 IU/mL; Cohorts 5 and 6: 30-700 IU/mL (4 subjects per cohort) and >700 IU/mL (6 subjects per cohort) or Japanese Cohorts 7-9: greater than or equal to (>=) 30 IU/mL
Nonsmoker for >=6 months
Obsolete criteria as no longer require Positive in vitro IgE fluorescence enzyme immunoassay (FEIA) response
A forced expiration volume in one second (FEV1) >= 80 percent (%) predicted in subjects with asthma. Non-asthmatic subjects with FEV1 >=80% predicted, or with FEV1 less than (<) 80% predicted but who, in the opinion of the investigator, do not have lung disease
Ability and willingness to complete the follow-up period through Day 85 as required by the protocol.
Exclusion Criteria:
Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results
Concurrent enrollment in another clinical study
Employees of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals
Exposure to an anti-IgE monoclonal antibodies (MAb) within 12 months prior to Screening
Positive drug screen at Screening or Day -1. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids, and benzodiazepines
History of regular alcohol abuse within 12 months prior to Screening
History of sensitivity to any component of the investigational product formulation or a history of drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates their participation
Subjects with abnormal liver function test values (aspartate transaminase [AST] and alanine transaminase [ALT]) at Screening as defined as follows: a) Liver function test values >= 1.5 times upper limit of normal (ULN)
Unwillingness or inability to follow the procedures outlined in the protocol
Positive test or history of hepatitis B or positive hepatitis C
Positive test or history of human immunodeficiency virus (HIV) or subject is known to be HIV seropositive
History of cancer, with the exception of basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success
Women who are pregnant, breastfeeding, or lactating
Plans to donate blood during the study period
Hyper-IgE syndrome or bronchopulmonary aspergillosis
Prior history of Immune Complex Disease or type 3 hypersensitivity reactions to MAb administration
Known history of prior infusion reaction to MAb administration
History of untreated parasitic/helminthic infection within 6 months prior to Screening
Uses any of the following medications: a) Oral corticosteroids b) Medium to high dose Immunocorticosteroids (ICS)/ long-acting beta agonists (LABA) c) Immunosuppressives d) Beta blockers
If receiving allergy immunotherapy, must be on stable dose for 3 months. Must not receive allergy immunotherapy within 7 days of investigational product administration.
Sheldon E, Schwickart M, Li J, Kim K, Crouch S, Parveen S, Kell C, Birrell C. Pharmacokinetics, Pharmacodynamics, and Safety of MEDI4212, an Anti-IgE Monoclonal Antibody, in Subjects with Atopy: A Phase I Study. Adv Ther. 2016 Feb;33(2):225-51. doi: 10.1007/s12325-016-0287-8. Epub 2016 Feb 3.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
A total of 295 participants were screened, out of which 209 were screen failures and 86 were randomized.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo
A single dose of placebo matched to MEDI4212 subcutaneous injection or intravenous infusion on Day 1.
FG001
Omalizumab
A single flexible dose of omalizumab between 150 to 375 milligram (mg) injection based upon participant's Immunoglobulin E (IgE) levels and body weight subcutaneously on Day 1.
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
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Experimental
A single dose of MEDI4212 150 mg injection subcutaneously on Day 1.
Biological: MEDI4212 150 mg Subcutaneous
MEDI4212 300 mg Subcutaneous
Experimental
A single dose of MEDI4212 300 mg injection subcutaneously on Day 1.
Biological: MEDI4212 300 mg Subcutaneous
MEDI4212 300 mg Intravenous
Experimental
A single dose of MEDI4212 300 mg intravenous infusion over 120 minutes on Day 1.
Biological: MEDI4212 300 mg Intravenous
Omalizumab
Biological
A single flexible dose of omalizumab between 150 to 375 milligram (mg) injection based upon participant's Immunoglobulin E (IgE) levels and body weight subcutaneously on Day 1.
Omalizumab
Xolair
MEDI4212 5 mg Subcutaneous
Biological
A single dose of MEDI4212 5 mg injection subcutaneously on Day 1.
MEDI4212 5 mg Subcutaneous
MEDI4212 15 mg Subcutaneous
Biological
A single dose of MEDI4212 15 mg injection subcutaneously on Day 1.
MEDI4212 15 mg Subcutaneous
MEDI4212 60 mg Subcutaneous
Biological
A single dose of MEDI4212 60 mg injection subcutaneously on Day 1.
MEDI4212 60 mg Subcutaneous
MEDI4212 150 mg Subcutaneous
Biological
A single dose of MEDI4212 150 mg injection subcutaneously on Day 1.
MEDI4212 150 mg Subcutaneous
MEDI4212 300 mg Subcutaneous
Biological
A single dose of MEDI4212 300 mg injection subcutaneously on Day 1.
MEDI4212 300 mg Subcutaneous
MEDI4212 300 mg Intravenous
Biological
A single dose of MEDI4212 300 mg intravenous infusion over 120 minutes on Day 1.
MEDI4212 300 mg Intravenous
Anti-drug antibodies for MEDI4212 were analyzed for participants who received placebo or MEDI4212 as per planned analysis.
Days 1 (pre-dose), 15, 43, and 85
Free Immunoglobulin E (IgE) Serum Concentration
Day -28 (Screening), -1, 1 (pre-dose), 2, 3, 5, 8, 15, 22, 29, 43, 57, and 85 for all groups; 2 hours post-dose on Day 1 for MEDI4212 300 mg Intravenous group only
Glendale
California
United States
Research Site
Denver
Colorado
United States
Research Site
Miami
Florida
United States
Research Site
Baltimore
Maryland
United States
Research Site
Pittsburgh
Pennsylvania
United States
Research Site
Madison
Wisconsin
United States
FG002
MEDI4212 5 mg Subcutaneous
A single dose of MEDI4212 5 mg injection subcutaneously on Day 1.
FG003
MEDI4212 15 mg Subcutaneous
A single dose of MEDI4212 15 mg injection subcutaneously on Day 1.
FG004
MEDI4212 60 mg Subcutaneous
A single dose of MEDI4212 60 mg injection subcutaneously on Day 1.
FG005
MEDI4212 150 mg Subcutaneous
A single dose of MEDI4212 150 mg injection subcutaneously on Day 1.
FG006
MEDI4212 300 mg Subcutaneous
A single dose of MEDI4212 300 mg injection subcutaneously on Day 1.
FG007
MEDI4212 300 mg Intravenous
A single dose of MEDI4212 300 mg intravenous infusion over 120 minutes on Day 1.
FG00017 subjects
FG0016 subjects
FG0023 subjects
FG0033 subjects
FG00416 subjects
FG00519 subjects
FG00614 subjects
FG0078 subjects
Treated
FG00017 subjects
FG0016 subjects
FG0023 subjects
FG0033 subjects
FG00415 subjects
FG00518 subjects
FG00614 subjects
FG0078 subjects
COMPLETED
FG00015 subjects
FG0016 subjects
FG0023 subjects
FG0033 subjects
FG00415 subjects
FG00516 subjects
FG00612 subjects
FG0078 subjects
NOT COMPLETED
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0053 subjects
FG0062 subjects
FG0070 subjects
Type
Comment
Reasons
Lost to Follow-up
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
Withdrawal by Subject
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Safety population included all participants who received any amount of investigational product and had safety data available.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo
A single dose of placebo matched to MEDI4212 subcutaneous injection or intravenous infusion on Day 1.
BG001
Omalizumab
A single flexible dose of omalizumab between 150 to 375 milligram (mg) injection based upon participant's Immunoglobulin E (IgE) levels and body weight subcutaneously on Day 1.
BG002
MEDI4212 5 mg Subcutaneous
A single dose of MEDI4212 5 mg injection subcutaneously on Day 1.
BG003
MEDI4212 15 mg Subcutaneous
A single dose of MEDI4212 15 mg injection subcutaneously on Day 1.
BG004
MEDI4212 60 mg Subcutaneous
A single dose of MEDI4212 60 mg injection subcutaneously on Day 1.
BG005
MEDI4212 150 mg Subcutaneous
A single dose of MEDI4212 150 mg injection subcutaneously on Day 1.
BG006
MEDI4212 300 mg Subcutaneous
A single dose of MEDI4212 300 mg injection subcutaneously on Day 1.
BG007
MEDI4212 300 mg Intravenous
A single dose of MEDI4212 300 mg intravenous infusion over 120 minutes on Day 1.
BG008
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00017
BG0016
BG0023
BG0033
BG00415
BG00518
BG00614
BG0078
BG00884
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
BG00039.6± 12.6
BG00139.3± 9.2
BG00244.7± 3.2
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0007
BG0012
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 (TESAEs)
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of study drug and up to Day 85 that were absent before treatment or that worsened relative to pre-treatment state.
Safety population included all participants who received any amount of investigational product and had safety data available.
Posted
Number
participants
Day 1 to 85
ID
Title
Description
OG000
Placebo
A single dose of placebo matched to MEDI4212 subcutaneous injection or intravenous infusion on Day 1.
OG001
Omalizumab
A single flexible dose of omalizumab between 150 to 375 milligram (mg) injection based upon participant's Immunoglobulin E (IgE) levels and body weight subcutaneously on Day 1.
OG002
MEDI4212 5 mg Subcutaneous
A single dose of MEDI4212 5 mg injection subcutaneously on Day 1.
OG003
MEDI4212 15 mg Subcutaneous
A single dose of MEDI4212 15 mg injection subcutaneously on Day 1.
OG004
MEDI4212 60 mg Subcutaneous
A single dose of MEDI4212 60 mg injection subcutaneously on Day 1.
OG005
MEDI4212 150 mg Subcutaneous
A single dose of MEDI4212 150 mg injection subcutaneously on Day 1.
OG006
MEDI4212 300 mg Subcutaneous
A single dose of MEDI4212 300 mg injection subcutaneously on Day 1.
OG007
MEDI4212 300 mg Intravenous
A single dose of MEDI4212 300 mg intravenous infusion over 120 minutes on Day 1.
Units
Counts
Participants
OG00017
OG0016
OG0023
OG003
Title
Denominators
Categories
TEAEs
Title
Measurements
OG0008
OG0012
OG0022
OG003
Secondary
Observed Serum Concentration
Serum concentration of omalizumab and MEDI4212 were measured for participants who received omalizumab and MEDI4212, respectively.
Pharmacokinetic (PK) population included all participants who received any investigational product and had a sufficient number of serum concentration measurements for computing PK parameters. Here 'n' signifies participants evaluable for this outcome measure at specified time point, for each group respectively
Posted
Mean
Standard Deviation
nanogram per milliliter (ng/mL)
Pre-dose and post-dose on Day 1; Day 2, 3, 5, 8, 15, 22, 29, 43, 57 and 85
ID
Title
Description
OG000
Omalizumab
A single flexible dose of omalizumab between 150 to 375 milligram (mg) injection based upon participant's Immunoglobulin E (IgE) levels and body weight subcutaneously on Day 1.
OG001
MEDI4212 5 mg Subcutaneous
A single dose of MEDI4212 5 mg injection subcutaneously on Day 1.
OG002
MEDI4212 15 mg Subcutaneous
A single dose of MEDI4212 15 mg injection subcutaneously on Day 1.
OG003
MEDI4212 60 mg Subcutaneous
Secondary
Number of Participants Exhibiting Anti-Drug Antibodies for MEDI4212 at Any Visit
Anti-drug antibodies for MEDI4212 were analyzed for participants who received placebo or MEDI4212 as per planned analysis.
Immunogenicity population included all participants who received any investigational product and had at least one valid immunogenicity test result.
Posted
Number
participants
Days 1 (pre-dose), 15, 43, and 85
ID
Title
Description
OG000
Placebo
A single dose of placebo matched to MEDI4212 subcutaneous injection or intravenous infusion on Day 1.
OG001
MEDI4212 5 mg Subcutaneous
A single dose of MEDI4212 5 mg injection subcutaneously on Day 1.
OG002
MEDI4212 15 mg Subcutaneous
A single dose of MEDI4212 15 mg injection subcutaneously on Day 1.
OG003
MEDI4212 60 mg Subcutaneous
A single dose of MEDI4212 60 mg injection subcutaneously on Day 1.
Secondary
Free Immunoglobulin E (IgE) Serum Concentration
Safety population included all participants who received any amount of investigational product and had safety data available. 'n' signifies those participants who evaluable for this outcome measure at specified time point for each group, respectively.
Posted
Mean
Standard Deviation
ng/mL
Day -28 (Screening), -1, 1 (pre-dose), 2, 3, 5, 8, 15, 22, 29, 43, 57, and 85 for all groups; 2 hours post-dose on Day 1 for MEDI4212 300 mg Intravenous group only
ID
Title
Description
OG000
Placebo
A single dose of placebo matched to MEDI4212 subcutaneous injection or intravenous infusion on Day 1.
OG001
Omalizumab
A single flexible dose of omalizumab between 150 to 375 milligram (mg) injection based upon participant's Immunoglobulin E (IgE) levels and body weight subcutaneously on Day 1.
OG002
MEDI4212 5 mg Subcutaneous
A single dose of MEDI4212 5 mg injection subcutaneously on Day 1.
OG003
MEDI4212 15 mg Subcutaneous
A single dose of MEDI4212 15 mg injection subcutaneously on Day 1.
Time Frame
Day 1 to 85
Description
Safety population included all participants who received any amount of investigational product and had safety data available.
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
Placebo
A single dose of placebo matched to MEDI4212 subcutaneous injection or intravenous infusion on Day 1.
0
17
8
17
EG001
Omalizumab
A single flexible dose of omalizumab between 150 to 375 milligram (mg) injection based upon participant's Immunoglobulin E (IgE) levels and body weight subcutaneously on Day 1.
0
6
2
6
EG002
MEDI4212 5 mg Subcutaneous
A single dose of MEDI4212 5 mg injection subcutaneously on Day 1.
0
3
2
3
EG003
MEDI4212 15 mg Subcutaneous
A single dose of MEDI4212 15 mg injection subcutaneously on Day 1.
0
3
1
3
EG004
MEDI4212 60 mg Subcutaneous
A single dose of MEDI4212 60 mg injection subcutaneously on Day 1.
0
15
4
15
EG005
MEDI4212 150 mg Subcutaneous
A single dose of MEDI4212 150 mg injection subcutaneously on Day 1.
0
18
9
18
EG006
MEDI4212 300 mg Subcutaneous
A single dose of MEDI4212 300 mg injection subcutaneously on Day 1.
0
14
7
14
EG007
MEDI4212 300 mg Intravenous
A single dose of MEDI4212 300 mg intravenous infusion over 120 minutes on Day 1.
0
8
6
8
Serious Adverse Events
Not provided
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Palpitations
Cardiac disorders
MedDRA 16.0
Systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected14 at risk
EG0070 events0 affected8 at risk
Dermoid cyst
Congenital, familial and genetic disorders
MedDRA 16.0
Systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Ear congestion
Ear and labyrinth disorders
MedDRA 16.0
Systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Eye irritation
Eye disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Vision blurred
Eye disorders
MedDRA 16.0
Systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected3 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Fatigue
General disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Feeling hot
General disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Injection site bruising
General disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Injection site pain
General disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Injection site paraesthesia
General disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 16.0
Systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0006 events6 affected17 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected3 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Headache
Nervous system disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Nerve compression
Nervous system disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected17 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected3 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Bronchospasm
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Pulmonary congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected3 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 16.0
Systematic Assessment
EG0001 events1 affected17 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected17 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected3 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Flushing
Vascular disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected17 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 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. The PIs also agree for data to be presented first as a joint, multi-center publication.
Point of Contact
Title
Organization
Phone
Extension
Email
Claire Birrell, Senior Clinical Scientist
MedImmune
301-398-0000
birrellc@medimmune.com
ID
Term
D003876
Dermatitis, Atopic
D065631
Rhinitis, Allergic
Ancestor Terms
ID
Term
D012873
Skin Diseases, Genetic
D030342
Genetic Diseases, Inborn
D009358
Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D003872
Dermatitis
D012871
Skin Diseases
D017437
Skin and Connective Tissue Diseases
D017443
Skin Diseases, Eczematous
D006969
Hypersensitivity, Immediate
D006967
Hypersensitivity
D007154
Immune System Diseases
D012220
Rhinitis
D009668
Nose Diseases
D012140
Respiratory Tract Diseases
D012130
Respiratory Hypersensitivity
D010038
Otorhinolaryngologic Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D000069444
Omalizumab
C000611149
MEDI4212
D007279
Injections, Subcutaneous
Ancestor Terms
ID
Term
D000888
Antibodies, Anti-Idiotypic
D000906
Antibodies
D007136
Immunoglobulins
D007162
Immunoproteins
D001798
Blood Proteins
D011506
Proteins
D000602
Amino Acids, Peptides, and Proteins
D061067
Antibodies, Monoclonal, Humanized
D000911
Antibodies, Monoclonal
D012712
Serum Globulins
D005916
Globulins
D007267
Injections
D004333
Drug Administration Routes
D004358
Drug Therapy
D013812
Therapeutics
Browse Leaves
Not provided
Browse Branches
Not provided
1 subjects
FG0052 subjects
FG0061 subjects
FG0070 subjects
0 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
40.3
± 9.6
BG00438.7± 12.5
BG00540.3± 11.1
BG00635.9± 13.1
BG00738.0± 8.6
BG00839.0± 11.2
1
BG0032
BG0044
BG0054
BG0062
BG0070
BG00822
Male
BG00010
BG0014
BG0022
BG0031
BG00411
BG00514
BG00612
BG0078
BG00862
3
OG00415
OG00518
OG00614
OG0078
1
OG0044
OG0059
OG0067
OG0076
TESAEs
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
A single dose of MEDI4212 60 mg injection subcutaneously on Day 1.
OG004
MEDI4212 150 mg Subcutaneous
A single dose of MEDI4212 150 mg injection subcutaneously on Day 1.
OG005
MEDI4212 300 mg Subcutaneous
A single dose of MEDI4212 300 mg injection subcutaneously on Day 1.
OG006
MEDI4212 300 mg Intravenous
A single dose of MEDI4212 300 mg intravenous infusion over 120 minutes on Day 1.
Units
Counts
Participants
OG0006
OG0013
OG0023
OG00315
OG00418
OG00514
OG0068
Title
Denominators
Categories
Day 1 (predose) (n=0,1,0,0,2,1,1)
Title
Measurements
OG000NA± NANo participant was evaluable for this outcome measure at this time point.
OG00196.76± NAStandard deviation was not estimable because only 1 participant was evaluable in this reporting group.
OG002NA± NANo participant was evaluable for this outcome measure at this time point.
OG003NA± NANo participant was evaluable for this outcome measure at this time point.
OG004254.71± 134.58
OG00591.69± NAStandard deviation was not estimable because only 1 participant was evaluable in this reporting group.
OG006158.32± NAStandard deviation was not estimable because only 1 participant was evaluable in this reporting group.
Day 1 (postdose) (n=0,0,0,0,0,0,8)
Title
Measurements
OG000NA± NANo participant was evaluable for this outcome measure at this time point.
OG001NA± NANo participant was evaluable for this outcome measure at this time point.
OG002NA± NANo participant was evaluable for this outcome measure at this time point.
OG003
Day 2 (n=5,1,1,12,17,13,8)
Title
Measurements
OG0008941.12± 6361.95
OG001100.36± NAStandard deviation was not estimable because only 1 participant was evaluable in this reporting group.
OG002292.76± NAStandard deviation was not estimable because only 1 participant was evaluable in this reporting group.
OG003
Day 3 (n=5,1,1,12,17,14,8)
Title
Measurements
OG00013912.4± 7546.50
OG001110.12± NAStandard deviation was not estimable because only 1 participant was evaluable in this reporting group.
OG002312.73± NAStandard deviation was not estimable because only 1 participant was evaluable in this reporting group.
OG003
Day 5 (n=5,1,1,11,16,14,8)
Title
Measurements
OG00017016.3± 6806.15
OG001116.44± NAStandard deviation was not estimable because only 1 participant was evaluable in this reporting group.
OG002284.28± NAStandard deviation was not estimable because only 1 participant was evaluable in this reporting group.
OG003
Day 8 (n=5,0,1,9,16,14,8)
Title
Measurements
OG00016467.4± 5374.97
OG001NA± NANo participant was evaluable for this outcome measure at this time point.
OG002190.38± NAStandard deviation was not estimable because only 1 participant was evaluable in this reporting group.
OG003
Day 15 (n=5,0,0,7,14,13,8)
Title
Measurements
OG00015099.6± 5470.44
OG001NA± NANo participant was evaluable for this outcome measure at this time point.
OG002NA± NANo participant was evaluable for this outcome measure at this time point.
OG003
Day 22 (n=5,0,0,6,12,10,8)
Title
Measurements
OG00012780.2± 4657.23
OG001NA± NANo participant was evaluable for this outcome measure at this time point.
OG002NA± NANo participant was evaluable for this outcome measure at this time point.
OG003
Day 29 (n=5,0,0,4,11,8,7)
Title
Measurements
OG0009466.26± 4040.07
OG001NA± NANo participant was evaluable for this outcome measure at this time point.
OG002NA± NANo participant was evaluable for this outcome measure at this time point.
OG003
Day 43 (n=5,2,0,0,5,5,3)
Title
Measurements
OG0005195.21± 2263.08
OG001121.39± 8.11
OG002NA± NANo participant was evaluable for this outcome measure at this time point.
OG003
Day 57 (n=5,2,0,0,4,4,3)
Title
Measurements
OG0002367.85± 984.70
OG001122.00± 0.35
OG002NA± NANo participant was evaluable for this outcome measure at this time point.
OG003
Day 85 (n=5,2,0,1, 3,1,1)
Title
Measurements
OG000829.55± 434.33
OG001104.07± 2.48
OG002NA± NANo participant was evaluable for this outcome measure at this time point.
OG003
OG004
MEDI4212 150 mg Subcutaneous
A single dose of MEDI4212 150 mg injection subcutaneously on Day 1.
OG005
MEDI4212 300 mg Subcutaneous
A single dose of MEDI4212 300 mg injection subcutaneously on Day 1.
OG006
MEDI4212 300 mg Intravenous
A single dose of MEDI4212 300 mg intravenous infusion over 120 minutes on Day 1.
Units
Counts
Participants
OG00017
OG0013
OG0023
OG00315
OG00418
OG00514
OG0068
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
OG0050
OG0060
OG004
MEDI4212 60 mg Subcutaneous
A single dose of MEDI4212 60 mg injection subcutaneously on Day 1.
OG005
MEDI4212 150 mg Subcutaneous
A single dose of MEDI4212 150 mg injection subcutaneously on Day 1.
OG006
MEDI4212 300 mg Subcutaneous
A single dose of MEDI4212 300 mg injection subcutaneously on Day 1.
OG007
MEDI4212 300 mg Intravenous
A single dose of MEDI4212 300 mg intravenous infusion over 120 minutes on Day 1.
Units
Counts
Participants
OG00017
OG0016
OG0023
OG0033
OG00415
OG00518
OG00614
OG0078
Title
Denominators
Categories
Day -28 (n=16,6,3,3,14,15,13,8)
Title
Measurements
OG0001160.79± 1402.74
OG001478.99± 369.31
OG002655.76± 240.78
OG003601.40± 342.13
OG0042170.63± 3899.67
OG0051976.98± 3172.11
OG0061775.68± 2558.08
OG0072641.68± 2332.13
Day -1 (n=17,6,3,3,15,17,14,7)
Title
Measurements
OG0001025.19± 1287.86
OG001296.73± 185.09
OG002589.62± 175.14
OG003
Day 1 (Predose) (n=17,6,3,3,15,17,14,8)
Title
Measurements
OG0001155.59± 1447.09
OG001410.78± 289.39
OG002552.30± 168.96
OG003
Day 1:2 hours postdose (n=0,0,0,0,0,0,0,8)
Title
Measurements
OG000NA± NANo participant was evaluable for this outcome measure at this time point.
OG001NA± NANo participant was evaluable for this outcome measure at this time point.
OG002NA± NANo participant was evaluable for this outcome measure at this time point.
OG003
Day 2 (n=17,6,3,3,15,17,14,8)
Title
Measurements
OG0001183.10± 1494.92
OG00171.89± 157.68
OG002302.31± 195.18
OG003
Day 3 (n=17,6,3,3,15,17,14,8)
Title
Measurements
OG0001175.50± 1550.93
OG00174.29± 168.46
OG002282.12± 179.53
OG003
Day 5 (n=17,6,3,3,15,17,14,8)
Title
Measurements
OG0001131.87± 1448.24
OG00174.85± 169.36
OG002297.90± 193.62
OG003
Day 8 (n=17,6,3,3,15,17,14,8)
Title
Measurements
OG0001119.38± 1417.95
OG00185.00± 192.16
OG002366.17± 239.65
OG003
Day 15 (n=17,6,3,3,15,17,14,8)
Title
Measurements
OG0001081.11± 1338.94
OG00174.94± 161.38
OG002418.27± 193.63
OG003
Day 22 (n=17,6,3,3,15,17,14,8)
Title
Measurements
OG0001084.02± 1294.17
OG00170.95± 145.36
OG002453.89± 191.07
OG003
Day 29 (n=16,6,3,3,15,17,13,8)
Title
Measurements
OG0001185.82± 1379.20
OG00174.02± 143.04
OG002478.53± 196.36
OG003
Day 43 (n=16,6,3,3,15,16,13,8)
Title
Measurements
OG0001089.90± 1306.97
OG00189.32± 157.95
OG002496.28± 179.01
OG003
Day 57 (n=16,6,3,3,15,15,12,8)
Title
Measurements
OG0001055.20± 1257.08
OG001105.46± 159.88
OG002506.63± 205.91
OG003
Day 85 (n=15,6,3,3,15,16,12,8)
Title
Measurements
OG000913.17± 1142.25
OG001294.89± 377.39
OG002526.93± 227.80
OG003
0 events
0 affected
3 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected14 at risk
EG0070 events0 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected14 at risk
EG0070 events0 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected14 at risk
EG0071 events1 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected15 at risk
EG0051 events1 affected18 at risk
EG0060 events0 affected14 at risk
EG0070 events0 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected14 at risk
EG0070 events0 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected14 at risk
EG0070 events0 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected14 at risk
EG0071 events1 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected14 at risk
EG0071 events1 affected8 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected15 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected14 at risk
EG0070 events0 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected14 at risk
EG0071 events1 affected8 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected15 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected14 at risk
EG0070 events0 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected18 at risk
EG0061 events1 affected14 at risk
EG0070 events0 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected18 at risk
EG0061 events1 affected14 at risk
EG0070 events0 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected14 at risk
EG0070 events0 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected14 at risk
EG0072 events2 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected15 at risk
EG0051 events1 affected18 at risk
EG0060 events0 affected14 at risk
EG0070 events0 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected15 at risk
EG0051 events1 affected18 at risk
EG0060 events0 affected14 at risk
EG0070 events0 affected8 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected15 at risk
EG0052 events2 affected18 at risk
EG0063 events2 affected14 at risk
EG0071 events1 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected14 at risk
EG0070 events0 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected14 at risk
EG0071 events1 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected14 at risk
EG0071 events1 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected14 at risk
EG0071 events1 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected18 at risk
EG0061 events1 affected14 at risk
EG0070 events0 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected14 at risk
EG0071 events1 affected8 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected15 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected14 at risk
EG0070 events0 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected15 at risk
EG0051 events1 affected18 at risk
EG0061 events1 affected14 at risk
EG0070 events0 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected15 at risk
EG0051 events1 affected18 at risk
EG0060 events0 affected14 at risk
EG0070 events0 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected15 at risk
EG0051 events1 affected18 at risk
EG0060 events0 affected14 at risk
EG0070 events0 affected8 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected15 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected14 at risk
EG0072 events2 affected8 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected15 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected14 at risk
EG0071 events1 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected14 at risk
EG0070 events0 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected14 at risk
EG0070 events0 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected15 at risk
EG0051 events1 affected18 at risk
EG0060 events0 affected14 at risk
EG0071 events1 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected14 at risk
EG0071 events1 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected14 at risk
EG0071 events1 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected15 at risk
EG0051 events1 affected18 at risk
EG0062 events2 affected14 at risk
EG0070 events0 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected18 at risk
EG0061 events1 affected14 at risk
EG0070 events0 affected8 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected15 at risk
EG0050 events0 affected18 at risk
EG0061 events1 affected14 at risk
EG0070 events0 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected14 at risk
EG0070 events0 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected14 at risk
EG0070 events0 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected14 at risk
EG0070 events0 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected14 at risk
EG0071 events1 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected15 at risk
EG0053 events3 affected18 at risk
EG0060 events0 affected14 at risk
EG0072 events2 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected14 at risk
EG0071 events1 affected8 at risk
NA
± NA
No participant was evaluable for this outcome measure at this time point.
OG004NA± NANo participant was evaluable for this outcome measure at this time point.
OG005NA± NANo participant was evaluable for this outcome measure at this time point.
OG006110693± 26060.2
3146.54
± 3820.61
OG0046108.21± 3401.45
OG00514971.9± 9608.63
OG00688457.0± 23398.4
3131.79
± 2513.43
OG0047969.07± 4004.75
OG00514771± 8692.16
OG00669776.5± 37738.7
3336.31
± 2759.69
OG0047227.93± 3210.9
OG00515183.4± 8522.98
OG00634359.5± 6817.40
2368.21
± 1364.28
OG0047144.03± 5078.61
OG00512611.1± 8382.56
OG00639290.2± 32657.3
1134.39
± 259.41
OG0044514.83± 2864.46
OG0058824.94± 6744.55
OG00611391.2± 3673.21
521.3
± 96.73
OG0043401± 2140.78
OG0057454.01± 4682.86
OG0064644.04± 2571.96
212.22
± 82.96
OG0042176.59± 1390.94
OG0052688.85± 2191.8
OG0062045.55± 1814.12
NA
± NA
No participant was evaluable for this outcome measure at this time point.
OG0041544.4± 2068.43
OG0051188.63± 949.33
OG0061669.74± 739.22
NA
± NA
No participant was evaluable for this outcome measure at this time point.
OG004290.44± 228.81
OG005485.18± 249.73
OG006150.90± 87.96
98.62
± NA
Standard deviation was not estimable because only 1 participant was evaluable in this reporting group.
OG004202.54± 107.75
OG00584.03± NAStandard deviation was not estimable because only 1 participant was evaluable in this reporting group.
OG006176.87± NAStandard deviation was not estimable because only 1 participant was evaluable in this reporting group.
522.23
± 259.96
OG0042453.85± 3795.64
OG0051655.06± 2866.87
OG0061681.82± 2161.25
OG0072772.55± 2320.93
558.69
± 305.68
OG0042754.09± 4468.96
OG0051910.45± 3268.58
OG0061850.27± 2435.13
OG0072426.66± 2460.85
NA
± NA
No participant was evaluable for this outcome measure at this time point.
OG004NA± NANo participant was evaluable for this outcome measure at this time point.
OG005NA± NANo participant was evaluable for this outcome measure at this time point.
OG006NA± NANo participant was evaluable for this outcome measure at this time point.