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    Clinical Trial Results:
    A Multi-Center, Multi-National, Randomized, Double-Blind, Placebo-Controlled Induction and Long-term Controlled Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Subjects with Active Eosinophilic Esophagitis

    Summary
    EudraCT number
    		 2020-004336-16
    Trial protocol
    		 DE   AT   PT   BE   PL   IT   ES  
    Global end of trial date
    29 Aug 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Jan 2025
    First version publication date
    26 Jan 2025
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    cc-93538-ee-001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04753697
    WHO universal trial number (UTN)
    		 U1111-1263-4351
    Sponsors
    Sponsor organisation name
    Bristol-Myers Squibb
    Sponsor organisation address
    Chaussée de la Hulpe 185, Brussels, Belgium, 1170
    Public contact
    EU Study Start-Up Unit, Bristol-Myers Squibb International Corporation, clinical.trials@bms.com
    Scientific contact
    EU Study Start-Up Unit, Bristol-Myers Squibb International Corporation, Clinical.Trials@bms.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    03 Oct 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Aug 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Study CC-93538-EE-001 is a Phase 3, multicenter, multinational, randomized, double-blind, placebo-controlled induction and maintenance study to evaluate the efficacy and safety of CC- 93538 in adult and adolescent participants with eosinophilic esophagitis (EoE).
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization Good Clinical Practice Guidelines. All the local regulatory requirements pertinent to safety of trial participants were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Feb 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 1
    Country: Number of subjects enrolled
    Australia: 38
    Country: Number of subjects enrolled
    Austria: 5
    Country: Number of subjects enrolled
    Belgium: 7
    Country: Number of subjects enrolled
    Canada: 53
    Country: Number of subjects enrolled
    Germany: 6
    Country: Number of subjects enrolled
    Israel: 6
    Country: Number of subjects enrolled
    Italy: 13
    Country: Number of subjects enrolled
    Japan: 22
    Country: Number of subjects enrolled
    Poland: 12
    Country: Number of subjects enrolled
    Portugal: 9
    Country: Number of subjects enrolled
    Spain: 7
    Country: Number of subjects enrolled
    Switzerland: 4
    Country: Number of subjects enrolled
    United Kingdom: 3
    Country: Number of subjects enrolled
    United States: 244
    Worldwide total number of subjects
    430
    EEA total number of subjects
    59
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    35
    Adults (18-64 years)
    391
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 805 participants were screened across 15 countries.

    Period 1
    Period 1 title
    Pre-Treatment Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 CC-93538 360 mg QW
    Arm description
    		 Participants with Eosinophilic Esophagitis received 360 mg CC-93538 SC once every week in the 24-week induction phase followed by 24-week maintenance phase.
    Arm type
    		 Experimental

    Investigational medicinal product name
    cendakimab
    Investigational medicinal product code
    CC-93538
    Other name
    Pharmaceutical forms
    Dispersion for injection, Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered 360 mg subcutaneously by self or caregiver

    Arm title
    		 CC-93538 360 mg QW/Q2W
    Arm description
    		 Participants with Eosinophilic Esophagitis received 360 mg CC-93538 SC once in a week (QW) in the 24-week induction phase and once every other week in 24-week maintenance phase.
    Arm type
    		 Experimental

    Investigational medicinal product name
    cendakimab
    Investigational medicinal product code
    CC-93538
    Other name
    Pharmaceutical forms
    Dispersion for injection, Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered 360 mg subcutaneously by self or caregiver

    Arm title
    		 Placebo
    Arm description
    		 Participants with active eosinophilic esophagitis received CC-93538 matching placebo during 24-week induction phase followed by 24-week maintenance phase.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Self administered or by care giver

    Number of subjects in period 1
    		CC-93538 360 mg QW CC-93538 360 mg QW/Q2W Placebo
    Started
    143
    143
    144
    Completed
    143
    141
    143
    Not completed
    0
    2
    1
         Other reasons
    -
    2
    1
    Period 2
    Period 2 title
    Induction Phase
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 CC-93538 360 mg QW
    Arm description
    		 Participants with Eosinophilic Esophagitis received 360 mg CC-93538 SC once every week in the 24-week induction phase followed by 24-week maintenance phase.
    Arm type
    		 Experimental

    Investigational medicinal product name
    cendakimab
    Investigational medicinal product code
    CC-93538
    Other name
    Pharmaceutical forms
    Dispersion for injection, Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered 360 mg subcutaneously by self or caregiver

    Arm title
    		 CC-93538 360 mg QW/Q2W
    Arm description
    		 Participants with Eosinophilic Esophagitis received 360 mg CC-93538 SC once in a week (QW) in the 24-week induction phase and once every other week in 24-week maintenance phase.
    Arm type
    		 Experimental

    Investigational medicinal product name
    cendakimab
    Investigational medicinal product code
    CC-93538
    Other name
    Pharmaceutical forms
    Dispersion for injection, Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered 360 mg subcutaneously by self or caregiver

    Arm title
    		 Placebo
    Arm description
    		 Participants with active eosinophilic esophagitis received CC-93538 matching placebo during 24-week induction phase followed by 24-week maintenance phase.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Self administered or by care giver

    Number of subjects in period 2
    		CC-93538 360 mg QW CC-93538 360 mg QW/Q2W Placebo
    Started
    143
    141
    143
    Completed
    127
    134
    136
    Not completed
    16
    7
    7
         Consent withdrawn by subject
    12
    5
    6
         Physician decision
    1
    -
    -
         Lost to follow-up
    2
    2
    1
         Lack of efficacy
    1
    -
    -
    Period 3
    Period 3 title
    Maintenance Phase
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 CC-93538 360 mg QW
    Arm description
    		 Participants with Eosinophilic Esophagitis received 360 mg CC-93538 SC once every week in the 24-week induction phase followed by 24-week maintenance phase.
    Arm type
    		 Experimental

    Investigational medicinal product name
    cendakimab
    Investigational medicinal product code
    CC-93538
    Other name
    Pharmaceutical forms
    Dispersion for injection, Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered 360 mg subcutaneously by self or caregiver

    Arm title
    		 CC-93538 360 mg QW/Q2W
    Arm description
    		 Participants with Eosinophilic Esophagitis received 360 mg CC-93538 SC once in a week (QW) or once every other week in the 24-week maintenance phase.
    Arm type
    		 Experimental

    Investigational medicinal product name
    cendakimab
    Investigational medicinal product code
    CC-93538
    Other name
    Pharmaceutical forms
    Dispersion for injection, Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered 360 mg subcutaneously by self or caregiver

    Arm title
    		 Placebo
    Arm description
    		 Participants with active eosinophilic esophagitis received CC-93538 matching placebo during 24-week induction phase followed by 24-week maintenance phase.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Self administered or by care giver

    Number of subjects in period 3 [1]
    		CC-93538 360 mg QW CC-93538 360 mg QW/Q2W Placebo
    Started
    114
    117
    90
    Completed
    107
    110
    82
    Not completed
    7
    7
    8
         Consent withdrawn by subject
    3
    4
    6
         Physician decision
    -
    -
    1
         NON-COMPLIANCE WITH STUDY DRUG
    1
    -
    -
         Adverse event, non-fatal
    -
    1
    1
         WITHDRAWAL BY PARENT/GUARDIAN
    1
    -
    -
         Lost to follow-up
    2
    2
    -
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: 77 participants across 3 arms did not enter maintenance period.

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    CC-93538 360 mg QW
    Reporting group description
    		 Participants with Eosinophilic Esophagitis received 360 mg CC-93538 SC once every week in the 24-week induction phase followed by 24-week maintenance phase.

    Reporting group title
    CC-93538 360 mg QW/Q2W
    Reporting group description
    		 Participants with Eosinophilic Esophagitis received 360 mg CC-93538 SC once in a week (QW) in the 24-week induction phase and once every other week in 24-week maintenance phase.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants with active eosinophilic esophagitis received CC-93538 matching placebo during 24-week induction phase followed by 24-week maintenance phase.

    Reporting group values
    		 CC-93538 360 mg QW CC-93538 360 mg QW/Q2W Placebo Total
    Number of subjects
    		 143 143 144 430
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 9 17 9 35
        Adults (18-64 years)
    		 131 126 134 391
        From 65-84 years
    		 3 0 1 4
        85 years and over
    		 0 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 35.9 ( 11.79 ) 34.8 ( 12.24 ) 36.2 ( 12.16 ) -
    Sex: Female, Male
    Units: participants
        Female
    		 53 33 45 131
        Male
    		 90 110 99 299
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 1 0 1
        Asian
    		 5 10 11 26
        Native Hawaiian or Other Pacific Islander
    		 1 0 1 2
        Black or African American
    		 2 3 0 5
        White
    		 134 128 130 392
        More than one race
    		 0 0 0 0
        Unknown or Not Reported
    		 1 1 2 4
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 6 5 6 17
        Not Hispanic or Latino
    		 135 138 137 410
        Unknown or Not Reported
    		 2 0 1 3

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    CC-93538 360 mg QW
    Reporting group description
    		 Participants with Eosinophilic Esophagitis received 360 mg CC-93538 SC once every week in the 24-week induction phase followed by 24-week maintenance phase.

    Reporting group title
    CC-93538 360 mg QW/Q2W
    Reporting group description
    		 Participants with Eosinophilic Esophagitis received 360 mg CC-93538 SC once in a week (QW) in the 24-week induction phase and once every other week in 24-week maintenance phase.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants with active eosinophilic esophagitis received CC-93538 matching placebo during 24-week induction phase followed by 24-week maintenance phase.
    Reporting group title
    CC-93538 360 mg QW
    Reporting group description
    		 Participants with Eosinophilic Esophagitis received 360 mg CC-93538 SC once every week in the 24-week induction phase followed by 24-week maintenance phase.

    Reporting group title
    CC-93538 360 mg QW/Q2W
    Reporting group description
    		 Participants with Eosinophilic Esophagitis received 360 mg CC-93538 SC once in a week (QW) in the 24-week induction phase and once every other week in 24-week maintenance phase.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants with active eosinophilic esophagitis received CC-93538 matching placebo during 24-week induction phase followed by 24-week maintenance phase.
    Reporting group title
    CC-93538 360 mg QW
    Reporting group description
    		 Participants with Eosinophilic Esophagitis received 360 mg CC-93538 SC once every week in the 24-week induction phase followed by 24-week maintenance phase.

    Reporting group title
    CC-93538 360 mg QW/Q2W
    Reporting group description
    		 Participants with Eosinophilic Esophagitis received 360 mg CC-93538 SC once in a week (QW) or once every other week in the 24-week maintenance phase.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants with active eosinophilic esophagitis received CC-93538 matching placebo during 24-week induction phase followed by 24-week maintenance phase.

    Subject analysis set title
    Induction Phase - CC-93538 360 mg QW
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants with Eosinophilic Esophagitis received 360 mg CC-93538 SC once every week in the 24-week induction phase.

    Subject analysis set title
    Induction Phase - Placebo
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24-week induction phase.

    Subject analysis set title
    Induction Phase - CC-93538 360 mg QW
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants with Eosinophilic Esophagitis received 360 mg CC-93538 SC once every week in the 24 week induction phase.

    Subject analysis set title
    Induction Phase - Placebo
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24 week induction phase.

    Subject analysis set title
    Maintenance Phase - CC-93538 360 mg QW
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants with Eosinophilic Esophagitis received 360 mg CC-93538 SC once every week in the 24 week maintenance phase.

    Subject analysis set title
    Maintenance Phase - CC-93538 360 mg Q2W
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants with Eosinophilic Esophagitis received 360 mg CC-93538 SC once every other week in the 24 week maintenance phase.

    Subject analysis set title
    Maintenance Phase - Placebo
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24 week maintenance phase.

    Subject analysis set title
    Maintenance Phase - Placebo
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24 week maintenance phase.

    Subject analysis set title
    Maintenance Phase - CC-93538 360 mg QW
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants with Eosinophilic Esophagitis received 360 mg CC-93538 SC once every week in the 24 week maintenance phase.

    Subject analysis set title
    Maintenance Phase - CC-93538 360 mg Q2W
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants with Eosinophilic Esophagitis received 360 mg CC-93538 SC once every other week in the 24 week maintenance phase.

    Subject analysis set title
    Maintenance Phase - Placebo
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24 week maintenance phase.

    Subject analysis set title
    Induction Phase - Placebo
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24 week induction phase.

    Subject analysis set title
    Maintenance Phase - CC-93538 360 mg QW
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants with Eosinophilic Esophagitis received 360 mg CC-93538 SC once every week in the 24 week maintenance phase.

    Subject analysis set title
    Maintenance Phase - CC-93538 360 mg Q2W
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants with Eosinophilic Esophagitis received 360 mg CC-93538 SC once every other week in the 24 week maintenance phase.

    Subject analysis set title
    Maintenance Phase - Placebo
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24 week maintenance phase.

    Subject analysis set title
    Induction Phase - CC-93538 360 mg QW
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants with Eosinophilic Esophagitis received 360 mg CC-93538 SC once every week in the 24 week induction phase.

    Subject analysis set title
    Induction Phase - Placebo
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24 week induction phase.

    Subject analysis set title
    Induction Phase - CC-93538 360 mg QW
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants with Eosinophilic Esophagitis received 360 mg CC-93538 SC once every week in the 24 week induction phase.

    Subject analysis set title
    Induction Phase - Placebo
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24 week induction phase.

    Subject analysis set title
    Induction Phase - Placebo
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24 week induction phase.

    Subject analysis set title
    Induction Phase - CC-93538 360 mg QW
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants with Eosinophilic Esophagitis received 360 mg CC-93538 SC once every week in the 24 week induction phase.

    Subject analysis set title
    Induction Phase - Placebo
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24 week induction phase.

    Subject analysis set title
    Maintenance Phase - CC-93538 360 mg QW
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants with Eosinophilic Esophagitis received 360 mg CC-93538 SC once every week in the 24 week maintenance phase.

    Subject analysis set title
    Maintenance Phase - CC-93538 360 mg Q2W
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants with Eosinophilic Esophagitis received 360 mg CC-93538 SC once every other week in the 24 week maintenance phase.

    Subject analysis set title
    Induction Phase - CC-93538 360 mg QW
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants with Eosinophilic Esophagitis received 360 mg CC-93538 SC once every week in the 24 week induction phase.

    Subject analysis set title
    Induction Phase - Placebo
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24 week induction phase.

    Subject analysis set title
    Maintenance Phase - CC-93538 360 mg QW
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants with Eosinophilic Esophagitis received 360 mg CC-93538 SC once every week in the 24 week maintenance phase.

    Subject analysis set title
    Maintenance Phase - CC-93538 360 mg Q2W
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants with Eosinophilic Esophagitis received 360 mg CC-93538 SC once every other week in the 24 week maintenance phase.

    Subject analysis set title
    Induction Phase - CC-93538 360 mg QW
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants with Eosinophilic Esophagitis received 360 mg CC-93538 SC once every week in the 24 week induction phase.

    Subject analysis set title
    Maintenance Phase - CC-93538 360 mg QW
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants with Eosinophilic Esophagitis received 360 mg CC-93538 SC once every week in the 24 week maintenance phase.

    Subject analysis set title
    CC-93538 360 mg QW
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants with Eosinophilic Esophagitis received 360 mg CC-93538 SC once every week in the 24-week induction phase followed by 24-week maintenance phase.

    Subject analysis set title
    CC-93538 360 mg QW/Q2W
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants with Eosinophilic Esophagitis received 360 mg CC-93538 SC once in a week (QW) or once every other week in the 24-week maintenance phase.

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants with active eosinophilic esophagitis received CC-93538 matching placebo during 24-week induction phase followed by 24-week maintenance phase.

    Subject analysis set title
    Induction Phase - Placebo
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24-week induction phase.

    Subject analysis set title
    Maintenance Phase - CC-93538 360 mg QW
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants with Eosinophilic Esophagitis received 360 mg CC-93538 SC once every week in the 24 week maintenance phase.

    Subject analysis set title
    Maintenance Phase - CC-93538 360 mg Q2W
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants with Eosinophilic Esophagitis received 360 mg CC-93538 SC once every other week in the 24 week maintenance phase.

    Subject analysis set title
    Maintenance Phase - Placebo
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24 week maintenance phase.

    Primary: Change from Baseline in Mean Dysphagia Days (DD) at Week 24

    		 Close Top of page
    End point title
    		 Change from Baseline in Mean Dysphagia Days (DD) at Week 24
    End point description
    Dysphagia Days (DD) was assessed using a modified daily symptom diary (mDSD). The DD was evaluated over the prior 14-day period using the mDSD, which includes 6 primary questions. These questions assess solid food consumption that day (Q1), experience with trouble swallowing (Q2), food going down slowly (Q3), food getting stuck in the throat or chest (Q4), actions taken by participants to obtain relief (Q5), and any pain associated with swallowing (Q6). The number of DD was normalized by calculating the number of diary days with a "yes" to any or all of Q2, Q3, and Q4 in the 14-day period prior to a visit, dividing by the number of measurable diary days in the 14-day period, and then multiplying by the length of the period (14). A measurable diary day for DD is defined as a diary day for which Questions 2 to 4 are answered. Mean DD ranges from 0 to 14 for the 14-day period.
    End point type
    Primary
    End point timeframe
    Baseline (Day 1) and Week 24
    End point values
    		 Induction Phase - CC-93538 360 mg QW Induction Phase - Placebo
    Number of subjects analysed
    236
    124
    Units: days
        arithmetic mean (standard deviation)
    -6.85 ( 5.259 )
    -4.98 ( 5.075 )
    Statistical analysis title
    		 Analysis 1
    Comparison groups
    Induction Phase - CC-93538 360 mg QW v Induction Phase - Placebo
    Number of subjects included in analysis
    360
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0005
    Method
    		 ANCOVA
    Parameter type
    		 Difference in Least Square Mean
    Point estimate
    -1.91
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.97
         upper limit
    		 -0.84
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.544

    Primary: Percentage of Participants with Peak Esophageal Eosinophil Count <= 6/high-power field (hpf) at Week 24

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    End point title
    		 Percentage of Participants with Peak Esophageal Eosinophil Count <= 6/high-power field (hpf) at Week 24
    End point description
    Blood samples were collected to assess esophageal eosinophil count.
    End point type
    Primary
    End point timeframe
    Week 24
    End point values
    		 Induction Phase - CC-93538 360 mg QW Induction Phase - Placebo
    Number of subjects analysed
    249
    129
    Units: percentage of participants
        number (not applicable)
    34.1
    3.1
    Statistical analysis title
    		 Analysis 1
    Comparison groups
    Induction Phase - CC-93538 360 mg QW v Induction Phase - Placebo
    Number of subjects included in analysis
    378
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    26.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 20.6
         upper limit
    		 32.2

    Secondary: Percentage of Participants with Peak Esophageal Eosinophil Count <= 6/high-power field (hpf) at Week 48

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    End point title
    		 Percentage of Participants with Peak Esophageal Eosinophil Count <= 6/high-power field (hpf) at Week 48
    End point description
    Blood samples were collected to assess esophageal eosinophil count.
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    		 Maintenance Phase - CC-93538 360 mg QW Maintenance Phase - CC-93538 360 mg Q2W Maintenance Phase - Placebo
    Number of subjects analysed
    104
    108
    82
    Units: percentage of participants
        number (not applicable)
    37.5
    34.3
    4.9
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Maintenance Phase - CC-93538 360 mg QW v Maintenance Phase - Placebo
    Number of subjects included in analysis
    186
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 DIFFERENCE IN RESPONSE RATE
    Point estimate
    18.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 11.3
         upper limit
    		 25.5
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Maintenance Phase - CC-93538 360 mg QW v Maintenance Phase - Placebo
    Number of subjects included in analysis
    186
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 DIFFERENCE IN RESPONSE RATE
    Point estimate
    17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 10.1
         upper limit
    		 24

    Secondary: Percentage of Participants with Peak Esophageal Eosinophil count < 15/high-power field (hpf) at Week 24

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    End point title
    		 Percentage of Participants with Peak Esophageal Eosinophil count < 15/high-power field (hpf) at Week 24
    End point description
    Blood samples were collected to assess esophageal eosinophil count.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 Induction Phase - CC-93538 360 mg QW Induction Phase - Placebo
    Number of subjects analysed
    249
    129
    Units: percentage of participants
        number (not applicable)
    53.0
    4.7
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Induction Phase - CC-93538 360 mg QW v Induction Phase - Placebo
    Number of subjects included in analysis
    378
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 DIFFERENCE IN RESPONSE RATE
    Point estimate
    40
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 33.3
         upper limit
    		 46.7

    Secondary: Percentage of Participants with Peak Esophageal Eosinophil Count < 15/high-power field (hpf) at Week 48

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    End point title
    		 Percentage of Participants with Peak Esophageal Eosinophil Count < 15/high-power field (hpf) at Week 48
    End point description
    Blood samples were collected to assess esophageal eosinophil count.
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    		 Maintenance Phase - CC-93538 360 mg QW Maintenance Phase - CC-93538 360 mg Q2W Maintenance Phase - Placebo
    Number of subjects analysed
    104
    108
    82
    Units: percentage of participants
        number (not applicable)
    50.0
    50.0
    8.5
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Maintenance Phase - CC-93538 360 mg QW v Maintenance Phase - Placebo
    Number of subjects included in analysis
    186
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 DIFFERENCE IN RESPONSE RATE
    Point estimate
    25.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 17.8
         upper limit
    		 33.6
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Maintenance Phase - CC-93538 360 mg Q2W v Maintenance Phase - Placebo
    Number of subjects included in analysis
    190
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 DIFFERENCE IN RESPONSE RATE
    Point estimate
    27.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 19.7
         upper limit
    		 35.7

    Secondary: Change from Baseline in Mean Dysphagia Days (DD) at Week 48

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    End point title
    		 Change from Baseline in Mean Dysphagia Days (DD) at Week 48
    End point description
    Dysphagia Days (DD) was assessed using a modified daily symptom diary (mDSD). The DD was evaluated over the prior 14-day period using the mDSD, which includes 6 primary questions. These questions assess solid food consumption that day (Q1), experience with trouble swallowing (Q2), food going down slowly (Q3), food getting stuck in the throat or chest (Q4), actions taken by participants to obtain relief (Q5), and any pain associated with swallowing (Q6). The number of DD was normalized by calculating the number of diary days with a "yes" to any or all of Q2, Q3, and Q4 in the 14-day period prior to a visit, dividing by the number of measurable diary days in the 14-day period, and then multiplying by the length of the period (14). A measurable diary day for DD is defined as a diary day for which Questions 2 to 4 are answered. Mean DD ranges from 0 to 14 for the 14-day period.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and Week 48
    End point values
    		 Maintenance Phase - CC-93538 360 mg QW Maintenance Phase - CC-93538 360 mg Q2W Maintenance Phase - Placebo
    Number of subjects analysed
    100
    101
    75
    Units: days
        arithmetic mean (standard deviation)
    -7.71 ( 5.401 )
    -8.07 ( 5.292 )
    -6.20 ( 5.118 )
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Maintenance Phase - CC-93538 360 mg Q2W v Maintenance Phase - Placebo
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0002
    Method
    		 ANCOVA
    Parameter type
    		 DIFFERENCE IN LSM
    Point estimate
    -2.49
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.78
         upper limit
    		 -1.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.657
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Maintenance Phase - CC-93538 360 mg QW v Maintenance Phase - Placebo
    Number of subjects included in analysis
    175
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0006
    Method
    		 ANCOVA
    Parameter type
    		 DIFFERENCE IN LSM
    Point estimate
    -2.26
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.55
         upper limit
    		 -0.98
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.655

    Secondary: Change from Baseline in Eosinophilic Esophagitis (EoE) Endoscopic Reference Score (EREFS) at Week 24

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    End point title
    		 Change from Baseline in Eosinophilic Esophagitis (EoE) Endoscopic Reference Score (EREFS) at Week 24
    End point description
    The EREFS, measures features of EoE including esophageal edema, fixed rings, exudates, furrows, and strictures. The instrument grades edema as none (0) or present (1) or severe; furrows as absent (0), present (1); rings as none (0), mild (1), moderate (2) and severe (3); exudates as none (0), mild (1) or severe (2); and strictures as absent (0) or present (1). Two sub-component scores will be calculated by adding up the grade from respective features across the 3 esophagus levels (proximal, mid, and distal). Inflammation composite score (ranging 0 to 12) includes edema, furrows and exudates while remodeling composite score (0 to 12) consist of stricture and fixed rings. The EREFS total score is the sum of the inflammation and remodeling composite scores. The EREFS total score ranges from 0 to 24. High score signifies severe condition.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) , Week 24
    End point values
    		 Induction Phase - CC-93538 360 mg QW Induction Phase - Placebo
    Number of subjects analysed
    249
    128
    Units: score on a scale
        arithmetic mean (standard deviation)
    -6.0 ( 4.54 )
    -1.5 ( 4.26 )
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Induction Phase - CC-93538 360 mg QW v Induction Phase - Placebo
    Number of subjects included in analysis
    377
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 DIFFERENCE IN LSM
    Point estimate
    -4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.8
         upper limit
    		 -3.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.42

    Secondary: Change from Baseline in Eosinophilic Esophagitis (EoE) Endoscopic Reference Score (EREFS) at Week 48

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    End point title
    		 Change from Baseline in Eosinophilic Esophagitis (EoE) Endoscopic Reference Score (EREFS) at Week 48
    End point description
    The EREFS, measures features of EoE including esophageal edema, fixed rings, exudates, furrows, and strictures. The instrument grades edema as none (0) or present (1) or severe; furrows as absent (0), present (1); rings as none (0), mild (1), moderate (2) and severe (3); exudates as none (0), mild (1) or severe (2); and strictures as absent (0) or present (1). Two sub-component scores will be calculated by adding up the grade from respective features across the 3 esophagus levels (proximal, mid, and distal). Inflammation composite score (ranging 0 to 12) includes edema, furrows and exudates while remodeling composite score (0 to 12) consist of stricture and fixed rings. The EREFS total score is the sum of the inflammation and remodeling composite scores. The EREFS total score ranges from 0 to 24. High score signifies severe condition.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) , Week 48
    End point values
    		 Maintenance Phase - CC-93538 360 mg QW Maintenance Phase - CC-93538 360 mg Q2W Maintenance Phase - Placebo
    Number of subjects analysed
    103
    105
    79
    Units: score on a scale
        arithmetic mean (standard deviation)
    -6.6 ( 4.24 )
    -6.5 ( 4.57 )
    -3.2 ( 4.15 )
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Maintenance Phase - CC-93538 360 mg Q2W v Maintenance Phase - Placebo
    Number of subjects included in analysis
    184
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 DIFFERENCE IN LSM
    Point estimate
    -3.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.1
         upper limit
    		 -2.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.51
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Maintenance Phase - CC-93538 360 mg QW v Maintenance Phase - Placebo
    Number of subjects included in analysis
    182
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 DIFFERENCE IN LSM
    Point estimate
    -3.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.5
         upper limit
    		 -2.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.51

    Secondary: Change from Baseline in Mean Adjusted Eosinophilic Esophagitis Histology Scoring System (EoEHSS) Grade Score at Week 24

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    End point title
    		 Change from Baseline in Mean Adjusted Eosinophilic Esophagitis Histology Scoring System (EoEHSS) Grade Score at Week 24
    End point description
    EoEHSS evaluates the grade (severity) of multiple pathologic features in esophageal biopsies. It has 8 features eosinophil inflammation, basal zone hyperplasia, eosinophil abscess, eosinophil surface layering, dilated intercellular spaces, surface epithelial alteration, dyskeratotic epithelial cells, and lamina propria fibrosis. In 3 separate esophagus levels (proximal, mid, and distal), each feature is scored independently for grade using a 4-point Likert scale (0 [absent] to 3 [severe]). The mean adjusted grade score is calculated by averaging the adjusted scores for the 3 levels (proximal, mid, and distal). The mean adjusted scores range from 0 to 100. High score signifies severe condition.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1), Week 24
    End point values
    		 Induction Phase - CC-93538 360 mg QW Induction Phase - Placebo
    Number of subjects analysed
    249
    129
    Units: Score on a scale
        arithmetic mean (standard deviation)
    -30.20 ( 15.811 )
    -6.47 ( 15.755 )
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Induction Phase - CC-93538 360 mg QW v Induction Phase - Placebo
    Number of subjects included in analysis
    378
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 DIFFERENCE IN LSM
    Point estimate
    -22.51
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -25.5
         upper limit
    		 -19.51
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.528

    Secondary: Change from Baseline in Mean Adjusted Eosinophilic Esophagitis Histology Scoring System (EoEHSS) Grade Score at Week 48

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    End point title
    		 Change from Baseline in Mean Adjusted Eosinophilic Esophagitis Histology Scoring System (EoEHSS) Grade Score at Week 48
    End point description
    EoEHSS evaluates the grade (severity) of multiple pathologic features in esophageal biopsies. It has 8 features eosinophil inflammation, basal zone hyperplasia, eosinophil abscess, eosinophil surface layering, dilated intercellular spaces, surface epithelial alteration, dyskeratotic epithelial cells, and lamina propria fibrosis. In 3 separate esophagus levels (proximal, mid, and distal), each feature is scored independently for grade using a 4-point Likert scale (0 [absent] to 3 [severe]). The mean adjusted grade score is calculated by averaging the adjusted scores for the 3 levels (proximal, mid, and distal). The mean adjusted scores range from 0 to 100. High score signifies severe condition.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) , Week 48
    End point values
    		 Maintenance Phase - CC-93538 360 mg QW Maintenance Phase - CC-93538 360 mg Q2W Maintenance Phase - Placebo
    Number of subjects analysed
    104
    108
    82
    Units: score on a scale
        arithmetic mean (standard deviation)
    -30.35 ( 17.146 )
    -30.96 ( 15.864 )
    -6.17 ( 16.579 )
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Maintenance Phase - CC-93538 360 mg QW v Maintenance Phase - Placebo
    Number of subjects included in analysis
    186
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 DIFFERENCE IN LSM
    Point estimate
    -18.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -21.85
         upper limit
    		 -14.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.9
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Maintenance Phase - CC-93538 360 mg Q2W v Maintenance Phase - Placebo
    Number of subjects included in analysis
    190
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 DIFFERENCE IN LSM
    Point estimate
    -19.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -22.9
         upper limit
    		 -15.53
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.88

    Secondary: Change from Baseline in Mean Adjusted Eosinophilic Esophagitis Histology Scoring System (EoEHSS) Stage Score at Week 24

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    End point title
    		 Change from Baseline in Mean Adjusted Eosinophilic Esophagitis Histology Scoring System (EoEHSS) Stage Score at Week 24
    End point description
    EoEHSS evaluates the stage (extent) of multiple pathologic features in esophageal biopsies. It has 8 features eosinophil inflammation (determined by peak EoS count(PEC)) and presence of basal zone hyperplasia, eosinophil abscess, eosinophil surface layering, dilated intercellular spaces, surface epithelial alteration, dyskeratotic epithelial cells, and lamina propria fibrosis in epithelium . In 3 separate esophagus levels (proximal, mid, and distal), each feature is scored independently for stage using a 4-point Likert scale (0 [absent], 1[PEC ≥15/hpf in <33% of hpfs or (any grade >0) <33% of epithelium for other features], 2 [PEC ≥15/hpf in 33-66% of hpfs or (any grade >0) in 33-66% of epithelium to 3 [PEC ≥15/hpf in >66% of hpfs or (any grade >0) in > 66% of epithelium]). The mean adjusted stage score is calculated by averaging the adjusted scores for the 3 levels (proximal, mid, and distal). The mean adjusted scores range from 0 to 100. High score signifies severe condition.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1), Week 24
    End point values
    		 Induction Phase - CC-93538 360 mg QW Induction Phase - Placebo
    Number of subjects analysed
    249
    129
    Units: Score on a scale
        arithmetic mean (standard deviation)
    -36.71 ( 19.370 )
    -9.90 ( 17.583 )
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Induction Phase - CC-93538 360 mg QW v Induction Phase - Placebo
    Number of subjects included in analysis
    378
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 DIFFERENCE IN LSM
    Point estimate
    -25.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -25.4
         upper limit
    		 -21.89
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.793

    Secondary: Change from Baseline in Mean Adjusted Eosinophilic Esophagitis Histology Scoring System (EoEHSS) Stage Score at Week 48

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    End point title
    		 Change from Baseline in Mean Adjusted Eosinophilic Esophagitis Histology Scoring System (EoEHSS) Stage Score at Week 48
    End point description
    EoEHSS evaluates the stage (extent) of multiple pathologic features in esophageal biopsies. It has 8 features eosinophil inflammation (determined by peak EoS count(PEC)) and presence of basal zone hyperplasia, eosinophil abscess, eosinophil surface layering, dilated intercellular spaces, surface epithelial alteration, dyskeratotic epithelial cells, and lamina propria fibrosis in epithelium . In 3 separate esophagus levels (proximal, mid, and distal), each feature is scored independently for stage using a 4-point Likert scale (0 [absent], 1[PEC ≥15/hpf in <33% of hpfs or (any grade >0) <33% of epithelium for other features], 2 [PEC ≥15/hpf in 33-66% of hpfs or (any grade >0) in 33-66% of epithelium to 3 [PEC ≥15/hpf in >66% of hpfs or (any grade >0) in > 66% of epithelium]). The mean adjusted stage score is calculated by averaging the adjusted scores for the 3 levels (proximal, mid, and distal). The mean adjusted scores range from 0 to 100. High score signifies severe condition.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) , Week 48
    End point values
    		 Maintenance Phase - CC-93538 360 mg QW Maintenance Phase - CC-93538 360 mg Q2W Maintenance Phase - Placebo
    Number of subjects analysed
    104
    108
    82
    Units: score on a scale
        arithmetic mean (standard deviation)
    -36.30 ( 20.904 )
    -37.36 ( 19.290 )
    -8.38 ( 19.935 )
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Maintenance Phase - CC-93538 360 mg QW v Maintenance Phase - Placebo
    Number of subjects included in analysis
    186
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 DIFFERENCE IN LSM
    Point estimate
    -20.82
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -25.17
         upper limit
    		 -18.91
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.229
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Maintenance Phase - CC-93538 360 mg Q2W v Maintenance Phase - Placebo
    Number of subjects included in analysis
    190
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 DIFFERENCE IN LSM
    Point estimate
    -23.43
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -27.73
         upper limit
    		 -21.56
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.222

    Secondary: Change from Baseline in Modified Daily Symptom Diary (mDSD) Composite Score at Week 24

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    End point title
    		 Change from Baseline in Modified Daily Symptom Diary (mDSD) Composite Score at Week 24
    End point description
    The mDSD composite score is evaluated over the prior 14-day period using the mDSD, which includes 6 primary questions. These questions assess solid food consumption that day (Q1), experience with trouble swallowing (Q2), food going down slowly (Q3), food getting stuck in the throat or chest (Q4), actions taken by participants to obtain relief (Q5), and any pain associated with swallowing (Q6). The daily symptom score (mDSD) is calculated by summing the responses to Q2, Q3, and Q4 (where "Yes" to any/all items equals 1, and "No" to all items equals 0), adding Q5 over the 14-day period prior to a visit, dividing by the number of measurable diary days over the 14-day period, and then multiplying by the length of the period (14). The daily symptom score ranges from 0 to 5, and the mDSD composite score ranges from 0 to 70 for the 14-day period. A higher composite diary score indicates more frequent and/or severe dysphagia symptoms.
    End point type
    Secondary
    End point timeframe
    Baseline (11 days prior to Day 1) and Week 24
    End point values
    		 Induction Phase - CC-93538 360 mg QW Induction Phase - Placebo
    Number of subjects analysed
    236
    124
    Units: Score on a scale
        arithmetic mean (standard deviation)
    -14.78 ( 11.353 )
    -10.93 ( 11.234 )
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Induction Phase - CC-93538 360 mg QW v Induction Phase - Placebo
    Number of subjects included in analysis
    360
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 DIFFERENCE IN LSM
    Point estimate
    -4.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.4
         upper limit
    		 -1.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.174

    Secondary: Change from Baseline in Modified Daily Symptom Diary (mDSD) Composite Score at Week 48

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    End point title
    		 Change from Baseline in Modified Daily Symptom Diary (mDSD) Composite Score at Week 48
    End point description
    The mDSD composite score is evaluated over the prior 14-day period using the mDSD, which includes 6 primary questions. These questions assess solid food consumption that day (Q1), experience with trouble swallowing (Q2), food going down slowly (Q3), food getting stuck in the throat or chest (Q4), actions taken by participants to obtain relief (Q5), and any pain associated with swallowing (Q6). The daily symptom score (mDSD) is calculated by summing the responses to Q2, Q3, and Q4 (where "Yes" to any/all items equals 1, and "No" to all items equals 0), adding Q5 over the 14-day period prior to a visit, dividing by the number of measurable diary days over the 14-day period, and then multiplying by the length of the period (14). The daily symptom score ranges from 0 to 5, and the mDSD composite score ranges from 0 to 70 for the 14-day period. A higher composite diary score indicates more frequent and/or severe dysphagia symptoms.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) , Week 48
    End point values
    		 Maintenance Phase - CC-93538 360 mg QW Maintenance Phase - CC-93538 360 mg Q2W Maintenance Phase - Placebo
    Number of subjects analysed
    100
    101
    75
    Units: score on a scale
        arithmetic mean (standard deviation)
    -16.77 ( 11.297 )
    -16.45 ( 11.635 )
    -13.44 ( 10.862 )
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Maintenance Phase - CC-93538 360 mg Q2W v Maintenance Phase - Placebo
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0003
    Method
    		 ANCOVA
    Parameter type
    		 DIFFERENCE IN LSM
    Point estimate
    -5.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8
         upper limit
    		 -2.41
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.425
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Maintenance Phase - CC-93538 360 mg QW v Maintenance Phase - Placebo
    Number of subjects included in analysis
    175
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0022
    Method
    		 ANCOVA
    Parameter type
    		 DIFFERENCE IN LSM
    Point estimate
    -4.35
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.14
         upper limit
    		 -1.57
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.42

    Secondary: Percentage of Participants with a ≥ 50% Decrease in Dysphagia Days(DD) from Baseline at Week 24

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    End point title
    		 Percentage of Participants with a ≥ 50% Decrease in Dysphagia Days(DD) from Baseline at Week 24
    End point description
    Dysphagia Days (DD) was assessed using a modified daily symptom diary (mDSD). The DD was evaluated over the prior 14-day period using the mDSD, which includes 6 primary questions. These questions assess solid food consumption that day (Q1), experience with trouble swallowing (Q2), food going down slowly (Q3), food getting stuck in the throat or chest (Q4), actions taken by participants to obtain relief (Q5), and any pain associated with swallowing (Q6). The number of DD was normalized by calculating the number of diary days with a "yes" to any or all of Q2, Q3, and Q4 in the 14-day period prior to a visit, dividing by the number of measurable diary days in the 14-day period, and then multiplying by the length of the period (14). A measurable diary day for DD is defined as a diary day for which Questions 2 to 4 are answered. DD ranges from 0 to 14 for the 14-day period.
    End point type
    Secondary
    End point timeframe
    Baseline (11 days prior to Day 1) and Week 24
    End point values
    		 Induction Phase - CC-93538 360 mg QW Induction Phase - Placebo
    Number of subjects analysed
    236
    124
    Units: percentage of participants
        number (not applicable)
    65.7
    50.0
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Induction Phase - CC-93538 360 mg QW v Induction Phase - Placebo
    Number of subjects included in analysis
    360
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0016
    Method
    		 ANCOVA
    Parameter type
    		 DIFFERENCE IN RESPONSE RATE
    Point estimate
    16.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6.7
         upper limit
    		 27.2

    Secondary: Percentage of Participants with a ≥ 50% Decrease in Dysphagia Days(DD) from Baseline at Week 48

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    End point title
    		 Percentage of Participants with a ≥ 50% Decrease in Dysphagia Days(DD) from Baseline at Week 48
    End point description
    Dysphagia Days (DD) was assessed using a modified daily symptom diary (mDSD). The DD was evaluated over the prior 14-day period using the mDSD, which includes 6 primary questions. These questions assess solid food consumption that day (Q1), experience with trouble swallowing (Q2), food going down slowly (Q3), food getting stuck in the throat or chest (Q4), actions taken by participants to obtain relief (Q5), and any pain associated with swallowing (Q6). The number of DD was normalized by calculating the number of diary days with a "yes" to any or all of Q2, Q3, and Q4 in the 14-day period prior to a visit, dividing by the number of measurable diary days in the 14-day period, and then multiplying by the length of the period (14). A measurable diary day for DD is defined as a diary day for which Questions 2 to 4 are answered. DD ranges from 0 to 14 for the 14-day period.
    End point type
    Secondary
    End point timeframe
    Baseline (11 days prior to Day 1) and Week 48
    End point values
    		 Maintenance Phase - CC-93538 360 mg QW Maintenance Phase - CC-93538 360 mg Q2W Maintenance Phase - Placebo
    Number of subjects analysed
    143
    143
    144
    Units: percentage of participants
        number (not applicable)
    50.3
    53.8
    50.3
    No statistical analyses for this end point

    Secondary: Change from Baseline in Mean Dysphagia Days (DD) through Week 24

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    End point title
    		 Change from Baseline in Mean Dysphagia Days (DD) through Week 24
    End point description
    Dysphagia Days (DD) was assessed using a modified daily symptom diary (mDSD). The DD was evaluated over the prior 14-day period using the mDSD, which includes 6 primary questions. These questions assess solid food consumption that day (Q1), experience with trouble swallowing (Q2), food going down slowly (Q3), food getting stuck in the throat or chest (Q4), actions taken by participants to obtain relief (Q5), and any pain associated with swallowing (Q6). The number of DD was normalized by calculating the number of diary days with a "yes" to any or all of Q2, Q3, and Q4 in the 14-day period prior to a visit, dividing by the number of measurable diary days in the 14-day period, and then multiplying by the length of the period (14). A measurable diary day for DD is defined as a diary day for which Questions 2 to 4 are answered. Mean DD ranges from 0 to 14 for the 14-day period.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1), Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24
    End point values
    		 Induction Phase - CC-93538 360 mg QW Induction Phase - Placebo
    Number of subjects analysed
    264
    144
    Units: days
    arithmetic mean (standard deviation)
        Week 2 (n=262, 139)
    -1.26 ( 2.607 )
    -0.80 ( 2.651 )
        Week 4 (n=264, 135)
    -3.19 ( 4.073 )
    -1.75 ( 3.460 )
        Week 8 (n=255, 132)
    -5.04 ( 4.755 )
    -3.51 ( 4.132 )
        Week 12 (n=244, 122)
    -5.88 ( 5.071 )
    -3.88 ( 4.379 )
        Week 16 (n=235, 121)
    -6.39 ( 5.299 )
    -4.90 ( 4.851 )
        Week 20 (n=229, 120)
    -6.91 ( 5.321 )
    -4.98 ( 4.960 )
        Week 24 (n=236, 124)
    -6.85 ( 5.259 )
    -4.98 ( 5.075 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Modified Daily Symptom Diary (mDSD) Composite Score through Week 24

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    End point title
    		 Change from Baseline in Modified Daily Symptom Diary (mDSD) Composite Score through Week 24
    End point description
    The mDSD composite score is evaluated over the prior 14-day period using the mDSD, which includes 6 primary questions. These questions assess solid food consumption that day (Q1), experience with trouble swallowing (Q2), food going down slowly (Q3), food getting stuck in the throat or chest (Q4), actions taken by participants to obtain relief (Q5), and any pain associated with swallowing (Q6). The daily symptom score (mDSD) is calculated by summing the responses to Q2, Q3, and Q4 (where "Yes" to any/all items equals 1, and "No" to all items equals 0), adding Q5 over the 14-day period prior to a visit, dividing by the number of measurable diary days over the 14-day period, and then multiplying by the length of the period (14). The daily symptom score ranges from 0 to 5, and the mDSD composite score ranges from 0 to 70 for the 14-day period. A higher composite diary score indicates more frequent and/or severe dysphagia symptoms.
    End point type
    Secondary
    End point timeframe
    Baseline (11 days prior to Day 1) and Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24
    End point values
    		 Induction Phase - CC-93538 360 mg QW Induction Phase - Placebo
    Number of subjects analysed
    264
    139
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Week 2 (n=262, 139)
    -3.89 ( 7.126 )
    -3.25 ( 6.621 )
        Week 4 (n=264, 135)
    -8.02 ( 9.118 )
    -4.98 ( 8.902 )
        Week 8 (n=255, 132)
    -11.63 ( 10.515 )
    -7.59 ( 9.938 )
        Week 12 (n=244, 122)
    -13.22 ( 10.987 )
    -9.00 ( 10.051 )
        Week 16 (n=235, 121)
    -13.54 ( 11.623 )
    -10.43 ( 10.419 )
        Week 20 (n=262, 139)
    -14.71 ( 11.496 )
    -10.99 ( 10.353 )
        Week 24 (n=229, 120)
    -14.78 ( 11.353 )
    -10.93 ( 11.234 )
    No statistical analyses for this end point

    Secondary: Time to First Event of Eosinophilic Esophagitis (EoE) Flare

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    End point title
    		 Time to First Event of Eosinophilic Esophagitis (EoE) Flare
    End point description
    First incidence of corresponding EoE flare event for any participant was considered in the analysis. Median and 95% CI are from Kaplan-Meier estimates. Participants without an event of EoE flare or discontinued the study by the end of maintenance phase were censored, if they are a dropout, they are censored at study discontinuation date, otherwise they are censored at either last dose date or last visit, whichever was longer.
    End point type
    Secondary
    End point timeframe
    From first dose (Day 1) and Up to Week 48
    End point values
    		 CC-93538 360 mg QW CC-93538 360 mg QW/Q2W Placebo
    Number of subjects analysed
    5 [1]
    13 [2]
    29 [3]
    Units: days
        median (confidence interval 95%)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    Notes
    [1] - 99999 stands for not estimable.
    [2] - 99999 stands for not estimable.
    [3] - 99999 stands for not estimable.
    No statistical analyses for this end point

    Secondary: Time to First Use of Rescue Medication

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    End point title
    		 Time to First Use of Rescue Medication
    End point description
    First use of rescue therapy including EoE standard of care pharmacotherapy, dietary modification (e.g., food elimination diet), and/or dilation procedure. was considered in the analysis. Median and 95% CI are from Kaplan-Meier estimates. Participants without an event or discontinued the study by the end of maintenance phase were censored, if they are a dropout, they are censored at study discontinuation date, otherwise they are censored at either last dose date or last visit, whichever was longer.
    End point type
    Secondary
    End point timeframe
    From first dose (Day 1) and Up to Week 48
    End point values
    		 CC-93538 360 mg QW CC-93538 360 mg QW/Q2W Placebo
    Number of subjects analysed
    7 [4]
    10 [5]
    20 [6]
    Units: days
        median (confidence interval 95%)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    Notes
    [4] - 99999 stands for not estimable.
    [5] - 99999 stands for not estimable.
    [6] - 99999 stands for not estimable.
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Any Events of Use of Rescue Medication

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    End point title
    		 Percentage of Participants with Any Events of Use of Rescue Medication
    End point description
    Use of rescue therapy including EoE standard of care pharmacotherapy, dietary modification (e.g., food elimination diet), and/or dilation procedure was considered in the analysis.
    End point type
    Secondary
    End point timeframe
    From first dose (Day 1) and up to Week 48
    End point values
    		 CC-93538 360 mg QW CC-93538 360 mg QW/Q2W Placebo
    Number of subjects analysed
    143
    143
    144
    Units: percentage of participants
        number (not applicable)
    4.9
    7.0
    13.9
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Eosinophilic Esophagitis (EoE) Flare

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    End point title
    		 Percentage of Participants with Eosinophilic Esophagitis (EoE) Flare
    End point description
    First incidence of corresponding EoE flare event for any participant was considered in the analysis.
    End point type
    Secondary
    End point timeframe
    From first dose (Day 1) and up to Week 48
    End point values
    		 CC-93538 360 mg QW CC-93538 360 mg QW/Q2W Placebo
    Number of subjects analysed
    143
    143
    144
    Units: percentage of participants
        number (not applicable)
    3.5
    9.1
    20.1
    No statistical analyses for this end point

    Secondary: Number of Participants with Treatment Emergent Adverse Events (TEAEs)

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    End point title
    		 Number of Participants with Treatment Emergent Adverse Events (TEAEs)
    End point description
    An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization.
    End point type
    Secondary
    End point timeframe
    From first dose (Day 1) till up to Week 48
    End point values
    		 CC-93538 360 mg QW CC-93538 360 mg QW/Q2W Placebo
    Number of subjects analysed
    167
    117
    143
    Units: participants
        Treatment Emergent Adverse Events
    140
    99
    105
        Treatment Emergent Serious Adverse Events
    4
    4
    8
        Any Treatment Emergent Severe Adverse Events
    7
    6
    13
        Any Treatment Emergent Moderate Adverse Events
    68
    55
    48
        Any Treatment Emergent Mild Adverse Events
    65
    38
    44
    No statistical analyses for this end point

    Secondary: Number of Participants with Maximum Post-Baseline Clinical Laboratory Range Shift

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    End point title
    		 Number of Participants with Maximum Post-Baseline Clinical Laboratory Range Shift
    End point description
    Blood samples were collected to assess clinical laboratory parameters. The row title contains parameter and category title contains shift. The category 'Normal to High' signifies the readings for the parameter were 'Normal' at baseline and it changed to 'High' post baseline.
    End point type
    Secondary
    End point timeframe
    From first dose (Day 1) till up to Week 48
    End point values
    		 CC-93538 360 mg QW CC-93538 360 mg QW/Q2W Placebo
    Number of subjects analysed
    167
    117
    143
    Units: participants
        Sodium (mmol/L)|Normal to Normal
    158
    113
    138
        Potassium (mmol/L)|Normal to Normal
    159
    108
    137
        Chloride (mmol/L)|Normal to Normal
    162
    116
    139
        Calcium (mmol/L)|Normal to Normal
    161
    114
    136
        Magnesium (mmol/L)|Normal to Normal
    162
    111
    138
        Phosphate (mmol/L)|Normal to Normal
    159
    112
    136
        Blood Urea Nitrogen (mmol/L)|Normal to Normal
    160
    108
    137
        Glucose (mmol/L)|Normal to Normal
    101
    69
    88
        Albumin (g/L)|Normal to Normal
    94
    60
    76
        Alkaline Phosphatase (U/L)|Normal to Normal
    140
    104
    129
        Creatinine (umol/L)|Normal to Normal
    152
    107
    131
        Creatine Kinase (U/L)|Normal to Normal
    115
    64
    100
        Alanine Aminotransferase (U/L)|Normal to Normal
    131
    88
    111
        Aspartate Aminotransferase (U/L)|Normal to Normal
    143
    93
    120
        Gamma Glutamyl Transferase (U/L)|Normal to Normal
    149
    103
    122
        Amylase (U/L)|Normal to Normal
    128
    98
    127
        Total Bilirubin (umol/L)|Normal to Normal
    146
    106
    123
        Direct Bilirubin (umol/L)|Normal to Normal
    165
    117
    143
        C Reactive Protein (mg/L)|Normal to Normal
    107
    70
    85
        Cholesterol (mmol/L)|Normal to Normal
    116
    91
    102
        Triglycerides (mmol/L)|Normal to Normal
    124
    93
    105
        HDL Cholesterol (mmol/L)|Normal to Normal
    63
    37
    65
        LDL Cholesterol (mmol/L)|Normal to Normal
    111
    88
    101
        Erythrocytes (10^12/L)|Normal to Normal
    154
    113
    138
        Leukocytes (10^9/L)|Normal to Normal
    148
    108
    131
        Basophils (10^9/L)|Normal to Normal
    154
    113
    137
        Basophils/Leukocytes (%)|Normal to Normal
    144
    96
    125
        Eosinophils (10^9/L)|Normal to Normal
    159
    112
    141
        Eosinophils/Leukocytes (%)|Normal to Normal
    124
    75
    113
        Lymphocytes (10^9/L)|Normal to Normal
    115
    81
    89
        Lymphocytes/Leukocytes (%)|Normal to Normal
    88
    56
    54
        Monocytes (10^9/L)|Normal to Normal
    157
    113
    138
        Monocytes/Leukocytes (%)|Normal to Normal
    148
    108
    131
        NEUTROPHILS, SEGMENTED (10^9/L)|Normal to Normal
    154
    109
    134
        NEUTROPHILS/LEUKOCYTES (%)|Normal to Normal
    142
    101
    122
        PLATELETS (10^9/L)|Normal to Normal
    153
    102
    128
        HEMOGLOBIN (g/L)|Normal to Normal
    158
    115
    142
        HEMATOCRIT (VOLUME FRACTION)|Normal to Normal
    158
    110
    140
        ERY MEAN CORPUSCULAR VOLUME|Normal to Normal
    128
    90
    120
        ERY MEAN CORPUSCULAR HEMOGLOBIN|Normal to Normal
    160
    115
    141
        ERY. MEAN CORPUSCULAR HGB (g/L)|Normal to Normal
    164
    114
    140
        Sodium (mmol/L)|Normal to Low
    0
    0
    0
        Potassium (mmol/L)|Normal to Low
    0
    0
    0
        Chloride (mmol/L)|Normal to Low
    0
    0
    0
        Calcium (mmol/L)|Normal to Low
    0
    0
    0
        Magnesium (mmol/L)|Normal to Low
    0
    0
    0
        Phosphate (mmol/L)|Normal to Low
    0
    0
    0
        Blood Urea Nitrogen (mmol/L)|Normal to Low
    0
    0
    0
        Glucose (mmol/L)|Normal to Low
    0
    0
    0
        Albumin (g/L)|Normal to Low
    0
    0
    0
        Alkaline Phosphatase (U/L)|Normal to Low
    0
    0
    0
        Creatinine (umol/L)|Normal to Low
    0
    0
    0
        Creatine Kinase (U/L)|Normal to Low
    0
    0
    0
        Alanine Aminotransferase (U/L)|Normal to Low
    0
    0
    0
        Aspartate Aminotransferase (U/L)|Normal to Low
    0
    0
    0
        Gamma Glutamyl Transferase (U/L)|Normal to Low
    0
    0
    0
        Amylase (U/L)|Normal to Low
    1
    0
    0
        Total Bilirubin (umol/L)|Normal to Low
    1
    0
    0
        Direct Bilirubin (umol/L)|Normal to Low
    0
    0
    0
        C Reactive Protein (mg/L)|Normal to Low
    0
    0
    0
        Cholesterol (mmol/L)|Normal to Low
    3
    3
    1
        Triglycerides (mmol/L)|Normal to Low
    0
    1
    2
        HDL Cholesterol (mmol/L)|Normal to Low
    5
    1
    3
        LDL Cholesterol (mmol/L)|Normal to Low
    2
    3
    3
        Erythrocytes (10^12/L)|Normal to Low
    1
    0
    0
        Leukocytes (10^9/L)|Normal to Low
    2
    0
    0
        Basophils (10^9/L)|Normal to Low
    0
    0
    0
        Basophils/Leukocytes (%)|Normal to Low
    0
    0
    0
        Eosinophils (10^9/L)|Normal to Low
    0
    0
    0
        Eosinophils/Leukocytes (%)|Normal to Low
    0
    0
    0
        Lymphocytes (10^9/L)|Normal to Low
    0
    0
    0
        Lymphocytes/Leukocytes (%)|Normal to Low
    0
    0
    0
        Monocytes (10^9/L)|Normal to Low
    0
    0
    0
        Monocytes/Leukocytes (%)|Normal to Low
    0
    0
    0
        NEUTROPHILS, SEGMENTED (10^9/L)|Normal to Low
    3
    0
    0
        NEUTROPHILS/LEUKOCYTES (%)|Normal to Low
    1
    0
    0
        PLATELETS (10^9/L)|Normal to Low
    0
    0
    0
        HEMOGLOBIN (g/L)|Normal to Low
    1
    0
    0
        HEMATOCRIT (VOLUME FRACTION)|Normal to Low
    1
    0
    0
        ERY MEAN CORPUSCULAR VOLUME|Normal to Low
    0
    0
    0
        ERY MEAN CORPUSCULAR HEMOGLOBIN|Normal to Low
    0
    0
    0
        ERY. MEAN CORPUSCULAR HGB (g/L)|Normal to Low
    0
    0
    0
        Sodium (mmol/L)|Normal to High
    7
    4
    4
        Potassium (mmol/L)|Normal to High
    6
    9
    6
        Chloride (mmol/L)|Normal to High
    3
    1
    3
        Calcium (mmol/L)|Normal to High
    2
    3
    3
        Magnesium (mmol/L)|Normal to High
    3
    4
    4
        Phosphate (mmol/L)|Normal to High
    4
    4
    5
        Blood Urea Nitrogen (mmol/L)|Normal to High
    6
    8
    6
        Glucose (mmol/L)|Normal to High
    40
    36
    30
        Albumin (g/L)|Normal to High
    37
    30
    35
        Alkaline Phosphatase (U/L)|Normal to High
    9
    4
    7
        Creatinine (umol/L)|Normal to High
    7
    6
    7
        Creatine Kinase (U/L)|Normal to High
    39
    39
    36
        Alanine Aminotransferase (U/L)|Normal to High
    22
    22
    22
        Aspartate Aminotransferase (U/L)|Normal to High
    18
    20
    17
        Gamma Glutamyl Transferase (U/L)|Normal to High
    5
    8
    9
        Amylase (U/L)|Normal to High
    15
    9
    4
        Total Bilirubin (umol/L)|Normal to High
    8
    5
    9
        Direct Bilirubin (umol/L)|Normal to High
    1
    0
    0
        C Reactive Protein (mg/L)|Normal to High
    34
    25
    35
        Cholesterol (mmol/L)|Normal to High
    5
    4
    5
        Triglycerides (mmol/L)|Normal to High
    7
    3
    4
        HDL Cholesterol (mmol/L)|Normal to High
    15
    10
    9
        LDL Cholesterol (mmol/L)|Normal to High
    5
    4
    5
        Erythrocytes (10^12/L)|Normal to High
    2
    0
    0
        Leukocytes (10^9/L)|Normal to High
    9
    11
    7
        Basophils (10^9/L)|Normal to High
    5
    5
    2
        Basophils/Leukocytes (%)|Normal to High
    36
    37
    26
        Eosinophils (10^9/L)|Normal to High
    32
    22
    41
        Eosinophils/Leukocytes (%)|Normal to High
    39
    26
    45
        Lymphocytes (10^9/L)|Normal to High
    6
    1
    4
        Lymphocytes/Leukocytes (%)|Normal to High
    14
    6
    8
        Monocytes (10^9/L)|Normal to High
    2
    0
    1
        Monocytes/Leukocytes (%)|Normal to High
    18
    14
    14
        NEUTROPHILS, SEGMENTED (10^9/L)|Normal to High
    12
    10
    12
        NEUTROPHILS/LEUKOCYTES (%)|Normal to High
    15
    7
    14
        PLATELETS (10^9/L)|Normal to High
    7
    11
    11
        HEMOGLOBIN (g/L)|Normal to High
    4
    0
    0
        HEMATOCRIT (VOLUME FRACTION)|Normal to High
    4
    2
    0
        ERYT MEAN CORPUSCULAR VOLUME|Normal to High
    24
    16
    14
        ERYT MEAN CORPUSCULAR HEMOGLOBIN|Normal to High
    0
    0
    0
        ERY. MEAN CORPUSCULAR HGB |Normal to High
    0
    0
    0
        Sodium (mmol/L)|Low to Normal
    0
    0
    1
        Potassium (mmol/L)|Low to Normal
    1
    0
    1
        Chloride (mmol/L)|Low to Normal
    1
    0
    1
        Calcium (mmol/L)|Low to Normal
    2
    0
    1
        Magnesium (mmol/L)|Low to Normal
    0
    0
    0
        Phosphate (mmol/L)|Low to Normal
    2
    0
    1
        Blood Urea Nitrogen (mmol/L)|Low to Normal
    0
    0
    0
        Glucose (mmol/L)|Low to Normal
    3
    0
    2
        Albumin (g/L)|Low to Normal
    0
    0
    0
        Alkaline Phosphatase (U/L)|Low to Normal
    1
    2
    1
        Creatinine (umol/L)|Low to Normal
    1
    0
    0
        Creatine Kinase (U/L)|Low to Normal
    1
    0
    0
        Alanine Aminotransferase (U/L)|Low to Normal
    0
    0
    0
        Aspartate Aminotransferase (U/L)|Low to Normal
    0
    0
    1
        Gamma Glutamyl Transferase (U/L)|Low to Normal
    0
    1
    1
        Amylase (U/L)|Low to Normal
    4
    2
    4
        Total Bilirubin (umol/L)|Low to Normal
    5
    2
    6
        Direct Bilirubin (umol/L)|Low to Normal
    0
    0
    0
        C Reactive Protein (mg/L)|Low to Normal
    0
    0
    0
        Cholesterol (mmol/L)|Low to Normal
    14
    5
    6
        Triglycerides (mmol/L)|Low to Normal
    3
    6
    3
        HDL Cholesterol (mmol/L)|Low to Normal
    4
    14
    11
        LDL Cholesterol (mmol/L)|Low to Normal
    12
    9
    3
        Erythrocytes (10^12/L)|Low to Normal
    5
    2
    3
        Leukocytes (10^9/L)|Low to Normal
    4
    7
    6
        Basophils (10^9/L)|Low to Normal
    0
    0
    0
        Basophils/Leukocytes (%)|Low to Normal
    0
    0
    0
        Eosinophils (10^9/L)|Low to Normal
    0
    0
    0
        Eosinophils/Leukocytes (%)|Low to Normal
    0
    0
    0
        Lymphocytes (10^9/L)|Low to Normal
    1
    3
    1
        Lymphocytes/Leukocytes (%)|Low to Normal
    1
    1
    3
        Monocytes (10^9/L)|Low to Normal
    5
    7
    3
        Monocytes/Leukocytes (%)|Low to Normal
    2
    1
    3
        NEUTROPHILS, SEGMENTED (10^9/L)|Low to Normal
    7
    10
    5
        NEUTROPHILS/LEUKOCYTES (%)|Low to Normal
    4
    7
    3
        PLATELETS (10^9/L)|Low to Normal
    1
    1
    2
        HEMOGLOBIN (g/L)|Low to Normal
    1
    0
    1
        HEMATOCRIT (VOLUME FRACTION)|Low to Normal
    1
    4
    2
        ERY MEAN CORPUSCULAR VOLUME|Low to Normal
    6
    3
    4
        ERY MEAN CORPUSCULAR HEMOGLOBIN|Low to Normal
    3
    0
    1
        ERY. MEAN CORPUSCULAR HGB |Low to Normal
    0
    3
    2
        Sodium (mmol/L)|Low to Low
    0
    0
    0
        Potassium (mmol/L)|Low to Low
    0
    0
    0
        Chloride (mmol/L)|Low to Low
    0
    0
    0
        Calcium (mmol/L)|Low to Low
    0
    0
    0
        Magnesium (mmol/L)|Low to Low
    0
    0
    0
        Phosphate (mmol/L)|Low to Low
    0
    0
    0
        Blood Urea Nitrogen (mmol/L)|Low to Low
    0
    0
    0
        Glucose (mmol/L)|Low to Low
    0
    0
    0
        Albumin (g/L)|Low to Low
    0
    0
    0
        Alkaline Phosphatase (U/L)|Low to Low
    1
    0
    0
        Creatinine (umol/L)|Low to Low
    0
    0
    0
        Creatine Kinase (U/L)|Low to Low
    0
    0
    0
        Alanine Aminotransferase (U/L)|Low to Low
    0
    0
    0
        Aspartate Aminotransferase (U/L)|Low to Low
    0
    0
    0
        Gamma Glutamyl Transferase (U/L)|Low to Low
    2
    0
    0
        Amylase (U/L)|Low to Low
    3
    0
    0
        Total Bilirubin (umol/L)|Low to Low
    0
    0
    0
        Direct Bilirubin (umol/L)|Low to Low
    0
    0
    0
        C Reactive Protein (mg/L)|Low to Low
    0
    0
    0
        Cholesterol (mmol/L)|Low to Low
    2
    5
    0
        Triglycerides (mmol/L)|Low to Low
    0
    1
    0
        HDL Cholesterol (mmol/L)|Low to Low
    18
    22
    14
        LDL Cholesterol (mmol/L)|Low to Low
    8
    4
    10
        Erythrocytes (10^12/L)|Low to Low
    1
    1
    1
        Leukocytes (10^9/L)|Low to Low
    0
    0
    0
        Basophils (10^9/L)|Low to Low
    0
    0
    0
        Basophils/Leukocytes (%)|Low to Low
    0
    0
    0
        Eosinophils (10^9/L)|Low to Low
    0
    0
    0
        Eosinophils/Leukocytes (%)|Low to Low
    0
    0
    0
        Lymphocytes (10^9/L)|Low to Low
    0
    0
    0
        Lymphocytes/Leukocytes (%)|Low to Low
    0
    0
    0
        Monocytes (10^9/L)|Low to Low
    2
    1
    4
        Monocytes/Leukocytes (%)|Low to Low
    0
    0
    0
        NEUTROPHILS, SEGMENTED (10^9/L)|Low to Low
    0
    0
    0
        NEUTROPHILS/LEUKOCYTES (%)|Low to Low
    0
    0
    0
        PLATELETS (10^9/L)|Low to Low
    0
    0
    0
        HEMOGLOBIN (g/L)|Low to Low
    0
    1
    0
        HEMATOCRIT (VOLUME FRACTION)|Low to Low
    0
    0
    0
        ERY MEAN CORPUSCULAR VOLUME|Low to Low
    1
    2
    1
        ERYT MEAN CORPUSCULAR HEMOGLOBIN|Low to Low
    1
    2
    1
        ERY. MEAN CORPUSCULAR HGB (g/L)|Low to Low
    0
    0
    0
        Sodium (mmol/L)|Low to High
    0
    0
    0
        Potassium (mmol/L)|Low to High
    0
    0
    0
        Chloride (mmol/L)|Low to High
    0
    0
    0
        Calcium (mmol/L)|Low to High
    0
    0
    0
        Magnesium (mmol/L)|Low to High
    0
    0
    0
        Phosphate (mmol/L)|Low to High
    0
    0
    0
        Blood Urea Nitrogen (mmol/L)|Low to High
    0
    0
    0
        Glucose (mmol/L)|Low to High
    0
    0
    0
        Albumin (g/L)|Low to High
    0
    0
    0
        Alkaline Phosphatase (U/L)|Low to High
    0
    0
    0
        Creatinine (umol/L)|Low to High
    0
    0
    0
        Creatine Kinase (U/L)|Low to High
    0
    0
    0
        Alanine Aminotransferase (U/L)|Low to High
    0
    0
    0
        Aspartate Aminotransferase (U/L)|Low to High
    0
    0
    0
        Gamma Glutamyl Transferase (U/L)|Low to High
    0
    0
    0
        Amylase (U/L)|Low to High
    0
    0
    0
        Total Bilirubin (umol/L)|Low to High
    0
    0
    0
        Direct Bilirubin (umol/L)|Low to High
    0
    0
    0
        C Reactive Protein (mg/L)|Low to High
    0
    0
    0
        Cholesterol (mmol/L)|Low to High
    0
    0
    0
        Triglycerides (mmol/L)|Low to High
    0
    0
    0
        HDL Cholesterol (mmol/L)|Low to High
    0
    0
    0
        LDL Cholesterol (mmol/L)|Low to High
    0
    0
    0
        Erythrocytes (10^12/L)|Low to High
    0
    0
    0
        Leukocytes (10^9/L)|Low to High
    0
    0
    0
        Basophils (10^9/L)|Low to High
    0
    0
    0
        Basophils/Leukocytes (%)|Low to High
    0
    0
    0
        Eosinophils (10^9/L)|Low to High
    0
    0
    0
        Eosinophils/Leukocytes (%)|Low to High
    0
    0
    0
        Lymphocytes (10^9/L)|Low to High
    0
    0
    0
        Lymphocytes/Leukocytes (%)|Low to High
    0
    0
    0
        Monocytes (10^9/L)|Low to High
    0
    0
    0
        Monocytes/Leukocytes (%)|Low to High
    0
    0
    0
        NEUTROPHILS, SEGMENTED (10^9/L)|Low to High
    0
    0
    1
        NEUTROPHILS/LEUKOCYTES (%)|Low to High
    0
    0
    0
        PLATELETS (10^9/L)|Low to High
    0
    0
    0
        HEMOGLOBIN (g/L)|Low to High
    0
    0
    0
        HEMATOCRIT (VOLUME FRACTION)|Low to High
    0
    0
    0
        ERYT MEAN CORPUSCULAR VOLUME|Low to High
    0
    0
    0
        ERYT MEAN CORPUSCULAR HEMOGLOBIN|Low to High
    0
    0
    0
        ERY. MEAN CORPUSCULAR HGB (g/L)|Low to High
    0
    0
    0
        Sodium (mmol/L)|High to Normal
    1
    0
    0
        Potassium (mmol/L)|High to Normal
    0
    0
    0
        Chloride (mmol/L)|High to Normal
    0
    0
    0
        Calcium (mmol/L)|High to Normal
    1
    0
    3
        Magnesium (mmol/L)|High to Normal
    0
    1
    0
        Phosphate (mmol/L)|High to Normal
    0
    0
    1
        Blood Urea Nitrogen (mmol/L)|High to Normal
    0
    0
    0
        Glucose (mmol/L)|High to Normal
    5
    2
    2
        Albumin (g/L)|High to Normal
    10
    2
    9
        Alkaline Phosphatase (U/L)|High to Normal
    3
    1
    1
        Creatinine (umol/L)|High to Normal
    1
    0
    1
        Creatine Kinase (U/L)|High to Normal
    4
    4
    0
        Alanine Aminotransferase (U/L)|High to Normal
    2
    1
    3
        Aspartate Aminotransferase (U/L)|High to Normal
    2
    0
    1
        Gamma Glutamyl Transferase (U/L)|High to Normal
    2
    0
    1
        Amylase (U/L)|High to Normal
    3
    0
    0
        Total Bilirubin (umol/L)|High to Normal
    2
    0
    0
        Direct Bilirubin (umol/L)|High to Normal
    0
    0
    0
        C Reactive Protein (mg/L)|High to Normal
    1
    4
    4
        Cholesterol (mmol/L)|High to Normal
    3
    3
    2
        Triglycerides (mmol/L)|High to Normal
    6
    3
    7
        HDL Cholesterol (mmol/L)|High to Normal
    5
    5
    5
        LDL Cholesterol (mmol/L)|High to Normal
    2
    0
    2
        Erythrocytes (10^12/L)|High to Normal
    0
    0
    0
        Leukocytes (10^9/L)|High to Normal
    2
    1
    3
        Basophils (10^9/L)|High to Normal
    0
    0
    0
        Basophils/Leukocytes (%)|High to Normal
    2
    3
    4
        Eosinophils (10^9/L)|High to Normal
    3
    1
    3
        Eosinophils/Leukocytes (%)|High to Normal
    7
    7
    4
        Lymphocytes (10^9/L)|High to Normal
    0
    0
    0
        Lymphocytes/Leukocytes (%)|High to Normal
    0
    0
    1
        Monocytes (10^9/L)|High to Normal
    0
    0
    0
        Monocytes/Leukocytes (%)|High to Normal
    0
    0
    1
        NEUTROPHILS, SEGMENTED (10^9/L)|High to Normal
    1
    1
    3
        NEUTROPHILS/LEUKOCYTES (%)|High to Normal
    1
    1
    3
        PLATELETS (10^9/L)|High to Normal
    1
    0
    0
        HEMOGLOBIN (g/L)|High to Normal
    0
    0
    0
        HEMATOCRIT (VOLUME FRACTION)|High to Normal
    0
    0
    0
        ERY MEAN CORPUSCULAR VOLUME|High to Normal
    1
    1
    0
        ERY MEAN CORPUSCULAR HEMOGLOBIN|High to Normal
    0
    0
    0
        ERY. MEAN CORPUSCULAR HGB|High to Normal
    0
    0
    0
        Sodium (mmol/L)|High to Low
    0
    0
    0
        Potassium (mmol/L)|High to Low
    0
    0
    0
        Chloride (mmol/L)|High to Low
    0
    0
    0
        Calcium (mmol/L)|High to Low
    0
    0
    0
        Magnesium (mmol/L)|High to Low
    0
    0
    0
        Phosphate (mmol/L)|High to Low
    0
    0
    0
        Blood Urea Nitrogen (mmol/L)|High to Low
    0
    0
    0
        Glucose (mmol/L)|High to Low
    0
    0
    0
        Albumin (g/L)|High to Low
    0
    0
    0
        Alkaline Phosphatase (U/L)|High to Low
    0
    0
    0
        Creatinine (umol/L)|High to Low
    0
    0
    0
        Creatine Kinase (U/L)|High to Low
    0
    0
    0
        Alanine Aminotransferase (U/L)|High to Low
    0
    0
    0
        Aspartate Aminotransferase (U/L)|High to Low
    0
    0
    0
        Gamma Glutamyl Transferase (U/L)|High to Low
    0
    0
    0
        Amylase (U/L)|High to Low
    0
    0
    0
        Total Bilirubin (umol/L)|High to Low
    0
    0
    0
        Direct Bilirubin (umol/L)|High to Low
    0
    0
    0
        C Reactive Protein (mg/L)|High to Low
    0
    0
    0
        Cholesterol (mmol/L)|High to Low
    0
    0
    0
        Triglycerides (mmol/L)|High to Low
    0
    0
    0
        HDL Cholesterol (mmol/L)|High to Low
    0
    0
    0
        LDL Cholesterol (mmol/L)|High to Low
    0
    0
    0
        Erythrocytes (10^12/L)|High to Low
    0
    0
    0
        Leukocytes (10^9/L)|High to Low
    0
    0
    0
        Basophils (10^9/L)|High to Low
    0
    0
    0
        Basophils/Leukocytes (%)|High to Low
    0
    0
    0
        Eosinophils (10^9/L)|High to Low
    0
    0
    0
        Eosinophils/Leukocytes (%)|High to Low
    0
    0
    0
        Lymphocytes (10^9/L)|High to Low
    0
    0
    0
        Lymphocytes/Leukocytes (%)|High to Low
    0
    0
    0
        Monocytes (10^9/L)|High to Low
    0
    0
    0
        Monocytes/Leukocytes (%)|High to Low
    0
    0
    0
        NEUTROPHILS, SEGMENTED (10^9/L)|High to Low
    0
    0
    0
        NEUTROPHILS/LEUKOCYTES (%)|High to Low
    0
    0
    0
        PLATELETS (10^9/L)|High to Low
    0
    0
    0
        HEMOGLOBIN (g/L)|High to Low
    0
    0
    0
        HEMATOCRIT (VOLUME FRACTION)|High to Low
    0
    0
    0
        ERY MEAN CORPUSCULAR VOLUME|High to Low
    0
    0
    0
        ERY MEAN CORPUSCULAR HEMOGLOBIN|High to Low
    0
    0
    0
        ERY. MEAN CORPUSCULAR HGB (g/L)|High to Low
    0
    0
    0
        Sodium (mmol/L)|High to High
    0
    0
    0
        Potassium (mmol/L)|High to High
    0
    0
    0
        Chloride (mmol/L)|High to High
    0
    0
    0
        Calcium (mmol/L)|High to High
    0
    0
    0
        Magnesium (mmol/L)|High to High
    1
    1
    1
        Phosphate (mmol/L)|High to High
    1
    1
    0
        Blood Urea Nitrogen (mmol/L)|High to High
    0
    1
    0
        Glucose (mmol/L)|High to High
    17
    10
    21
        Albumin (g/L)|High to High
    25
    25
    23
        Alkaline Phosphatase (U/L)|High to High
    12
    6
    5
        Creatinine (umol/L)|High to High
    5
    4
    4
        Creatine Kinase (U/L)|High to High
    7
    10
    7
        Alanine Aminotransferase (U/L)|High to High
    11
    6
    7
        Aspartate Aminotransferase (U/L)|High to High
    3
    4
    4
        Gamma Glutamyl Transferase (U/L)|High to High
    8
    10
    10
        Amylase (U/L)|High to High
    12
    6
    8
        Total Bilirubin (umol/L)|High to High
    4
    4
    5
        Direct Bilirubin (umol/L)|High to High
    0
    5
    0
        C Reactive Protein (mg/L)|High to High
    18
    8
    13
        Cholesterol (mmol/L)|High to High
    1
    4
    2
        Triglycerides (mmol/L)|High to High
    3
    0
    5
        HDL Cholesterol (mmol/L)|High to High
    33
    9
    19
        LDL Cholesterol (mmol/L)|High to High
    2
    3
    1
        Erythrocytes (10^12/L)|High to High
    1
    6
    2
        Leukocytes (10^9/L)|High to High
    3
    25
    2
        Basophils (10^9/L)|High to High
    0
    2
    0
        Basophils/Leukocytes (%)|High to High
    2
    1
    0
        Eosinophils (10^9/L)|High to High
    14
    2
    10
        Eosinophils/Leukocytes (%)|High to High
    30
    0
    40
        Lymphocytes (10^9/L)|High to High
    0
    2
    0
        Lymphocytes/Leukocytes (%)|High to High
    1
    13
    0
        Monocytes (10^9/L)|High to High
    1
    28
    1
        Monocytes/Leukocytes (%)|High to High
    4
    0
    1
        NEUTROPHILS, SEGMENTED (10^9/L)|High to High
    3
    2
    2
        NEUTROPHILS/LEUKOCYTES (%)|High to High
    1
    0
    0
        PLATELETS (10^9/L)|High to High
    1
    5
    0
        HEMOGLOBIN (g/L)|High to High
    0
    3
    3
        HEMATOCRIT (VOLUME FRACTION)|High to High
    0
    1
    0
        ERY MEAN CORPUSCULAR VOLUME|High to High
    4
    3
    0
        ERYT MEAN CORPUSCULAR HEMOGLOBIN|High to High
    1
    1
    0
        ERY. MEAN CORPUSCULAR HGB|High to High
    1
    1
    0
        Sodium (mmol/L)|Missing
    1
    5
    0
        Potassium (mmol/L)|Missing
    1
    0
    0
        Chloride (mmol/L)|Missing
    1
    0
    0
        Calcium (mmol/L)|Missing
    1
    0
    0
        Magnesium (mmol/L)|Missing
    1
    0
    0
        Phosphate (mmol/L)|Missing
    1
    0
    0
        Blood Urea Nitrogen (mmol/L)|Missing
    1
    0
    0
        Glucose (mmol/L)|Missing
    1
    0
    0
        Albumin (g/L)|Missing
    1
    0
    0
        Alkaline Phosphatase (U/L)|Missing
    1
    0
    0
        Creatinine (umol/L)|Missing
    1
    0
    0
        Creatine Kinase (U/L)|Missing
    1
    0
    0
        Alanine Aminotransferase (U/L)|Missing
    1
    0
    0
        Aspartate Aminotransferase (U/L)|Missing
    1
    0
    0
        Gamma Glutamyl Transferase (U/L)|Missing
    1
    0
    0
        Amylase (U/L)|Missing
    1
    0
    0
        Total Bilirubin (umol/L)|Missing
    1
    0
    0
        Direct Bilirubin (umol/L)|Missing
    1
    0
    0
        C Reactive Protein (mg/L)|Missing
    7
    9
    6
        Cholesterol (mmol/L)|Missing
    23
    3
    16
        Triglycerides (mmol/L)|Missing
    24
    4
    17
        HDL Cholesterol (mmol/L)|Missing
    24
    3
    17
        LDL Cholesterol (mmol/L)|Missing
    25
    7
    18
        Erythrocytes (10^12/L)|Missing
    3
    0
    0
        Leukocytes (10^9/L)|Missing
    3
    0
    0
        Basophils (10^9/L)|Missing
    3
    0
    0
        Basophils/Leukocytes (%)|Missing
    3
    0
    0
        Eosinophils (10^9/L)|Missing
    3
    0
    0
        Eosinophils/Leukocytes (%)|Missing
    3
    0
    0
        Lymphocytes (10^9/L)|Missing
    3
    0
    0
        Lymphocytes/Leukocytes (%)|Missing
    3
    0
    0
        Monocytes (10^9/L)|Missing
    3
    0
    0
        Monocytes/Leukocytes (%)|Missing
    3
    0
    0
        NEUTROPHILS, SEGMENTED (10^9/L)|Missing
    3
    0
    0
        NEUTROPHILS/LEUKOCYTES (%)|Missing
    3
    0
    0
        PLATELETS (10^9/L)|Missing
    4
    0
    0
        HEMOGLOBIN (g/L)|Missing
    3
    0
    0
        HEMATOCRIT (VOLUME FRACTION)|Missing
    3
    0
    1
        ERY MEAN CORPUSCULAR VOLUME|Missing
    3
    0
    1
        ERY MEAN CORPUSCULAR HEMOGLOBIN|Missing
    3
    0
    0
        ERY. MEAN CORPUSCULAR HGB |Missing
    3
    0
    1
    No statistical analyses for this end point

    Secondary: Number of Participants with Post-Baseline Vital Sign Abnormalities

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    End point title
    		 Number of Participants with Post-Baseline Vital Sign Abnormalities
    End point description
    Vital signs like feart rate (beats per minute) and systolic blood pressure (mmHg) and diastolic blood pressure (mmHg) was measured to assess the abnormalities.
    End point type
    Secondary
    End point timeframe
    From first dose (Day 1) till up to Week 48
    End point values
    		 CC-93538 360 mg QW CC-93538 360 mg QW/Q2W Placebo
    Number of subjects analysed
    167
    117
    143
    Units: participants
        Hear rate (> 100 AND CHANGE FROM BASELINE > 30)
    6
    1
    3
        Hear rate (< 55 AND CHANGE FROM BASELINE < -15)
    0
    0
    0
        SBP (> 140 AND CHANGE FROM BASELINE > 20)
    16
    11
    15
        SBP (< 90 AND CHANGE FROM BASELINE < -20)
    0
    0
    0
        DBP > 90 AND CHANGE FROM BASELINE > 10
    18
    21
    25
        DBP < 55 AND CHANGE FROM BASELINE < -10
    4
    6
    8
    No statistical analyses for this end point

    Secondary: Change from Baseline in Physical Parameters - Height at Week 24

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    End point title
    		 Change from Baseline in Physical Parameters - Height at Week 24
    End point description
    Height was measured at specified timepoints to assess the change from baseline.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and Week 24
    End point values
    		 Induction Phase - CC-93538 360 mg QW Induction Phase - Placebo
    Number of subjects analysed
    225
    115
    Units: cm
        arithmetic mean (standard deviation)
    0.30 ( 1.479 )
    -0.08 ( 0.932 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Physical Parameters - Height at Week 48

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    End point title
    		 Change from Baseline in Physical Parameters - Height at Week 48
    End point description
    Height was measured at specified timepoints to assess the change from baseline.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and Week 48
    End point values
    		 Maintenance Phase - Placebo Maintenance Phase - CC-93538 360 mg QW Maintenance Phase - CC-93538 360 mg Q2W
    Number of subjects analysed
    75
    88
    96
    Units: cm
        arithmetic mean (standard deviation)
    0.12 ( 1.114 )
    0.42 ( 1.929 )
    0.42 ( 1.973 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Physical Parameters - Weight at Week 24

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    End point title
    		 Change from Baseline in Physical Parameters - Weight at Week 24
    End point description
    Weight was measured at specified timepoints to assess the change from baseline.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and Week 24
    End point values
    		 Induction Phase - CC-93538 360 mg QW Induction Phase - Placebo
    Number of subjects analysed
    257
    133
    Units: kg
        arithmetic mean (standard deviation)
    0.35 ( 3.369 )
    0.24 ( 3.108 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Physical Parameters - Weight at Week 48

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    End point title
    		 Change from Baseline in Physical Parameters - Weight at Week 48
    End point description
    Weight was measured at specified timepoints to assess the change from baseline.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and Week 48
    End point values
    		 Maintenance Phase - Placebo Maintenance Phase - CC-93538 360 mg QW Maintenance Phase - CC-93538 360 mg Q2W
    Number of subjects analysed
    82
    107
    110
    Units: cm
        arithmetic mean (standard deviation)
    0.22 ( 4.270 )
    0.11 ( 4.908 )
    1.26 ( 4.766 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Physical Parameters - Body Mass Index at Week 24

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    End point title
    		 Change from Baseline in Physical Parameters - Body Mass Index at Week 24
    End point description
    Data was collected for height and weight to assess body mass index.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and Week 24
    End point values
    		 Induction Phase - Placebo Induction Phase - CC-93538 360 mg QW
    Number of subjects analysed
    133
    256
    Units: kg/m^2
        arithmetic mean (standard deviation)
    0.084 ( 1.0676 )
    0.044 ( 1.1629 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Physical Parameters - Body Mass Index at Week 48

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    End point title
    		 Change from Baseline in Physical Parameters - Body Mass Index at Week 48
    End point description
    Data was collected for height and weight to assess body mass index.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and Week 48
    End point values
    		 Maintenance Phase - Placebo Maintenance Phase - CC-93538 360 mg Q2W Maintenance Phase - CC-93538 360 mg QW
    Number of subjects analysed
    82
    110
    106
    Units: kg/m^2
        arithmetic mean (standard deviation)
    0.037 ( 1.4223 )
    0.350 ( 1.5218 )
    -0.074 ( 1.6716 )
    No statistical analyses for this end point

    Secondary: Number of Participants with Anti-Drug Antibodies (ADA)

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    End point title
    		 Number of Participants with Anti-Drug Antibodies (ADA)
    End point description
    ADA status were categorized as Baseline ADA Positive: Pre-existing Immunoreactivity (baseline positive and 1) post baseline negative or 2) titer < 4-fold baseline titer). NAb+/baseline ADA+: At least one ADA positive sample with positive NAb in subject with pre-existing immunoreactivity. ADA Positive Status: 1) at least one positive response post first dose given negative or missing baseline; or 2) at least one post-baseline with titer greater than or equal to 4-fold of baseline titer given positive baseline. NAb+/ADA+: At least one ADA positive sample with positive NAb in ADA positive subjects.
    End point type
    Secondary
    End point timeframe
    Pre-dose Week 24 and Pre-dose Week 48
    End point values
    		 CC-93538 360 mg QW CC-93538 360 mg QW/Q2W
    Number of subjects analysed
    167
    117
    Units: participants
        BASELINE ADA POSITIVE (Week 24)
    6
    7
        BASELINE ADA POSITIVE (Week 48)
    4
    6
        NAB+/BASELINE ADA+ (Week 24)
    2
    1
        NAB+/BASELINE ADA+ (Week 48)
    1
    1
        ADA POSITIVE (Week 24)
    12
    13
        ADA POSITIVE (Week 48)
    8
    12
        NAB+/ADA+ (Week 24)
    4
    7
        NAB+/ADA+ (Week 48)
    1
    7
    No statistical analyses for this end point

    Secondary: Serum Trough Concentration of CC-93538 at Week 24 and Week 48

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    End point title
    		 Serum Trough Concentration of CC-93538 at Week 24 and Week 48
    End point description
    Blood samples were collected to assess trough concentration of CC-93538. The Evaluable PK population is defined as all participants in the PK population who have at least one evaluable trough concentration.
    End point type
    Secondary
    End point timeframe
    Pre-dose Week 24 and Pre-dose Week 48
    End point values
    		 CC-93538 360 mg QW CC-93538 360 mg QW/Q2W
    Number of subjects analysed
    110
    97
    Units: ng/mL
    geometric mean (geometric coefficient of variation)
        Pre-dose Week 24
    148133.6 ( 69.9 )
    151735.2 ( 55.8 )
        Pre-dose Week 48
    138545.4 ( 121.1 )
    79884.3 ( 45.4 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All Serious AEs, Non-Serious AEs and all cause mortality were collected from signing of informed consent form (Day -28) until 16 weeks after the last dose of IP was administered (Up to approximately 21 months).
    Adverse event reporting additional description
    The Safety population consist of all randomized subjects who received at least 1 dose of IP and analyzed based on the actual treatments they received.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.0
    Reporting groups
    Reporting group title
    Induction Phase - CC-93538 360 mg QW
    Reporting group description
    		 Participants with Eosinophilic Esophagitis received 360 mg CC-93538 SC once every week in the 24 week induction phase.

    Reporting group title
    Induction Phase - Placebo
    Reporting group description
    		 Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24 week induction phase.

    Reporting group title
    Maintenance Phase - Placebo
    Reporting group description
    		 Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24 week maintenance phase.

    Reporting group title
    Maintenance Phase - CC-93538 360 mg Q2W
    Reporting group description
    		 Participants with Eosinophilic Esophagitis received 360 mg CC-93538 SC once every other week in the 24 week maintenance phase.

    Reporting group title
    Maintenance Phase - CC-93538 360 mg QW
    Reporting group description
    		 Participants with Eosinophilic Esophagitis received 360 mg CC-93538 SC once every week in the 24 week maintenance phase.

    Serious adverse events
    		 Induction Phase - CC-93538 360 mg QW Induction Phase - Placebo Maintenance Phase - Placebo Maintenance Phase - CC-93538 360 mg Q2W Maintenance Phase - CC-93538 360 mg QW
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 284 (1.76%)
    4 / 143 (2.80%)
    8 / 143 (5.59%)
    4 / 117 (3.42%)
    4 / 167 (2.40%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Overdose
         subjects affected / exposed
    1 / 284 (0.35%)
    0 / 143 (0.00%)
    0 / 143 (0.00%)
    0 / 117 (0.00%)
    1 / 167 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Traumatic haematoma
         subjects affected / exposed
    0 / 284 (0.00%)
    0 / 143 (0.00%)
    0 / 143 (0.00%)
    1 / 117 (0.85%)
    0 / 167 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    0 / 284 (0.00%)
    1 / 143 (0.70%)
    1 / 143 (0.70%)
    0 / 117 (0.00%)
    0 / 167 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    0 / 284 (0.00%)
    0 / 143 (0.00%)
    1 / 143 (0.70%)
    0 / 117 (0.00%)
    0 / 167 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    1 / 284 (0.35%)
    0 / 143 (0.00%)
    0 / 143 (0.00%)
    1 / 117 (0.85%)
    0 / 167 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebral infarction
         subjects affected / exposed
    0 / 284 (0.00%)
    0 / 143 (0.00%)
    0 / 143 (0.00%)
    0 / 117 (0.00%)
    1 / 167 (0.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Migraine
         subjects affected / exposed
    0 / 284 (0.00%)
    0 / 143 (0.00%)
    0 / 143 (0.00%)
    1 / 117 (0.85%)
    0 / 167 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Complication associated with device
         subjects affected / exposed
    0 / 284 (0.00%)
    0 / 143 (0.00%)
    0 / 143 (0.00%)
    1 / 117 (0.85%)
    0 / 167 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Eosinophilic oesophagitis
         subjects affected / exposed
    2 / 284 (0.70%)
    1 / 143 (0.70%)
    1 / 143 (0.70%)
    0 / 117 (0.00%)
    2 / 167 (1.20%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 284 (0.00%)
    0 / 143 (0.00%)
    1 / 143 (0.70%)
    0 / 117 (0.00%)
    0 / 167 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Drug-induced liver injury
         subjects affected / exposed
    1 / 284 (0.35%)
    0 / 143 (0.00%)
    0 / 143 (0.00%)
    0 / 117 (0.00%)
    1 / 167 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression suicidal
         subjects affected / exposed
    0 / 284 (0.00%)
    0 / 143 (0.00%)
    1 / 143 (0.70%)
    0 / 117 (0.00%)
    0 / 167 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mental status changes
         subjects affected / exposed
    0 / 284 (0.00%)
    0 / 143 (0.00%)
    1 / 143 (0.70%)
    0 / 117 (0.00%)
    0 / 167 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    0 / 284 (0.00%)
    0 / 143 (0.00%)
    0 / 143 (0.00%)
    1 / 117 (0.85%)
    0 / 167 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 284 (0.00%)
    1 / 143 (0.70%)
    1 / 143 (0.70%)
    0 / 117 (0.00%)
    0 / 167 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 284 (0.00%)
    1 / 143 (0.70%)
    2 / 143 (1.40%)
    0 / 117 (0.00%)
    0 / 167 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 284 (0.00%)
    0 / 143 (0.00%)
    0 / 143 (0.00%)
    1 / 117 (0.85%)
    0 / 167 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Induction Phase - CC-93538 360 mg QW Induction Phase - Placebo Maintenance Phase - Placebo Maintenance Phase - CC-93538 360 mg Q2W Maintenance Phase - CC-93538 360 mg QW
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    150 / 284 (52.82%)
    62 / 143 (43.36%)
    69 / 143 (48.25%)
    73 / 117 (62.39%)
    103 / 167 (61.68%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    26 / 284 (9.15%)
    10 / 143 (6.99%)
    14 / 143 (9.79%)
    7 / 117 (5.98%)
    20 / 167 (11.98%)
         occurrences all number
    40
    12
    17
    8
    45
    General disorders and administration site conditions
    Injection site reaction
         subjects affected / exposed
    48 / 284 (16.90%)
    20 / 143 (13.99%)
    21 / 143 (14.69%)
    20 / 117 (17.09%)
    32 / 167 (19.16%)
         occurrences all number
    169
    29
    34
    96
    155
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    8 / 284 (2.82%)
    5 / 143 (3.50%)
    5 / 143 (3.50%)
    6 / 117 (5.13%)
    7 / 167 (4.19%)
         occurrences all number
    19
    6
    6
    17
    7
    Vomiting
         subjects affected / exposed
    12 / 284 (4.23%)
    2 / 143 (1.40%)
    4 / 143 (2.80%)
    10 / 117 (8.55%)
    6 / 167 (3.59%)
         occurrences all number
    13
    2
    4
    11
    7
    Nausea
         subjects affected / exposed
    12 / 284 (4.23%)
    2 / 143 (1.40%)
    6 / 143 (4.20%)
    6 / 117 (5.13%)
    11 / 167 (6.59%)
         occurrences all number
    13
    2
    7
    7
    11
    Diarrhoea
         subjects affected / exposed
    12 / 284 (4.23%)
    8 / 143 (5.59%)
    9 / 143 (6.29%)
    8 / 117 (6.84%)
    8 / 167 (4.79%)
         occurrences all number
    19
    9
    10
    18
    10
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    7 / 284 (2.46%)
    3 / 143 (2.10%)
    4 / 143 (2.80%)
    6 / 117 (5.13%)
    7 / 167 (4.19%)
         occurrences all number
    7
    3
    4
    7
    7
    Arthralgia
         subjects affected / exposed
    11 / 284 (3.87%)
    5 / 143 (3.50%)
    6 / 143 (4.20%)
    9 / 117 (7.69%)
    8 / 167 (4.79%)
         occurrences all number
    11
    5
    6
    9
    8
    Infections and infestations
    COVID-19
         subjects affected / exposed
    40 / 284 (14.08%)
    15 / 143 (10.49%)
    21 / 143 (14.69%)
    28 / 117 (23.93%)
    29 / 167 (17.37%)
         occurrences all number
    40
    15
    21
    29
    31
    Urinary tract infection
         subjects affected / exposed
    8 / 284 (2.82%)
    1 / 143 (0.70%)
    2 / 143 (1.40%)
    5 / 117 (4.27%)
    9 / 167 (5.39%)
         occurrences all number
    9
    1
    2
    8
    10
    Upper respiratory tract infection
         subjects affected / exposed
    20 / 284 (7.04%)
    10 / 143 (6.99%)
    12 / 143 (8.39%)
    11 / 117 (9.40%)
    17 / 167 (10.18%)
         occurrences all number
    20
    10
    15
    15
    18
    Nasopharyngitis
         subjects affected / exposed
    23 / 284 (8.10%)
    10 / 143 (6.99%)
    13 / 143 (9.09%)
    14 / 117 (11.97%)
    16 / 167 (9.58%)
         occurrences all number
    27
    11
    15
    20
    24
    Influenza
         subjects affected / exposed
    5 / 284 (1.76%)
    2 / 143 (1.40%)
    4 / 143 (2.80%)
    6 / 117 (5.13%)
    3 / 167 (1.80%)
         occurrences all number
    5
    2
    4
    6
    4
    Gastroenteritis
         subjects affected / exposed
    9 / 284 (3.17%)
    1 / 143 (0.70%)
    2 / 143 (1.40%)
    4 / 117 (3.42%)
    10 / 167 (5.99%)
         occurrences all number
    9
    1
    2
    4
    11

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Sep 2023
    The purpose of this amendment was to update the statistical methodology, revisethe study discontinuation criteriaper Health Authorityfeedback, add the Pre-filled Syringe(PFS) Administration Questionnaire,as well as align this protocol with guidance provided across the developmentprogram.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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