Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Participants With Eosinophilic Esophagitis (NCT NCT04753697)
NCT ID: NCT04753697
Last Updated: 2025-03-13
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
430 participants
Primary outcome timeframe
Baseline (Day 1) and Week 24
Results posted on
2025-03-13
Participant Flow
Participant milestones
| Measure |
CC-93538 360 mg QW
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.
|
CC-93538 360 mg QW/Q2W
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.
|
Placebo
Participants with active eosinophilic esophagitis received CC-93538 matching placebo during 24-week induction phase followed by 24-week maintenance phase.
|
|---|---|---|---|
|
Pre-Treatment Period
STARTED
|
143
|
143
|
144
|
|
Pre-Treatment Period
COMPLETED
|
143
|
141
|
143
|
|
Pre-Treatment Period
NOT COMPLETED
|
0
|
2
|
1
|
|
Induction Phase
STARTED
|
143
|
141
|
143
|
|
Induction Phase
COMPLETED
|
127
|
134
|
136
|
|
Induction Phase
NOT COMPLETED
|
16
|
7
|
7
|
|
Maintenance Phase
STARTED
|
114
|
117
|
90
|
|
Maintenance Phase
COMPLETED
|
107
|
110
|
82
|
|
Maintenance Phase
NOT COMPLETED
|
7
|
7
|
8
|
Reasons for withdrawal
| Measure |
CC-93538 360 mg QW
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.
|
CC-93538 360 mg QW/Q2W
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.
|
Placebo
Participants with active eosinophilic esophagitis received CC-93538 matching placebo during 24-week induction phase followed by 24-week maintenance phase.
|
|---|---|---|---|
|
Induction Phase
Withdrawal by Subject
|
12
|
5
|
6
|
|
Induction Phase
Physician Decision
|
1
|
0
|
0
|
|
Induction Phase
Lost to Follow-up
|
2
|
2
|
1
|
|
Induction Phase
Lack of Efficacy
|
1
|
0
|
0
|
|
Maintenance Phase
Physician Decision
|
0
|
0
|
1
|
|
Maintenance Phase
Withdrawal by Subject
|
3
|
4
|
6
|
|
Maintenance Phase
Lost to Follow-up
|
2
|
2
|
0
|
|
Maintenance Phase
NON-COMPLIANCE WITH STUDY DRUG
|
1
|
0
|
0
|
|
Maintenance Phase
Adverse Event
|
0
|
1
|
1
|
|
Maintenance Phase
WITHDRAWAL BY PARENT/GUARDIAN
|
1
|
0
|
0
|
Baseline Characteristics
A Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Participants With Eosinophilic Esophagitis
Baseline characteristics by cohort
| Measure |
CC-93538 360 mg QW
n=143 Participants
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.
|
CC-93538 360 mg QW/Q2W
n=143 Participants
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.
|
Placebo
n=144 Participants
Participants with active eosinophilic esophagitis received CC-93538 matching placebo during 24-week induction phase followed by 24-week maintenance phase.
|
Total
n=430 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
35.9 years
STANDARD_DEVIATION 11.79 • n=5 Participants
|
34.8 years
STANDARD_DEVIATION 12.24 • n=7 Participants
|
36.2 years
STANDARD_DEVIATION 12.16 • n=5 Participants
|
35.6 years
STANDARD_DEVIATION 12.05 • n=4 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
131 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
90 Participants
n=5 Participants
|
110 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
299 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
135 Participants
n=5 Participants
|
138 Participants
n=7 Participants
|
137 Participants
n=5 Participants
|
410 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
134 Participants
n=5 Participants
|
128 Participants
n=7 Participants
|
130 Participants
n=5 Participants
|
392 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and Week 24Population: The Intent-to-Treat (ITT) population consist of all randomized participants and analyzed according to their randomized treatment group regardless of whether or not the participant received IP CC-93538 or placebo. Number of participants with observed values at the specified timepoint are included in the analysis.
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.
Outcome measures
| Measure |
Induction Phase - CC-93538 360 mg QW
n=236 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 SC once every week in the 24-week induction phase.
|
Induction Phase - Placebo
n=124 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24-week induction phase.
|
Maintenance Phase - Placebo
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24 week maintenance phase.
|
|---|---|---|---|
|
Change From Baseline in Mean Dysphagia Days (DD) at Week 24
|
-6.85 days
Standard Deviation 5.259
|
-4.98 days
Standard Deviation 5.075
|
—
|
PRIMARY outcome
Timeframe: Week 24Population: The Intent-to-Treat (ITT) population consist of all randomized participants and analyzed according to their randomized treatment group regardless of whether or not the participant received IP CC-93538 or placebo. Number of participants with observed values at the specified timepoint are included in the analysis.
Blood samples were collected to assess esophageal eosinophil count.
Outcome measures
| Measure |
Induction Phase - CC-93538 360 mg QW
n=249 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 SC once every week in the 24-week induction phase.
|
Induction Phase - Placebo
n=129 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24-week induction phase.
|
Maintenance Phase - Placebo
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24 week maintenance phase.
|
|---|---|---|---|
|
Percentage of Participants With Peak Esophageal Eosinophil Count <= 6/High-power Field (Hpf) at Week 24
|
34.1 percentage of participants
|
3.1 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Week 48Population: The Intent-to-Treat (ITT) population consist of all randomized participants and analyzed according to their randomized treatment group regardless of whether or not the participant received IP CC-93538 or placebo. Number of participants with observed values at the specified timepoint are included in the analysis.
Blood samples were collected to assess esophageal eosinophil count.
Outcome measures
| Measure |
Induction Phase - CC-93538 360 mg QW
n=104 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 SC once every week in the 24-week induction phase.
|
Induction Phase - Placebo
n=108 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24-week induction phase.
|
Maintenance Phase - Placebo
n=82 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24 week maintenance phase.
|
|---|---|---|---|
|
Percentage of Participants With Peak Esophageal Eosinophil Count <= 6/High-power Field (Hpf) at Week 48
|
37.5 percentage of participants
|
34.3 percentage of participants
|
4.9 percentage of participants
|
SECONDARY outcome
Timeframe: Week 24Population: The Intent-to-Treat (ITT) population consist of all randomized participants and analyzed according to their randomized treatment group regardless of whether or not the participant received IP CC-93538 or placebo. Number of participants with observed values at the specified timepoint are included in the analysis.
Blood samples were collected to assess esophageal eosinophil count.
Outcome measures
| Measure |
Induction Phase - CC-93538 360 mg QW
n=249 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 SC once every week in the 24-week induction phase.
|
Induction Phase - Placebo
n=129 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24-week induction phase.
|
Maintenance Phase - Placebo
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24 week maintenance phase.
|
|---|---|---|---|
|
Percentage of Participants With Peak Esophageal Eosinophil Count < 15/High-power Field (Hpf) at Week 24
|
53.0 percentage of participants
|
4.7 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Week 48Population: The Intent-to-Treat (ITT) population consist of all randomized participants and analyzed according to their randomized treatment group regardless of whether or not the participant received IP CC-93538 or placebo. Number of participants with observed values at the specified timepoint are included in the analysis.
Blood samples were collected to assess esophageal eosinophil count.
Outcome measures
| Measure |
Induction Phase - CC-93538 360 mg QW
n=104 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 SC once every week in the 24-week induction phase.
|
Induction Phase - Placebo
n=108 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24-week induction phase.
|
Maintenance Phase - Placebo
n=82 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24 week maintenance phase.
|
|---|---|---|---|
|
Percentage of Participants With Peak Esophageal Eosinophil Count < 15/High-power Field (Hpf) at Week 48
|
50.0 percentage of participants
|
50.0 percentage of participants
|
8.5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 48Population: The Intent-to-Treat (ITT) population consist of all randomized participants and analyzed according to their randomized treatment group regardless of whether or not the participant received IP CC-93538 or placebo. Number of participants with observed values at the specified timepoint are included in the analysis.
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.
Outcome measures
| Measure |
Induction Phase - CC-93538 360 mg QW
n=100 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 SC once every week in the 24-week induction phase.
|
Induction Phase - Placebo
n=101 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24-week induction phase.
|
Maintenance Phase - Placebo
n=75 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24 week maintenance phase.
|
|---|---|---|---|
|
Change From Baseline in Mean Dysphagia Days (DD) at Week 48
|
-7.71 days
Standard Deviation 5.401
|
-8.07 days
Standard Deviation 5.292
|
-6.20 days
Standard Deviation 5.118
|
SECONDARY outcome
Timeframe: Baseline (Day 1) , Week 24Population: The Intent-to-Treat (ITT) population consist of all randomized participants and analyzed according to their randomized treatment group regardless of whether or not the participant received IP CC-93538 or placebo. Number of participants with observed values at the specified timepoint are included in the analysis.
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.
Outcome measures
| Measure |
Induction Phase - CC-93538 360 mg QW
n=249 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 SC once every week in the 24-week induction phase.
|
Induction Phase - Placebo
n=128 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24-week induction phase.
|
Maintenance Phase - Placebo
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24 week maintenance phase.
|
|---|---|---|---|
|
Change From Baseline in Eosinophilic Esophagitis (EoE) Endoscopic Reference Score (EREFS) at Week 24
|
-6.0 score on a scale
Standard Deviation 4.54
|
-1.5 score on a scale
Standard Deviation 4.26
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) , Week 48Population: The Intent-to-Treat (ITT) population consist of all randomized participants and analyzed according to their randomized treatment group regardless of whether or not the participant received IP CC-93538 or placebo. Number of participants with observed values at the specified timepoint are included in the analysis.
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.
Outcome measures
| Measure |
Induction Phase - CC-93538 360 mg QW
n=103 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 SC once every week in the 24-week induction phase.
|
Induction Phase - Placebo
n=105 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24-week induction phase.
|
Maintenance Phase - Placebo
n=79 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24 week maintenance phase.
|
|---|---|---|---|
|
Change From Baseline in Eosinophilic Esophagitis (EoE) Endoscopic Reference Score (EREFS) at Week 48
|
-6.6 score on a scale
Standard Deviation 4.24
|
-6.5 score on a scale
Standard Deviation 4.57
|
-3.2 score on a scale
Standard Deviation 4.15
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 24Population: The Intent-to-Treat (ITT) population consist of all randomized participants and analyzed according to their randomized treatment group regardless of whether or not the participant received IP CC-93538 or placebo. Number of participants with observed values at the specified timepoint are included in the analysis.
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.
Outcome measures
| Measure |
Induction Phase - CC-93538 360 mg QW
n=249 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 SC once every week in the 24-week induction phase.
|
Induction Phase - Placebo
n=129 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24-week induction phase.
|
Maintenance Phase - Placebo
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24 week maintenance phase.
|
|---|---|---|---|
|
Change From Baseline in Mean Adjusted Eosinophilic Esophagitis Histology Scoring System (EoEHSS) Grade Score at Week 24
|
-30.20 Score on a scale
Standard Deviation 15.811
|
-6.47 Score on a scale
Standard Deviation 15.755
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) , Week 48Population: The Intent-to-Treat (ITT) population consist of all randomized participants and analyzed according to their randomized treatment group regardless of whether or not the participant received IP CC-93538 or placebo. Number of participants with observed values at the specified timepoint are included in the analysis.
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.
Outcome measures
| Measure |
Induction Phase - CC-93538 360 mg QW
n=104 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 SC once every week in the 24-week induction phase.
|
Induction Phase - Placebo
n=108 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24-week induction phase.
|
Maintenance Phase - Placebo
n=82 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24 week maintenance phase.
|
|---|---|---|---|
|
Change From Baseline in Mean Adjusted Eosinophilic Esophagitis Histology Scoring System (EoEHSS) Grade Score at Week 48
|
-30.35 score on a scale
Standard Deviation 17.146
|
-30.96 score on a scale
Standard Deviation 15.864
|
-6.17 score on a scale
Standard Deviation 16.579
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 24Population: The Intent-to-Treat (ITT) population consist of all randomized participants and analyzed according to their randomized treatment group regardless of whether or not the participant received IP CC-93538 or placebo. Number of participants with observed values at the specified timepoint are included in the analysis.
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.
Outcome measures
| Measure |
Induction Phase - CC-93538 360 mg QW
n=249 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 SC once every week in the 24-week induction phase.
|
Induction Phase - Placebo
n=129 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24-week induction phase.
|
Maintenance Phase - Placebo
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24 week maintenance phase.
|
|---|---|---|---|
|
Change From Baseline in Mean Adjusted Eosinophilic Esophagitis Histology Scoring System (EoEHSS) Stage Score at Week 24
|
-36.71 Score on a scale
Standard Deviation 19.370
|
-9.90 Score on a scale
Standard Deviation 17.583
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) , Week 48Population: The Intent-to-Treat (ITT) population consist of all randomized participants and analyzed according to their randomized treatment group regardless of whether or not the participant received IP CC-93538 or placebo. Number of participants with observed values at the specified timepoint are included in the analysis.
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.
Outcome measures
| Measure |
Induction Phase - CC-93538 360 mg QW
n=104 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 SC once every week in the 24-week induction phase.
|
Induction Phase - Placebo
n=108 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24-week induction phase.
|
Maintenance Phase - Placebo
n=82 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24 week maintenance phase.
|
|---|---|---|---|
|
Change From Baseline in Mean Adjusted Eosinophilic Esophagitis Histology Scoring System (EoEHSS) Stage Score at Week 48
|
-36.30 score on a scale
Standard Deviation 20.904
|
-37.36 score on a scale
Standard Deviation 19.290
|
-8.38 score on a scale
Standard Deviation 19.935
|
SECONDARY outcome
Timeframe: Baseline (11 days prior to Day 1) and Week 24Population: The Intent-to-Treat (ITT) population consist of all randomized participants and analyzed according to their randomized treatment group regardless of whether or not the participant received IP CC-93538 or placebo. Number of participants with observed values at the specified timepoint are included in the analysis.
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.
Outcome measures
| Measure |
Induction Phase - CC-93538 360 mg QW
n=236 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 SC once every week in the 24-week induction phase.
|
Induction Phase - Placebo
n=124 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24-week induction phase.
|
Maintenance Phase - Placebo
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24 week maintenance phase.
|
|---|---|---|---|
|
Change From Baseline in Modified Daily Symptom Diary (mDSD) Composite Score at Week 24
|
-14.78 Score on a scale
Standard Deviation 11.353
|
-10.93 Score on a scale
Standard Deviation 11.234
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) , Week 48Population: The Intent-to-Treat (ITT) population consist of all randomized participants and analyzed according to their randomized treatment group regardless of whether or not the participant received IP CC-93538 or placebo. Number of participants with observed values at the specified timepoint are included in the analysis.
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.
Outcome measures
| Measure |
Induction Phase - CC-93538 360 mg QW
n=100 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 SC once every week in the 24-week induction phase.
|
Induction Phase - Placebo
n=101 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24-week induction phase.
|
Maintenance Phase - Placebo
n=75 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24 week maintenance phase.
|
|---|---|---|---|
|
Change From Baseline in Modified Daily Symptom Diary (mDSD) Composite Score at Week 48
|
-16.77 score on a scale
Standard Deviation 11.297
|
-16.45 score on a scale
Standard Deviation 11.635
|
-13.44 score on a scale
Standard Deviation 10.862
|
SECONDARY outcome
Timeframe: Baseline (11 days prior to Day 1) and Week 24Population: The Intent-to-Treat (ITT) population consist of all randomized participants and analyzed according to their randomized treatment group regardless of whether or not the participant received IP CC-93538 or placebo. Number of participants with observed values at the specified timepoint are included in the analysis.
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.
Outcome measures
| Measure |
Induction Phase - CC-93538 360 mg QW
n=236 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 SC once every week in the 24-week induction phase.
|
Induction Phase - Placebo
n=124 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24-week induction phase.
|
Maintenance Phase - Placebo
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24 week maintenance phase.
|
|---|---|---|---|
|
Percentage of Participants With a ≥ 50% Decrease in Dysphagia Days(DD) From Baseline at Week 24
|
65.7 percentage of participants
|
50.0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline (11 days prior to Day 1) and Week 48Population: The Intent-to-Treat (ITT)population consist of all randomized participants and analyzed according to their randomized treatment group regardless of whether or not the participant received IP CC-93538 or placebo. Number of participants with observed values at the specified timepoint are included in the analysis.
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.
Outcome measures
| Measure |
Induction Phase - CC-93538 360 mg QW
n=143 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 SC once every week in the 24-week induction phase.
|
Induction Phase - Placebo
n=143 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24-week induction phase.
|
Maintenance Phase - Placebo
n=144 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24 week maintenance phase.
|
|---|---|---|---|
|
Percentage of Participants With a ≥ 50% Decrease in Dysphagia Days(DD) From Baseline at Week 48
|
50.3 percentage of participants
|
53.8 percentage of participants
|
31.9 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24Population: The Intent-to-Treat (ITT)population consist of all randomized participants and analyzed according to their randomized treatment group regardless of whether or not the participant received IP CC-93538 or placebo. Number of participants with observed values at the specified timepoint are included in the analysis.
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.
Outcome measures
| Measure |
Induction Phase - CC-93538 360 mg QW
n=264 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 SC once every week in the 24-week induction phase.
|
Induction Phase - Placebo
n=144 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24-week induction phase.
|
Maintenance Phase - Placebo
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24 week maintenance phase.
|
|---|---|---|---|
|
Change From Baseline in Mean Dysphagia Days (DD) Through Week 24
Week 24
|
-6.85 days
Standard Deviation 5.259
|
-4.98 days
Standard Deviation 5.075
|
—
|
|
Change From Baseline in Mean Dysphagia Days (DD) Through Week 24
Week 2
|
-1.26 days
Standard Deviation 2.607
|
-0.80 days
Standard Deviation 2.651
|
—
|
|
Change From Baseline in Mean Dysphagia Days (DD) Through Week 24
Week 4
|
-3.19 days
Standard Deviation 4.073
|
-1.75 days
Standard Deviation 3.460
|
—
|
|
Change From Baseline in Mean Dysphagia Days (DD) Through Week 24
Week 8
|
-5.04 days
Standard Deviation 4.755
|
-3.51 days
Standard Deviation 4.132
|
—
|
|
Change From Baseline in Mean Dysphagia Days (DD) Through Week 24
Week 12
|
-5.88 days
Standard Deviation 5.071
|
-3.88 days
Standard Deviation 4.379
|
—
|
|
Change From Baseline in Mean Dysphagia Days (DD) Through Week 24
Week 16
|
-6.39 days
Standard Deviation 5.299
|
-4.90 days
Standard Deviation 4.851
|
—
|
|
Change From Baseline in Mean Dysphagia Days (DD) Through Week 24
Week 20
|
-6.91 days
Standard Deviation 5.321
|
-4.98 days
Standard Deviation 4.960
|
—
|
SECONDARY outcome
Timeframe: Baseline (11 days prior to Day 1) and Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24Population: The Intent-to-Treat (ITT)population consist of all randomized participants and analyzed according to their randomized treatment group regardless of whether or not the participant received IP CC-93538 or placebo. Number of participants with observed values at the specified timepoint are included in the analysis.
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.
Outcome measures
| Measure |
Induction Phase - CC-93538 360 mg QW
n=264 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 SC once every week in the 24-week induction phase.
|
Induction Phase - Placebo
n=139 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24-week induction phase.
|
Maintenance Phase - Placebo
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24 week maintenance phase.
|
|---|---|---|---|
|
Change From Baseline in Modified Daily Symptom Diary (mDSD) Composite Score Through Week 24
Week 2
|
-3.89 Score on a scale
Standard Deviation 7.126
|
-3.25 Score on a scale
Standard Deviation 6.621
|
—
|
|
Change From Baseline in Modified Daily Symptom Diary (mDSD) Composite Score Through Week 24
Week 4
|
-8.02 Score on a scale
Standard Deviation 9.118
|
-4.98 Score on a scale
Standard Deviation 8.902
|
—
|
|
Change From Baseline in Modified Daily Symptom Diary (mDSD) Composite Score Through Week 24
Week 8
|
-11.63 Score on a scale
Standard Deviation 10.515
|
-7.59 Score on a scale
Standard Deviation 9.938
|
—
|
|
Change From Baseline in Modified Daily Symptom Diary (mDSD) Composite Score Through Week 24
Week 12
|
-13.22 Score on a scale
Standard Deviation 10.987
|
-9.00 Score on a scale
Standard Deviation 10.051
|
—
|
|
Change From Baseline in Modified Daily Symptom Diary (mDSD) Composite Score Through Week 24
Week 16
|
-13.54 Score on a scale
Standard Deviation 11.623
|
-10.43 Score on a scale
Standard Deviation 10.419
|
—
|
|
Change From Baseline in Modified Daily Symptom Diary (mDSD) Composite Score Through Week 24
Week 20
|
-14.71 Score on a scale
Standard Deviation 11.496
|
-10.99 Score on a scale
Standard Deviation 10.353
|
—
|
|
Change From Baseline in Modified Daily Symptom Diary (mDSD) Composite Score Through Week 24
Week 24
|
-14.78 Score on a scale
Standard Deviation 11.353
|
-10.93 Score on a scale
Standard Deviation 11.234
|
—
|
SECONDARY outcome
Timeframe: From first dose (Day 1) and Up to Week 48Population: The Intent-to-Treat (ITT) population consist of all randomized participants and analyzed according to their randomized treatment group regardless of whether or not the participant received IP CC-93538 or placebo.
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.
Outcome measures
| Measure |
Induction Phase - CC-93538 360 mg QW
n=143 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 SC once every week in the 24-week induction phase.
|
Induction Phase - Placebo
n=143 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24-week induction phase.
|
Maintenance Phase - Placebo
n=144 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24 week maintenance phase.
|
|---|---|---|---|
|
Time to First Event of Eosinophilic Esophagitis (EoE) Flare
|
NA days
Not Estimable due to inadequate number of events.
|
NA days
Not Estimable due to inadequate number of events.
|
NA days
Not Estimable due to inadequate number of events.
|
SECONDARY outcome
Timeframe: From first dose (Day 1) and Up to Week 48Population: The Intent-to-Treat (ITT)population consist of all randomized participants and analyzed according to their randomized treatment group regardless of whether or not the participant received IP CC-93538 or placebo.
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.
Outcome measures
| Measure |
Induction Phase - CC-93538 360 mg QW
n=143 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 SC once every week in the 24-week induction phase.
|
Induction Phase - Placebo
n=143 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24-week induction phase.
|
Maintenance Phase - Placebo
n=144 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24 week maintenance phase.
|
|---|---|---|---|
|
Time to First Use of Rescue Medication
|
NA days
Not Estimable due to inadequate number of events.
|
NA days
Not Estimable due to inadequate number of events.
|
NA days
Not Estimable due to inadequate number of events.
|
SECONDARY outcome
Timeframe: From first dose (Day 1) and up to Week 48Population: The Intent-to-Treat (ITT)population consist of all randomized participants and analyzed according to their randomized treatment group regardless of whether or not the participant received IP CC-93538 or placebo.
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.
Outcome measures
| Measure |
Induction Phase - CC-93538 360 mg QW
n=143 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 SC once every week in the 24-week induction phase.
|
Induction Phase - Placebo
n=143 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24-week induction phase.
|
Maintenance Phase - Placebo
n=144 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24 week maintenance phase.
|
|---|---|---|---|
|
Percentage of Participants With Any Events of Use of Rescue Medication
|
4.9 percentage of participants
|
7.0 percentage of participants
|
13.9 percentage of participants
|
SECONDARY outcome
Timeframe: From first dose (Day 1) and up to Week 48Population: The Intent-to-Treat (ITT)population consist of all randomized participants and analyzed according to their randomized treatment group regardless of whether or not the participant received IP CC-93538 or placebo.
First incidence of corresponding EoE flare event for any participant was considered in the analysis.
Outcome measures
| Measure |
Induction Phase - CC-93538 360 mg QW
n=143 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 SC once every week in the 24-week induction phase.
|
Induction Phase - Placebo
n=143 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24-week induction phase.
|
Maintenance Phase - Placebo
n=144 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24 week maintenance phase.
|
|---|---|---|---|
|
Percentage of Participants With Eosinophilic Esophagitis (EoE) Flare
|
3.5 percentage of participants
|
9.1 percentage of participants
|
20.1 percentage of participants
|
SECONDARY outcome
Timeframe: From first dose (Day 1) till up to Week 48Population: Safety population includes all the participants who received at least one dose of study treatment and analyzed based on the actual treatments they received.
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.
Outcome measures
| Measure |
Induction Phase - CC-93538 360 mg QW
n=167 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 SC once every week in the 24-week induction phase.
|
Induction Phase - Placebo
n=117 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24-week induction phase.
|
Maintenance Phase - Placebo
n=143 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24 week maintenance phase.
|
|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Treatment Emergent Adverse Events
|
140 Participants
|
99 Participants
|
105 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Treatment Emergent Serious Adverse Events
|
4 Participants
|
4 Participants
|
8 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Any Treatment Emergent Severe Adverse Events
|
7 Participants
|
6 Participants
|
13 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Any Treatment Emergent Moderate Adverse Events
|
68 Participants
|
55 Participants
|
48 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Any Treatment Emergent Mild Adverse Events
|
65 Participants
|
38 Participants
|
44 Participants
|
SECONDARY outcome
Timeframe: From first dose (Day 1) till up to Week 48Population: The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
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.
Outcome measures
| Measure |
Induction Phase - CC-93538 360 mg QW
n=167 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 SC once every week in the 24-week induction phase.
|
Induction Phase - Placebo
n=117 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24-week induction phase.
|
Maintenance Phase - Placebo
n=143 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24 week maintenance phase.
|
|---|---|---|---|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Lymphocytes (10^9/L) · Low to Normal
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Lymphocytes (10^9/L) · Normal to High
|
6 Participants
|
1 Participants
|
4 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Creatine Kinase (U/L) · High to Normal
|
4 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Creatine Kinase (U/L) · High to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Creatine Kinase (U/L) · High to High
|
7 Participants
|
10 Participants
|
7 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Creatine Kinase (U/L) · Missing
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Alanine Aminotransferase (U/L) · Normal to Normal
|
131 Participants
|
88 Participants
|
111 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Alanine Aminotransferase (U/L) · Normal to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Alanine Aminotransferase (U/L) · Normal to High
|
22 Participants
|
22 Participants
|
22 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Phosphate (mmol/L) · High to High
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Total Bilirubin (umol/L) · Missing
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Direct Bilirubin (umol/L) · Normal to Normal
|
165 Participants
|
117 Participants
|
143 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Direct Bilirubin (umol/L) · Normal to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Alanine Aminotransferase (U/L) · Low to Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Alanine Aminotransferase (U/L) · Low to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Alanine Aminotransferase (U/L) · Low to High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Alanine Aminotransferase (U/L) · High to Normal
|
2 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Alanine Aminotransferase (U/L) · High to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Alanine Aminotransferase (U/L) · High to High
|
11 Participants
|
6 Participants
|
7 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Alanine Aminotransferase (U/L) · Missing
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Aspartate Aminotransferase (U/L) · Normal to Normal
|
143 Participants
|
93 Participants
|
120 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Aspartate Aminotransferase (U/L) · Normal to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Aspartate Aminotransferase (U/L) · Normal to High
|
18 Participants
|
20 Participants
|
17 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Aspartate Aminotransferase (U/L) · Low to Normal
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Aspartate Aminotransferase (U/L) · Low to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Aspartate Aminotransferase (U/L) · Low to High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Aspartate Aminotransferase (U/L) · High to Normal
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Aspartate Aminotransferase (U/L) · High to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Aspartate Aminotransferase (U/L) · High to High
|
3 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Aspartate Aminotransferase (U/L) · Missing
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Gamma Glutamyl Transferase (U/L) · Normal to Normal
|
149 Participants
|
103 Participants
|
122 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Gamma Glutamyl Transferase (U/L) · Normal to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Gamma Glutamyl Transferase (U/L) · Normal to High
|
5 Participants
|
8 Participants
|
9 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Gamma Glutamyl Transferase (U/L) · Low to Normal
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Gamma Glutamyl Transferase (U/L) · Low to Low
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Gamma Glutamyl Transferase (U/L) · Low to High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Gamma Glutamyl Transferase (U/L) · High to Normal
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Gamma Glutamyl Transferase (U/L) · High to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Gamma Glutamyl Transferase (U/L) · High to High
|
8 Participants
|
5 Participants
|
10 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Gamma Glutamyl Transferase (U/L) · Missing
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Amylase (U/L) · Normal to High
|
15 Participants
|
9 Participants
|
4 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Amylase (U/L) · Normal to Normal
|
128 Participants
|
98 Participants
|
127 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Amylase (U/L) · Normal to Low
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
HDL Cholesterol (mmol/L) · Low to Low
|
18 Participants
|
22 Participants
|
14 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Amylase (U/L) · Low to Normal
|
4 Participants
|
2 Participants
|
4 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Amylase (U/L) · Low to Low
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Amylase (U/L) · Low to High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Amylase (U/L) · High to Normal
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Amylase (U/L) · High to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Amylase (U/L) · High to High
|
12 Participants
|
8 Participants
|
8 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Amylase (U/L) · Missing
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Total Bilirubin (umol/L) · Normal to Normal
|
146 Participants
|
106 Participants
|
123 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Total Bilirubin (umol/L) · Normal to Low
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Total Bilirubin (umol/L) · Normal to High
|
8 Participants
|
5 Participants
|
9 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Total Bilirubin (umol/L) · Low to Normal
|
5 Participants
|
2 Participants
|
6 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Total Bilirubin (umol/L) · Low to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Total Bilirubin (umol/L) · Low to High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Total Bilirubin (umol/L) · High to Normal
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
HDL Cholesterol (mmol/L) · Low to High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Total Bilirubin (umol/L) · High to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Total Bilirubin (umol/L) · High to High
|
4 Participants
|
4 Participants
|
5 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Direct Bilirubin (umol/L) · Normal to High
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Direct Bilirubin (umol/L) · Low to Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Direct Bilirubin (umol/L) · Low to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Direct Bilirubin (umol/L) · Low to High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Direct Bilirubin (umol/L) · High to Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Direct Bilirubin (umol/L) · High to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Direct Bilirubin (umol/L) · High to High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Direct Bilirubin (umol/L) · Missing
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
C Reactive Protein (mg/L) · Normal to Normal
|
107 Participants
|
70 Participants
|
85 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
C Reactive Protein (mg/L) · Normal to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
C Reactive Protein (mg/L) · Normal to High
|
34 Participants
|
25 Participants
|
35 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
C Reactive Protein (mg/L) · Low to Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
C Reactive Protein (mg/L) · Low to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
C Reactive Protein (mg/L) · Low to High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
C Reactive Protein (mg/L) · High to Normal
|
1 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
C Reactive Protein (mg/L) · High to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
C Reactive Protein (mg/L) · High to High
|
18 Participants
|
9 Participants
|
13 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
C Reactive Protein (mg/L) · Missing
|
7 Participants
|
9 Participants
|
6 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Cholesterol (mmol/L) · Normal to Normal
|
116 Participants
|
91 Participants
|
102 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Cholesterol (mmol/L) · Normal to Low
|
3 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Cholesterol (mmol/L) · Normal to High
|
5 Participants
|
4 Participants
|
5 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Cholesterol (mmol/L) · Low to Normal
|
14 Participants
|
5 Participants
|
6 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Cholesterol (mmol/L) · Low to Low
|
2 Participants
|
5 Participants
|
9 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Cholesterol (mmol/L) · Low to High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Cholesterol (mmol/L) · High to Normal
|
3 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Cholesterol (mmol/L) · High to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Cholesterol (mmol/L) · High to High
|
1 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Cholesterol (mmol/L) · Missing
|
23 Participants
|
3 Participants
|
16 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Triglycerides (mmol/L) · Normal to Normal
|
124 Participants
|
93 Participants
|
105 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Triglycerides (mmol/L) · Normal to Low
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Triglycerides (mmol/L) · Normal to High
|
7 Participants
|
3 Participants
|
4 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Triglycerides (mmol/L) · Low to Normal
|
3 Participants
|
6 Participants
|
3 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Triglycerides (mmol/L) · Low to Low
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Triglycerides (mmol/L) · Low to High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Triglycerides (mmol/L) · High to Normal
|
6 Participants
|
3 Participants
|
7 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Triglycerides (mmol/L) · High to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Triglycerides (mmol/L) · High to High
|
3 Participants
|
6 Participants
|
5 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Triglycerides (mmol/L) · Missing
|
24 Participants
|
4 Participants
|
17 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
HDL Cholesterol (mmol/L) · Normal to Normal
|
63 Participants
|
37 Participants
|
65 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
HDL Cholesterol (mmol/L) · Normal to Low
|
5 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
HDL Cholesterol (mmol/L) · Normal to High
|
15 Participants
|
10 Participants
|
9 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
HDL Cholesterol (mmol/L) · Low to Normal
|
4 Participants
|
14 Participants
|
11 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
HDL Cholesterol (mmol/L) · High to Normal
|
5 Participants
|
5 Participants
|
5 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
HDL Cholesterol (mmol/L) · High to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
HDL Cholesterol (mmol/L) · High to High
|
33 Participants
|
25 Participants
|
19 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
HDL Cholesterol (mmol/L) · Missing
|
24 Participants
|
3 Participants
|
17 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
LDL Cholesterol (mmol/L) · Normal to Normal
|
111 Participants
|
88 Participants
|
101 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
LDL Cholesterol (mmol/L) · Normal to Low
|
2 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Lymphocytes (10^9/L) · Normal to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
LDL Cholesterol (mmol/L) · Normal to High
|
5 Participants
|
4 Participants
|
5 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
LDL Cholesterol (mmol/L) · Low to Normal
|
12 Participants
|
9 Participants
|
3 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
LDL Cholesterol (mmol/L) · Low to Low
|
8 Participants
|
4 Participants
|
10 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
LDL Cholesterol (mmol/L) · Low to High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
LDL Cholesterol (mmol/L) · High to Normal
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
LDL Cholesterol (mmol/L) · High to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
LDL Cholesterol (mmol/L) · High to High
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
LDL Cholesterol (mmol/L) · Missing
|
25 Participants
|
7 Participants
|
18 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Erythrocytes (10^12/L) · Normal to Normal
|
154 Participants
|
113 Participants
|
137 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Erythrocytes (10^12/L) · Normal to Low
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Erythrocytes (10^12/L) · Normal to High
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Erythrocytes (10^12/L) · Low to Normal
|
5 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Erythrocytes (10^12/L) · Low to Low
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Erythrocytes (10^12/L) · Low to High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Erythrocytes (10^12/L) · High to Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Erythrocytes (10^12/L) · High to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Erythrocytes (10^12/L) · High to High
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Erythrocytes (10^12/L) · Missing
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Leukocytes (10^9/L) · Normal to Normal
|
144 Participants
|
96 Participants
|
125 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Leukocytes (10^9/L) · Normal to Low
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Leukocytes (10^9/L) · Normal to High
|
9 Participants
|
11 Participants
|
7 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Leukocytes (10^9/L) · Low to Normal
|
4 Participants
|
7 Participants
|
6 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Leukocytes (10^9/L) · Low to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Leukocytes (10^9/L) · Low to High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Leukocytes (10^9/L) · High to Normal
|
2 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Leukocytes (10^9/L) · High to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Leukocytes (10^9/L) · High to High
|
3 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Leukocytes (10^9/L) · Missing
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Basophils (10^9/L) · Normal to Normal
|
159 Participants
|
112 Participants
|
141 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Basophils (10^9/L) · Normal to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Basophils (10^9/L) · Normal to High
|
5 Participants
|
5 Participants
|
2 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Basophils (10^9/L) · Low to Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Basophils (10^9/L) · Low to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Basophils (10^9/L) · Low to High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Basophils (10^9/L) · High to Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Basophils (10^9/L) · High to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Basophils (10^9/L) · High to High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Basophils (10^9/L) · Missing
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Basophils/Leukocytes (%) · Normal to Normal
|
124 Participants
|
75 Participants
|
113 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Basophils/Leukocytes (%) · Normal to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Basophils/Leukocytes (%) · Normal to High
|
36 Participants
|
37 Participants
|
26 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Basophils/Leukocytes (%) · Low to Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Basophils/Leukocytes (%) · Low to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Basophils/Leukocytes (%) · Low to High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Basophils/Leukocytes (%) · High to Normal
|
2 Participants
|
3 Participants
|
4 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Basophils/Leukocytes (%) · High to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Basophils/Leukocytes (%) · High to High
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Basophils/Leukocytes (%) · Missing
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Eosinophils (10^9/L) · Normal to Normal
|
115 Participants
|
81 Participants
|
89 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Eosinophils (10^9/L) · Normal to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Eosinophils (10^9/L) · Normal to High
|
32 Participants
|
22 Participants
|
41 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Eosinophils (10^9/L) · Low to Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Eosinophils (10^9/L) · Low to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Eosinophils (10^9/L) · Low to High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Eosinophils (10^9/L) · High to Normal
|
3 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Eosinophils (10^9/L) · High to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Eosinophils (10^9/L) · High to High
|
14 Participants
|
13 Participants
|
10 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Eosinophils (10^9/L) · Missing
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Eosinophils/Leukocytes (%) · Normal to Normal
|
88 Participants
|
56 Participants
|
54 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Eosinophils/Leukocytes (%) · Normal to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Eosinophils/Leukocytes (%) · Normal to High
|
39 Participants
|
26 Participants
|
45 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Eosinophils/Leukocytes (%) · Low to Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Eosinophils/Leukocytes (%) · Low to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Eosinophils/Leukocytes (%) · Low to High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Eosinophils/Leukocytes (%) · High to Normal
|
7 Participants
|
7 Participants
|
4 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Eosinophils/Leukocytes (%) · High to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Eosinophils/Leukocytes (%) · High to High
|
30 Participants
|
28 Participants
|
40 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Eosinophils/Leukocytes (%) · Missing
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Lymphocytes (10^9/L) · Normal to Normal
|
157 Participants
|
113 Participants
|
138 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Lymphocytes (10^9/L) · Low to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Lymphocytes (10^9/L) · Low to High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Lymphocytes (10^9/L) · High to Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Lymphocytes (10^9/L) · High to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Lymphocytes (10^9/L) · High to High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Lymphocytes (10^9/L) · Missing
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Lymphocytes/Leukocytes (%) · Normal to Normal
|
148 Participants
|
108 Participants
|
131 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Lymphocytes/Leukocytes (%) · Normal to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Lymphocytes/Leukocytes (%) · Normal to High
|
14 Participants
|
6 Participants
|
8 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Lymphocytes/Leukocytes (%) · Low to Normal
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Lymphocytes/Leukocytes (%) · Low to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Lymphocytes/Leukocytes (%) · Low to High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Lymphocytes/Leukocytes (%) · High to Normal
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Lymphocytes/Leukocytes (%) · High to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Lymphocytes/Leukocytes (%) · High to High
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Lymphocytes/Leukocytes (%) · Missing
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Monocytes (10^9/L) · Normal to Normal
|
154 Participants
|
109 Participants
|
134 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Monocytes (10^9/L) · Normal to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Monocytes (10^9/L) · Normal to High
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Monocytes (10^9/L) · Low to Normal
|
5 Participants
|
7 Participants
|
3 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Monocytes (10^9/L) · Low to Low
|
2 Participants
|
1 Participants
|
4 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Monocytes (10^9/L) · Low to High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Monocytes (10^9/L) · High to Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Monocytes (10^9/L) · High to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Monocytes (10^9/L) · High to High
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Monocytes (10^9/L) · Missing
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Monocytes/Leukocytes (%) · Normal to Normal
|
140 Participants
|
97 Participants
|
124 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Monocytes/Leukocytes (%) · Normal to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Monocytes/Leukocytes (%) · Normal to High
|
18 Participants
|
14 Participants
|
14 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Monocytes/Leukocytes (%) · Low to Normal
|
2 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Monocytes/Leukocytes (%) · Low to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Monocytes/Leukocytes (%) · Low to High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Monocytes/Leukocytes (%) · High to Normal
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Monocytes/Leukocytes (%) · High to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Monocytes/Leukocytes (%) · High to High
|
4 Participants
|
5 Participants
|
1 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Monocytes/Leukocytes (%) · Missing
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
NEUTROPHILS, SEGMENTED (10^9/L) · Normal to Normal
|
138 Participants
|
93 Participants
|
120 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
NEUTROPHILS, SEGMENTED (10^9/L) · Normal to Low
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
NEUTROPHILS, SEGMENTED (10^9/L) · Normal to High
|
12 Participants
|
10 Participants
|
12 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
NEUTROPHILS, SEGMENTED (10^9/L) · Low to Normal
|
7 Participants
|
10 Participants
|
5 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
NEUTROPHILS, SEGMENTED (10^9/L) · Low to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
NEUTROPHILS, SEGMENTED (10^9/L) · Low to High
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
NEUTROPHILS, SEGMENTED (10^9/L) · High to Normal
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
NEUTROPHILS, SEGMENTED (10^9/L) · High to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
NEUTROPHILS, SEGMENTED (10^9/L) · High to High
|
3 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
NEUTROPHILS, SEGMENTED (10^9/L) · Missing
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
NEUTROPHILS/LEUKOCYTES (%) · Normal to Normal
|
142 Participants
|
101 Participants
|
122 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
NEUTROPHILS/LEUKOCYTES (%) · Normal to Low
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
NEUTROPHILS/LEUKOCYTES (%) · Normal to High
|
15 Participants
|
7 Participants
|
14 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
NEUTROPHILS/LEUKOCYTES (%) · Low to Normal
|
4 Participants
|
7 Participants
|
3 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
NEUTROPHILS/LEUKOCYTES (%) · Low to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
NEUTROPHILS/LEUKOCYTES (%) · Low to High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
NEUTROPHILS/LEUKOCYTES (%) · High to Normal
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
NEUTROPHILS/LEUKOCYTES (%) · High to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
NEUTROPHILS/LEUKOCYTES (%) · High to High
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
NEUTROPHILS/LEUKOCYTES (%) · Missing
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
PLATELETS (10^9/L) · Normal to Normal
|
153 Participants
|
102 Participants
|
128 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
PLATELETS (10^9/L) · Normal to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
PLATELETS (10^9/L) · Normal to High
|
7 Participants
|
11 Participants
|
11 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
PLATELETS (10^9/L) · Low to Normal
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
PLATELETS (10^9/L) · Low to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
PLATELETS (10^9/L) · Low to High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
PLATELETS (10^9/L) · High to Normal
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
PLATELETS (10^9/L) · High to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
PLATELETS (10^9/L) · High to High
|
1 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
PLATELETS (10^9/L) · Missing
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
HEMOGLOBIN (g/L) · Normal to Normal
|
158 Participants
|
115 Participants
|
142 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
HEMOGLOBIN (g/L) · Normal to Low
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
HEMOGLOBIN (g/L) · Normal to High
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
HEMOGLOBIN (g/L) · Low to Normal
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
HEMOGLOBIN (g/L) · Low to Low
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
HEMOGLOBIN (g/L) · Low to High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
HEMOGLOBIN (g/L) · High to Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
HEMOGLOBIN (g/L) · High to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
HEMOGLOBIN (g/L) · High to High
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
HEMOGLOBIN (g/L) · Missing
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
HEMATOCRIT (VOLUME FRACTION) · Normal to Normal
|
158 Participants
|
110 Participants
|
140 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
HEMATOCRIT (VOLUME FRACTION) · Normal to Low
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
HEMATOCRIT (VOLUME FRACTION) · Normal to High
|
4 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
HEMATOCRIT (VOLUME FRACTION) · Low to Normal
|
1 Participants
|
4 Participants
|
2 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
HEMATOCRIT (VOLUME FRACTION) · Low to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
HEMATOCRIT (VOLUME FRACTION) · Low to High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
HEMATOCRIT (VOLUME FRACTION) · High to Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
HEMATOCRIT (VOLUME FRACTION) · High to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
HEMATOCRIT (VOLUME FRACTION) · High to High
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
HEMATOCRIT (VOLUME FRACTION) · Missing
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
ERYTHROCYTES MEAN CORPUSCULAR VOLUME (Femtoliter) · Normal to Normal
|
128 Participants
|
90 Participants
|
120 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
ERYTHROCYTES MEAN CORPUSCULAR VOLUME (Femtoliter) · Normal to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
ERYTHROCYTES MEAN CORPUSCULAR VOLUME (Femtoliter) · Normal to High
|
24 Participants
|
16 Participants
|
14 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
ERYTHROCYTES MEAN CORPUSCULAR VOLUME (Femtoliter) · Low to Normal
|
6 Participants
|
3 Participants
|
4 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
ERYTHROCYTES MEAN CORPUSCULAR VOLUME (Femtoliter) · Low to Low
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
ERYTHROCYTES MEAN CORPUSCULAR VOLUME (Femtoliter) · Low to High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
ERYTHROCYTES MEAN CORPUSCULAR VOLUME (Femtoliter) · High to Normal
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
ERYTHROCYTES MEAN CORPUSCULAR VOLUME (Femtoliter) · High to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
ERYTHROCYTES MEAN CORPUSCULAR VOLUME (Femtoliter) · High to High
|
4 Participants
|
5 Participants
|
3 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
ERYTHROCYTES MEAN CORPUSCULAR VOLUME (Femtoliter) · Missing
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
ERYTHROCTES MEAN CORPUSCULAR HEMOGLOBIN (picogram) · Normal to Normal
|
160 Participants
|
115 Participants
|
141 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
ERYTHROCTES MEAN CORPUSCULAR HEMOGLOBIN (picogram) · Normal to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
ERYTHROCTES MEAN CORPUSCULAR HEMOGLOBIN (picogram) · Normal to High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
ERYTHROCTES MEAN CORPUSCULAR HEMOGLOBIN (picogram) · Low to Normal
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
ERYTHROCTES MEAN CORPUSCULAR HEMOGLOBIN (picogram) · Low to Low
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
ERYTHROCTES MEAN CORPUSCULAR HEMOGLOBIN (picogram) · Low to High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
ERYTHROCTES MEAN CORPUSCULAR HEMOGLOBIN (picogram) · High to Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
ERYTHROCTES MEAN CORPUSCULAR HEMOGLOBIN (picogram) · High to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
ERYTHROCTES MEAN CORPUSCULAR HEMOGLOBIN (picogram) · High to High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
ERYTHROCTES MEAN CORPUSCULAR HEMOGLOBIN (picogram) · Missing
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
ERY. MEAN CORPUSCULAR HGB CONCENTRATION (g/L) · Normal to Normal
|
164 Participants
|
114 Participants
|
140 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
ERY. MEAN CORPUSCULAR HGB CONCENTRATION (g/L) · Normal to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
ERY. MEAN CORPUSCULAR HGB CONCENTRATION (g/L) · Normal to High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
ERY. MEAN CORPUSCULAR HGB CONCENTRATION (g/L) · Low to Normal
|
0 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
ERY. MEAN CORPUSCULAR HGB CONCENTRATION (g/L) · Low to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
ERY. MEAN CORPUSCULAR HGB CONCENTRATION (g/L) · Low to High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
ERY. MEAN CORPUSCULAR HGB CONCENTRATION (g/L) · High to Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
ERY. MEAN CORPUSCULAR HGB CONCENTRATION (g/L) · High to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
ERY. MEAN CORPUSCULAR HGB CONCENTRATION (g/L) · High to High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
ERY. MEAN CORPUSCULAR HGB CONCENTRATION (g/L) · Missing
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Sodium (mmol/L) · Normal to Normal
|
158 Participants
|
113 Participants
|
138 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Sodium (mmol/L) · Normal to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Sodium (mmol/L) · Normal to High
|
7 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Sodium (mmol/L) · Low to Normal
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Sodium (mmol/L) · Low to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Sodium (mmol/L) · Low to High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Sodium (mmol/L) · High to Normal
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Sodium (mmol/L) · High to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Sodium (mmol/L) · High to High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Sodium (mmol/L) · Missing
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Potassium (mmol/L) · Normal to Normal
|
159 Participants
|
108 Participants
|
137 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Potassium (mmol/L) · Normal to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Potassium (mmol/L) · Normal to High
|
6 Participants
|
9 Participants
|
6 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Potassium (mmol/L) · Low to Normal
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Potassium (mmol/L) · Low to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Potassium (mmol/L) · Low to High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Potassium (mmol/L) · High to Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Potassium (mmol/L) · High to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Potassium (mmol/L) · High to High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Potassium (mmol/L) · Missing
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Chloride (mmol/L) · Normal to Normal
|
162 Participants
|
116 Participants
|
139 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Chloride (mmol/L) · Normal to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Chloride (mmol/L) · Normal to High
|
3 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Chloride (mmol/L) · Low to Normal
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Chloride (mmol/L) · Low to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Chloride (mmol/L) · Low to High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Chloride (mmol/L) · High to Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Chloride (mmol/L) · High to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Chloride (mmol/L) · High to High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Chloride (mmol/L) · Missing
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Calcium (mmol/L) · Normal to Normal
|
161 Participants
|
114 Participants
|
136 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Calcium (mmol/L) · Normal to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Calcium (mmol/L) · Normal to High
|
2 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Calcium (mmol/L) · Low to Normal
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Calcium (mmol/L) · Low to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Calcium (mmol/L) · Low to High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Calcium (mmol/L) · High to Normal
|
1 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Calcium (mmol/L) · High to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Calcium (mmol/L) · High to High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Calcium (mmol/L) · Missing
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Magnesium (mmol/L) · Normal to Normal
|
162 Participants
|
111 Participants
|
138 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Magnesium (mmol/L) · Normal to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Magnesium (mmol/L) · Normal to High
|
3 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Magnesium (mmol/L) · Low to Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Magnesium (mmol/L) · Low to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Magnesium (mmol/L) · Low to High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Magnesium (mmol/L) · High to Normal
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Magnesium (mmol/L) · High to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Magnesium (mmol/L) · High to High
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Magnesium (mmol/L) · Missing
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Phosphate (mmol/L) · Normal to Normal
|
159 Participants
|
112 Participants
|
136 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Phosphate (mmol/L) · Normal to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Phosphate (mmol/L) · Normal to High
|
4 Participants
|
4 Participants
|
5 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Phosphate (mmol/L) · Low to Normal
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Phosphate (mmol/L) · Low to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Phosphate (mmol/L) · Low to High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Phosphate (mmol/L) · High to Normal
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Phosphate (mmol/L) · High to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Phosphate (mmol/L) · Missing
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Blood Urea Nitrogen (mmol/L) · Normal to Normal
|
160 Participants
|
108 Participants
|
137 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Blood Urea Nitrogen (mmol/L) · Normal to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Blood Urea Nitrogen (mmol/L) · Normal to High
|
6 Participants
|
8 Participants
|
6 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Blood Urea Nitrogen (mmol/L) · Low to Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Blood Urea Nitrogen (mmol/L) · Low to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Blood Urea Nitrogen (mmol/L) · Low to High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Blood Urea Nitrogen (mmol/L) · High to Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Blood Urea Nitrogen (mmol/L) · High to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Blood Urea Nitrogen (mmol/L) · High to High
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Blood Urea Nitrogen (mmol/L) · Missing
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Glucose (mmol/L) · Normal to Normal
|
101 Participants
|
69 Participants
|
88 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Glucose (mmol/L) · Normal to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Glucose (mmol/L) · Normal to High
|
40 Participants
|
36 Participants
|
30 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Glucose (mmol/L) · Low to Normal
|
3 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Glucose (mmol/L) · Low to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Glucose (mmol/L) · Low to High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Glucose (mmol/L) · High to Normal
|
5 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Glucose (mmol/L) · High to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Glucose (mmol/L) · High to High
|
17 Participants
|
10 Participants
|
21 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Glucose (mmol/L) · Missing
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Albumin (g/L) · Normal to Normal
|
94 Participants
|
60 Participants
|
76 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Albumin (g/L) · Normal to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Albumin (g/L) · Normal to High
|
37 Participants
|
30 Participants
|
35 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Albumin (g/L) · Low to Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Albumin (g/L) · Low to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Albumin (g/L) · Low to High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Albumin (g/L) · High to Normal
|
10 Participants
|
2 Participants
|
9 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Albumin (g/L) · High to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Albumin (g/L) · High to High
|
25 Participants
|
25 Participants
|
23 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Albumin (g/L) · Missing
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Alkaline Phosphatase (U/L) · Normal to Normal
|
140 Participants
|
104 Participants
|
129 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Alkaline Phosphatase (U/L) · Normal to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Alkaline Phosphatase (U/L) · Normal to High
|
9 Participants
|
4 Participants
|
7 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Alkaline Phosphatase (U/L) · Low to Normal
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Alkaline Phosphatase (U/L) · Low to Low
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Alkaline Phosphatase (U/L) · Low to High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Alkaline Phosphatase (U/L) · High to Normal
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Alkaline Phosphatase (U/L) · High to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Alkaline Phosphatase (U/L) · High to High
|
12 Participants
|
6 Participants
|
5 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Alkaline Phosphatase (U/L) · Missing
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Creatinine (umol/L) · Normal to Normal
|
152 Participants
|
107 Participants
|
131 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Creatinine (umol/L) · Normal to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Creatinine (umol/L) · Normal to High
|
7 Participants
|
6 Participants
|
7 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Creatinine (umol/L) · Low to Normal
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Creatinine (umol/L) · Low to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Creatinine (umol/L) · Low to High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Creatinine (umol/L) · High to Normal
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Creatinine (umol/L) · High to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Creatinine (umol/L) · High to High
|
5 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Creatinine (umol/L) · Missing
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Creatine Kinase (U/L) · Normal to Normal
|
115 Participants
|
64 Participants
|
100 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Creatine Kinase (U/L) · Normal to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Creatine Kinase (U/L) · Normal to High
|
39 Participants
|
39 Participants
|
36 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Creatine Kinase (U/L) · Low to Normal
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Creatine Kinase (U/L) · Low to Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
Creatine Kinase (U/L) · Low to High
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From first dose (Day 1) till up to Week 48Population: The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received. Only number of participants with observed values at specified timepoints are included in the analysis.
Vital signs like feart rate (beats per minute) and systolic blood pressure (mmHg) and diastolic blood pressure (mmHg) was measured to assess the abnormalities.
Outcome measures
| Measure |
Induction Phase - CC-93538 360 mg QW
n=167 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 SC once every week in the 24-week induction phase.
|
Induction Phase - Placebo
n=117 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24-week induction phase.
|
Maintenance Phase - Placebo
n=143 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24 week maintenance phase.
|
|---|---|---|---|
|
Number of Participants With Post-Baseline Vital Sign Abnormalities
DBP < 55 AND CHANGE FROM BASELINE < -10
|
4 Participants
|
6 Participants
|
8 Participants
|
|
Number of Participants With Post-Baseline Vital Sign Abnormalities
Hear rate (> 100 AND CHANGE FROM BASELINE > 30)
|
6 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Post-Baseline Vital Sign Abnormalities
Hear rate (< 55 AND CHANGE FROM BASELINE < -15)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Post-Baseline Vital Sign Abnormalities
SBP (> 140 AND CHANGE FROM BASELINE > 20)
|
16 Participants
|
11 Participants
|
15 Participants
|
|
Number of Participants With Post-Baseline Vital Sign Abnormalities
SBP (< 90 AND CHANGE FROM BASELINE < -20)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Post-Baseline Vital Sign Abnormalities
DBP > 90 AND CHANGE FROM BASELINE > 10
|
18 Participants
|
21 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 24Population: The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received. Only number of participants with observed values at specified timepoints are included in the analysis.
Height was measured at specified timepoints to assess the change from baseline.
Outcome measures
| Measure |
Induction Phase - CC-93538 360 mg QW
n=225 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 SC once every week in the 24-week induction phase.
|
Induction Phase - Placebo
n=115 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24-week induction phase.
|
Maintenance Phase - Placebo
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24 week maintenance phase.
|
|---|---|---|---|
|
Change From Baseline in Physical Parameters - Height at Week 24
|
0.30 cm
Standard Deviation 1.479
|
-0.08 cm
Standard Deviation 0.932
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 48Population: The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received. Only number of participants with observed values at specified timepoints are included in the analysis.
Height was measured at specified timepoints to assess the change from baseline.
Outcome measures
| Measure |
Induction Phase - CC-93538 360 mg QW
n=88 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 SC once every week in the 24-week induction phase.
|
Induction Phase - Placebo
n=96 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24-week induction phase.
|
Maintenance Phase - Placebo
n=75 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24 week maintenance phase.
|
|---|---|---|---|
|
Change From Baseline in Physical Parameters - Height at Week 48
|
0.42 cm
Standard Deviation 1.929
|
0.42 cm
Standard Deviation 1.973
|
0.12 cm
Standard Deviation 1.114
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 24Population: The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received. Only number of participants with observed values at specified timepoints are included in the analysis.
Weight was measured at specified timepoints to assess the change from baseline.
Outcome measures
| Measure |
Induction Phase - CC-93538 360 mg QW
n=257 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 SC once every week in the 24-week induction phase.
|
Induction Phase - Placebo
n=133 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24-week induction phase.
|
Maintenance Phase - Placebo
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24 week maintenance phase.
|
|---|---|---|---|
|
Change From Baseline in Physical Parameters - Weight at Week 24
|
0.35 kg
Standard Deviation 3.369
|
0.24 kg
Standard Deviation 3.108
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 48Population: The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received. Only number of participants with observed values at specified timepoints are included in the analysis.
Weight was measured at specified timepoints to assess the change from baseline.
Outcome measures
| Measure |
Induction Phase - CC-93538 360 mg QW
n=107 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 SC once every week in the 24-week induction phase.
|
Induction Phase - Placebo
n=110 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24-week induction phase.
|
Maintenance Phase - Placebo
n=82 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24 week maintenance phase.
|
|---|---|---|---|
|
Change From Baseline in Physical Parameters - Weight at Week 48
|
0.11 cm
Standard Deviation 4.908
|
1.26 cm
Standard Deviation 4.766
|
0.22 cm
Standard Deviation 4.270
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 24Population: The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received. Only number of participants with observed values at specified timepoints are included in the analysis.
Data was collected for height and weight to assess body mass index.
Outcome measures
| Measure |
Induction Phase - CC-93538 360 mg QW
n=256 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 SC once every week in the 24-week induction phase.
|
Induction Phase - Placebo
n=133 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24-week induction phase.
|
Maintenance Phase - Placebo
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24 week maintenance phase.
|
|---|---|---|---|
|
Change From Baseline in Physical Parameters - Body Mass Index at Week 24
|
0.044 kg/m^2
Standard Deviation 1.1629
|
0.084 kg/m^2
Standard Deviation 1.0676
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 48Population: The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received. Only number of participants with observed values at specified timepoints are included in the analysis.
Data was collected for height and weight to assess body mass index.
Outcome measures
| Measure |
Induction Phase - CC-93538 360 mg QW
n=106 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 SC once every week in the 24-week induction phase.
|
Induction Phase - Placebo
n=110 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24-week induction phase.
|
Maintenance Phase - Placebo
n=82 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24 week maintenance phase.
|
|---|---|---|---|
|
Change From Baseline in Physical Parameters - Body Mass Index at Week 48
|
-0.074 kg/m^2
Standard Deviation 1.6716
|
0.350 kg/m^2
Standard Deviation 1.5218
|
0.037 kg/m^2
Standard Deviation 1.4223
|
SECONDARY outcome
Timeframe: Pre-dose Week 24 and Pre-dose Week 48Population: The Pharmacokinetic population consist of all randomized participants who received at least one dose of CC-93538 and have any available concentration data.
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 participant 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 participant.
Outcome measures
| Measure |
Induction Phase - CC-93538 360 mg QW
n=167 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 SC once every week in the 24-week induction phase.
|
Induction Phase - Placebo
n=117 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24-week induction phase.
|
Maintenance Phase - Placebo
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24 week maintenance phase.
|
|---|---|---|---|
|
Number of Participants With Anti-Drug Antibodies (ADA)
BASELINE ADA POSITIVE (Week 24)
|
6 Participants
|
5 Participants
|
—
|
|
Number of Participants With Anti-Drug Antibodies (ADA)
BASELINE ADA POSITIVE (Week 48)
|
4 Participants
|
6 Participants
|
—
|
|
Number of Participants With Anti-Drug Antibodies (ADA)
NAB+/BASELINE ADA+ (Week 24)
|
2 Participants
|
1 Participants
|
—
|
|
Number of Participants With Anti-Drug Antibodies (ADA)
NAB+/BASELINE ADA+ (Week 48)
|
1 Participants
|
1 Participants
|
—
|
|
Number of Participants With Anti-Drug Antibodies (ADA)
ADA POSITIVE (Week 24)
|
12 Participants
|
13 Participants
|
—
|
|
Number of Participants With Anti-Drug Antibodies (ADA)
ADA POSITIVE (Week 48)
|
8 Participants
|
12 Participants
|
—
|
|
Number of Participants With Anti-Drug Antibodies (ADA)
NAB+/ADA+ (Week 24)
|
4 Participants
|
7 Participants
|
—
|
|
Number of Participants With Anti-Drug Antibodies (ADA)
NAB+/ADA+ (Week 48)
|
1 Participants
|
7 Participants
|
—
|
SECONDARY outcome
Timeframe: Pre-dose Week 24 and Pre-dose Week 48Population: The PK population will consist of all randomized participants who received at least one dose of CC-93538 and have any available concentration data. Only evaluable PK population was included in the analysis.
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.
Outcome measures
| Measure |
Induction Phase - CC-93538 360 mg QW
n=110 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 SC once every week in the 24-week induction phase.
|
Induction Phase - Placebo
n=97 Participants
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24-week induction phase.
|
Maintenance Phase - Placebo
Participants with Eosinophilic Esophagitis received 360 mg CC-93538 matching placebo SC once every week in the 24 week maintenance phase.
|
|---|---|---|---|
|
Serum Trough Concentration of CC-93538 at Week 24 and Week 48
Pre-dose Week 48
|
138545.4 ng/mL
Geometric Coefficient of Variation 121.1
|
79884.3 ng/mL
Geometric Coefficient of Variation 45.4
|
—
|
|
Serum Trough Concentration of CC-93538 at Week 24 and Week 48
Pre-dose Week 24
|
148133.6 ng/mL
Geometric Coefficient of Variation 69.9
|
151735.2 ng/mL
Geometric Coefficient of Variation 55.8
|
—
|
Adverse Events
CC-93538 360 mg QW
Serious events: 4 serious events
Other events: 103 other events
Deaths: 0 deaths
CC-93538 360 mg Q2W
Serious events: 4 serious events
Other events: 73 other events
Deaths: 0 deaths
Placebo
Serious events: 8 serious events
Other events: 69 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CC-93538 360 mg QW
n=167 participants at risk
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.
|
CC-93538 360 mg Q2W
n=117 participants at risk
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.
|
Placebo
n=143 participants at risk
Participants with active eosinophilic esophagitis received CC-93538 matching placebo during 24-week induction phase followed by 24-week maintenance phase.
|
|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/167 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
0.00%
0/117 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
0.70%
1/143 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/167 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
0.85%
1/117 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
0.00%
0/143 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
|
Gastrointestinal disorders
Eosinophilic oesophagitis
|
1.2%
2/167 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
0.00%
0/117 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
0.70%
1/143 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/167 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
0.00%
0/117 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
0.70%
1/143 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
|
General disorders
Complication associated with device
|
0.00%
0/167 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
0.85%
1/117 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
0.00%
0/143 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.60%
1/167 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
0.00%
0/117 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
0.00%
0/143 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/167 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
0.00%
0/117 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
1.4%
2/143 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/167 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
0.85%
1/117 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
0.00%
0/143 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.60%
1/167 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
0.00%
0/117 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
0.00%
0/143 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/167 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
0.00%
0/117 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
0.70%
1/143 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.00%
0/167 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
0.85%
1/117 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
0.00%
0/143 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/167 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
0.00%
0/117 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
0.70%
1/143 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
|
Nervous system disorders
Cerebral infarction
|
0.60%
1/167 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
0.00%
0/117 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
0.00%
0/143 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
|
Nervous system disorders
Migraine
|
0.00%
0/167 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
0.85%
1/117 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
0.00%
0/143 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
|
Psychiatric disorders
Depression suicidal
|
0.00%
0/167 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
0.00%
0/117 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
0.70%
1/143 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/167 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
0.00%
0/117 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
0.70%
1/143 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/167 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
0.85%
1/117 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
0.00%
0/143 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
Other adverse events
| Measure |
CC-93538 360 mg QW
n=167 participants at risk
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.
|
CC-93538 360 mg Q2W
n=117 participants at risk
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.
|
Placebo
n=143 participants at risk
Participants with active eosinophilic esophagitis received CC-93538 matching placebo during 24-week induction phase followed by 24-week maintenance phase.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
4.2%
7/167 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
5.1%
6/117 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
3.5%
5/143 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.8%
8/167 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
6.8%
8/117 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
6.3%
9/143 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
|
Gastrointestinal disorders
Nausea
|
6.6%
11/167 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
5.1%
6/117 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
4.2%
6/143 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
|
Gastrointestinal disorders
Vomiting
|
3.6%
6/167 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
8.5%
10/117 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
2.8%
4/143 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
|
General disorders
Injection site reaction
|
19.2%
32/167 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
17.1%
20/117 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
14.7%
21/143 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
|
Infections and infestations
COVID-19
|
17.4%
29/167 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
23.9%
28/117 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
14.7%
21/143 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
|
Infections and infestations
Gastroenteritis
|
6.0%
10/167 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
3.4%
4/117 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
1.4%
2/143 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
|
Infections and infestations
Influenza
|
1.8%
3/167 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
5.1%
6/117 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
2.8%
4/143 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
|
Infections and infestations
Nasopharyngitis
|
9.6%
16/167 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
12.0%
14/117 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
9.1%
13/143 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.2%
17/167 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
9.4%
11/117 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
8.4%
12/143 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
|
Infections and infestations
Urinary tract infection
|
5.4%
9/167 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
4.3%
5/117 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
1.4%
2/143 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.8%
8/167 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
7.7%
9/117 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
4.2%
6/143 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.2%
7/167 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
5.1%
6/117 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
2.8%
4/143 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
|
Nervous system disorders
Headache
|
12.0%
20/167 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
6.0%
7/117 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
9.8%
14/143 • 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 CC-93538 or placebo was administered (Up to approximately 21 months).
The Safety population consist of all randomized participants who received at least 1 dose of IP and analyzed based on the actual treatments they received.
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please email
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication
- Publication restrictions are in place
Restriction type: OTHER