Eosinophilic Esophagitis
Conditions
Keywords
Eosinophilic Esophagitis, CC-93538, RPC4046, Adult, Adolescent, Gastrointestinal Diseases, Esophagitis, Gastroenteritis, Eosinophils, Eosinophilia, Esophageal Diseases, Allergic Diseases, Antibody, Monoclonal, Hypersensitivity, Immunologic factors, Physiological Effects of Drugs, cendakimab
Brief summary
Study CC-93538-EE-001 is a Phase 3, multicenter, multinational, randomized, double-blind, placebo-controlled induction and maintenance study to evaluate the efficacy and safety of CC- 93538 in adult and adolescent participants with eosinophilic esophagitis (EoE). The study will incorporate a 24-week Induction Phase followed by a 24-week Maintenance Phase. Participants will be randomized at the beginning of the study into 3 treatment arms: * Placebo for Induction and Maintenance * CC-93538 360 mg Subcutaneous (SC) once weekly for Induction followed by 360 mg SC once every other week for Maintenance * CC-93538 360 mg SC once weekly for Induction and Maintenance
Interventions
DRUGCC-93538
Subcutaneous
OTHERPlacebo
Subcutaneous
Sponsors
Celgene
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Participants must satisfy the following criteria to be enrolled in the study: 1. Male or female patients aged ≥ 12 and ≤ 75 years, with a body weight of \> 40 kg. 2. Histologic evidence of eosinophilic esophagitis, defined as a peak count of ≥ 15 eosinophils/high-power field at 2 levels of the esophagus. 3 Participant-reported history of 4 or more Dysphagia Days within 2 consecutive weeks prior to end of screening. 4\. Lack of complete response to an adequate trial of proton pump inhibitor (8 weeks). Participants on a proton pump inhibitor must have been on a stable dose for at least 4 weeks prior to first Screening Visit and agree to continue the same dose throughout the study. 5\. Participants currently receiving inhaled corticosteroids, leukotriene receptor antagonists, or mast cell stabilizers for indications other than EoE, or medium potency topical corticosteroids for dermatologic conditions, must maintain stable doses for at least 4 weeks prior to the first Screening Visit and throughout the duration of the study. 6\. Participants must agree to maintain a stable diet (including any food elimination diet for the treatment of food allergy or eosinophilic esophagitis) and not introduce any changes in their diet from the first Screening Visit to the end of the study. 7\. Females of childbearing potential must have 2 negative pregnancy tests as verified by the Investigator prior to starting study therapy and agree to practice a highly effective method of contraception until 5 months after the last dose.
Exclusion criteria
The presence of any of the following will exclude a participant from enrollment: 1. Clinical or endoscopic evidence of other diseases that may affect the histologic, endoscopic, and clinical symptom evaluation for this study. 2. Other gastrointestinal disorders such as active Helicobacter pylori infection, esophageal varices, gastritis, colitis, celiac disease, Mendelian disorder associated with eosinophilic esophagitis, liver function impairment, or a known hereditary fructose intolerance. 3. Evidence of a severe endoscopic structural abnormality in the esophagus. 4. Esophageal dilation for symptom relief within 8 weeks prior to first Screening Visit or during the Screening Period, or if esophageal dilation is anticipated within 48 weeks of dosing during the study. 5. Evidence of immunosuppression, or of having received systemic immunosuppressive or immunomodulating drugs within 5 drug half-lives prior to the first Screening Visit. 6. Treatment with a high potency topical corticosteroid for dermatologic use, or a systemic corticosteroid within 8 weeks of the first Screening Visit. 7. Treatment with a swallowed topical corticosteroid, leukotriene receptor antagonist, or mast cell stabilizer for EoE, within 4 weeks of the first Screening Visit. 8. Treatment with oral or sublingual immunotherapy within 6 months of the first Screening Visit (any use will be prohibited during the study). Subcutaneous immunotherapy may be allowed if on stable doses for at least 3 months prior to the first Screening Visit and during the study. 9. Actively successful dietary modification adherence (e.g. food elimination diet), resulting in a complete response to EoE. 10. Prior treatment with CC-93538 during a Phase 1 or 2 clinical study. 11. Receipt of a live attenuated vaccine within 4 weeks of the first Screening Visit. 12. Any disease that would affect the conduct of the protocol or interpretation of the study results, or would put a patient at risk by participating in the study (e.g. severe uncontrolled asthma, infection causing eosinophilia, hypereosinophilic syndrome, or cardiovascular condition, or neurologic disorder or psychiatric illness that compromises the Participant's ability to accurately document symptoms of eosinophilic esophagitis). 13. Active or ongoing infections including parasitic/helminthic, hepatitis, tuberculosis, or human immunodeficiency virus. 14. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 4 weeks of the first Screening Visit. 15. Females who are pregnant or lactating.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Mean Dysphagia Days (DD) at Week 24 | Baseline (Day 1) and Week 24 | 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. |
| Percentage of Participants With Peak Esophageal Eosinophil Count <= 6/High-power Field (Hpf) at Week 24 | Week 24 | Blood samples were collected to assess esophageal eosinophil count. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Physical Parameters - Weight at Week 24 | Baseline (Day 1) and Week 24 | Weight was measured at specified timepoints to assess the change from baseline. |
| Change From Baseline in Physical Parameters - Weight at Week 48 | Baseline (Day 1) and Week 48 | Weight was measured at specified timepoints to assess the change from baseline. |
| Percentage of Participants With Peak Esophageal Eosinophil Count <= 6/High-power Field (Hpf) at Week 48 | Week 48 | Blood samples were collected to assess esophageal eosinophil count. |
| Percentage of Participants With Peak Esophageal Eosinophil Count < 15/High-power Field (Hpf) at Week 24 | Week 24 | Blood samples were collected to assess esophageal eosinophil count. |
| Percentage of Participants With Peak Esophageal Eosinophil Count < 15/High-power Field (Hpf) at Week 48 | Week 48 | Blood samples were collected to assess esophageal eosinophil count. |
| Change From Baseline in Mean Dysphagia Days (DD) at Week 48 | Baseline (Day 1) and Week 48 | 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. |
| Change From Baseline in Eosinophilic Esophagitis (EoE) Endoscopic Reference Score (EREFS) at Week 24 | Baseline (Day 1) , Week 24 | 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. |
| Change From Baseline in Eosinophilic Esophagitis (EoE) Endoscopic Reference Score (EREFS) at Week 48 | Baseline (Day 1) , Week 48 | 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. |
| Change From Baseline in Physical Parameters - Body Mass Index at Week 24 | Baseline (Day 1) and Week 24 | Data was collected for height and weight to assess body mass index. |
| Change From Baseline in Physical Parameters - Body Mass Index at Week 48 | Baseline (Day 1) and Week 48 | Data was collected for height and weight to assess body mass index. |
| Change From Baseline in Mean Adjusted Eosinophilic Esophagitis Histology Scoring System (EoEHSS) Grade Score at Week 24 | Baseline (Day 1), Week 24 | 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. |
| Change From Baseline in Mean Adjusted Eosinophilic Esophagitis Histology Scoring System (EoEHSS) Grade Score at Week 48 | Baseline (Day 1) , Week 48 | 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. |
| Change From Baseline in Mean Adjusted Eosinophilic Esophagitis Histology Scoring System (EoEHSS) Stage Score at Week 24 | Baseline (Day 1), Week 24 | 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. |
| Change From Baseline in Mean Adjusted Eosinophilic Esophagitis Histology Scoring System (EoEHSS) Stage Score at Week 48 | Baseline (Day 1) , Week 48 | 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. |
| Change From Baseline in Physical Parameters - Height at Week 24 | Baseline (Day 1) and Week 24 | Height was measured at specified timepoints to assess the change from baseline. |
| Change From Baseline in Modified Daily Symptom Diary (mDSD) Composite Score at Week 48 | Baseline (Day 1) , Week 48 | 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. |
| Percentage of Participants With a ≥ 50% Decrease in Dysphagia Days(DD) From Baseline at Week 24 | Baseline (11 days prior to Day 1) and Week 24 | 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. |
| Percentage of Participants With a ≥ 50% Decrease in Dysphagia Days(DD) From Baseline at Week 48 | Baseline (11 days prior to Day 1) and Week 48 | 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. |
| Change From Baseline in Mean Dysphagia Days (DD) Through Week 24 | Baseline (Day 1), Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 | 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. |
| Change From Baseline in Modified Daily Symptom Diary (mDSD) Composite Score Through Week 24 | Baseline (11 days prior to Day 1) and Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 | 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. |
| Time to First Event of Eosinophilic Esophagitis (EoE) Flare | From first dose (Day 1) and Up to Week 48 | 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. |
| Time to First Use of Rescue Medication | From first dose (Day 1) and Up to Week 48 | 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. |
| Percentage of Participants With Any Events of Use of Rescue Medication | From first dose (Day 1) and up to Week 48 | 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. |
| Percentage of Participants With Eosinophilic Esophagitis (EoE) Flare | From first dose (Day 1) and up to Week 48 | First incidence of corresponding EoE flare event for any participant was considered in the analysis. |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | From first dose (Day 1) till up to Week 48 | 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. |
| Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | From first dose (Day 1) till up to Week 48 | 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. |
| Number of Participants With Post-Baseline Vital Sign Abnormalities | From first dose (Day 1) till up to Week 48 | Vital signs like feart rate (beats per minute) and systolic blood pressure (mmHg) and diastolic blood pressure (mmHg) was measured to assess the abnormalities. |
| Number of Participants With Anti-Drug Antibodies (ADA) | Pre-dose Week 24 and Pre-dose Week 48 | 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. |
| Serum Trough Concentration of CC-93538 at Week 24 and Week 48 | Pre-dose Week 24 and Pre-dose Week 48 | 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. |
| Change From Baseline in Modified Daily Symptom Diary (mDSD) Composite Score at Week 24 | Baseline (11 days prior to Day 1) and Week 24 | 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. |
| Change From Baseline in Physical Parameters - Height at Week 48 | Baseline (Day 1) and Week 48 | Height was measured at specified timepoints to assess the change from baseline. |
Countries
Argentina, Australia, Austria, Belgium, Canada, Germany, Israel, Italy, Japan, Poland, Portugal, Spain, Switzerland, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 143 |
| 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. | 143 |
| Placebo Participants with active eosinophilic esophagitis received CC-93538 matching placebo during 24-week induction phase followed by 24-week maintenance phase. | 144 |
| Total | 430 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Induction Phase | Lack of Efficacy | 1 | 0 | 0 |
| Induction Phase | Lost to Follow-up | 2 | 2 | 1 |
| Induction Phase | Physician Decision | 1 | 0 | 0 |
| Induction Phase | Withdrawal by Subject | 12 | 5 | 6 |
| Maintenance Phase | Adverse Event | 0 | 1 | 1 |
| Maintenance Phase | Lost to Follow-up | 2 | 2 | 0 |
| Maintenance Phase | NON-COMPLIANCE WITH STUDY DRUG | 1 | 0 | 0 |
| Maintenance Phase | Physician Decision | 0 | 0 | 1 |
| Maintenance Phase | WITHDRAWAL BY PARENT/GUARDIAN | 1 | 0 | 0 |
| Maintenance Phase | Withdrawal by Subject | 3 | 4 | 6 |
Baseline characteristics
| Characteristic | CC-93538 360 mg QW | CC-93538 360 mg QW/Q2W | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 35.9 years STANDARD_DEVIATION 11.79 | 34.8 years STANDARD_DEVIATION 12.24 | 36.2 years STANDARD_DEVIATION 12.16 | 35.6 years STANDARD_DEVIATION 12.05 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 5 Participants | 6 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 135 Participants | 138 Participants | 137 Participants | 410 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 10 Participants | 11 Participants | 26 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 3 Participants | 0 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) White | 134 Participants | 128 Participants | 130 Participants | 392 Participants |
| Sex: Female, Male Female | 53 Participants | 33 Participants | 45 Participants | 131 Participants |
| Sex: Female, Male Male | 90 Participants | 110 Participants | 99 Participants | 299 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 167 | 0 / 117 | 0 / 143 |
| other Total, other adverse events | 103 / 167 | 73 / 117 | 69 / 143 |
| serious Total, serious adverse events | 4 / 167 | 4 / 117 | 8 / 143 |
Outcome results
Primary
Change From Baseline in Mean Dysphagia Days (DD) at Week 24
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.
Time frame: Baseline (Day 1) and Week 24
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Induction Phase - CC-93538 360 mg QW | Change From Baseline in Mean Dysphagia Days (DD) at Week 24 | -6.85 days | Standard Deviation 5.259 |
| Induction Phase - Placebo | Change From Baseline in Mean Dysphagia Days (DD) at Week 24 | -4.98 days | Standard Deviation 5.075 |
p-value: 0.000595% CI: [-2.97, -0.84]ANCOVA
Primary
Percentage of Participants With Peak Esophageal Eosinophil Count <= 6/High-power Field (Hpf) at Week 24
Blood samples were collected to assess esophageal eosinophil count.
Time frame: Week 24
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Induction Phase - CC-93538 360 mg QW | Percentage of Participants With Peak Esophageal Eosinophil Count <= 6/High-power Field (Hpf) at Week 24 | 34.1 percentage of participants |
| Induction Phase - Placebo | Percentage of Participants With Peak Esophageal Eosinophil Count <= 6/High-power Field (Hpf) at Week 24 | 3.1 percentage of participants |
p-value: <0.000195% CI: [20.6, 32.2]Cochran-Mantel-Haenszel
Secondary
Change From Baseline in Eosinophilic Esophagitis (EoE) Endoscopic Reference Score (EREFS) at Week 24
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.
Time frame: Baseline (Day 1) , Week 24
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Induction Phase - CC-93538 360 mg QW | Change From Baseline in Eosinophilic Esophagitis (EoE) Endoscopic Reference Score (EREFS) at Week 24 | -6.0 score on a scale | Standard Deviation 4.54 |
| Induction Phase - Placebo | Change From Baseline in Eosinophilic Esophagitis (EoE) Endoscopic Reference Score (EREFS) at Week 24 | -1.5 score on a scale | Standard Deviation 4.26 |
p-value: <0.000195% CI: [-4.8, -3.2]ANCOVA
Secondary
Change From Baseline in Eosinophilic Esophagitis (EoE) Endoscopic Reference Score (EREFS) at Week 48
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.
Time frame: Baseline (Day 1) , Week 48
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Induction Phase - CC-93538 360 mg QW | Change From Baseline in Eosinophilic Esophagitis (EoE) Endoscopic Reference Score (EREFS) at Week 48 | -6.6 score on a scale | Standard Deviation 4.24 |
| Induction Phase - Placebo | Change From Baseline in Eosinophilic Esophagitis (EoE) Endoscopic Reference Score (EREFS) at Week 48 | -6.5 score on a scale | Standard Deviation 4.57 |
| Maintenance Phase - Placebo | Change From Baseline in Eosinophilic Esophagitis (EoE) Endoscopic Reference Score (EREFS) at Week 48 | -3.2 score on a scale | Standard Deviation 4.15 |
p-value: <0.000195% CI: [-4.5, -2.4]ANCOVA
p-value: <0.000195% CI: [-4.1, -2.1]ANCOVA
Secondary
Change From Baseline in Mean Adjusted Eosinophilic Esophagitis Histology Scoring System (EoEHSS) Grade Score at Week 24
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.
Time frame: Baseline (Day 1), Week 24
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Induction Phase - CC-93538 360 mg QW | 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 |
| Induction Phase - Placebo | Change From Baseline in Mean Adjusted Eosinophilic Esophagitis Histology Scoring System (EoEHSS) Grade Score at Week 24 | -6.47 Score on a scale | Standard Deviation 15.755 |
p-value: <0.000195% CI: [-25.5, -19.51]ANCOVA
Secondary
Change From Baseline in Mean Adjusted Eosinophilic Esophagitis Histology Scoring System (EoEHSS) Grade Score at Week 48
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.
Time frame: Baseline (Day 1) , Week 48
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Induction Phase - CC-93538 360 mg QW | 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 |
| Induction Phase - Placebo | Change From Baseline in Mean Adjusted Eosinophilic Esophagitis Histology Scoring System (EoEHSS) Grade Score at Week 48 | -30.96 score on a scale | Standard Deviation 15.864 |
| Maintenance Phase - Placebo | Change From Baseline in Mean Adjusted Eosinophilic Esophagitis Histology Scoring System (EoEHSS) Grade Score at Week 48 | -6.17 score on a scale | Standard Deviation 16.579 |
p-value: <0.000195% CI: [-21.85, -14.4]ANCOVA
p-value: <0.000195% CI: [-22.9, -15.53]ANCOVA
Secondary
Change From Baseline in Mean Adjusted Eosinophilic Esophagitis Histology Scoring System (EoEHSS) Stage Score at Week 24
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.
Time frame: Baseline (Day 1), Week 24
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Induction Phase - CC-93538 360 mg QW | 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 19.37 |
| Induction Phase - Placebo | Change From Baseline in Mean Adjusted Eosinophilic Esophagitis Histology Scoring System (EoEHSS) Stage Score at Week 24 | -9.90 Score on a scale | Standard Deviation 17.583 |
p-value: <0.000195% CI: [-28.92, -21.89]ANCOVA
Secondary
Change From Baseline in Mean Adjusted Eosinophilic Esophagitis Histology Scoring System (EoEHSS) Stage Score at Week 48
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.
Time frame: Baseline (Day 1) , Week 48
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Induction Phase - CC-93538 360 mg QW | 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 |
| Induction Phase - Placebo | Change From Baseline in Mean Adjusted Eosinophilic Esophagitis Histology Scoring System (EoEHSS) Stage Score at Week 48 | -37.36 score on a scale | Standard Deviation 19.29 |
| Maintenance Phase - Placebo | Change From Baseline in Mean Adjusted Eosinophilic Esophagitis Histology Scoring System (EoEHSS) Stage Score at Week 48 | -8.38 score on a scale | Standard Deviation 19.935 |
p-value: <0.000195% CI: [-25.17, -18.91]Cochran-Mantel-Haenszel
p-value: <0.000195% CI: [-27.73, -21.56]ANCOVA
Secondary
Change From Baseline in Mean Dysphagia Days (DD) at Week 48
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.
Time frame: Baseline (Day 1) and Week 48
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Induction Phase - CC-93538 360 mg QW | Change From Baseline in Mean Dysphagia Days (DD) at Week 48 | -7.71 days | Standard Deviation 5.401 |
| Induction Phase - Placebo | Change From Baseline in Mean Dysphagia Days (DD) at Week 48 | -8.07 days | Standard Deviation 5.292 |
| Maintenance Phase - Placebo | Change From Baseline in Mean Dysphagia Days (DD) at Week 48 | -6.20 days | Standard Deviation 5.118 |
p-value: 0.000695% CI: [-3.55, -0.98]ANCOVA
p-value: 0.000295% CI: [-3.78, -1.2]ANCOVA
Secondary
Change From Baseline in Mean Dysphagia Days (DD) Through Week 24
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.
Time frame: Baseline (Day 1), Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Induction Phase - CC-93538 360 mg QW | Change From Baseline in Mean Dysphagia Days (DD) Through Week 24 | Week 8 | -5.04 days | Standard Deviation 4.755 |
| Induction Phase - CC-93538 360 mg QW | Change From Baseline in Mean Dysphagia Days (DD) Through Week 24 | Week 16 | -6.39 days | Standard Deviation 5.299 |
| Induction Phase - CC-93538 360 mg QW | Change From Baseline in Mean Dysphagia Days (DD) Through Week 24 | Week 4 | -3.19 days | Standard Deviation 4.073 |
| Induction Phase - CC-93538 360 mg QW | Change From Baseline in Mean Dysphagia Days (DD) Through Week 24 | Week 20 | -6.91 days | Standard Deviation 5.321 |
| Induction Phase - CC-93538 360 mg QW | Change From Baseline in Mean Dysphagia Days (DD) Through Week 24 | Week 12 | -5.88 days | Standard Deviation 5.071 |
| Induction Phase - CC-93538 360 mg QW | Change From Baseline in Mean Dysphagia Days (DD) Through Week 24 | Week 24 | -6.85 days | Standard Deviation 5.259 |
| Induction Phase - CC-93538 360 mg QW | Change From Baseline in Mean Dysphagia Days (DD) Through Week 24 | Week 2 | -1.26 days | Standard Deviation 2.607 |
| Induction Phase - Placebo | Change From Baseline in Mean Dysphagia Days (DD) Through Week 24 | Week 24 | -4.98 days | Standard Deviation 5.075 |
| Induction Phase - Placebo | Change From Baseline in Mean Dysphagia Days (DD) Through Week 24 | Week 2 | -0.80 days | Standard Deviation 2.651 |
| Induction Phase - Placebo | Change From Baseline in Mean Dysphagia Days (DD) Through Week 24 | Week 4 | -1.75 days | Standard Deviation 3.46 |
| Induction Phase - Placebo | Change From Baseline in Mean Dysphagia Days (DD) Through Week 24 | Week 8 | -3.51 days | Standard Deviation 4.132 |
| Induction Phase - Placebo | Change From Baseline in Mean Dysphagia Days (DD) Through Week 24 | Week 12 | -3.88 days | Standard Deviation 4.379 |
| Induction Phase - Placebo | Change From Baseline in Mean Dysphagia Days (DD) Through Week 24 | Week 16 | -4.90 days | Standard Deviation 4.851 |
| Induction Phase - Placebo | Change From Baseline in Mean Dysphagia Days (DD) Through Week 24 | Week 20 | -4.98 days | Standard Deviation 4.96 |
Secondary
Change From Baseline in Modified Daily Symptom Diary (mDSD) Composite Score at Week 24
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.
Time frame: Baseline (11 days prior to Day 1) and Week 24
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Induction Phase - CC-93538 360 mg QW | Change From Baseline in Modified Daily Symptom Diary (mDSD) Composite Score at Week 24 | -14.78 Score on a scale | Standard Deviation 11.353 |
| Induction Phase - Placebo | Change From Baseline in Modified Daily Symptom Diary (mDSD) Composite Score at Week 24 | -10.93 Score on a scale | Standard Deviation 11.234 |
p-value: 0.000595% CI: [-6.4, -1.8]ANCOVA
Secondary
Change From Baseline in Modified Daily Symptom Diary (mDSD) Composite Score at Week 48
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.
Time frame: Baseline (Day 1) , Week 48
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Induction Phase - CC-93538 360 mg QW | Change From Baseline in Modified Daily Symptom Diary (mDSD) Composite Score at Week 48 | -16.77 score on a scale | Standard Deviation 11.297 |
| Induction Phase - Placebo | Change From Baseline in Modified Daily Symptom Diary (mDSD) Composite Score at Week 48 | -16.45 score on a scale | Standard Deviation 11.635 |
| Maintenance Phase - Placebo | Change From Baseline in Modified Daily Symptom Diary (mDSD) Composite Score at Week 48 | -13.44 score on a scale | Standard Deviation 10.862 |
p-value: 0.002295% CI: [-7.14, -1.57]ANCOVA
p-value: 0.000395% CI: [-8, -2.41]ANCOVA
Secondary
Change From Baseline in Modified Daily Symptom Diary (mDSD) Composite Score Through Week 24
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.
Time frame: Baseline (11 days prior to Day 1) and Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Induction Phase - CC-93538 360 mg QW | 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 |
| Induction Phase - CC-93538 360 mg QW | 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 |
| Induction Phase - CC-93538 360 mg QW | 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 |
| Induction Phase - CC-93538 360 mg QW | 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 |
| Induction Phase - CC-93538 360 mg QW | 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 |
| Induction Phase - CC-93538 360 mg QW | 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 |
| Induction Phase - CC-93538 360 mg QW | 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 |
| Induction Phase - Placebo | Change From Baseline in Modified Daily Symptom Diary (mDSD) Composite Score Through Week 24 | Week 24 | -10.93 Score on a scale | Standard Deviation 11.234 |
| Induction Phase - Placebo | Change From Baseline in Modified Daily Symptom Diary (mDSD) Composite Score Through Week 24 | Week 2 | -3.25 Score on a scale | Standard Deviation 6.621 |
| Induction Phase - Placebo | Change From Baseline in Modified Daily Symptom Diary (mDSD) Composite Score Through Week 24 | Week 4 | -4.98 Score on a scale | Standard Deviation 8.902 |
| Induction Phase - Placebo | Change From Baseline in Modified Daily Symptom Diary (mDSD) Composite Score Through Week 24 | Week 8 | -7.59 Score on a scale | Standard Deviation 9.938 |
| Induction Phase - Placebo | Change From Baseline in Modified Daily Symptom Diary (mDSD) Composite Score Through Week 24 | Week 12 | -9.00 Score on a scale | Standard Deviation 10.051 |
| Induction Phase - Placebo | Change From Baseline in Modified Daily Symptom Diary (mDSD) Composite Score Through Week 24 | Week 16 | -10.43 Score on a scale | Standard Deviation 10.419 |
| Induction Phase - Placebo | Change From Baseline in Modified Daily Symptom Diary (mDSD) Composite Score Through Week 24 | Week 20 | -10.99 Score on a scale | Standard Deviation 10.353 |
Secondary
Change From Baseline in Physical Parameters - Body Mass Index at Week 24
Data was collected for height and weight to assess body mass index.
Time frame: Baseline (Day 1) and Week 24
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Induction Phase - CC-93538 360 mg QW | Change From Baseline in Physical Parameters - Body Mass Index at Week 24 | 0.044 kg/m^2 | Standard Deviation 1.1629 |
| Induction Phase - Placebo | Change From Baseline in Physical Parameters - Body Mass Index at Week 24 | 0.084 kg/m^2 | Standard Deviation 1.0676 |
Secondary
Change From Baseline in Physical Parameters - Body Mass Index at Week 48
Data was collected for height and weight to assess body mass index.
Time frame: Baseline (Day 1) and Week 48
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Induction Phase - CC-93538 360 mg QW | Change From Baseline in Physical Parameters - Body Mass Index at Week 48 | -0.074 kg/m^2 | Standard Deviation 1.6716 |
| Induction Phase - Placebo | Change From Baseline in Physical Parameters - Body Mass Index at Week 48 | 0.350 kg/m^2 | Standard Deviation 1.5218 |
| Maintenance Phase - Placebo | Change From Baseline in Physical Parameters - Body Mass Index at Week 48 | 0.037 kg/m^2 | Standard Deviation 1.4223 |
Secondary
Change From Baseline in Physical Parameters - Height at Week 24
Height was measured at specified timepoints to assess the change from baseline.
Time frame: Baseline (Day 1) and Week 24
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Induction Phase - CC-93538 360 mg QW | Change From Baseline in Physical Parameters - Height at Week 24 | 0.30 cm | Standard Deviation 1.479 |
| Induction Phase - Placebo | Change From Baseline in Physical Parameters - Height at Week 24 | -0.08 cm | Standard Deviation 0.932 |
Secondary
Change From Baseline in Physical Parameters - Height at Week 48
Height was measured at specified timepoints to assess the change from baseline.
Time frame: Baseline (Day 1) and Week 48
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Induction Phase - CC-93538 360 mg QW | Change From Baseline in Physical Parameters - Height at Week 48 | 0.42 cm | Standard Deviation 1.929 |
| Induction Phase - Placebo | Change From Baseline in Physical Parameters - Height at Week 48 | 0.42 cm | Standard Deviation 1.973 |
| Maintenance Phase - Placebo | Change From Baseline in Physical Parameters - Height at Week 48 | 0.12 cm | Standard Deviation 1.114 |
Secondary
Change From Baseline in Physical Parameters - Weight at Week 24
Weight was measured at specified timepoints to assess the change from baseline.
Time frame: Baseline (Day 1) and Week 24
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Induction Phase - CC-93538 360 mg QW | Change From Baseline in Physical Parameters - Weight at Week 24 | 0.35 kg | Standard Deviation 3.369 |
| Induction Phase - Placebo | Change From Baseline in Physical Parameters - Weight at Week 24 | 0.24 kg | Standard Deviation 3.108 |
Secondary
Change From Baseline in Physical Parameters - Weight at Week 48
Weight was measured at specified timepoints to assess the change from baseline.
Time frame: Baseline (Day 1) and Week 48
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Induction Phase - CC-93538 360 mg QW | Change From Baseline in Physical Parameters - Weight at Week 48 | 0.11 cm | Standard Deviation 4.908 |
| Induction Phase - Placebo | Change From Baseline in Physical Parameters - Weight at Week 48 | 1.26 cm | Standard Deviation 4.766 |
| Maintenance Phase - Placebo | Change From Baseline in Physical Parameters - Weight at Week 48 | 0.22 cm | Standard Deviation 4.27 |
Secondary
Number of Participants With Anti-Drug Antibodies (ADA)
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.
Time frame: Pre-dose Week 24 and Pre-dose Week 48
Population: The Pharmacokinetic population consist of all randomized participants who received at least one dose of CC-93538 and have any available concentration data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Anti-Drug Antibodies (ADA) | BASELINE ADA POSITIVE (Week 24) | 6 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Anti-Drug Antibodies (ADA) | BASELINE ADA POSITIVE (Week 48) | 4 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Anti-Drug Antibodies (ADA) | NAB+/BASELINE ADA+ (Week 24) | 2 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Anti-Drug Antibodies (ADA) | NAB+/BASELINE ADA+ (Week 48) | 1 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Anti-Drug Antibodies (ADA) | ADA POSITIVE (Week 24) | 12 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Anti-Drug Antibodies (ADA) | ADA POSITIVE (Week 48) | 8 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Anti-Drug Antibodies (ADA) | NAB+/ADA+ (Week 24) | 4 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Anti-Drug Antibodies (ADA) | NAB+/ADA+ (Week 48) | 1 Participants |
| Induction Phase - Placebo | Number of Participants With Anti-Drug Antibodies (ADA) | NAB+/ADA+ (Week 48) | 7 Participants |
| Induction Phase - Placebo | Number of Participants With Anti-Drug Antibodies (ADA) | BASELINE ADA POSITIVE (Week 24) | 5 Participants |
| Induction Phase - Placebo | Number of Participants With Anti-Drug Antibodies (ADA) | ADA POSITIVE (Week 24) | 13 Participants |
| Induction Phase - Placebo | Number of Participants With Anti-Drug Antibodies (ADA) | BASELINE ADA POSITIVE (Week 48) | 6 Participants |
| Induction Phase - Placebo | Number of Participants With Anti-Drug Antibodies (ADA) | NAB+/ADA+ (Week 24) | 7 Participants |
| Induction Phase - Placebo | Number of Participants With Anti-Drug Antibodies (ADA) | NAB+/BASELINE ADA+ (Week 24) | 1 Participants |
| Induction Phase - Placebo | Number of Participants With Anti-Drug Antibodies (ADA) | ADA POSITIVE (Week 48) | 12 Participants |
| Induction Phase - Placebo | Number of Participants With Anti-Drug Antibodies (ADA) | NAB+/BASELINE ADA+ (Week 48) | 1 Participants |
Secondary
Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift
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.
Time frame: From first dose (Day 1) till up to Week 48
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Cholesterol (mmol/L) | Low to Normal | 14 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Phosphate (mmol/L) | High to Normal | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | NEUTROPHILS, SEGMENTED (10^9/L) | Low to Normal | 7 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Cholesterol (mmol/L) | Normal to High | 5 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Phosphate (mmol/L) | High to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Eosinophils/Leukocytes (%) | Normal to High | 39 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Blood Urea Nitrogen (mmol/L) | Normal to High | 6 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HEMATOCRIT (VOLUME FRACTION) | High to Normal | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Cholesterol (mmol/L) | Normal to Low | 3 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Blood Urea Nitrogen (mmol/L) | Low to Normal | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Monocytes (10^9/L) | High to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Cholesterol (mmol/L) | Normal to Normal | 116 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Blood Urea Nitrogen (mmol/L) | Low to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Eosinophils/Leukocytes (%) | Normal to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | C Reactive Protein (mg/L) | Missing | 7 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Blood Urea Nitrogen (mmol/L) | Low to High | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HEMATOCRIT (VOLUME FRACTION) | High to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | C Reactive Protein (mg/L) | High to High | 18 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Blood Urea Nitrogen (mmol/L) | High to Normal | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | NEUTROPHILS/LEUKOCYTES (%) | Low to High | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | C Reactive Protein (mg/L) | High to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Blood Urea Nitrogen (mmol/L) | High to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Eosinophils/Leukocytes (%) | Normal to Normal | 88 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | C Reactive Protein (mg/L) | High to Normal | 1 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Blood Urea Nitrogen (mmol/L) | High to High | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HEMATOCRIT (VOLUME FRACTION) | High to High | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | C Reactive Protein (mg/L) | Low to High | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Blood Urea Nitrogen (mmol/L) | Missing | 1 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | NEUTROPHILS, SEGMENTED (10^9/L) | Missing | 3 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Direct Bilirubin (umol/L) | Low to High | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Glucose (mmol/L) | Normal to Normal | 101 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Eosinophils (10^9/L) | Missing | 3 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Direct Bilirubin (umol/L) | Low to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Glucose (mmol/L) | Normal to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Direct Bilirubin (umol/L) | Low to Normal | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Glucose (mmol/L) | Missing | 1 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HEMATOCRIT (VOLUME FRACTION) | Missing | 3 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Direct Bilirubin (umol/L) | Normal to High | 1 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Albumin (g/L) | Normal to Normal | 94 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Monocytes (10^9/L) | High to Normal | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Direct Bilirubin (umol/L) | Normal to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Albumin (g/L) | Normal to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Eosinophils (10^9/L) | High to High | 14 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Direct Bilirubin (umol/L) | Normal to Normal | 165 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Albumin (g/L) | Normal to High | 37 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | NEUTROPHILS/LEUKOCYTES (%) | High to Normal | 1 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Total Bilirubin (umol/L) | Missing | 1 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Albumin (g/L) | Low to Normal | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Eosinophils (10^9/L) | High to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Total Bilirubin (umol/L) | High to High | 4 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Albumin (g/L) | Low to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERYTHROCYTES MEAN CORPUSCULAR VOLUME (Femtoliter) | High to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Total Bilirubin (umol/L) | High to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Albumin (g/L) | Low to High | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Alkaline Phosphatase (U/L) | Normal to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | NEUTROPHILS, SEGMENTED (10^9/L) | High to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Total Bilirubin (umol/L) | High to Normal | 2 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Alkaline Phosphatase (U/L) | Normal to High | 9 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Eosinophils (10^9/L) | High to Normal | 3 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Total Bilirubin (umol/L) | Low to High | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Alkaline Phosphatase (U/L) | Low to Normal | 1 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERYTHROCYTES MEAN CORPUSCULAR VOLUME (Femtoliter) | High to High | 4 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Amylase (U/L) | Low to Low | 3 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Alkaline Phosphatase (U/L) | Low to Low | 1 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Monocytes (10^9/L) | Low to High | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Amylase (U/L) | Low to Normal | 4 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Alkaline Phosphatase (U/L) | Low to High | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Eosinophils (10^9/L) | Low to High | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Amylase (U/L) | Normal to High | 15 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Alkaline Phosphatase (U/L) | High to Normal | 3 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERYTHROCYTES MEAN CORPUSCULAR VOLUME (Femtoliter) | Missing | 3 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Amylase (U/L) | Normal to Low | 1 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Alkaline Phosphatase (U/L) | High to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | NEUTROPHILS/LEUKOCYTES (%) | High to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Amylase (U/L) | Normal to Normal | 128 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Alkaline Phosphatase (U/L) | High to High | 12 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Basophils/Leukocytes (%) | Low to High | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Gamma Glutamyl Transferase (U/L) | Missing | 1 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Alkaline Phosphatase (U/L) | Missing | 1 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERYTHROCTES MEAN CORPUSCULAR HEMOGLOBIN (picogram) | Normal to Normal | 160 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Gamma Glutamyl Transferase (U/L) | High to High | 8 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Creatinine (umol/L) | Normal to Normal | 152 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | NEUTROPHILS, SEGMENTED (10^9/L) | Normal to High | 12 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Gamma Glutamyl Transferase (U/L) | High to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Creatinine (umol/L) | High to Normal | 1 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Basophils/Leukocytes (%) | Low to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Gamma Glutamyl Transferase (U/L) | High to Normal | 2 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Creatinine (umol/L) | High to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERYTHROCTES MEAN CORPUSCULAR HEMOGLOBIN (picogram) | Normal to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Gamma Glutamyl Transferase (U/L) | Low to High | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Creatinine (umol/L) | High to High | 5 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Monocytes (10^9/L) | Low to Low | 2 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Aspartate Aminotransferase (U/L) | Low to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Creatinine (umol/L) | Missing | 1 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Basophils/Leukocytes (%) | Low to Normal | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Aspartate Aminotransferase (U/L) | Low to Normal | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Creatine Kinase (U/L) | Normal to Normal | 115 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERYTHROCTES MEAN CORPUSCULAR HEMOGLOBIN (picogram) | Normal to High | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Aspartate Aminotransferase (U/L) | Normal to High | 18 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Creatine Kinase (U/L) | Normal to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | NEUTROPHILS/LEUKOCYTES (%) | High to High | 1 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Aspartate Aminotransferase (U/L) | Normal to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Creatine Kinase (U/L) | Normal to High | 39 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Basophils/Leukocytes (%) | Normal to High | 36 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Aspartate Aminotransferase (U/L) | Normal to Normal | 143 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Creatine Kinase (U/L) | Low to Normal | 1 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Basophils/Leukocytes (%) | Normal to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Alanine Aminotransferase (U/L) | Missing | 1 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Creatine Kinase (U/L) | Low to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERYTHROCTES MEAN CORPUSCULAR HEMOGLOBIN (picogram) | High to High | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Alanine Aminotransferase (U/L) | High to High | 11 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Creatine Kinase (U/L) | Low to High | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | PLATELETS (10^9/L) | Low to Normal | 1 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Basophils/Leukocytes (%) | Normal to Normal | 124 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Alanine Aminotransferase (U/L) | High to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Alanine Aminotransferase (U/L) | High to Normal | 2 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERYTHROCTES MEAN CORPUSCULAR HEMOGLOBIN (picogram) | Missing | 3 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | NEUTROPHILS/LEUKOCYTES (%) | Normal to Normal | 142 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Basophils (10^9/L) | Missing | 3 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERY. MEAN CORPUSCULAR HGB CONCENTRATION (g/L) | Normal to Normal | 164 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Monocytes (10^9/L) | Low to Normal | 5 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Basophils (10^9/L) | High to High | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERY. MEAN CORPUSCULAR HGB CONCENTRATION (g/L) | Normal to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Basophils (10^9/L) | High to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERY. MEAN CORPUSCULAR HGB CONCENTRATION (g/L) | Low to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | PLATELETS (10^9/L) | Low to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Basophils (10^9/L) | High to Normal | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERY. MEAN CORPUSCULAR HGB CONCENTRATION (g/L) | Low to High | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | NEUTROPHILS, SEGMENTED (10^9/L) | High to Normal | 1 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Basophils (10^9/L) | Low to High | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERY. MEAN CORPUSCULAR HGB CONCENTRATION (g/L) | High to Normal | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Monocytes (10^9/L) | Normal to High | 2 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Basophils (10^9/L) | Low to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERY. MEAN CORPUSCULAR HGB CONCENTRATION (g/L) | High to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | PLATELETS (10^9/L) | Low to High | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Basophils (10^9/L) | Low to Normal | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERY. MEAN CORPUSCULAR HGB CONCENTRATION (g/L) | High to High | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Monocytes/Leukocytes (%) | Normal to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Basophils (10^9/L) | Normal to High | 5 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERY. MEAN CORPUSCULAR HGB CONCENTRATION (g/L) | Missing | 3 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Lymphocytes/Leukocytes (%) | Normal to High | 14 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Basophils (10^9/L) | Normal to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Sodium (mmol/L) | Normal to Normal | 158 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | PLATELETS (10^9/L) | High to Normal | 1 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Basophils (10^9/L) | Normal to Normal | 159 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Sodium (mmol/L) | Normal to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | NEUTROPHILS/LEUKOCYTES (%) | Low to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Leukocytes (10^9/L) | Missing | 3 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Sodium (mmol/L) | Normal to High | 7 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Lymphocytes/Leukocytes (%) | Normal to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Leukocytes (10^9/L) | High to High | 3 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Sodium (mmol/L) | Low to Normal | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | PLATELETS (10^9/L) | High to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Leukocytes (10^9/L) | High to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Sodium (mmol/L) | Low to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | NEUTROPHILS/LEUKOCYTES (%) | Normal to Low | 1 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Potassium (mmol/L) | Low to Normal | 1 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Lymphocytes/Leukocytes (%) | Normal to Normal | 148 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Leukocytes (10^9/L) | High to Normal | 2 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Potassium (mmol/L) | Low to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HEMOGLOBIN (g/L) | High to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Leukocytes (10^9/L) | Low to High | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Potassium (mmol/L) | Low to High | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | NEUTROPHILS, SEGMENTED (10^9/L) | Low to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Leukocytes (10^9/L) | Low to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Potassium (mmol/L) | High to Normal | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Lymphocytes (10^9/L) | Missing | 3 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Erythrocytes (10^12/L) | Low to Low | 1 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Potassium (mmol/L) | High to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HEMOGLOBIN (g/L) | High to High | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Erythrocytes (10^12/L) | Low to Normal | 5 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Potassium (mmol/L) | High to High | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Monocytes/Leukocytes (%) | Normal to Normal | 140 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Erythrocytes (10^12/L) | Normal to High | 2 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Potassium (mmol/L) | Missing | 1 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Lymphocytes (10^9/L) | High to High | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Erythrocytes (10^12/L) | Normal to Low | 1 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Chloride (mmol/L) | Normal to Normal | 162 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HEMOGLOBIN (g/L) | Missing | 3 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Erythrocytes (10^12/L) | Normal to Normal | 154 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Chloride (mmol/L) | Normal to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | NEUTROPHILS/LEUKOCYTES (%) | Normal to High | 15 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | LDL Cholesterol (mmol/L) | Missing | 25 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Chloride (mmol/L) | Normal to High | 3 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Lymphocytes (10^9/L) | High to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | LDL Cholesterol (mmol/L) | High to High | 2 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Chloride (mmol/L) | Low to Normal | 1 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HEMATOCRIT (VOLUME FRACTION) | Normal to Normal | 158 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | LDL Cholesterol (mmol/L) | High to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Chloride (mmol/L) | Low to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | NEUTROPHILS, SEGMENTED (10^9/L) | High to High | 3 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | LDL Cholesterol (mmol/L) | High to Normal | 2 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Calcium (mmol/L) | Normal to High | 2 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Lymphocytes (10^9/L) | High to Normal | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | LDL Cholesterol (mmol/L) | Low to High | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Calcium (mmol/L) | Low to Normal | 2 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HEMATOCRIT (VOLUME FRACTION) | Normal to Low | 1 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HDL Cholesterol (mmol/L) | Low to Low | 18 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Calcium (mmol/L) | Low to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Monocytes (10^9/L) | Missing | 3 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HDL Cholesterol (mmol/L) | Low to Normal | 4 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Calcium (mmol/L) | Low to High | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Lymphocytes (10^9/L) | Low to High | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HDL Cholesterol (mmol/L) | Normal to High | 15 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Calcium (mmol/L) | High to Normal | 1 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HEMATOCRIT (VOLUME FRACTION) | Normal to High | 4 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HDL Cholesterol (mmol/L) | Normal to Low | 5 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | NEUTROPHILS/LEUKOCYTES (%) | Low to Normal | 4 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HDL Cholesterol (mmol/L) | Normal to Normal | 63 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Magnesium (mmol/L) | Low to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Lymphocytes (10^9/L) | Low to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Triglycerides (mmol/L) | Missing | 24 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Magnesium (mmol/L) | Low to High | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HEMATOCRIT (VOLUME FRACTION) | Low to Normal | 1 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Triglycerides (mmol/L) | High to High | 3 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Magnesium (mmol/L) | High to Normal | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | NEUTROPHILS, SEGMENTED (10^9/L) | Low to High | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Lymphocytes (10^9/L) | Low to Normal | 1 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Triglycerides (mmol/L) | High to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Phosphate (mmol/L) | Normal to High | 4 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HEMATOCRIT (VOLUME FRACTION) | Low to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Triglycerides (mmol/L) | High to Normal | 6 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Phosphate (mmol/L) | Low to Normal | 2 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Monocytes (10^9/L) | High to High | 1 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Triglycerides (mmol/L) | Low to High | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Phosphate (mmol/L) | Low to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Eosinophils/Leukocytes (%) | Low to Normal | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Cholesterol (mmol/L) | Low to Low | 2 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Phosphate (mmol/L) | Low to High | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HEMATOCRIT (VOLUME FRACTION) | Low to High | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Erythrocytes (10^12/L) | High to Normal | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | NEUTROPHILS/LEUKOCYTES (%) | Missing | 3 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | PLATELETS (10^9/L) | Normal to Normal | 153 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | PLATELETS (10^9/L) | Normal to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | PLATELETS (10^9/L) | Normal to High | 7 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | PLATELETS (10^9/L) | High to High | 1 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | PLATELETS (10^9/L) | Missing | 4 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HEMOGLOBIN (g/L) | Normal to Normal | 158 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HEMOGLOBIN (g/L) | Normal to Low | 1 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HEMOGLOBIN (g/L) | Normal to High | 4 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HEMOGLOBIN (g/L) | Low to Normal | 1 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HEMOGLOBIN (g/L) | Low to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HEMOGLOBIN (g/L) | Low to High | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HEMOGLOBIN (g/L) | High to Normal | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERYTHROCYTES MEAN CORPUSCULAR VOLUME (Femtoliter) | Normal to Normal | 128 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERYTHROCYTES MEAN CORPUSCULAR VOLUME (Femtoliter) | Normal to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERYTHROCYTES MEAN CORPUSCULAR VOLUME (Femtoliter) | Normal to High | 24 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERYTHROCYTES MEAN CORPUSCULAR VOLUME (Femtoliter) | Low to Normal | 6 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERYTHROCYTES MEAN CORPUSCULAR VOLUME (Femtoliter) | Low to Low | 1 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERYTHROCYTES MEAN CORPUSCULAR VOLUME (Femtoliter) | Low to High | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERYTHROCYTES MEAN CORPUSCULAR VOLUME (Femtoliter) | High to Normal | 1 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERYTHROCTES MEAN CORPUSCULAR HEMOGLOBIN (picogram) | Low to Normal | 3 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERYTHROCTES MEAN CORPUSCULAR HEMOGLOBIN (picogram) | Low to Low | 1 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERYTHROCTES MEAN CORPUSCULAR HEMOGLOBIN (picogram) | Low to High | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERYTHROCTES MEAN CORPUSCULAR HEMOGLOBIN (picogram) | High to Normal | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERYTHROCTES MEAN CORPUSCULAR HEMOGLOBIN (picogram) | High to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERY. MEAN CORPUSCULAR HGB CONCENTRATION (g/L) | Normal to High | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERY. MEAN CORPUSCULAR HGB CONCENTRATION (g/L) | Low to Normal | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Sodium (mmol/L) | Low to High | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Sodium (mmol/L) | High to Normal | 1 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Sodium (mmol/L) | High to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Sodium (mmol/L) | High to High | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Sodium (mmol/L) | Missing | 1 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Potassium (mmol/L) | Normal to Normal | 159 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Potassium (mmol/L) | Normal to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Potassium (mmol/L) | Normal to High | 6 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Chloride (mmol/L) | Low to High | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Chloride (mmol/L) | High to Normal | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Chloride (mmol/L) | High to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Chloride (mmol/L) | High to High | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Chloride (mmol/L) | Missing | 1 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Calcium (mmol/L) | Normal to Normal | 161 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Calcium (mmol/L) | Normal to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Calcium (mmol/L) | High to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Calcium (mmol/L) | High to High | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Calcium (mmol/L) | Missing | 1 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Magnesium (mmol/L) | Normal to Normal | 162 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Magnesium (mmol/L) | Normal to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Magnesium (mmol/L) | Normal to High | 3 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Magnesium (mmol/L) | Low to Normal | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Magnesium (mmol/L) | High to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Magnesium (mmol/L) | High to High | 1 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Magnesium (mmol/L) | Missing | 1 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Phosphate (mmol/L) | Normal to Normal | 159 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Phosphate (mmol/L) | Normal to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Phosphate (mmol/L) | High to High | 1 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Phosphate (mmol/L) | Missing | 1 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Blood Urea Nitrogen (mmol/L) | Normal to Normal | 160 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Blood Urea Nitrogen (mmol/L) | Normal to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Glucose (mmol/L) | Normal to High | 40 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Glucose (mmol/L) | Low to Normal | 3 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Glucose (mmol/L) | Low to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Glucose (mmol/L) | Low to High | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Glucose (mmol/L) | High to Normal | 5 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Glucose (mmol/L) | High to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Glucose (mmol/L) | High to High | 17 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Albumin (g/L) | High to Normal | 10 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Albumin (g/L) | High to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Albumin (g/L) | High to High | 25 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Albumin (g/L) | Missing | 1 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Alkaline Phosphatase (U/L) | Normal to Normal | 140 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Creatinine (umol/L) | Normal to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Creatinine (umol/L) | Normal to High | 7 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Creatinine (umol/L) | Low to Normal | 1 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Creatinine (umol/L) | Low to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Creatinine (umol/L) | Low to High | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Creatine Kinase (U/L) | High to Normal | 4 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Creatine Kinase (U/L) | High to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Creatine Kinase (U/L) | High to High | 7 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Creatine Kinase (U/L) | Missing | 1 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Alanine Aminotransferase (U/L) | Normal to Normal | 131 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Alanine Aminotransferase (U/L) | Normal to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Alanine Aminotransferase (U/L) | Normal to High | 22 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Alanine Aminotransferase (U/L) | Low to Normal | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Alanine Aminotransferase (U/L) | Low to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Alanine Aminotransferase (U/L) | Low to High | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Aspartate Aminotransferase (U/L) | Low to High | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Aspartate Aminotransferase (U/L) | High to Normal | 2 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Aspartate Aminotransferase (U/L) | High to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Aspartate Aminotransferase (U/L) | High to High | 3 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Aspartate Aminotransferase (U/L) | Missing | 1 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Gamma Glutamyl Transferase (U/L) | Normal to Normal | 149 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Gamma Glutamyl Transferase (U/L) | Normal to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Gamma Glutamyl Transferase (U/L) | Normal to High | 5 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Gamma Glutamyl Transferase (U/L) | Low to Normal | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Gamma Glutamyl Transferase (U/L) | Low to Low | 2 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Amylase (U/L) | Low to High | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Amylase (U/L) | High to Normal | 3 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Amylase (U/L) | High to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Amylase (U/L) | High to High | 12 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Amylase (U/L) | Missing | 1 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Total Bilirubin (umol/L) | Normal to Normal | 146 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Total Bilirubin (umol/L) | Normal to Low | 1 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Total Bilirubin (umol/L) | Normal to High | 8 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Total Bilirubin (umol/L) | Low to Normal | 5 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Total Bilirubin (umol/L) | Low to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Direct Bilirubin (umol/L) | High to Normal | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Direct Bilirubin (umol/L) | High to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Direct Bilirubin (umol/L) | High to High | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Direct Bilirubin (umol/L) | Missing | 1 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | C Reactive Protein (mg/L) | Normal to Normal | 107 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | C Reactive Protein (mg/L) | Normal to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | C Reactive Protein (mg/L) | Normal to High | 34 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | C Reactive Protein (mg/L) | Low to Normal | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | C Reactive Protein (mg/L) | Low to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Cholesterol (mmol/L) | Low to High | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Cholesterol (mmol/L) | High to Normal | 3 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Cholesterol (mmol/L) | High to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Cholesterol (mmol/L) | High to High | 1 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Cholesterol (mmol/L) | Missing | 23 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Triglycerides (mmol/L) | Normal to Normal | 124 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Triglycerides (mmol/L) | Normal to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Triglycerides (mmol/L) | Normal to High | 7 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Triglycerides (mmol/L) | Low to Normal | 3 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Triglycerides (mmol/L) | Low to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HDL Cholesterol (mmol/L) | Low to High | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HDL Cholesterol (mmol/L) | High to Normal | 5 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HDL Cholesterol (mmol/L) | High to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HDL Cholesterol (mmol/L) | High to High | 33 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HDL Cholesterol (mmol/L) | Missing | 24 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | LDL Cholesterol (mmol/L) | Normal to Normal | 111 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | LDL Cholesterol (mmol/L) | Normal to Low | 2 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | LDL Cholesterol (mmol/L) | Normal to High | 5 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | LDL Cholesterol (mmol/L) | Low to Normal | 12 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | LDL Cholesterol (mmol/L) | Low to Low | 8 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Erythrocytes (10^12/L) | Low to High | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Erythrocytes (10^12/L) | High to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Erythrocytes (10^12/L) | High to High | 1 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Erythrocytes (10^12/L) | Missing | 3 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Leukocytes (10^9/L) | Normal to Normal | 144 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Leukocytes (10^9/L) | Normal to Low | 2 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Leukocytes (10^9/L) | Normal to High | 9 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Leukocytes (10^9/L) | Low to Normal | 4 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Basophils/Leukocytes (%) | High to Normal | 2 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Basophils/Leukocytes (%) | High to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Basophils/Leukocytes (%) | High to High | 2 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Basophils/Leukocytes (%) | Missing | 3 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Eosinophils (10^9/L) | Normal to Normal | 115 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Eosinophils (10^9/L) | Normal to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Eosinophils (10^9/L) | Normal to High | 32 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Eosinophils (10^9/L) | Low to Normal | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Eosinophils (10^9/L) | Low to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Eosinophils/Leukocytes (%) | Low to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Eosinophils/Leukocytes (%) | Low to High | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Eosinophils/Leukocytes (%) | High to Normal | 7 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Eosinophils/Leukocytes (%) | High to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Eosinophils/Leukocytes (%) | High to High | 30 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Eosinophils/Leukocytes (%) | Missing | 3 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Lymphocytes (10^9/L) | Normal to Normal | 157 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Lymphocytes (10^9/L) | Normal to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Lymphocytes (10^9/L) | Normal to High | 6 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Lymphocytes/Leukocytes (%) | Low to Normal | 1 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Lymphocytes/Leukocytes (%) | Low to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Lymphocytes/Leukocytes (%) | Low to High | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Lymphocytes/Leukocytes (%) | High to Normal | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Lymphocytes/Leukocytes (%) | High to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Lymphocytes/Leukocytes (%) | High to High | 1 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Lymphocytes/Leukocytes (%) | Missing | 3 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Monocytes (10^9/L) | Normal to Normal | 154 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Monocytes (10^9/L) | Normal to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Monocytes/Leukocytes (%) | Normal to High | 18 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Monocytes/Leukocytes (%) | Low to Normal | 2 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Monocytes/Leukocytes (%) | Low to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Monocytes/Leukocytes (%) | Low to High | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Monocytes/Leukocytes (%) | High to Normal | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Monocytes/Leukocytes (%) | High to Low | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Monocytes/Leukocytes (%) | High to High | 4 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Monocytes/Leukocytes (%) | Missing | 3 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | NEUTROPHILS, SEGMENTED (10^9/L) | Normal to Normal | 138 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | NEUTROPHILS, SEGMENTED (10^9/L) | Normal to Low | 3 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Creatine Kinase (U/L) | High to Normal | 4 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Monocytes (10^9/L) | Normal to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Gamma Glutamyl Transferase (U/L) | Normal to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | NEUTROPHILS/LEUKOCYTES (%) | Missing | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Basophils/Leukocytes (%) | Low to High | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Triglycerides (mmol/L) | Normal to High | 3 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | PLATELETS (10^9/L) | Normal to Normal | 102 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Eosinophils (10^9/L) | Low to Normal | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Gamma Glutamyl Transferase (U/L) | Normal to High | 8 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | PLATELETS (10^9/L) | Normal to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Albumin (g/L) | Missing | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Lymphocytes (10^9/L) | Normal to High | 1 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | PLATELETS (10^9/L) | Normal to High | 11 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Creatine Kinase (U/L) | High to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Triglycerides (mmol/L) | Low to Normal | 6 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | PLATELETS (10^9/L) | High to High | 3 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Gamma Glutamyl Transferase (U/L) | Low to Normal | 1 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Glucose (mmol/L) | High to High | 10 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | PLATELETS (10^9/L) | Missing | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Basophils/Leukocytes (%) | High to High | 2 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Gamma Glutamyl Transferase (U/L) | Low to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HEMOGLOBIN (g/L) | Normal to Normal | 115 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Creatine Kinase (U/L) | High to High | 10 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Triglycerides (mmol/L) | Low to Low | 1 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HEMOGLOBIN (g/L) | Normal to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Eosinophils (10^9/L) | Low to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Amylase (U/L) | Low to High | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HEMOGLOBIN (g/L) | Normal to High | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Albumin (g/L) | Low to High | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Alkaline Phosphatase (U/L) | Normal to Normal | 104 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HEMOGLOBIN (g/L) | Low to Normal | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Amylase (U/L) | High to Normal | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | NEUTROPHILS, SEGMENTED (10^9/L) | Normal to Normal | 93 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HEMOGLOBIN (g/L) | Low to Low | 1 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Creatine Kinase (U/L) | Missing | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HDL Cholesterol (mmol/L) | Low to High | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HEMOGLOBIN (g/L) | Low to High | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Glucose (mmol/L) | High to Normal | 2 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Amylase (U/L) | High to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Lymphocytes/Leukocytes (%) | Low to Normal | 1 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERYTHROCYTES MEAN CORPUSCULAR VOLUME (Femtoliter) | Normal to Normal | 90 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Monocytes/Leukocytes (%) | High to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HDL Cholesterol (mmol/L) | High to Normal | 5 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERYTHROCYTES MEAN CORPUSCULAR VOLUME (Femtoliter) | Normal to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Eosinophils/Leukocytes (%) | Low to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Amylase (U/L) | High to High | 8 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERYTHROCYTES MEAN CORPUSCULAR VOLUME (Femtoliter) | Normal to High | 16 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Alanine Aminotransferase (U/L) | Normal to Normal | 88 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Creatinine (umol/L) | Normal to Normal | 107 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERYTHROCYTES MEAN CORPUSCULAR VOLUME (Femtoliter) | Low to Normal | 3 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Amylase (U/L) | Missing | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HDL Cholesterol (mmol/L) | High to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERYTHROCYTES MEAN CORPUSCULAR VOLUME (Femtoliter) | Low to Low | 2 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Basophils/Leukocytes (%) | Missing | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Monocytes/Leukocytes (%) | Normal to High | 14 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERYTHROCYTES MEAN CORPUSCULAR VOLUME (Femtoliter) | Low to High | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Total Bilirubin (umol/L) | Normal to Normal | 106 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Monocytes/Leukocytes (%) | Low to High | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HDL Cholesterol (mmol/L) | High to High | 25 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERYTHROCTES MEAN CORPUSCULAR HEMOGLOBIN (picogram) | Low to Normal | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Alanine Aminotransferase (U/L) | Normal to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Eosinophils/Leukocytes (%) | Low to High | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERYTHROCTES MEAN CORPUSCULAR HEMOGLOBIN (picogram) | Low to Low | 2 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Total Bilirubin (umol/L) | Normal to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Lymphocytes/Leukocytes (%) | Low to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERYTHROCTES MEAN CORPUSCULAR HEMOGLOBIN (picogram) | Low to High | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Glucose (mmol/L) | Low to High | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HDL Cholesterol (mmol/L) | Missing | 3 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERYTHROCTES MEAN CORPUSCULAR HEMOGLOBIN (picogram) | High to Normal | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Albumin (g/L) | High to Normal | 2 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Total Bilirubin (umol/L) | Normal to High | 5 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERYTHROCTES MEAN CORPUSCULAR HEMOGLOBIN (picogram) | High to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERY. MEAN CORPUSCULAR HGB CONCENTRATION (g/L) | Normal to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Alanine Aminotransferase (U/L) | Normal to High | 22 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Creatinine (umol/L) | Normal to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERY. MEAN CORPUSCULAR HGB CONCENTRATION (g/L) | Normal to High | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Total Bilirubin (umol/L) | Low to Normal | 2 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | LDL Cholesterol (mmol/L) | Normal to Normal | 88 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERY. MEAN CORPUSCULAR HGB CONCENTRATION (g/L) | Low to Normal | 3 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Monocytes (10^9/L) | Normal to Normal | 109 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Eosinophils/Leukocytes (%) | High to Normal | 7 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Total Bilirubin (umol/L) | Low to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Sodium (mmol/L) | Low to High | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Alanine Aminotransferase (U/L) | Low to Normal | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Leukocytes (10^9/L) | Normal to High | 11 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Sodium (mmol/L) | High to Normal | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Eosinophils (10^9/L) | Normal to Normal | 81 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | LDL Cholesterol (mmol/L) | Normal to Low | 3 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Sodium (mmol/L) | High to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Direct Bilirubin (umol/L) | High to Normal | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Alanine Aminotransferase (U/L) | Low to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Sodium (mmol/L) | High to High | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Monocytes/Leukocytes (%) | High to High | 5 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Lymphocytes/Leukocytes (%) | Low to High | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Sodium (mmol/L) | Missing | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Direct Bilirubin (umol/L) | High to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | LDL Cholesterol (mmol/L) | Normal to High | 4 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Potassium (mmol/L) | Normal to Normal | 108 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Basophils/Leukocytes (%) | High to Normal | 3 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Eosinophils/Leukocytes (%) | High to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Potassium (mmol/L) | Normal to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Direct Bilirubin (umol/L) | High to High | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Creatinine (umol/L) | Normal to High | 6 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Potassium (mmol/L) | Normal to High | 9 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Leukocytes (10^9/L) | Low to Normal | 7 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | LDL Cholesterol (mmol/L) | Low to Normal | 9 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Chloride (mmol/L) | Low to High | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Direct Bilirubin (umol/L) | Missing | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Albumin (g/L) | High to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Chloride (mmol/L) | High to Normal | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Monocytes/Leukocytes (%) | Low to Normal | 1 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Monocytes/Leukocytes (%) | Missing | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Chloride (mmol/L) | High to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | C Reactive Protein (mg/L) | Normal to Normal | 70 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | LDL Cholesterol (mmol/L) | Low to Low | 4 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Chloride (mmol/L) | High to High | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Aspartate Aminotransferase (U/L) | Low to High | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Erythrocytes (10^12/L) | Low to Low | 1 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Chloride (mmol/L) | Missing | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Eosinophils/Leukocytes (%) | High to High | 28 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | C Reactive Protein (mg/L) | Normal to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Calcium (mmol/L) | Normal to Normal | 114 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Creatinine (umol/L) | Low to Normal | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Lymphocytes/Leukocytes (%) | High to Normal | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Calcium (mmol/L) | Normal to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Eosinophils (10^9/L) | Normal to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Erythrocytes (10^12/L) | Low to High | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Calcium (mmol/L) | High to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | C Reactive Protein (mg/L) | Normal to High | 25 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Aspartate Aminotransferase (U/L) | High to Normal | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Calcium (mmol/L) | High to High | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Glucose (mmol/L) | High to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | NEUTROPHILS/LEUKOCYTES (%) | High to High | 1 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Calcium (mmol/L) | Missing | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | C Reactive Protein (mg/L) | Low to Normal | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Erythrocytes (10^12/L) | High to Normal | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Magnesium (mmol/L) | Normal to Normal | 111 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Lymphocytes/Leukocytes (%) | Missing | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Eosinophils/Leukocytes (%) | Missing | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Magnesium (mmol/L) | Normal to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | C Reactive Protein (mg/L) | Low to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Aspartate Aminotransferase (U/L) | High to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Magnesium (mmol/L) | Normal to High | 4 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Cholesterol (mmol/L) | Low to High | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Erythrocytes (10^12/L) | High to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Creatinine (umol/L) | Low to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Glucose (mmol/L) | Low to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Magnesium (mmol/L) | High to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Cholesterol (mmol/L) | High to Normal | 3 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Monocytes/Leukocytes (%) | High to Normal | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Magnesium (mmol/L) | High to High | 1 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Aspartate Aminotransferase (U/L) | High to High | 4 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Erythrocytes (10^12/L) | High to High | 1 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Magnesium (mmol/L) | Missing | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Lymphocytes (10^9/L) | Normal to Normal | 113 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Cholesterol (mmol/L) | High to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Phosphate (mmol/L) | Normal to Normal | 112 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Basophils/Leukocytes (%) | High to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Lymphocytes/Leukocytes (%) | High to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Eosinophils (10^9/L) | Normal to High | 22 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Erythrocytes (10^12/L) | Missing | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Phosphate (mmol/L) | High to High | 1 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Cholesterol (mmol/L) | High to High | 3 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Aspartate Aminotransferase (U/L) | Missing | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Phosphate (mmol/L) | Missing | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Monocytes/Leukocytes (%) | Low to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Cholesterol (mmol/L) | Missing | 3 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Blood Urea Nitrogen (mmol/L) | Normal to Normal | 108 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Albumin (g/L) | High to High | 25 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Leukocytes (10^9/L) | Normal to Normal | 96 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Blood Urea Nitrogen (mmol/L) | Normal to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Lymphocytes (10^9/L) | Normal to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Glucose (mmol/L) | Normal to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Triglycerides (mmol/L) | Normal to Normal | 93 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Lymphocytes/Leukocytes (%) | High to High | 2 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Glucose (mmol/L) | Normal to High | 36 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Gamma Glutamyl Transferase (U/L) | Normal to Normal | 103 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Triglycerides (mmol/L) | Normal to Low | 1 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Glucose (mmol/L) | Low to Normal | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Leukocytes (10^9/L) | Normal to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Alanine Aminotransferase (U/L) | Low to High | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | NEUTROPHILS, SEGMENTED (10^9/L) | High to Normal | 1 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | NEUTROPHILS, SEGMENTED (10^9/L) | High to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | NEUTROPHILS, SEGMENTED (10^9/L) | High to High | 3 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | NEUTROPHILS, SEGMENTED (10^9/L) | Missing | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | NEUTROPHILS/LEUKOCYTES (%) | Normal to Normal | 101 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | NEUTROPHILS/LEUKOCYTES (%) | Normal to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | NEUTROPHILS/LEUKOCYTES (%) | Normal to High | 7 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | NEUTROPHILS/LEUKOCYTES (%) | Low to Normal | 7 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | NEUTROPHILS/LEUKOCYTES (%) | Low to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | NEUTROPHILS/LEUKOCYTES (%) | Low to High | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | NEUTROPHILS/LEUKOCYTES (%) | High to Normal | 1 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | NEUTROPHILS/LEUKOCYTES (%) | High to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | PLATELETS (10^9/L) | Low to Normal | 1 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | PLATELETS (10^9/L) | Low to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | PLATELETS (10^9/L) | Low to High | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | PLATELETS (10^9/L) | High to Normal | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | PLATELETS (10^9/L) | High to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HEMOGLOBIN (g/L) | High to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HEMOGLOBIN (g/L) | High to High | 1 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HEMOGLOBIN (g/L) | Missing | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HEMATOCRIT (VOLUME FRACTION) | Normal to Normal | 110 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HEMATOCRIT (VOLUME FRACTION) | Normal to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HEMATOCRIT (VOLUME FRACTION) | Normal to High | 2 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HEMATOCRIT (VOLUME FRACTION) | Low to Normal | 4 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HEMATOCRIT (VOLUME FRACTION) | Low to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HEMATOCRIT (VOLUME FRACTION) | Low to High | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HEMATOCRIT (VOLUME FRACTION) | High to Normal | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HEMATOCRIT (VOLUME FRACTION) | High to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HEMATOCRIT (VOLUME FRACTION) | High to High | 1 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HEMATOCRIT (VOLUME FRACTION) | Missing | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERYTHROCYTES MEAN CORPUSCULAR VOLUME (Femtoliter) | High to Normal | 1 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERYTHROCYTES MEAN CORPUSCULAR VOLUME (Femtoliter) | High to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERYTHROCYTES MEAN CORPUSCULAR VOLUME (Femtoliter) | High to High | 5 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERYTHROCYTES MEAN CORPUSCULAR VOLUME (Femtoliter) | Missing | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERYTHROCTES MEAN CORPUSCULAR HEMOGLOBIN (picogram) | Normal to Normal | 115 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERYTHROCTES MEAN CORPUSCULAR HEMOGLOBIN (picogram) | Normal to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERYTHROCTES MEAN CORPUSCULAR HEMOGLOBIN (picogram) | Normal to High | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERYTHROCTES MEAN CORPUSCULAR HEMOGLOBIN (picogram) | High to High | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERYTHROCTES MEAN CORPUSCULAR HEMOGLOBIN (picogram) | Missing | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERY. MEAN CORPUSCULAR HGB CONCENTRATION (g/L) | Normal to Normal | 114 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERY. MEAN CORPUSCULAR HGB CONCENTRATION (g/L) | Low to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERY. MEAN CORPUSCULAR HGB CONCENTRATION (g/L) | Low to High | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERY. MEAN CORPUSCULAR HGB CONCENTRATION (g/L) | High to Normal | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERY. MEAN CORPUSCULAR HGB CONCENTRATION (g/L) | High to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERY. MEAN CORPUSCULAR HGB CONCENTRATION (g/L) | High to High | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERY. MEAN CORPUSCULAR HGB CONCENTRATION (g/L) | Missing | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Sodium (mmol/L) | Normal to Normal | 113 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Sodium (mmol/L) | Normal to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Sodium (mmol/L) | Normal to High | 4 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Sodium (mmol/L) | Low to Normal | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Sodium (mmol/L) | Low to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Potassium (mmol/L) | Low to Normal | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Potassium (mmol/L) | Low to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Potassium (mmol/L) | Low to High | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Potassium (mmol/L) | High to Normal | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Potassium (mmol/L) | High to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Potassium (mmol/L) | High to High | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Potassium (mmol/L) | Missing | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Chloride (mmol/L) | Normal to Normal | 116 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Chloride (mmol/L) | Normal to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Chloride (mmol/L) | Normal to High | 1 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Chloride (mmol/L) | Low to Normal | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Chloride (mmol/L) | Low to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Calcium (mmol/L) | Normal to High | 3 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Calcium (mmol/L) | Low to Normal | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Calcium (mmol/L) | Low to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Calcium (mmol/L) | Low to High | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Calcium (mmol/L) | High to Normal | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Magnesium (mmol/L) | Low to Normal | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Magnesium (mmol/L) | Low to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Magnesium (mmol/L) | Low to High | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Magnesium (mmol/L) | High to Normal | 1 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Phosphate (mmol/L) | Normal to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Phosphate (mmol/L) | Normal to High | 4 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Phosphate (mmol/L) | Low to Normal | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Phosphate (mmol/L) | Low to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Phosphate (mmol/L) | Low to High | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Phosphate (mmol/L) | High to Normal | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Phosphate (mmol/L) | High to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Blood Urea Nitrogen (mmol/L) | Normal to High | 8 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Blood Urea Nitrogen (mmol/L) | Low to Normal | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Blood Urea Nitrogen (mmol/L) | Low to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Blood Urea Nitrogen (mmol/L) | Low to High | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Blood Urea Nitrogen (mmol/L) | High to Normal | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Blood Urea Nitrogen (mmol/L) | High to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Blood Urea Nitrogen (mmol/L) | High to High | 1 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Blood Urea Nitrogen (mmol/L) | Missing | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Glucose (mmol/L) | Normal to Normal | 69 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Glucose (mmol/L) | Missing | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Albumin (g/L) | Normal to Normal | 60 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Albumin (g/L) | Normal to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Albumin (g/L) | Normal to High | 30 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Albumin (g/L) | Low to Normal | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Albumin (g/L) | Low to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Alkaline Phosphatase (U/L) | Normal to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Alkaline Phosphatase (U/L) | Normal to High | 4 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Alkaline Phosphatase (U/L) | Low to Normal | 2 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Alkaline Phosphatase (U/L) | Low to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Alkaline Phosphatase (U/L) | Low to High | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Alkaline Phosphatase (U/L) | High to Normal | 1 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Alkaline Phosphatase (U/L) | High to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Alkaline Phosphatase (U/L) | High to High | 6 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Alkaline Phosphatase (U/L) | Missing | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Creatinine (umol/L) | Low to High | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Creatinine (umol/L) | High to Normal | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Creatinine (umol/L) | High to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Creatinine (umol/L) | High to High | 4 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Creatinine (umol/L) | Missing | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Creatine Kinase (U/L) | Normal to Normal | 64 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Creatine Kinase (U/L) | Normal to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Creatine Kinase (U/L) | Normal to High | 39 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Creatine Kinase (U/L) | Low to Normal | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Creatine Kinase (U/L) | Low to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Creatine Kinase (U/L) | Low to High | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HEMOGLOBIN (g/L) | High to Normal | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Alanine Aminotransferase (U/L) | High to Normal | 1 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Alanine Aminotransferase (U/L) | High to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Alanine Aminotransferase (U/L) | High to High | 6 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Alanine Aminotransferase (U/L) | Missing | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Aspartate Aminotransferase (U/L) | Normal to Normal | 93 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Aspartate Aminotransferase (U/L) | Normal to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Aspartate Aminotransferase (U/L) | Normal to High | 20 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Aspartate Aminotransferase (U/L) | Low to Normal | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Aspartate Aminotransferase (U/L) | Low to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Gamma Glutamyl Transferase (U/L) | Low to High | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Gamma Glutamyl Transferase (U/L) | High to Normal | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Gamma Glutamyl Transferase (U/L) | High to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Gamma Glutamyl Transferase (U/L) | High to High | 5 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Gamma Glutamyl Transferase (U/L) | Missing | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Amylase (U/L) | Normal to Normal | 98 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Amylase (U/L) | Normal to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Amylase (U/L) | Normal to High | 9 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Amylase (U/L) | Low to Normal | 2 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Amylase (U/L) | Low to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Total Bilirubin (umol/L) | Low to High | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Total Bilirubin (umol/L) | High to Normal | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Total Bilirubin (umol/L) | High to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Total Bilirubin (umol/L) | High to High | 4 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Total Bilirubin (umol/L) | Missing | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Direct Bilirubin (umol/L) | Normal to Normal | 117 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Direct Bilirubin (umol/L) | Normal to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Direct Bilirubin (umol/L) | Normal to High | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Direct Bilirubin (umol/L) | Low to Normal | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Direct Bilirubin (umol/L) | Low to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Direct Bilirubin (umol/L) | Low to High | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | C Reactive Protein (mg/L) | Low to High | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | C Reactive Protein (mg/L) | High to Normal | 4 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | C Reactive Protein (mg/L) | High to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | C Reactive Protein (mg/L) | High to High | 9 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | C Reactive Protein (mg/L) | Missing | 9 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Cholesterol (mmol/L) | Normal to Normal | 91 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Cholesterol (mmol/L) | Normal to Low | 3 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Cholesterol (mmol/L) | Normal to High | 4 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Cholesterol (mmol/L) | Low to Normal | 5 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Cholesterol (mmol/L) | Low to Low | 5 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Triglycerides (mmol/L) | Low to High | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Triglycerides (mmol/L) | High to Normal | 3 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Triglycerides (mmol/L) | High to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Triglycerides (mmol/L) | High to High | 6 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Triglycerides (mmol/L) | Missing | 4 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HDL Cholesterol (mmol/L) | Normal to Normal | 37 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HDL Cholesterol (mmol/L) | Normal to Low | 1 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HDL Cholesterol (mmol/L) | Normal to High | 10 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HDL Cholesterol (mmol/L) | Low to Normal | 14 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HDL Cholesterol (mmol/L) | Low to Low | 22 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | LDL Cholesterol (mmol/L) | Low to High | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | LDL Cholesterol (mmol/L) | High to Normal | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | LDL Cholesterol (mmol/L) | High to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | LDL Cholesterol (mmol/L) | High to High | 2 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | LDL Cholesterol (mmol/L) | Missing | 7 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Erythrocytes (10^12/L) | Normal to Normal | 113 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Erythrocytes (10^12/L) | Normal to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Erythrocytes (10^12/L) | Normal to High | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Erythrocytes (10^12/L) | Low to Normal | 2 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Leukocytes (10^9/L) | Low to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Leukocytes (10^9/L) | Low to High | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Leukocytes (10^9/L) | High to Normal | 1 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Leukocytes (10^9/L) | High to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Leukocytes (10^9/L) | High to High | 2 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Leukocytes (10^9/L) | Missing | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Basophils (10^9/L) | Normal to Normal | 112 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Basophils (10^9/L) | Normal to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Basophils (10^9/L) | Normal to High | 5 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Basophils (10^9/L) | Low to Normal | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Basophils (10^9/L) | Low to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Basophils (10^9/L) | Low to High | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Basophils (10^9/L) | High to Normal | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Basophils (10^9/L) | High to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Basophils (10^9/L) | High to High | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Basophils (10^9/L) | Missing | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Basophils/Leukocytes (%) | Normal to Normal | 75 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Basophils/Leukocytes (%) | Normal to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Basophils/Leukocytes (%) | Normal to High | 37 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Basophils/Leukocytes (%) | Low to Normal | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Basophils/Leukocytes (%) | Low to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Eosinophils (10^9/L) | Low to High | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Eosinophils (10^9/L) | High to Normal | 1 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Eosinophils (10^9/L) | High to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Eosinophils (10^9/L) | High to High | 13 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Eosinophils (10^9/L) | Missing | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Eosinophils/Leukocytes (%) | Normal to Normal | 56 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Eosinophils/Leukocytes (%) | Normal to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Eosinophils/Leukocytes (%) | Normal to High | 26 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Eosinophils/Leukocytes (%) | Low to Normal | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Lymphocytes (10^9/L) | Low to Normal | 3 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Lymphocytes (10^9/L) | Low to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Lymphocytes (10^9/L) | Low to High | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Lymphocytes (10^9/L) | High to Normal | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Lymphocytes (10^9/L) | High to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Lymphocytes (10^9/L) | High to High | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Lymphocytes (10^9/L) | Missing | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Lymphocytes/Leukocytes (%) | Normal to Normal | 108 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Lymphocytes/Leukocytes (%) | Normal to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Lymphocytes/Leukocytes (%) | Normal to High | 6 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Monocytes (10^9/L) | Normal to High | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Monocytes (10^9/L) | Low to Normal | 7 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Monocytes (10^9/L) | Low to Low | 1 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Monocytes (10^9/L) | Low to High | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Monocytes (10^9/L) | High to Normal | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Monocytes (10^9/L) | High to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Monocytes (10^9/L) | High to High | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Monocytes (10^9/L) | Missing | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Monocytes/Leukocytes (%) | Normal to Normal | 97 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Monocytes/Leukocytes (%) | Normal to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | NEUTROPHILS, SEGMENTED (10^9/L) | Normal to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | NEUTROPHILS, SEGMENTED (10^9/L) | Normal to High | 10 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | NEUTROPHILS, SEGMENTED (10^9/L) | Low to Normal | 10 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | NEUTROPHILS, SEGMENTED (10^9/L) | Low to Low | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | NEUTROPHILS, SEGMENTED (10^9/L) | Low to High | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Cholesterol (mmol/L) | Low to Normal | 6 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Phosphate (mmol/L) | Low to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Lymphocytes (10^9/L) | Normal to High | 4 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Cholesterol (mmol/L) | Low to Low | 9 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Phosphate (mmol/L) | Low to Normal | 1 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HEMATOCRIT (VOLUME FRACTION) | Low to Normal | 2 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Triglycerides (mmol/L) | Low to High | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Phosphate (mmol/L) | Normal to High | 5 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Monocytes (10^9/L) | High to High | 1 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Triglycerides (mmol/L) | High to Normal | 7 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Phosphate (mmol/L) | Normal to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Lymphocytes (10^9/L) | Low to Normal | 1 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Triglycerides (mmol/L) | High to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Magnesium (mmol/L) | Low to High | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HEMATOCRIT (VOLUME FRACTION) | Normal to High | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Triglycerides (mmol/L) | High to High | 5 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Magnesium (mmol/L) | Low to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | NEUTROPHILS/LEUKOCYTES (%) | Normal to High | 14 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Triglycerides (mmol/L) | Missing | 17 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Magnesium (mmol/L) | Low to Normal | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Lymphocytes (10^9/L) | Low to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HDL Cholesterol (mmol/L) | Normal to Normal | 65 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Calcium (mmol/L) | High to Normal | 3 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HEMATOCRIT (VOLUME FRACTION) | Normal to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HDL Cholesterol (mmol/L) | Normal to Low | 3 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Calcium (mmol/L) | Low to High | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | NEUTROPHILS, SEGMENTED (10^9/L) | Low to Normal | 5 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HDL Cholesterol (mmol/L) | Normal to High | 9 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Calcium (mmol/L) | Low to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Lymphocytes (10^9/L) | Low to High | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HDL Cholesterol (mmol/L) | Low to Normal | 11 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Calcium (mmol/L) | Low to Normal | 1 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HEMATOCRIT (VOLUME FRACTION) | Normal to Normal | 140 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | LDL Cholesterol (mmol/L) | Low to Low | 10 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Calcium (mmol/L) | Normal to High | 3 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Monocytes (10^9/L) | Missing | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | LDL Cholesterol (mmol/L) | Low to High | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Chloride (mmol/L) | Low to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Lymphocytes (10^9/L) | High to Normal | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | LDL Cholesterol (mmol/L) | High to Normal | 2 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Chloride (mmol/L) | Low to Normal | 1 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HEMOGLOBIN (g/L) | Missing | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | LDL Cholesterol (mmol/L) | High to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Chloride (mmol/L) | Normal to High | 3 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | NEUTROPHILS/LEUKOCYTES (%) | Normal to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | LDL Cholesterol (mmol/L) | High to High | 1 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Chloride (mmol/L) | Normal to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Lymphocytes (10^9/L) | High to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | LDL Cholesterol (mmol/L) | Missing | 18 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Chloride (mmol/L) | Normal to Normal | 139 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HEMOGLOBIN (g/L) | High to High | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Erythrocytes (10^12/L) | Normal to Normal | 137 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Potassium (mmol/L) | Missing | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | NEUTROPHILS, SEGMENTED (10^9/L) | High to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Erythrocytes (10^12/L) | Normal to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Potassium (mmol/L) | High to High | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Lymphocytes (10^9/L) | High to High | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Erythrocytes (10^12/L) | Normal to High | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Potassium (mmol/L) | High to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HEMOGLOBIN (g/L) | High to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Erythrocytes (10^12/L) | Low to Normal | 3 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Potassium (mmol/L) | High to Normal | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Potassium (mmol/L) | Low to High | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Monocytes/Leukocytes (%) | Normal to Normal | 124 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Leukocytes (10^9/L) | Low to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Potassium (mmol/L) | Low to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Lymphocytes (10^9/L) | Missing | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Leukocytes (10^9/L) | Low to High | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Potassium (mmol/L) | Low to Normal | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | PLATELETS (10^9/L) | High to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Leukocytes (10^9/L) | High to Normal | 3 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Sodium (mmol/L) | Low to Normal | 1 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | NEUTROPHILS/LEUKOCYTES (%) | Normal to Normal | 122 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Leukocytes (10^9/L) | High to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Sodium (mmol/L) | Normal to High | 4 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Lymphocytes/Leukocytes (%) | Normal to Normal | 131 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Leukocytes (10^9/L) | High to High | 2 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Sodium (mmol/L) | Normal to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | PLATELETS (10^9/L) | High to Normal | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Leukocytes (10^9/L) | Missing | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Sodium (mmol/L) | Normal to Normal | 138 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | NEUTROPHILS, SEGMENTED (10^9/L) | Low to High | 1 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Basophils (10^9/L) | Normal to Normal | 141 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERY. MEAN CORPUSCULAR HGB CONCENTRATION (g/L) | Missing | 1 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Lymphocytes/Leukocytes (%) | Normal to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Basophils (10^9/L) | Normal to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERY. MEAN CORPUSCULAR HGB CONCENTRATION (g/L) | High to High | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | PLATELETS (10^9/L) | Low to High | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Basophils (10^9/L) | Normal to High | 2 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERY. MEAN CORPUSCULAR HGB CONCENTRATION (g/L) | High to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Monocytes/Leukocytes (%) | Normal to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Basophils (10^9/L) | Low to Normal | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERY. MEAN CORPUSCULAR HGB CONCENTRATION (g/L) | High to Normal | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | PLATELETS (10^9/L) | Low to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Basophils (10^9/L) | Low to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERY. MEAN CORPUSCULAR HGB CONCENTRATION (g/L) | Low to High | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | NEUTROPHILS, SEGMENTED (10^9/L) | Low to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Basophils (10^9/L) | Low to High | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERY. MEAN CORPUSCULAR HGB CONCENTRATION (g/L) | Low to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Monocytes (10^9/L) | Normal to High | 1 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Basophils (10^9/L) | High to Normal | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERY. MEAN CORPUSCULAR HGB CONCENTRATION (g/L) | Low to Normal | 2 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | PLATELETS (10^9/L) | Low to Normal | 2 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Basophils (10^9/L) | High to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERY. MEAN CORPUSCULAR HGB CONCENTRATION (g/L) | Normal to Normal | 140 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | NEUTROPHILS, SEGMENTED (10^9/L) | Normal to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Basophils (10^9/L) | High to High | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERYTHROCTES MEAN CORPUSCULAR HEMOGLOBIN (picogram) | Missing | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Monocytes (10^9/L) | Low to Normal | 3 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Basophils (10^9/L) | Missing | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERYTHROCTES MEAN CORPUSCULAR HEMOGLOBIN (picogram) | High to High | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | NEUTROPHILS/LEUKOCYTES (%) | High to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERYTHROCTES MEAN CORPUSCULAR HEMOGLOBIN (picogram) | High to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | NEUTROPHILS, SEGMENTED (10^9/L) | Missing | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Alanine Aminotransferase (U/L) | High to Normal | 3 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Alanine Aminotransferase (U/L) | Low to High | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Basophils/Leukocytes (%) | Normal to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Alanine Aminotransferase (U/L) | High to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Creatine Kinase (U/L) | Low to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERYTHROCTES MEAN CORPUSCULAR HEMOGLOBIN (picogram) | Normal to High | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Alanine Aminotransferase (U/L) | High to High | 7 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Creatine Kinase (U/L) | Low to Normal | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Monocytes (10^9/L) | Low to Low | 4 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Alanine Aminotransferase (U/L) | Missing | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Creatine Kinase (U/L) | Normal to High | 36 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Basophils/Leukocytes (%) | Normal to High | 26 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Aspartate Aminotransferase (U/L) | Normal to Normal | 120 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Creatine Kinase (U/L) | Normal to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERYTHROCTES MEAN CORPUSCULAR HEMOGLOBIN (picogram) | Normal to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Aspartate Aminotransferase (U/L) | Normal to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Creatine Kinase (U/L) | Normal to Normal | 100 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | NEUTROPHILS/LEUKOCYTES (%) | High to Normal | 3 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Aspartate Aminotransferase (U/L) | Normal to High | 17 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Creatinine (umol/L) | Missing | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Basophils/Leukocytes (%) | Low to Normal | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Aspartate Aminotransferase (U/L) | Low to Normal | 1 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Creatinine (umol/L) | High to High | 4 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERYTHROCTES MEAN CORPUSCULAR HEMOGLOBIN (picogram) | Normal to Normal | 141 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Creatinine (umol/L) | High to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | NEUTROPHILS, SEGMENTED (10^9/L) | High to Normal | 3 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Gamma Glutamyl Transferase (U/L) | Low to High | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Creatinine (umol/L) | High to Normal | 1 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Basophils/Leukocytes (%) | Low to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Gamma Glutamyl Transferase (U/L) | High to Normal | 1 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Creatinine (umol/L) | Low to High | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERYTHROCYTES MEAN CORPUSCULAR VOLUME (Femtoliter) | Missing | 1 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Gamma Glutamyl Transferase (U/L) | High to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Alkaline Phosphatase (U/L) | Missing | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Eosinophils (10^9/L) | Low to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Gamma Glutamyl Transferase (U/L) | High to High | 10 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Alkaline Phosphatase (U/L) | High to High | 5 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERYTHROCYTES MEAN CORPUSCULAR VOLUME (Femtoliter) | High to High | 3 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Gamma Glutamyl Transferase (U/L) | Missing | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Alkaline Phosphatase (U/L) | High to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Monocytes (10^9/L) | Low to High | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Amylase (U/L) | Normal to Normal | 127 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Alkaline Phosphatase (U/L) | High to Normal | 1 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Eosinophils (10^9/L) | Low to High | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Amylase (U/L) | Normal to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Alkaline Phosphatase (U/L) | Low to High | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERYTHROCYTES MEAN CORPUSCULAR VOLUME (Femtoliter) | High to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Amylase (U/L) | Normal to High | 4 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Alkaline Phosphatase (U/L) | Low to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | NEUTROPHILS/LEUKOCYTES (%) | Low to High | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Amylase (U/L) | Low to Normal | 4 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Alkaline Phosphatase (U/L) | Low to Normal | 1 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Eosinophils (10^9/L) | High to Normal | 3 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Amylase (U/L) | Low to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Alkaline Phosphatase (U/L) | Normal to High | 7 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERYTHROCYTES MEAN CORPUSCULAR VOLUME (Femtoliter) | High to Normal | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Total Bilirubin (umol/L) | Low to High | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Alkaline Phosphatase (U/L) | Normal to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | NEUTROPHILS, SEGMENTED (10^9/L) | Normal to High | 12 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Total Bilirubin (umol/L) | High to Normal | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Albumin (g/L) | Low to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Eosinophils (10^9/L) | High to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Total Bilirubin (umol/L) | High to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Albumin (g/L) | Low to Normal | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HEMATOCRIT (VOLUME FRACTION) | Missing | 1 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Total Bilirubin (umol/L) | High to High | 5 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Albumin (g/L) | Normal to High | 35 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Monocytes (10^9/L) | High to Normal | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Total Bilirubin (umol/L) | Missing | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Albumin (g/L) | Normal to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Eosinophils (10^9/L) | High to High | 10 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Direct Bilirubin (umol/L) | Normal to Normal | 143 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Albumin (g/L) | Normal to Normal | 76 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HEMATOCRIT (VOLUME FRACTION) | High to High | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Direct Bilirubin (umol/L) | Normal to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Glucose (mmol/L) | Missing | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | NEUTROPHILS/LEUKOCYTES (%) | Low to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Direct Bilirubin (umol/L) | Normal to High | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Glucose (mmol/L) | High to High | 21 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Eosinophils (10^9/L) | Missing | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Direct Bilirubin (umol/L) | Low to Normal | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Glucose (mmol/L) | Normal to Normal | 88 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HEMATOCRIT (VOLUME FRACTION) | High to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Direct Bilirubin (umol/L) | Low to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Blood Urea Nitrogen (mmol/L) | Missing | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | NEUTROPHILS, SEGMENTED (10^9/L) | High to High | 2 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | C Reactive Protein (mg/L) | Low to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Blood Urea Nitrogen (mmol/L) | High to High | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Eosinophils/Leukocytes (%) | Normal to Normal | 54 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | C Reactive Protein (mg/L) | Low to High | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Blood Urea Nitrogen (mmol/L) | High to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HEMATOCRIT (VOLUME FRACTION) | High to Normal | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | C Reactive Protein (mg/L) | High to Normal | 4 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Blood Urea Nitrogen (mmol/L) | High to Normal | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Monocytes (10^9/L) | High to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | C Reactive Protein (mg/L) | High to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Blood Urea Nitrogen (mmol/L) | Low to High | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Eosinophils/Leukocytes (%) | Normal to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | C Reactive Protein (mg/L) | High to High | 13 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Blood Urea Nitrogen (mmol/L) | Low to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HEMATOCRIT (VOLUME FRACTION) | Low to High | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | C Reactive Protein (mg/L) | Missing | 6 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Blood Urea Nitrogen (mmol/L) | Low to Normal | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | NEUTROPHILS/LEUKOCYTES (%) | Low to Normal | 3 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Cholesterol (mmol/L) | Normal to Normal | 102 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Blood Urea Nitrogen (mmol/L) | Normal to High | 6 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Eosinophils/Leukocytes (%) | Normal to High | 45 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Cholesterol (mmol/L) | Normal to Low | 1 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Phosphate (mmol/L) | High to Normal | 1 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HEMATOCRIT (VOLUME FRACTION) | Low to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Cholesterol (mmol/L) | Normal to High | 5 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Phosphate (mmol/L) | Low to High | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HEMOGLOBIN (g/L) | High to Normal | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Leukocytes (10^9/L) | Normal to Normal | 125 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Glucose (mmol/L) | Normal to High | 30 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Monocytes/Leukocytes (%) | High to Normal | 1 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Glucose (mmol/L) | Low to Normal | 2 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Glucose (mmol/L) | Low to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Leukocytes (10^9/L) | Normal to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Glucose (mmol/L) | Low to High | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Glucose (mmol/L) | High to Normal | 2 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Glucose (mmol/L) | High to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Leukocytes (10^9/L) | Normal to High | 7 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Albumin (g/L) | Low to High | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Lymphocytes/Leukocytes (%) | High to High | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Albumin (g/L) | High to Normal | 9 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Albumin (g/L) | High to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Leukocytes (10^9/L) | Low to Normal | 6 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Albumin (g/L) | High to High | 23 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Albumin (g/L) | Missing | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Basophils/Leukocytes (%) | Low to High | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Alkaline Phosphatase (U/L) | Normal to Normal | 129 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Creatinine (umol/L) | Normal to Normal | 131 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Monocytes/Leukocytes (%) | Missing | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Creatinine (umol/L) | Normal to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Creatinine (umol/L) | Normal to High | 7 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Basophils/Leukocytes (%) | High to Normal | 4 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Creatinine (umol/L) | Low to Normal | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Creatinine (umol/L) | Low to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Creatine Kinase (U/L) | Low to High | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Basophils/Leukocytes (%) | High to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Creatine Kinase (U/L) | High to Normal | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Lymphocytes/Leukocytes (%) | Missing | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Creatine Kinase (U/L) | High to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Creatine Kinase (U/L) | High to High | 7 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Basophils/Leukocytes (%) | High to High | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Creatine Kinase (U/L) | Missing | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Alanine Aminotransferase (U/L) | Normal to Normal | 111 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Alanine Aminotransferase (U/L) | Normal to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Basophils/Leukocytes (%) | Missing | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Alanine Aminotransferase (U/L) | Normal to High | 22 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Alanine Aminotransferase (U/L) | Low to Normal | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Alanine Aminotransferase (U/L) | Low to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Eosinophils (10^9/L) | Normal to Normal | 89 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Aspartate Aminotransferase (U/L) | Low to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Monocytes (10^9/L) | Normal to Normal | 134 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Aspartate Aminotransferase (U/L) | Low to High | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Aspartate Aminotransferase (U/L) | High to Normal | 1 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Eosinophils (10^9/L) | Normal to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Aspartate Aminotransferase (U/L) | High to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Monocytes/Leukocytes (%) | High to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Aspartate Aminotransferase (U/L) | High to High | 4 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Aspartate Aminotransferase (U/L) | Missing | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Eosinophils (10^9/L) | Normal to High | 41 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Gamma Glutamyl Transferase (U/L) | Normal to Normal | 122 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Gamma Glutamyl Transferase (U/L) | Normal to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Gamma Glutamyl Transferase (U/L) | Normal to High | 9 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Eosinophils (10^9/L) | Low to Normal | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Gamma Glutamyl Transferase (U/L) | Low to Normal | 1 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Monocytes (10^9/L) | Normal to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Gamma Glutamyl Transferase (U/L) | Low to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Amylase (U/L) | Low to High | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Eosinophils/Leukocytes (%) | Low to Normal | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Amylase (U/L) | High to Normal | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | NEUTROPHILS, SEGMENTED (10^9/L) | Normal to Normal | 120 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Amylase (U/L) | High to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Amylase (U/L) | High to High | 8 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Eosinophils/Leukocytes (%) | Low to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Amylase (U/L) | Missing | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Total Bilirubin (umol/L) | Normal to Normal | 123 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Total Bilirubin (umol/L) | Normal to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Eosinophils/Leukocytes (%) | Low to High | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Total Bilirubin (umol/L) | Normal to High | 9 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Monocytes/Leukocytes (%) | Normal to High | 14 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Total Bilirubin (umol/L) | Low to Normal | 6 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Total Bilirubin (umol/L) | Low to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Direct Bilirubin (umol/L) | Low to High | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Eosinophils/Leukocytes (%) | High to Normal | 4 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Direct Bilirubin (umol/L) | High to Normal | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Direct Bilirubin (umol/L) | High to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Direct Bilirubin (umol/L) | High to High | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Eosinophils/Leukocytes (%) | High to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Direct Bilirubin (umol/L) | Missing | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | C Reactive Protein (mg/L) | Normal to Normal | 85 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | C Reactive Protein (mg/L) | Normal to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Eosinophils/Leukocytes (%) | High to High | 40 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | C Reactive Protein (mg/L) | Normal to High | 35 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Monocytes/Leukocytes (%) | Low to Normal | 3 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | C Reactive Protein (mg/L) | Low to Normal | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Eosinophils/Leukocytes (%) | Missing | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Cholesterol (mmol/L) | Low to High | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Monocytes/Leukocytes (%) | High to High | 1 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Cholesterol (mmol/L) | High to Normal | 2 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Cholesterol (mmol/L) | High to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Lymphocytes (10^9/L) | Normal to Normal | 138 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Cholesterol (mmol/L) | High to High | 2 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Cholesterol (mmol/L) | Missing | 16 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Triglycerides (mmol/L) | Normal to Normal | 105 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Lymphocytes (10^9/L) | Normal to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Triglycerides (mmol/L) | Normal to Low | 2 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | NEUTROPHILS/LEUKOCYTES (%) | High to High | 1 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Monocytes/Leukocytes (%) | Low to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | NEUTROPHILS/LEUKOCYTES (%) | Missing | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | PLATELETS (10^9/L) | Normal to Normal | 128 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Triglycerides (mmol/L) | Normal to High | 4 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | PLATELETS (10^9/L) | Normal to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | PLATELETS (10^9/L) | Normal to High | 11 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | PLATELETS (10^9/L) | High to High | 2 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Triglycerides (mmol/L) | Low to Normal | 3 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | PLATELETS (10^9/L) | Missing | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Lymphocytes/Leukocytes (%) | Normal to High | 8 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HEMOGLOBIN (g/L) | Normal to Normal | 142 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HEMOGLOBIN (g/L) | Normal to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Triglycerides (mmol/L) | Low to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HEMOGLOBIN (g/L) | Normal to High | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HDL Cholesterol (mmol/L) | Low to Low | 14 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HEMOGLOBIN (g/L) | Low to Normal | 1 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HEMOGLOBIN (g/L) | Low to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HEMOGLOBIN (g/L) | Low to High | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HDL Cholesterol (mmol/L) | Low to High | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERYTHROCYTES MEAN CORPUSCULAR VOLUME (Femtoliter) | Normal to Normal | 120 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERYTHROCYTES MEAN CORPUSCULAR VOLUME (Femtoliter) | Normal to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HDL Cholesterol (mmol/L) | High to Normal | 5 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERYTHROCYTES MEAN CORPUSCULAR VOLUME (Femtoliter) | Normal to High | 14 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Lymphocytes/Leukocytes (%) | Low to Normal | 3 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERYTHROCYTES MEAN CORPUSCULAR VOLUME (Femtoliter) | Low to Normal | 4 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERYTHROCYTES MEAN CORPUSCULAR VOLUME (Femtoliter) | Low to Low | 1 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HDL Cholesterol (mmol/L) | High to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERYTHROCYTES MEAN CORPUSCULAR VOLUME (Femtoliter) | Low to High | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERYTHROCTES MEAN CORPUSCULAR HEMOGLOBIN (picogram) | Low to Normal | 1 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HDL Cholesterol (mmol/L) | High to High | 19 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERYTHROCTES MEAN CORPUSCULAR HEMOGLOBIN (picogram) | Low to Low | 1 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERYTHROCTES MEAN CORPUSCULAR HEMOGLOBIN (picogram) | Low to High | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERYTHROCTES MEAN CORPUSCULAR HEMOGLOBIN (picogram) | High to Normal | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | HDL Cholesterol (mmol/L) | Missing | 17 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERY. MEAN CORPUSCULAR HGB CONCENTRATION (g/L) | Normal to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Lymphocytes/Leukocytes (%) | Low to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | ERY. MEAN CORPUSCULAR HGB CONCENTRATION (g/L) | Normal to High | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Basophils/Leukocytes (%) | Normal to Normal | 113 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Sodium (mmol/L) | Low to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | LDL Cholesterol (mmol/L) | Normal to Normal | 101 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Sodium (mmol/L) | Low to High | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Monocytes/Leukocytes (%) | Low to High | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Sodium (mmol/L) | High to Normal | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Sodium (mmol/L) | High to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | LDL Cholesterol (mmol/L) | Normal to Low | 3 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Sodium (mmol/L) | High to High | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Sodium (mmol/L) | Missing | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Potassium (mmol/L) | Normal to Normal | 137 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | LDL Cholesterol (mmol/L) | Normal to High | 5 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Potassium (mmol/L) | Normal to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Lymphocytes/Leukocytes (%) | Low to High | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Potassium (mmol/L) | Normal to High | 6 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Chloride (mmol/L) | Low to High | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | LDL Cholesterol (mmol/L) | Low to Normal | 3 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Chloride (mmol/L) | High to Normal | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Chloride (mmol/L) | High to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Chloride (mmol/L) | High to High | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Chloride (mmol/L) | Missing | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Erythrocytes (10^12/L) | Low to Low | 1 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Calcium (mmol/L) | Normal to Normal | 136 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Calcium (mmol/L) | Normal to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Calcium (mmol/L) | High to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Erythrocytes (10^12/L) | Low to High | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Calcium (mmol/L) | High to High | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Calcium (mmol/L) | Missing | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Magnesium (mmol/L) | Normal to Normal | 138 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Erythrocytes (10^12/L) | High to Normal | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Magnesium (mmol/L) | Normal to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Lymphocytes/Leukocytes (%) | High to Normal | 1 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Magnesium (mmol/L) | Normal to High | 4 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Magnesium (mmol/L) | High to Normal | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Erythrocytes (10^12/L) | High to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Magnesium (mmol/L) | High to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Magnesium (mmol/L) | High to High | 1 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Magnesium (mmol/L) | Missing | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Erythrocytes (10^12/L) | High to High | 2 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Phosphate (mmol/L) | Normal to Normal | 136 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Phosphate (mmol/L) | High to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Phosphate (mmol/L) | High to High | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Erythrocytes (10^12/L) | Missing | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Phosphate (mmol/L) | Missing | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Lymphocytes/Leukocytes (%) | High to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Blood Urea Nitrogen (mmol/L) | Normal to Normal | 137 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Blood Urea Nitrogen (mmol/L) | Normal to Low | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Maximum Post-Baseline Clinical Laboratory Range Shift | Glucose (mmol/L) | Normal to Low | 0 Participants |
Secondary
Number of Participants With Post-Baseline Vital Sign Abnormalities
Vital signs like feart rate (beats per minute) and systolic blood pressure (mmHg) and diastolic blood pressure (mmHg) was measured to assess the abnormalities.
Time frame: From first dose (Day 1) till up to Week 48
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Post-Baseline Vital Sign Abnormalities | Hear rate (> 100 AND CHANGE FROM BASELINE > 30) | 6 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Post-Baseline Vital Sign Abnormalities | Hear rate (< 55 AND CHANGE FROM BASELINE < -15) | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Post-Baseline Vital Sign Abnormalities | SBP (> 140 AND CHANGE FROM BASELINE > 20) | 16 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Post-Baseline Vital Sign Abnormalities | SBP (< 90 AND CHANGE FROM BASELINE < -20) | 0 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Post-Baseline Vital Sign Abnormalities | DBP > 90 AND CHANGE FROM BASELINE > 10 | 18 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Post-Baseline Vital Sign Abnormalities | DBP < 55 AND CHANGE FROM BASELINE < -10 | 4 Participants |
| Induction Phase - Placebo | Number of Participants With Post-Baseline Vital Sign Abnormalities | DBP < 55 AND CHANGE FROM BASELINE < -10 | 6 Participants |
| Induction Phase - Placebo | Number of Participants With Post-Baseline Vital Sign Abnormalities | Hear rate (> 100 AND CHANGE FROM BASELINE > 30) | 1 Participants |
| Induction Phase - Placebo | Number of Participants With Post-Baseline Vital Sign Abnormalities | SBP (< 90 AND CHANGE FROM BASELINE < -20) | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Post-Baseline Vital Sign Abnormalities | DBP > 90 AND CHANGE FROM BASELINE > 10 | 21 Participants |
| Induction Phase - Placebo | Number of Participants With Post-Baseline Vital Sign Abnormalities | Hear rate (< 55 AND CHANGE FROM BASELINE < -15) | 0 Participants |
| Induction Phase - Placebo | Number of Participants With Post-Baseline Vital Sign Abnormalities | SBP (> 140 AND CHANGE FROM BASELINE > 20) | 11 Participants |
| Maintenance Phase - Placebo | Number of Participants With Post-Baseline Vital Sign Abnormalities | Hear rate (< 55 AND CHANGE FROM BASELINE < -15) | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Post-Baseline Vital Sign Abnormalities | SBP (> 140 AND CHANGE FROM BASELINE > 20) | 15 Participants |
| Maintenance Phase - Placebo | Number of Participants With Post-Baseline Vital Sign Abnormalities | DBP < 55 AND CHANGE FROM BASELINE < -10 | 8 Participants |
| Maintenance Phase - Placebo | Number of Participants With Post-Baseline Vital Sign Abnormalities | SBP (< 90 AND CHANGE FROM BASELINE < -20) | 0 Participants |
| Maintenance Phase - Placebo | Number of Participants With Post-Baseline Vital Sign Abnormalities | Hear rate (> 100 AND CHANGE FROM BASELINE > 30) | 3 Participants |
| Maintenance Phase - Placebo | Number of Participants With Post-Baseline Vital Sign Abnormalities | DBP > 90 AND CHANGE FROM BASELINE > 10 | 25 Participants |
Secondary
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
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.
Time frame: From first dose (Day 1) till up to Week 48
Population: Safety population includes all the participants who received at least one dose of study treatment and analyzed based on the actual treatments they received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Any Treatment Emergent Moderate Adverse Events | 68 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Any Treatment Emergent Severe Adverse Events | 7 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Treatment Emergent Adverse Events | 140 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Treatment Emergent Serious Adverse Events | 4 Participants |
| Induction Phase - CC-93538 360 mg QW | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Any Treatment Emergent Mild Adverse Events | 65 Participants |
| Induction Phase - Placebo | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Any Treatment Emergent Severe Adverse Events | 6 Participants |
| Induction Phase - Placebo | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Treatment Emergent Adverse Events | 99 Participants |
| Induction Phase - Placebo | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Treatment Emergent Serious Adverse Events | 4 Participants |
| Induction Phase - Placebo | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Any Treatment Emergent Moderate Adverse Events | 55 Participants |
| Induction Phase - Placebo | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Any Treatment Emergent Mild Adverse Events | 38 Participants |
| Maintenance Phase - Placebo | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Any Treatment Emergent Mild Adverse Events | 44 Participants |
| Maintenance Phase - Placebo | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Any Treatment Emergent Moderate Adverse Events | 48 Participants |
| Maintenance Phase - Placebo | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Treatment Emergent Adverse Events | 105 Participants |
| Maintenance Phase - Placebo | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Any Treatment Emergent Severe Adverse Events | 13 Participants |
| Maintenance Phase - Placebo | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Treatment Emergent Serious Adverse Events | 8 Participants |
Secondary
Percentage of Participants With a ≥ 50% Decrease in Dysphagia Days(DD) From Baseline at Week 24
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.
Time frame: Baseline (11 days prior to Day 1) and Week 24
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Induction Phase - CC-93538 360 mg QW | Percentage of Participants With a ≥ 50% Decrease in Dysphagia Days(DD) From Baseline at Week 24 | 65.7 percentage of participants |
| Induction Phase - Placebo | Percentage of Participants With a ≥ 50% Decrease in Dysphagia Days(DD) From Baseline at Week 24 | 50.0 percentage of participants |
p-value: 0.001695% CI: [6.7, 27.2]ANCOVA
Secondary
Percentage of Participants With a ≥ 50% Decrease in Dysphagia Days(DD) From Baseline at Week 48
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.
Time frame: Baseline (11 days prior to Day 1) and Week 48
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Induction Phase - CC-93538 360 mg QW | Percentage of Participants With a ≥ 50% Decrease in Dysphagia Days(DD) From Baseline at Week 48 | 50.3 percentage of participants |
| Induction Phase - Placebo | Percentage of Participants With a ≥ 50% Decrease in Dysphagia Days(DD) From Baseline at Week 48 | 53.8 percentage of participants |
| Maintenance Phase - Placebo | Percentage of Participants With a ≥ 50% Decrease in Dysphagia Days(DD) From Baseline at Week 48 | 31.9 percentage of participants |
Secondary
Percentage of Participants With Any Events of Use of Rescue Medication
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.
Time frame: From first dose (Day 1) and up to Week 48
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Induction Phase - CC-93538 360 mg QW | Percentage of Participants With Any Events of Use of Rescue Medication | 4.9 percentage of participants |
| Induction Phase - Placebo | Percentage of Participants With Any Events of Use of Rescue Medication | 7.0 percentage of participants |
| Maintenance Phase - Placebo | Percentage of Participants With Any Events of Use of Rescue Medication | 13.9 percentage of participants |
Secondary
Percentage of Participants With Eosinophilic Esophagitis (EoE) Flare
First incidence of corresponding EoE flare event for any participant was considered in the analysis.
Time frame: From first dose (Day 1) and up to Week 48
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Induction Phase - CC-93538 360 mg QW | Percentage of Participants With Eosinophilic Esophagitis (EoE) Flare | 3.5 percentage of participants |
| Induction Phase - Placebo | Percentage of Participants With Eosinophilic Esophagitis (EoE) Flare | 9.1 percentage of participants |
| Maintenance Phase - Placebo | Percentage of Participants With Eosinophilic Esophagitis (EoE) Flare | 20.1 percentage of participants |
Secondary
Percentage of Participants With Peak Esophageal Eosinophil Count < 15/High-power Field (Hpf) at Week 24
Blood samples were collected to assess esophageal eosinophil count.
Time frame: Week 24
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Induction Phase - CC-93538 360 mg QW | Percentage of Participants With Peak Esophageal Eosinophil Count < 15/High-power Field (Hpf) at Week 24 | 53.0 percentage of participants |
| Induction Phase - Placebo | Percentage of Participants With Peak Esophageal Eosinophil Count < 15/High-power Field (Hpf) at Week 24 | 4.7 percentage of participants |
p-value: <0.000195% CI: [33.3, 46.7]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Peak Esophageal Eosinophil Count < 15/High-power Field (Hpf) at Week 48
Blood samples were collected to assess esophageal eosinophil count.
Time frame: Week 48
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Induction Phase - CC-93538 360 mg QW | Percentage of Participants With Peak Esophageal Eosinophil Count < 15/High-power Field (Hpf) at Week 48 | 50.0 percentage of participants |
| Induction Phase - Placebo | Percentage of Participants With Peak Esophageal Eosinophil Count < 15/High-power Field (Hpf) at Week 48 | 50.0 percentage of participants |
| Maintenance Phase - Placebo | Percentage of Participants With Peak Esophageal Eosinophil Count < 15/High-power Field (Hpf) at Week 48 | 8.5 percentage of participants |
p-value: <0.000195% CI: [17.8, 33.6]Cochran-Mantel-Haenszel
p-value: <0.000195% CI: [19.7, 35.7]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Peak Esophageal Eosinophil Count <= 6/High-power Field (Hpf) at Week 48
Blood samples were collected to assess esophageal eosinophil count.
Time frame: Week 48
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Induction Phase - CC-93538 360 mg QW | Percentage of Participants With Peak Esophageal Eosinophil Count <= 6/High-power Field (Hpf) at Week 48 | 37.5 percentage of participants |
| Induction Phase - Placebo | Percentage of Participants With Peak Esophageal Eosinophil Count <= 6/High-power Field (Hpf) at Week 48 | 34.3 percentage of participants |
| Maintenance Phase - Placebo | Percentage of Participants With Peak Esophageal Eosinophil Count <= 6/High-power Field (Hpf) at Week 48 | 4.9 percentage of participants |
p-value: <0.000195% CI: [11.3, 25.5]Cochran-Mantel-Haenszel
p-value: <0.000195% CI: [10.1, 24]Cochran-Mantel-Haenszel
Secondary
Serum Trough Concentration of CC-93538 at Week 24 and Week 48
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.
Time frame: Pre-dose Week 24 and Pre-dose Week 48
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Induction Phase - CC-93538 360 mg QW | 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 |
| Induction Phase - CC-93538 360 mg QW | 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 |
| Induction Phase - Placebo | Serum Trough Concentration of CC-93538 at Week 24 and Week 48 | Pre-dose Week 24 | 151735.2 ng/mL | Geometric Coefficient of Variation 55.8 |
| Induction Phase - Placebo | Serum Trough Concentration of CC-93538 at Week 24 and Week 48 | Pre-dose Week 48 | 79884.3 ng/mL | Geometric Coefficient of Variation 45.4 |
Secondary
Time to First Event of Eosinophilic Esophagitis (EoE) Flare
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.
Time frame: From first dose (Day 1) and Up to Week 48
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Induction Phase - CC-93538 360 mg QW | Time to First Event of Eosinophilic Esophagitis (EoE) Flare | NA days |
| Induction Phase - Placebo | Time to First Event of Eosinophilic Esophagitis (EoE) Flare | NA days |
| Maintenance Phase - Placebo | Time to First Event of Eosinophilic Esophagitis (EoE) Flare | NA days |
Secondary
Time to First Use of Rescue Medication
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.
Time frame: From first dose (Day 1) and Up to Week 48
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Induction Phase - CC-93538 360 mg QW | Time to First Use of Rescue Medication | NA days |
| Induction Phase - Placebo | Time to First Use of Rescue Medication | NA days |
| Maintenance Phase - Placebo | Time to First Use of Rescue Medication | NA days |