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Efficacy and Safety Study of Apremilast in Subjects With Moderate to Severe Atopic Dermatitis

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ClinicalTrials.gov Identifier: NCT02087943
Recruitment Status : Completed
First Posted : March 14, 2014
Results First Posted : December 12, 2016
Last Update Posted : April 26, 2017
Sponsor:
Information provided by (Responsible Party):
Celgene

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Dermatitis, Atopic Dermatitis
Interventions Drug: Apremilast
Drug: Placebo
Enrollment 191
Recruitment Details  
Pre-assignment Details Treatment assignment was stratified by geographic region and within each region, by the Eczema Area and Severity Index (EASI) score (≤ 20 or > 20). Six participants were excluded from analysis due to unsigned case books; a total of 185 participants were included in the final analyses.
Arm/Group Title Placebo Apremilast 30 mg Apremilast 40 mg Placebo/Apremilast 30 mg Placebo/Apremilast 40 mg
Hide Arm/Group Description Participants initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-12) Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled phase and continued to receive 30 mg apremilast tablets twice daily (BID) for up to Week 24 in the active treatment phase Participants initially randomized to receive 40 mg apremilast tablets twice daily in the 12-week placebo-controlled phase and continued to receive 40 mg apremilast tablets twice daily (BID) for up to Week 24 in the active treatment phase. Participants initially randomized to identically matching placebo tablets twice daily and were re-randomized at Week 12 to 30 mg apremilast for 12 weeks, up to week 24. Participants initially randomized to identically matching placebo tablets twice daily and were re-randomized at Week 12 to 40 mg apremilast for 12 weeks, up to week 24.
Period Title: Placebo-Controlled Phase Week 0-12
Started 64 58 63 0 0
Safety Population 64 [1] 58 [1] 63 [1] 0 0
Completed 50 [2] 46 50 [3] 0 0
Not Completed 14 12 13 0 0
Reason Not Completed
Adverse Event             1             2             6             0             0
Lack of Efficacy             8             7             4             0             0
Withdrawal by Subject             4             2             2             0             0
Lost to Follow-up             1             0             1             0             0
Protocol Violation             0             1             0             0             0
[1]
Includes all participants who received at least one dose of study drug.
[2]
3 participants who completed week 12 did not enter the active treatment phase.
[3]
1 participant who completed week 12 did not enter the active treatment phase.
Period Title: Active Treatment Phase Week 12-24
Started 0 46 49 24 23
Completed 0 42 44 22 21
Not Completed 0 4 5 2 2
Reason Not Completed
Adverse Event             0             1             2             0             1
Lack of Efficacy             0             3             1             1             0
Withdrawal by Subject             0             0             1             0             0
Lost to Follow-up             0             0             0             0             1
Other-Unspecified             0             0             1             1             0
Period Title: Observational Follow-up Phase Week 24-30
Started 0 46 48 24 23
Completed 0 46 45 23 22
Not Completed 0 0 3 1 1
Arm/Group Title Placebo Apremilast 30 mg Apremilast 40 mg Total
Hide Arm/Group Description Participants initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-16) Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled phase. Participants initially randomized to receive 40 mg apremilast tablets twice daily in the 12-week placebo-controlled phase. Total of all reporting groups
Overall Number of Baseline Participants 64 58 63 185
Hide Baseline Analysis Population Description
Intent to Treat (ITT) includes all participants who were randomized as specified in the protocol and received at least one dose of Investigational product (IP)
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 64 participants 58 participants 63 participants 185 participants
37.7  (14.71) 39.2  (15.80) 38.3  (14.74) 38.4  (15.00)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants 58 participants 63 participants 185 participants
Female
39
  60.9%
27
  46.6%
32
  50.8%
98
  53.0%
Male
25
  39.1%
31
  53.4%
31
  49.2%
87
  47.0%
1.Primary Outcome
Title Percentage Change From Baseline in the Eczema Area and Severity Index (EASI) Score at Week 12.
Hide Description EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). A representative lesion is selected for each of the four body regions for assessing the intensity of each of the four signs (erythema, induration /papulation, excoriation, and lichenification). Symptoms (eg, pruritus) and secondary signs (eg, xerosis, scaling) are excluded from the assessment. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized as specified per protocol and who received at least one dose of IP with a baseline and at least 1 post baseline value at or before week 12; A missing value at Week 12 was imputed by last observation carried forward (LOCF), including the value obtained at the Early Termination Visit prior to Week 12.
Arm/Group Title Placebo Apremilast 30 mg Apremilast 40 mg
Hide Arm/Group Description:
Participants initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-12)
Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
Participants initially randomized to receive 40 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
Overall Number of Participants Analyzed 62 58 63
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-10.98  (6.873) -25.99  (7.106) -31.57  (6.820)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Apremilast 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1308
Comments Based on an analysis of covariance model with the percentage change from baseline as the response variable and the treatment group and Baseline EASI score stratification (≤ 20, > 20) as factors.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -15.01
Confidence Interval (2-Sided) 95%
-34.52 to 4.50
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Apremilast 40 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0347
Comments Based on an analysis of covariance model with the percentage change from Baseline as the response variable and the treatment group and Baseline EASI score stratification (≤ 20, > 20) as factors.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -20.60
Confidence Interval (2-Sided) 95%
-39.70 to -1.50
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants Who Achieved a Score of 0 (Cleared) or 1 (Almost Cleared) and at Least a 2-point Reduction From Baseline in a Static Physician’s Global Assessment of Acute Signs (sPGA-A) at Week 12.
Hide Description The sPGA-A is intended to assess the global severities (ie, a “visual average” integrating all areas of AD) of key acute clinical signs of AD, including erythema, induration/papulation, oozing/crusting (lichenification excluded) based on a 5-point scale of cleared (0), almost cleared (1), mild (2), moderate (3) and severe (4).
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT includes all participants who were randomized as specified per protocol and received at least one dose of IP. LOCF for missing data handling.
Arm/Group Title Placebo Apremilast 30 mg Apremilast 40 mg
Hide Arm/Group Description:
Participants initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-12)
Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
Participants initially randomized to receive 40 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
Overall Number of Participants Analyzed 64 58 63
Measure Type: Number
Unit of Measure: percentage of participants
6.3 3.4 14.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Apremilast 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4938
Comments Adjusted treatment differences in proportions using the weighted average of the treatment differences across the stratum of baseline EASI score stratification (≤ 20, > 20) with, Cochran-Mantel-Haenszel (CMH) weights.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Difference in Proportion
Estimated Value -2.7
Confidence Interval (2-Sided) 95%
-10.2 to 4.8
Estimation Comments 2-sided 95% Confidence Intervals (CI) is based on a normal approximation to the weighted average.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Apremilast 40 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1368
Comments Adjusted treatment differences in proportions using the weighted average of the treatment differences across the stratum of baseline EASI score stratification (≤ 20, > 20) with, CMH weights.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Difference in Proportion
Estimated Value 8.0
Confidence Interval (2-Sided) 95%
-2.3 to 18.2
Estimation Comments 2-sided 95% Confidence Intervals (CI) is based on a normal approximation to the weighted average.
3.Secondary Outcome
Title Percentage of Participants Who Achieved at Least a 50% Reduction From Baseline in the EASI Score (EASI 50) at Week 12
Hide Description The EASI 50 reduction (defined as ≥ 50% reduction from baseline in EASI score) was selected to serve as the key responder endpoint. A ≥ 50% improvement is clinically meaningful for this population.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT includes all participants who were randomized as specified in the protocol and received at least one dose of IP. LOCF.
Arm/Group Title Placebo Apremilast 30 mg Apremilast 40 mg
Hide Arm/Group Description:
Participants initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-12)
Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
Participants initially randomized to receive 40 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
Overall Number of Participants Analyzed 64 58 63
Measure Type: Number
Unit of Measure: percentage of participants
32.8 31.0 42.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Apremilast 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8589
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Difference in Proportion
Estimated Value -1.5
Confidence Interval (2-Sided) 95%
-18.0 to 14.9
Estimation Comments Adjusted differences in proportions was the weighted average of the treatment differences across the stratum of baseline EASI score stratification (≤ 20, > 20) with the CMH weights.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Apremilast 40 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2476
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Difference in Proportion
Estimated Value 9.9
Confidence Interval (2-Sided) 95%
-6.7 to 26.6
Estimation Comments Adjusted differences in proportions was the weighted average of the treatment differences across the stratum of baseline EASI score stratification (≤ 20, > 20) with the CMH weights.
4.Secondary Outcome
Title The Percentage Change From Baseline in the Average Weekly Pruritus Numerical Rating Scale (NRS) Score at Week 4
Hide Description The participant completed a daily diary recording the average intensity of pruritus they experienced during the preceding 24 hrs. The intensity of pruritus was assessed using a validated 11-point NRS, ranging from 0 (“no pruritus”) to 10 (“the worst pruritus imaginable”). It should be noted that this NRS is distinct from the pruritus, Visual Analogue Scale (VAS) in the Modified SCORAD Index with respect to recall period (three days for the VAS). The weekly NRS score was calculated as the average of the NRS scores over 7 days within the specified week. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.
Time Frame Baseline to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized as specified in the protocol and who received at least one dose of IP with a baseline and at least 1 postbaseline value at or before Week 4 were included. LOCF.
Arm/Group Title Placebo Apremilast 30 mg Apremilast 40 mg
Hide Arm/Group Description:
Participants initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-12)
Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
Participants initially randomized to receive 40 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
Overall Number of Participants Analyzed 63 58 59
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-4.83  (5.657) -10.00  (5.911) -9.00  (5.850)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Apremilast 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5286
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -5.17
Confidence Interval (2-Sided) 95%
-21.34 to 10.99
Estimation Comments Based on an analysis of covariance model with the percentage change from baseline as the response variable, treatment group and baseline EASI stratification (≤ 20, > 20) as factors, and the baseline average weekly pruritus NRS score as a covariate.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Apremilast 40 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6092
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -4.17
Confidence Interval (2-Sided) 95%
-20.22 to 11.88
Estimation Comments Based on an analysis of covariance model with the percentage change from baseline as the response variable, treatment group and baseline EASI stratification (≤ 20, > 20) as factors, and the baseline average weekly pruritus NRS score as a covariate.
5.Secondary Outcome
Title Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Placebo Controlled Period
Hide Description A TEAE is an adverse event with a start date on or after the date of the first dose of IP and no later than 28 days after the last dose of IP for participants who discontinued early. An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a pre existing condition) should be considered an AE. A serious AE is any which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect; constitutes an important medical event.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population includes all participants who received at least one dose of IP.
Arm/Group Title Placebo Apremilast 30 mg Apremilast 40 mg
Hide Arm/Group Description:
Participants initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-12)
Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
Participants initially randomized to receive 40 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
Overall Number of Participants Analyzed 64 58 63
Measure Type: Number
Unit of Measure: participants
TEAE 30 36 44
Drug-related TEAE 8 26 27
Severe TEAE 0 0 1
Serious TEAE (SAE) 0 1 2
Drug-related SAE 0 0 1
TEAE Leading to Drug Interruption 3 0 4
TEAE Leading to Drug Withdrawal 1 2 6
Death 0 0 0
6.Secondary Outcome
Title Number of Participants With TEAEs During the Apremilast Exposure Period
Hide Description A TEAE is an adverse event with a start date on or after the date of the first dose of investigational product (IP) and no later than 28 days after the last dose of IP. An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a pre existing condition) should be considered an AE. A serious AE is any which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect; constitutes an important medical event.
Time Frame Baseline to Week 24; median duration of apremilast 30 mg was 23.3 weeks and 22.4 weeks for apremilast 40 mg
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population includes all participants who received at least one dose of IP. These were Apremilast participants as treated.
Arm/Group Title Apremilast 30 mg Apremilast 40 mg
Hide Arm/Group Description:
Participants initially randomized to 30 mg apremilast tablets twice daily in the 12-week placebo-controlled phase and continued receiving 30 mg apremilast tablets twice daily (BID) up to Week 24 in the active treatment, and for participants who were initially randomized to placebo and at week 12 subsequently randomized to 30 mg apremilast tablets twice daily in the active treatment phase.
Participants initially randomized to 40 mg apremilast tablets twice daily in the 12-week placebo-controlled phase and continued receiving 40 mg apremilast tablets twice daily (BID) up to Week 24 in the active treatment phase, and for participants who were initially randomized to placebo and at week 12 subsequently randomized to 40 mg apremilast tablets twice daily in the active treatment phase.
Overall Number of Participants Analyzed 82 86
Measure Type: Number
Unit of Measure: participants
TEAE 49 61
Drug-related TEAE 29 38
Severe TEAE 1 1
Serious TEAE (SAE) 2 3
Drug-related SAE 0 2
TEAE Leading to Drug Interruption 0 8
TEAE Leading to Drug Withdrawal 3 9
Death 0 0
Time Frame Adverse Events are reported for the 12-week placebo-controlled phase and up to 24 weeks for all participants who received apremilast at any time during the study. All TEAEs were recorded by the investigator from the time the participant received the first dose of study drug to no later than 28 days after the last dose of study drug.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo (Weeks 0-12) Apremilast 30 mg (Weeks 0-12) Apremilast 40 mg (Weeks 0-12) Apremilast 30 mg (Apremilast Exposure Period) 0-24 Apremilast 40 mg (Apremilast Exposure Period) 0-24
Hide Arm/Group Description Participants initially randomized to identically matching PBO tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-12) Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled phase. Participants initially randomized to receive 40 mg apremilast tablets twice daily in the 12-week placebo-controlled phase. Participants who received 30 mg PO BID apremilast, regardless of when the apremilast exposure started (at Week 0 or at Week 12 up until Week 24. Participants who received 40 mg PO BID apremilast, regardless of when the apremilast exposure started (at Week 0 or at Week 12 up until Week 24.
All-Cause Mortality
Placebo (Weeks 0-12) Apremilast 30 mg (Weeks 0-12) Apremilast 40 mg (Weeks 0-12) Apremilast 30 mg (Apremilast Exposure Period) 0-24 Apremilast 40 mg (Apremilast Exposure Period) 0-24
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo (Weeks 0-12) Apremilast 30 mg (Weeks 0-12) Apremilast 40 mg (Weeks 0-12) Apremilast 30 mg (Apremilast Exposure Period) 0-24 Apremilast 40 mg (Apremilast Exposure Period) 0-24
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/64 (0.00%)   1/58 (1.72%)   2/63 (3.17%)   2/82 (2.44%)   3/86 (3.49%) 
Infections and infestations           
Cellulitis  1  0/64 (0.00%)  0/58 (0.00%)  1/63 (1.59%)  0/82 (0.00%)  2/86 (2.33%) 
Pneumonia  1  0/64 (0.00%)  0/58 (0.00%)  0/63 (0.00%)  1/82 (1.22%)  0/86 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Squamous Cell Carcinoma  1  0/64 (0.00%)  1/58 (1.72%)  0/63 (0.00%)  1/82 (1.22%)  0/86 (0.00%) 
Psychiatric disorders           
Suicidal ideation  1  0/64 (0.00%)  0/58 (0.00%)  1/63 (1.59%)  0/82 (0.00%)  1/86 (1.16%) 
Renal and urinary disorders           
Glomerulonephritis  1  0/64 (0.00%)  0/58 (0.00%)  1/63 (1.59%)  0/82 (0.00%)  1/86 (1.16%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (18.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo (Weeks 0-12) Apremilast 30 mg (Weeks 0-12) Apremilast 40 mg (Weeks 0-12) Apremilast 30 mg (Apremilast Exposure Period) 0-24 Apremilast 40 mg (Apremilast Exposure Period) 0-24
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   14/64 (21.88%)   22/58 (37.93%)   30/63 (47.62%)   30/82 (36.59%)   45/86 (52.33%) 
Gastrointestinal disorders           
Diarrhoea  1  1/64 (1.56%)  10/58 (17.24%)  15/63 (23.81%)  11/82 (13.41%)  21/86 (24.42%) 
Nausea  1  1/64 (1.56%)  9/58 (15.52%)  7/63 (11.11%)  10/82 (12.20%)  14/86 (16.28%) 
Abdominal discomfort  1  0/64 (0.00%)  3/58 (5.17%)  2/63 (3.17%)  3/82 (3.66%)  2/86 (2.33%) 
Vomiting  1  1/64 (1.56%)  0/58 (0.00%)  3/63 (4.76%)  1/82 (1.22%)  5/86 (5.81%) 
Dyspepsia  1  1/64 (1.56%)  3/58 (5.17%)  0/63 (0.00%)  3/82 (3.66%)  1/86 (1.16%) 
Infections and infestations           
Nasopharyngitis  1  1/64 (1.56%)  6/58 (10.34%)  6/63 (9.52%)  8/82 (9.76%)  14/86 (16.28%) 
Upper respiratory tract infection  1  8/64 (12.50%)  2/58 (3.45%)  3/63 (4.76%)  8/82 (9.76%)  6/86 (6.98%) 
Cellulitis  1  0/64 (0.00%)  0/58 (0.00%)  3/63 (4.76%)  0/82 (0.00%)  5/86 (5.81%) 
Nervous system disorders           
Headache  1  5/64 (7.81%)  4/58 (6.90%)  8/63 (12.70%)  7/82 (8.54%)  8/86 (9.30%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (18.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results from a center cannot be submitted for publication before results of multicenter study are published unless it is > 12 months since study completion. Then, Investigator can publish if manuscript is submitted to Celgene 60 days prior to submission. If Celgene decides publication would hinder drug development, Investigator must delay submission for up to 90 days. Investigator must delete confidential information before submission or defer publication to permit patent applications.
Results Point of Contact
Name/Title: Anne McClain, Senior Manager, Clinical Trial Disclosure
Organization: CelgeneCorp
Phone: 1-888-260-1599
Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT02087943     History of Changes
Other Study ID Numbers: CC-10004-AD-001
First Submitted: March 13, 2014
First Posted: March 14, 2014
Results First Submitted: October 18, 2016
Results First Posted: December 12, 2016
Last Update Posted: April 26, 2017