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Study of Efficacy and Safety of CJM112 in Patients With Moderate to Severe Inflammatory Acne

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ClinicalTrials.gov Identifier: NCT02998671
Recruitment Status : Terminated (Futility)
First Posted : December 20, 2016
Results First Posted : October 10, 2019
Last Update Posted : October 10, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Acne Vulgaris
Interventions Biological: CJM112
Other: Placebo
Enrollment 52
Recruitment Details A total of approximately 75 subjects were planned to be enrolled in the study. The study was terminated early due to futility after a total of 52 subjects were enrolled and randomized.
Pre-assignment Details

For period 1 (12 weeks) subjects were randomized to one of the 3 treatment groups CJM112 high dose, CJM112 low dose or placebo.

For Period 2 (12 weeks) subjects treated with Placebo in Period 1 were rerandomized to CJM112 high dose or CJM112 low dose. All other subjects remained on the same dose.
Arm/Group Title P1: CJM112 High Dose / P2: CJM112 High Dose P1: CJM112 Low Dose / P2: CJM112 Low Dose P1: Placebo / P2: CJM112 High Dose P1: Placebo / P2: CJM112 Low Dose P1: Placebo / P2: NA
Hide Arm/Group Description CJM112 high dose in treatment period 1 (Day 1 - 85) ; CJM112 high dose in extension period 2 (Day 86 - 169) CJM112 low dose in treatment period 1 (Day 1 - 85) ; CJM112 low dose in extension period 2 (Day 86 - 169) Placebo in treatment period 1 (Day 1 - 85); CJM112 high dose in extension period 2 (Day 86 - 169) Placebo in treatment period 1 (Day 1 - 85) ; CJM112 low dose in extension period 2 (Day 86 - 169) Placebo in treatment period 1 (Day 1 - 85); Patients did not enter extension period 2
Period Title: Period 1
Started 21 13 6 8 4
Completed 17 10 6 8 0
Not Completed 4 3 0 0 4
Reason Not Completed
Study Terminated By Sponsor             2             1             0             0             1
Withdrawal by Subject             1             2             0             0             2
Pregnancy             1             0             0             0             0
Adverse Event             0             0             0             0             1
Period Title: Period 2
Started 17 10 6 8 0
Completed 14 3 5 4 0
Not Completed 3 7 1 4 0
Reason Not Completed
Adverse Event             0             1             0             0             0
Study Terminated By Sponsor             3             5             1             3             0
Withdrawal by Subject             0             1             0             0             0
Lost to Follow-up             0             0             0             1             0
Arm/Group Title P1: CJM112 High Dose / P2: CJM112 High Dose P1: CJM112 Low Dose / P2: CJM112 Low Dose P1: Placebo / P2: CJM112 High Dose P1: Placebo / P2: CJM112 Low Dose P1: Placebo / P2: NA Total
Hide Arm/Group Description CJM112 high dose in treatment period 1 (Day 1 - 85) ; CJM112 high dose in extension period 2 (Day 86 - 169) CJM112 low dose in treatment period 1 (Day 1 - 85) ; CJM112 low dose in extension period 2 (Day 86 - 169) Placebo in treatment period 1 (Day 1 - 85); CJM112 high dose in extension period 2 (Day 86 - 169) Placebo in treatment period 1 (Day 1 - 85) ; CJM112 low dose in extension period 2 (Day 86 - 169) Placebo in treatment period 1 (Day 1 - 85); Patients did not enter extension period 2 Total of all reporting groups
Overall Number of Baseline Participants 21 13 6 8 4 52
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants 13 participants 6 participants 8 participants 4 participants 52 participants
23.8  (4.19) 25.5  (5.99) 22.5  (3.21) 25  (4.66) 23.75  (4.35) 24.3  (4.62)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 13 participants 6 participants 8 participants 4 participants 52 participants
Female
13
  61.9%
8
  61.5%
3
  50.0%
6
  75.0%
4
 100.0%
34
  65.4%
Male
8
  38.1%
5
  38.5%
3
  50.0%
2
  25.0%
0
   0.0%
18
  34.6%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 13 participants 6 participants 8 participants 4 participants 52 participants
White
18
  85.7%
10
  76.9%
5
  83.3%
8
 100.0%
4
 100.0%
45
  86.5%
Other
3
  14.3%
3
  23.1%
1
  16.7%
0
   0.0%
0
   0.0%
7
  13.5%
1.Primary Outcome
Title Total Inflammatory Facial Lesion Count at Day 85
Hide Description Total inflammatory facial lesion count was the total count of papules, pustules and nodules assessed at day 85
Time Frame Day 85
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacodynamic analysis set, including only patients completing 12-week assessments.
Arm/Group Title P1: CJM112 High Dose / P2: CJM112 High Dose P1: CJM112 Low Dose / P2: CJM112 Low Dose P1: Placebo / P2 CJM112 Low Dose or High Dose
Hide Arm/Group Description:
CJM112 high dose in treatment period 1 (Day 1 - 85) ; CJM112 high dose in extension period 2 (Day 86 - 169)
CJM112 low dose in treatment period 1 (Day 1 - 85) ; CJM112 low dose in extension period 2 (Day 86 - 169)
Placebo in treatment period 1 (Day 1 - 85) ; CJM112 low dose or CJM112 high dose in extension period 2 (Day 86 - 169)
Overall Number of Participants Analyzed 17 10 15
Geometric Mean (90% Confidence Interval)
Unit of Measure: Lesions
21.9
(16.58 to 29.14)
20.3
(13.76 to 29.66)
18.5
(13.51 to 25.13)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection P1: CJM112 High Dose / P2: CJM112 High Dose, P1: Placebo / P2 CJM112 Low Dose or High Dose
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Comparison at end of Period 1 (P1): CJM112 versus Placebo.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Bayesian model for repeated measurements
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric means
Estimated Value 1.18
Confidence Interval (2-Sided) 90%
0.79 to 1.81
Estimation Comments

Ratio of Geometric Means (CJM112 / Placebo) calculated. A value > 1 indicates a higher number of lesion counts in the CJM112 group.

Bayesian analysis. The “credible interval” was calculated and presented under "confidence interval".
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection P1: CJM112 Low Dose / P2: CJM112 Low Dose, P1: Placebo / P2 CJM112 Low Dose or High Dose
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Comparison at end of Period 1 (P1): CJM112 versus Placebo.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Bayesian model for repeated measurements
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric means
Estimated Value 1.10
Confidence Interval (2-Sided) 90%
0.66 to 1.80
Estimation Comments

Ratio of Geometric Means (CJM112 / Placebo) calculated. A value > 1 indicates a higher number of lesion counts in the CJM112 group.

Bayesian analysis. The “credible interval” was calculated and presented under "confidence interval".
2.Secondary Outcome
Title Number and Severity of Adverse Events in Period 1
Hide Description Frequency and severity of adverse events in Period 1
Time Frame Day 1 to Day 85
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set
Arm/Group Title P1: CJM112 High Dose / P2: CJM112 High Dose P1: CJM112 Low Dose / P2: CJM112 Low Dose P1: Placebo / P2 CJM112 Low Dose or High Dose
Hide Arm/Group Description:
CJM112 high dose in treatment period 1 (Day 1 - 85) ; CJM112 high dose in extension period 2 (Day 86 - 169)
CJM112 low dose in treatment period 1 (Day 1 - 85) ; CJM112 low dose in extension period 2 (Day 86 - 169)
Placebo in treatment period 1 (Day 1 - 85) ; CJM112 low dose or CJM112 high dose in extension period 2 (Day 86 - 169)
Overall Number of Participants Analyzed 21 13 18
Measure Type: Number
Unit of Measure: Adverse Events
Number of AEs of mild intensity 27 25 20
Number of AEs of moderate intensity 5 7 9
Number of AEs of severe intensity 0 1 0
3.Secondary Outcome
Title Number and Severity of Adverse Events in Period 2
Hide Description Frequency and severity of adverse events in Period 2
Time Frame Day 86 to Day 260
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set
Arm/Group Title P1: CJM112 High Dose / P2: CJM112 High Dose P1: CJM112 Low Dose / P2: CJM112 Low Dose P1: Placebo / P2: CJM112 High Dose P1: Placebo / P2: CJM112 Low Dose
Hide Arm/Group Description:
CJM112 high dose in treatment period 1 (Day 1 - 85) ; CJM112 high dose in extension period 2 (Day 86 - 169)
CJM112 low dose in treatment period 1 (Day 1 - 85) ; CJM112 low dose in extension period 2 (Day 86 - 169)
Placebo in treatment period 1; CJM112 high dose in extension period 2
Placebo in treatment period 1; CJM112 low dose in extension period 2
Overall Number of Participants Analyzed 17 10 6 8
Measure Type: Number
Unit of Measure: Adverse Events
Number of AEs of mild intensity 21 20 6 13
Number of AEs of moderate intensity 6 1 3 1
Number of AEs of severe intensity 1 1 0 0
4.Secondary Outcome
Title Pharmacokinetics (PK): Serum Trough Concentrations of CJM112 in Period 1
Hide Description Pharmacokinetics (PK): Serum trough concentrations of CJM112. Concentrations below the lower limit of quantification were reported as 0.
Time Frame Day 1, Day 29, Day 57 and Day 85
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic analysis set
Arm/Group Title P1: CJM112 High Dose / P2: CJM112 High Dose P1: CJM112 Low Dose / P2: CJM112 Low Dose
Hide Arm/Group Description:
CJM112 high dose in treatment period 1 (Day 1 - 85) ; CJM112 high dose in extension period 2 (Day 86 - 169)
CJM112 low dose in treatment period 1 (Day 1 - 85) ; CJM112 low dose in extension period 2 (Day 86 - 169)
Overall Number of Participants Analyzed 21 12
Mean (Standard Deviation)
Unit of Measure: ng/mL
Period 1 Day 1 (Pre Dose) Number Analyzed 19 participants 11 participants
152  (663) 0  (0)
Period 1 Day 29 (Pre Dose) Number Analyzed 20 participants 11 participants
8670  (3370) 802  (961)
Period 1 Day 57 (Pre Dose) Number Analyzed 19 participants 10 participants
11500  (5020) 1550  (1130)
Period 1 Day 85 (Pre Dose) Number Analyzed 16 participants 9 participants
17000  (8080) 2040  (1570)
5.Secondary Outcome
Title Pharmacokinetics (PK): Serum Trough Concentrations of CJM112 in Period 2
Hide Description Pharmacokinetics (PK): Serum trough concentrations of CJM112. Concentrations below the lower limit of quantification were reported as 0.
Time Frame Day 85, Day 113, Day 141 and Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic analysis set
Arm/Group Title P1: CJM112 High Dose / P2: CJM112 High Dose P1: CJM112 Low Dose / P2: CJM112 Low Dose P1: Placebo / P2: CJM112 High Dose P1: Placebo / P2: CJM112 Low Dose
Hide Arm/Group Description:
CJM112 high dose in treatment period 1 (Day 1 - 85) ; CJM112 high dose in extension period 2 (Day 86 - 169)
CJM112 low dose in treatment period 1 (Day 1 - 85) ; CJM112 low dose in extension period 2 (Day 86 - 169)
Placebo in treatment period 1; CJM112 high dose in extension period 2
Placebo in treatment period 1; CJM112 low dose in extension period 2
Overall Number of Participants Analyzed 21 12 6 8
Mean (Standard Deviation)
Unit of Measure: ng/mL
Period 2 Day 85 (Pre Dose) Number Analyzed 16 participants 9 participants 6 participants 8 participants
17000  (8080) 2040  (1570) 713  (1750) 0  (0)
Period 2 Day 113 (Pre Dose) Number Analyzed 16 participants 6 participants 6 participants 7 participants
15900  (8140) 1890  (634) 8260  (5120) 1430  (1190)
Period 2 Day 141 (Pre Dose) Number Analyzed 16 participants 3 participants 5 participants 6 participants
18700  (9450) 3140  (2180) 15700  (10700) 3700  (1250)
Period 2 Day 169 (Pre Dose) Number Analyzed 14 participants 3 participants 5 participants 4 participants
19400  (9650) 3890  (1890) 16600  (6610) 2890  (672)
6.Secondary Outcome
Title Number of Patients With Clinically Significant Abnormal Hematology Laboratory Parameters
Hide Description Abnormalities were considered clinically significant by the Investigator if they could impact the study conduct or safety of the subjects.
Time Frame 38 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title P1: CJM112 High Dose / P2: CJM112 High Dose P1: CJM112 Low Dose / P2: CJM112 Low Dose P1: Placebo / P2: CJM112 High Dose P1: Placebo / P2: CJM112 Low Dose P1: Placebo / P2: NA
Hide Arm/Group Description:
CJM112 high dose in treatment period 1 (Day 1 - 85) ; CJM112 high dose in extension period 2 (Day 86 - 169)
CJM112 low dose in treatment period 1 (Day 1 - 85) ; CJM112 low dose in extension period 2 (Day 86 - 169)
Placebo in treatment period 1 (Day 1 - 85); CJM112 high dose in extension period 2 (Day 86 - 169)
Placebo in treatment period 1 (Day 1 - 85) ; CJM112 low dose in extension period 2 (Day 86 - 169)
Placebo in treatment period 1 (Day 1 - 85); Patients did not enter extension period 2
Overall Number of Participants Analyzed 21 13 6 8 4
Measure Type: Count of Participants
Unit of Measure: Participants
Period 1 Number Analyzed 21 participants 13 participants 6 participants 8 participants 4 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Period 2 Number Analyzed 17 participants 10 participants 6 participants 8 participants 0 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
7.Secondary Outcome
Title Number of Patients With Clinically Significant Abnormal Clinical Chemistry Laboratory Parameters Parameters
Hide Description Abnormalities were considered clinically significant by the Investigator if they could impact the study conduct or safety of the subjects.
Time Frame 38 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title P1: CJM112 High Dose / P2: CJM112 High Dose P1: CJM112 Low Dose / P2: CJM112 Low Dose P1: Placebo / P2: CJM112 High Dose P1: Placebo / P2: CJM112 Low Dose P1: Placebo / P2: NA
Hide Arm/Group Description:
CJM112 high dose in treatment period 1 (Day 1 - 85) ; CJM112 high dose in extension period 2 (Day 86 - 169)
CJM112 low dose in treatment period 1 (Day 1 - 85) ; CJM112 low dose in extension period 2 (Day 86 - 169)
Placebo in treatment period 1 (Day 1 - 85); CJM112 high dose in extension period 2 (Day 86 - 169)
Placebo in treatment period 1 (Day 1 - 85) ; CJM112 low dose in extension period 2 (Day 86 - 169)
Placebo in treatment period 1 (Day 1 - 85); Patients did not enter extension period 2
Overall Number of Participants Analyzed 21 13 6 8 4
Measure Type: Count of Participants
Unit of Measure: Participants
Period 1 Number Analyzed 21 participants 13 participants 6 participants 8 participants 4 participants
3
  14.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Period 2 Number Analyzed 17 participants 10 participants 6 participants 8 participants 0 participants
0
   0.0%
3
  30.0%
1
  16.7%
1
  12.5%
8.Secondary Outcome
Title Number of Patients With Clinically Significant Abnormal Urinalysis Laboratory Parameters
Hide Description Abnormalities were considered clinically significant by the Investigator if they could impact the study conduct or safety of the subjects.
Time Frame 38 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title P1: CJM112 High Dose / P2: CJM112 High Dose P1: CJM112 Low Dose / P2: CJM112 Low Dose P1: Placebo / P2: CJM112 High Dose P1: Placebo / P2: CJM112 Low Dose P1: Placebo / P2: NA
Hide Arm/Group Description:
CJM112 high dose in treatment period 1 (Day 1 - 85) ; CJM112 high dose in extension period 2 (Day 86 - 169)
CJM112 low dose in treatment period 1 (Day 1 - 85) ; CJM112 low dose in extension period 2 (Day 86 - 169)
Placebo in treatment period 1 (Day 1 - 85); CJM112 high dose in extension period 2 (Day 86 - 169)
Placebo in treatment period 1 (Day 1 - 85) ; CJM112 low dose in extension period 2 (Day 86 - 169)
Placebo in treatment period 1 (Day 1 - 85); Patients did not enter extension period 2
Overall Number of Participants Analyzed 21 13 6 8 4
Measure Type: Count of Participants
Unit of Measure: Participants
Period 1 Number Analyzed 21 participants 13 participants 6 participants 8 participants 4 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Period 2 Number Analyzed 17 participants 10 participants 6 participants 8 participants 0 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Time Frame 38 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Period 1: CJM112 High Dose Period 1: CJM112 Low Dose Period 1: Placebo Period 1: Pooled CJM112 Period 2: CJM112 High Dose/CJM112 High Dose Period 2: CJM112 Low Dose/CJM112 Low Dose Period 2: Placebo/ CJM112 High Dose Period 2: Placebo/ CJM112 Low Dose Period 2: Pooled CJM112 High Dose Period 2: Pooled CJM112 Low Dose
Hide Arm/Group Description Period 1: CJM112 high dose Period 1: CJM112 low dose Period 1: Placebo Period 1: Pooled CJM112 CJM112 high dose in treatment period 1; CJM112 high dose in extension period 2 CJM112 low dose in treatment period 1; CJM112 low dose in extension period 2 Placebo in treatment period 1; CJM112 high dose in extension period 2 Placebo in treatment period 1; CJM112 low dose in extension period 2 Period 2: Pooled CJM112 high dose Period 2: Pooled CJM112 low dose
All-Cause Mortality
Period 1: CJM112 High Dose Period 1: CJM112 Low Dose Period 1: Placebo Period 1: Pooled CJM112 Period 2: CJM112 High Dose/CJM112 High Dose Period 2: CJM112 Low Dose/CJM112 Low Dose Period 2: Placebo/ CJM112 High Dose Period 2: Placebo/ CJM112 Low Dose Period 2: Pooled CJM112 High Dose Period 2: Pooled CJM112 Low Dose
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/13 (0.00%)   0/18 (0.00%)   0/34 (0.00%)   0/17 (0.00%)   0/10 (0.00%)   0/6 (0.00%)   0/8 (0.00%)   0/23 (0.00%)   0/18 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Period 1: CJM112 High Dose Period 1: CJM112 Low Dose Period 1: Placebo Period 1: Pooled CJM112 Period 2: CJM112 High Dose/CJM112 High Dose Period 2: CJM112 Low Dose/CJM112 Low Dose Period 2: Placebo/ CJM112 High Dose Period 2: Placebo/ CJM112 Low Dose Period 2: Pooled CJM112 High Dose Period 2: Pooled CJM112 Low Dose
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/13 (0.00%)   0/18 (0.00%)   0/34 (0.00%)   1/17 (5.88%)   0/10 (0.00%)   0/6 (0.00%)   0/8 (0.00%)   1/23 (4.35%)   0/18 (0.00%) 
Hepatobiliary disorders                     
Cholelithiasis † 1  0/21 (0.00%)  0/13 (0.00%)  0/18 (0.00%)  0/34 (0.00%)  1/17 (5.88%)  0/10 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  1/23 (4.35%)  0/18 (0.00%) 
1
Term from vocabulary, MedDRA (21.0)
†
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Period 1: CJM112 High Dose Period 1: CJM112 Low Dose Period 1: Placebo Period 1: Pooled CJM112 Period 2: CJM112 High Dose/CJM112 High Dose Period 2: CJM112 Low Dose/CJM112 Low Dose Period 2: Placebo/ CJM112 High Dose Period 2: Placebo/ CJM112 Low Dose Period 2: Pooled CJM112 High Dose Period 2: Pooled CJM112 Low Dose
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   16/21 (76.19%)   11/13 (84.62%)   10/18 (55.56%)   27/34 (79.41%)   10/17 (58.82%)   9/10 (90.00%)   5/6 (83.33%)   5/8 (62.50%)   15/23 (65.22%)   14/18 (77.78%) 
Blood and lymphatic system disorders                     
Increased tendency to bruise † 1  1/21 (4.76%)  0/13 (0.00%)  0/18 (0.00%)  1/34 (2.94%)  0/17 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/23 (0.00%)  0/18 (0.00%) 
Cardiac disorders                     
Sinus arrest † 1  0/21 (0.00%)  0/13 (0.00%)  0/18 (0.00%)  0/34 (0.00%)  1/17 (5.88%)  0/10 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  1/23 (4.35%)  0/18 (0.00%) 
Supraventricular extrasystoles † 1  0/21 (0.00%)  0/13 (0.00%)  0/18 (0.00%)  0/34 (0.00%)  1/17 (5.88%)  0/10 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  1/23 (4.35%)  0/18 (0.00%) 
Eye disorders                     
Blepharospasm † 1  0/21 (0.00%)  0/13 (0.00%)  0/18 (0.00%)  0/34 (0.00%)  0/17 (0.00%)  0/10 (0.00%)  1/6 (16.67%)  0/8 (0.00%)  1/23 (4.35%)  0/18 (0.00%) 
Dry eye † 1  0/21 (0.00%)  0/13 (0.00%)  0/18 (0.00%)  0/34 (0.00%)  0/17 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  1/8 (12.50%)  0/23 (0.00%)  1/18 (5.56%) 
Eye irritation † 1  0/21 (0.00%)  0/13 (0.00%)  0/18 (0.00%)  0/34 (0.00%)  1/17 (5.88%)  0/10 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  1/23 (4.35%)  0/18 (0.00%) 
Eye pruritus † 1  0/21 (0.00%)  0/13 (0.00%)  0/18 (0.00%)  0/34 (0.00%)  0/17 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  1/8 (12.50%)  0/23 (0.00%)  1/18 (5.56%) 
Gastrointestinal disorders                     
Diarrhoea † 1  1/21 (4.76%)  0/13 (0.00%)  2/18 (11.11%)  1/34 (2.94%)  1/17 (5.88%)  1/10 (10.00%)  1/6 (16.67%)  0/8 (0.00%)  2/23 (8.70%)  1/18 (5.56%) 
Flatulence † 1  0/21 (0.00%)  0/13 (0.00%)  1/18 (5.56%)  0/34 (0.00%)  0/17 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/23 (0.00%)  0/18 (0.00%) 
Frequent bowel movements † 1  0/21 (0.00%)  1/13 (7.69%)  0/18 (0.00%)  1/34 (2.94%)  0/17 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/23 (0.00%)  0/18 (0.00%) 
Inguinal hernia † 1  0/21 (0.00%)  0/13 (0.00%)  0/18 (0.00%)  0/34 (0.00%)  1/17 (5.88%)  0/10 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  1/23 (4.35%)  0/18 (0.00%) 
Lip dry † 1  0/21 (0.00%)  0/13 (0.00%)  0/18 (0.00%)  0/34 (0.00%)  0/17 (0.00%)  1/10 (10.00%)  0/6 (0.00%)  0/8 (0.00%)  0/23 (0.00%)  1/18 (5.56%) 
Nausea † 1  0/21 (0.00%)  0/13 (0.00%)  0/18 (0.00%)  0/34 (0.00%)  1/17 (5.88%)  0/10 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  1/23 (4.35%)  0/18 (0.00%) 
Toothache † 1  1/21 (4.76%)  1/13 (7.69%)  0/18 (0.00%)  2/34 (5.88%)  0/17 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/23 (0.00%)  0/18 (0.00%) 
General disorders                     
Asthenia † 1  0/21 (0.00%)  0/13 (0.00%)  1/18 (5.56%)  0/34 (0.00%)  0/17 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/23 (0.00%)  0/18 (0.00%) 
Fatigue † 1  0/21 (0.00%)  1/13 (7.69%)  1/18 (5.56%)  1/34 (2.94%)  0/17 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/23 (0.00%)  0/18 (0.00%) 
Influenza like illness † 1  1/21 (4.76%)  0/13 (0.00%)  1/18 (5.56%)  1/34 (2.94%)  0/17 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/23 (0.00%)  0/18 (0.00%) 
Injection site bruising † 1  1/21 (4.76%)  0/13 (0.00%)  0/18 (0.00%)  1/34 (2.94%)  0/17 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/23 (0.00%)  0/18 (0.00%) 
Injection site reaction † 1  0/21 (0.00%)  1/13 (7.69%)  0/18 (0.00%)  1/34 (2.94%)  0/17 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/23 (0.00%)  0/18 (0.00%) 
Non-cardiac chest pain † 1  0/21 (0.00%)  0/13 (0.00%)  1/18 (5.56%)  0/34 (0.00%)  0/17 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/23 (0.00%)  0/18 (0.00%) 
Sensation of foreign body † 1  0/21 (0.00%)  0/13 (0.00%)  0/18 (0.00%)  0/34 (0.00%)  1/17 (5.88%)  0/10 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  1/23 (4.35%)  0/18 (0.00%) 
Immune system disorders                     
Hypersensitivity † 1  0/21 (0.00%)  0/13 (0.00%)  1/18 (5.56%)  0/34 (0.00%)  0/17 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/23 (0.00%)  0/18 (0.00%) 
Seasonal allergy † 1  0/21 (0.00%)  0/13 (0.00%)  0/18 (0.00%)  0/34 (0.00%)  0/17 (0.00%)  1/10 (10.00%)  0/6 (0.00%)  0/8 (0.00%)  0/23 (0.00%)  1/18 (5.56%) 
Infections and infestations                     
Bacterial vaginosis † 1  0/21 (0.00%)  1/13 (7.69%)  0/18 (0.00%)  1/34 (2.94%)  0/17 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/23 (0.00%)  0/18 (0.00%) 
Bronchitis † 1  0/21 (0.00%)  1/13 (7.69%)  0/18 (0.00%)  1/34 (2.94%)  0/17 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/23 (0.00%)  0/18 (0.00%) 
Conjunctivitis † 1  0/21 (0.00%)  0/13 (0.00%)  0/18 (0.00%)  0/34 (0.00%)  0/17 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  1/8 (12.50%)  0/23 (0.00%)  1/18 (5.56%) 
Cystitis † 1  1/21 (4.76%)  1/13 (7.69%)  0/18 (0.00%)  2/34 (5.88%)  0/17 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/23 (0.00%)  0/18 (0.00%) 
Fungal skin infection † 1  0/21 (0.00%)  0/13 (0.00%)  0/18 (0.00%)  0/34 (0.00%)  1/17 (5.88%)  0/10 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  1/23 (4.35%)  0/18 (0.00%) 
Gastroenteritis † 1  0/21 (0.00%)  1/13 (7.69%)  0/18 (0.00%)  1/34 (2.94%)  1/17 (5.88%)  0/10 (0.00%)  1/6 (16.67%)  0/8 (0.00%)  2/23 (8.70%)  0/18 (0.00%) 
Gastroenteritis viral † 1  0/21 (0.00%)  1/13 (7.69%)  0/18 (0.00%)  1/34 (2.94%)  0/17 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/23 (0.00%)  0/18 (0.00%) 
Helicobacter gastritis † 1  0/21 (0.00%)  0/13 (0.00%)  0/18 (0.00%)  0/34 (0.00%)  1/17 (5.88%)  0/10 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  1/23 (4.35%)  0/18 (0.00%) 
Laryngitis † 1  1/21 (4.76%)  0/13 (0.00%)  0/18 (0.00%)  1/34 (2.94%)  0/17 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/23 (0.00%)  0/18 (0.00%) 
Nasopharyngitis † 1  3/21 (14.29%)  1/13 (7.69%)  1/18 (5.56%)  4/34 (11.76%)  2/17 (11.76%)  1/10 (10.00%)  0/6 (0.00%)  2/8 (25.00%)  2/23 (8.70%)  3/18 (16.67%) 
Oral herpes † 1  0/21 (0.00%)  0/13 (0.00%)  1/18 (5.56%)  0/34 (0.00%)  0/17 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/23 (0.00%)  0/18 (0.00%) 
Pharyngitis † 1  1/21 (4.76%)  1/13 (7.69%)  0/18 (0.00%)  2/34 (5.88%)  0/17 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/23 (0.00%)  0/18 (0.00%) 
Sinusitis † 1  0/21 (0.00%)  0/13 (0.00%)  0/18 (0.00%)  0/34 (0.00%)  0/17 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  1/8 (12.50%)  0/23 (0.00%)  1/18 (5.56%) 
Tonsillitis † 1  0/21 (0.00%)  0/13 (0.00%)  0/18 (0.00%)  0/34 (0.00%)  1/17 (5.88%)  0/10 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  1/23 (4.35%)  0/18 (0.00%) 
Tooth infection † 1  0/21 (0.00%)  0/13 (0.00%)  0/18 (0.00%)  0/34 (0.00%)  0/17 (0.00%)  0/10 (0.00%)  1/6 (16.67%)  0/8 (0.00%)  1/23 (4.35%)  0/18 (0.00%) 
Upper respiratory tract infection † 1  1/21 (4.76%)  2/13 (15.38%)  0/18 (0.00%)  3/34 (8.82%)  1/17 (5.88%)  2/10 (20.00%)  1/6 (16.67%)  0/8 (0.00%)  2/23 (8.70%)  2/18 (11.11%) 
Urinary tract infection † 1  1/21 (4.76%)  1/13 (7.69%)  1/18 (5.56%)  2/34 (5.88%)  2/17 (11.76%)  0/10 (0.00%)  0/6 (0.00%)  1/8 (12.50%)  2/23 (8.70%)  1/18 (5.56%) 
Vulvovaginal mycotic infection † 1  1/21 (4.76%)  0/13 (0.00%)  0/18 (0.00%)  1/34 (2.94%)  0/17 (0.00%)  1/10 (10.00%)  0/6 (0.00%)  0/8 (0.00%)  0/23 (0.00%)  1/18 (5.56%) 
Injury, poisoning and procedural complications                     
Concussion † 1  0/21 (0.00%)  1/13 (7.69%)  0/18 (0.00%)  1/34 (2.94%)  0/17 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/23 (0.00%)  0/18 (0.00%) 
Joint dislocation † 1  0/21 (0.00%)  0/13 (0.00%)  0/18 (0.00%)  0/34 (0.00%)  0/17 (0.00%)  0/10 (0.00%)  1/6 (16.67%)  0/8 (0.00%)  1/23 (4.35%)  0/18 (0.00%) 
Ligament sprain † 1  0/21 (0.00%)  0/13 (0.00%)  0/18 (0.00%)  0/34 (0.00%)  1/17 (5.88%)  0/10 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  1/23 (4.35%)  0/18 (0.00%) 
Limb injury † 1  0/21 (0.00%)  1/13 (7.69%)  0/18 (0.00%)  1/34 (2.94%)  0/17 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/23 (0.00%)  0/18 (0.00%) 
Road traffic accident † 1  0/21 (0.00%)  1/13 (7.69%)  0/18 (0.00%)  1/34 (2.94%)  0/17 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/23 (0.00%)  0/18 (0.00%) 
Sports injury † 1  0/21 (0.00%)  0/13 (0.00%)  1/18 (5.56%)  0/34 (0.00%)  0/17 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/23 (0.00%)  0/18 (0.00%) 
Wound † 1  1/21 (4.76%)  0/13 (0.00%)  0/18 (0.00%)  1/34 (2.94%)  0/17 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/23 (0.00%)  0/18 (0.00%) 
Investigations                     
Alanine aminotransferase increased † 1  1/21 (4.76%)  0/13 (0.00%)  0/18 (0.00%)  1/34 (2.94%)  0/17 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/23 (0.00%)  0/18 (0.00%) 
Aspartate aminotransferase increased † 1  0/21 (0.00%)  0/13 (0.00%)  0/18 (0.00%)  0/34 (0.00%)  0/17 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  1/8 (12.50%)  0/23 (0.00%)  1/18 (5.56%) 
Blood creatine phosphokinase increased † 1  1/21 (4.76%)  0/13 (0.00%)  0/18 (0.00%)  1/34 (2.94%)  0/17 (0.00%)  2/10 (20.00%)  1/6 (16.67%)  1/8 (12.50%)  1/23 (4.35%)  3/18 (16.67%) 
Blood creatinine increased † 1  0/21 (0.00%)  0/13 (0.00%)  0/18 (0.00%)  0/34 (0.00%)  0/17 (0.00%)  1/10 (10.00%)  0/6 (0.00%)  0/8 (0.00%)  0/23 (0.00%)  1/18 (5.56%) 
Blood triglycerides increased † 1  1/21 (4.76%)  0/13 (0.00%)  0/18 (0.00%)  1/34 (2.94%)  0/17 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/23 (0.00%)  0/18 (0.00%) 
Glucose urine present † 1  1/21 (4.76%)  0/13 (0.00%)  0/18 (0.00%)  1/34 (2.94%)  0/17 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/23 (0.00%)  0/18 (0.00%) 
Metabolism and nutrition disorders                     
Hypoglycaemia † 1  0/21 (0.00%)  0/13 (0.00%)  0/18 (0.00%)  0/34 (0.00%)  0/17 (0.00%)  0/10 (0.00%)  1/6 (16.67%)  0/8 (0.00%)  1/23 (4.35%)  0/18 (0.00%) 
Vitamin D deficiency † 1  0/21 (0.00%)  0/13 (0.00%)  0/18 (0.00%)  0/34 (0.00%)  1/17 (5.88%)  0/10 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  1/23 (4.35%)  0/18 (0.00%) 
Musculoskeletal and connective tissue disorders                     
Arthritis † 1  0/21 (0.00%)  1/13 (7.69%)  0/18 (0.00%)  1/34 (2.94%)  0/17 (0.00%)  1/10 (10.00%)  0/6 (0.00%)  0/8 (0.00%)  0/23 (0.00%)  1/18 (5.56%) 
Back pain † 1  0/21 (0.00%)  1/13 (7.69%)  1/18 (5.56%)  1/34 (2.94%)  1/17 (5.88%)  0/10 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  1/23 (4.35%)  0/18 (0.00%) 
Joint effusion † 1  0/21 (0.00%)  0/13 (0.00%)  0/18 (0.00%)  0/34 (0.00%)  0/17 (0.00%)  1/10 (10.00%)  0/6 (0.00%)  0/8 (0.00%)  0/23 (0.00%)  1/18 (5.56%) 
Myalgia † 1  0/21 (0.00%)  0/13 (0.00%)  0/18 (0.00%)  0/34 (0.00%)  0/17 (0.00%)  1/10 (10.00%)  0/6 (0.00%)  1/8 (12.50%)  0/23 (0.00%)  2/18 (11.11%) 
Neck pain † 1  0/21 (0.00%)  1/13 (7.69%)  0/18 (0.00%)  1/34 (2.94%)  0/17 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/23 (0.00%)  0/18 (0.00%) 
Pain in extremity † 1  1/21 (4.76%)  0/13 (0.00%)  0/18 (0.00%)  1/34 (2.94%)  0/17 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/23 (0.00%)  0/18 (0.00%) 
Nervous system disorders                     
Headache † 1  1/21 (4.76%)  3/13 (23.08%)  1/18 (5.56%)  4/34 (11.76%)  1/17 (5.88%)  0/10 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  1/23 (4.35%)  0/18 (0.00%) 
Psychiatric disorders                     
Depression † 1  0/21 (0.00%)  0/13 (0.00%)  1/18 (5.56%)  0/34 (0.00%)  0/17 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/23 (0.00%)  0/18 (0.00%) 
Renal and urinary disorders                     
Micturition urgency † 1  1/21 (4.76%)  0/13 (0.00%)  0/18 (0.00%)  1/34 (2.94%)  0/17 (0.00%)  1/10 (10.00%)  0/6 (0.00%)  0/8 (0.00%)  0/23 (0.00%)  1/18 (5.56%) 
Pollakiuria † 1  1/21 (4.76%)  0/13 (0.00%)  0/18 (0.00%)  1/34 (2.94%)  0/17 (0.00%)  1/10 (10.00%)  0/6 (0.00%)  0/8 (0.00%)  0/23 (0.00%)  1/18 (5.56%) 
Proteinuria † 1  0/21 (0.00%)  0/13 (0.00%)  0/18 (0.00%)  0/34 (0.00%)  0/17 (0.00%)  2/10 (20.00%)  0/6 (0.00%)  1/8 (12.50%)  0/23 (0.00%)  3/18 (16.67%) 
Reproductive system and breast disorders                     
Dysmenorrhoea † 1  0/21 (0.00%)  1/13 (7.69%)  0/18 (0.00%)  1/34 (2.94%)  0/17 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/23 (0.00%)  0/18 (0.00%) 
Respiratory, thoracic and mediastinal disorders                     
Cough † 1  0/21 (0.00%)  1/13 (7.69%)  0/18 (0.00%)  1/34 (2.94%)  0/17 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/23 (0.00%)  0/18 (0.00%) 
Dyspnoea † 1  0/21 (0.00%)  0/13 (0.00%)  1/18 (5.56%)  0/34 (0.00%)  0/17 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/23 (0.00%)  0/18 (0.00%) 
Nasal congestion † 1  0/21 (0.00%)  0/13 (0.00%)  0/18 (0.00%)  0/34 (0.00%)  1/17 (5.88%)  0/10 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  1/23 (4.35%)  0/18 (0.00%) 
Oropharyngeal pain † 1  1/21 (4.76%)  1/13 (7.69%)  0/18 (0.00%)  2/34 (5.88%)  0/17 (0.00%)  1/10 (10.00%)  0/6 (0.00%)  1/8 (12.50%)  0/23 (0.00%)  2/18 (11.11%) 
Rhinorrhoea † 1  1/21 (4.76%)  0/13 (0.00%)  0/18 (0.00%)  1/34 (2.94%)  0/17 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/23 (0.00%)  0/18 (0.00%) 
Skin and subcutaneous tissue disorders                     
Acne † 1  0/21 (0.00%)  2/13 (15.38%)  0/18 (0.00%)  2/34 (5.88%)  0/17 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/23 (0.00%)  0/18 (0.00%) 
Dermal cyst † 1  1/21 (4.76%)  0/13 (0.00%)  0/18 (0.00%)  1/34 (2.94%)  0/17 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/23 (0.00%)  0/18 (0.00%) 
Dermatitis † 1  0/21 (0.00%)  0/13 (0.00%)  1/18 (5.56%)  0/34 (0.00%)  0/17 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/23 (0.00%)  0/18 (0.00%) 
Diffuse alopecia † 1  0/21 (0.00%)  0/13 (0.00%)  1/18 (5.56%)  0/34 (0.00%)  0/17 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/23 (0.00%)  0/18 (0.00%) 
Dry skin † 1  2/21 (9.52%)  0/13 (0.00%)  2/18 (11.11%)  2/34 (5.88%)  0/17 (0.00%)  1/10 (10.00%)  0/6 (0.00%)  0/8 (0.00%)  0/23 (0.00%)  1/18 (5.56%) 
Erythema † 1  0/21 (0.00%)  0/13 (0.00%)  0/18 (0.00%)  0/34 (0.00%)  1/17 (5.88%)  0/10 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  1/23 (4.35%)  0/18 (0.00%) 
Papule † 1  0/21 (0.00%)  0/13 (0.00%)  0/18 (0.00%)  0/34 (0.00%)  0/17 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  1/8 (12.50%)  0/23 (0.00%)  1/18 (5.56%) 
Pityriasis rosea † 1  0/21 (0.00%)  1/13 (7.69%)  0/18 (0.00%)  1/34 (2.94%)  0/17 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/23 (0.00%)  0/18 (0.00%) 
Pruritus † 1  1/21 (4.76%)  0/13 (0.00%)  3/18 (16.67%)  1/34 (2.94%)  0/17 (0.00%)  0/10 (0.00%)  1/6 (16.67%)  0/8 (0.00%)  1/23 (4.35%)  0/18 (0.00%) 
Psoriasis † 1  0/21 (0.00%)  0/13 (0.00%)  1/18 (5.56%)  0/34 (0.00%)  0/17 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/23 (0.00%)  0/18 (0.00%) 
Rash maculo-papular † 1  0/21 (0.00%)  0/13 (0.00%)  1/18 (5.56%)  0/34 (0.00%)  0/17 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/23 (0.00%)  0/18 (0.00%) 
Urticaria † 1  0/21 (0.00%)  0/13 (0.00%)  1/18 (5.56%)  0/34 (0.00%)  0/17 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/8 (0.00%)  0/23 (0.00%)  0/18 (0.00%) 
1
Term from vocabulary, MedDRA (21.0)
†
Indicates events were collected by systematic assessment
[Not Specified]
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.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
EMail: novartis.email@novartis.com
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT02998671     History of Changes
Other Study ID Numbers: CCJM112X2203
First Submitted: December 13, 2016
First Posted: December 20, 2016
Results First Submitted: July 31, 2019
Results First Posted: October 10, 2019
Last Update Posted: October 10, 2019