Trial Outcomes & Findings for Study of Efficacy and Safety of CJM112 in Patients With Moderate to Severe Inflammatory Acne (NCT NCT02998671)
NCT ID: NCT02998671
Last Updated: 2022-07-12
Results Overview
Total inflammatory facial lesion count was the total count of papules, pustules and nodules assessed at day 85
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
52 participants
Primary outcome timeframe
Day 85
Results posted on
2022-07-12
Participant Flow
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.
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.
Participant milestones
| Measure |
P1: CJM112 High Dose / P2: CJM112 High Dose
CJM112 high dose (300mg) in treatment period 1 (Day 1 - 85) ; CJM112 high dose (300mg) in extension period 2 (Day 86 - 169)
|
P1: CJM112 Low Dose / P2: CJM112 Low Dose
CJM112 low dose (75mg) in treatment period 1 (Day 1 - 85) ; CJM112 low dose (75mg) in extension period 2 (Day 86 - 169)
|
P1: Placebo / P2: CJM112 High Dose
Placebo in treatment period 1 (Day 1 - 85); CJM112 high dose (300mg) in extension period 2 (Day 86 - 169)
|
P1: Placebo / P2: CJM112 Low Dose
Placebo in treatment period 1 (Day 1 - 85) ; CJM112 low dose (75mg) in extension period 2 (Day 86 - 169)
|
P1: Placebo / P2: NA
Placebo in treatment period 1 (Day 1 - 85); Patients did not enter extension period 2
|
|---|---|---|---|---|---|
|
Period 1
STARTED
|
21
|
13
|
6
|
8
|
4
|
|
Period 1
COMPLETED
|
17
|
10
|
6
|
8
|
0
|
|
Period 1
NOT COMPLETED
|
4
|
3
|
0
|
0
|
4
|
|
Period 2
STARTED
|
17
|
10
|
6
|
8
|
0
|
|
Period 2
COMPLETED
|
14
|
3
|
5
|
4
|
0
|
|
Period 2
NOT COMPLETED
|
3
|
7
|
1
|
4
|
0
|
Reasons for withdrawal
| Measure |
P1: CJM112 High Dose / P2: CJM112 High Dose
CJM112 high dose (300mg) in treatment period 1 (Day 1 - 85) ; CJM112 high dose (300mg) in extension period 2 (Day 86 - 169)
|
P1: CJM112 Low Dose / P2: CJM112 Low Dose
CJM112 low dose (75mg) in treatment period 1 (Day 1 - 85) ; CJM112 low dose (75mg) in extension period 2 (Day 86 - 169)
|
P1: Placebo / P2: CJM112 High Dose
Placebo in treatment period 1 (Day 1 - 85); CJM112 high dose (300mg) in extension period 2 (Day 86 - 169)
|
P1: Placebo / P2: CJM112 Low Dose
Placebo in treatment period 1 (Day 1 - 85) ; CJM112 low dose (75mg) in extension period 2 (Day 86 - 169)
|
P1: Placebo / P2: NA
Placebo in treatment period 1 (Day 1 - 85); Patients did not enter extension period 2
|
|---|---|---|---|---|---|
|
Period 1
Study Terminated By Sponsor
|
2
|
1
|
0
|
0
|
1
|
|
Period 1
Withdrawal by Subject
|
1
|
2
|
0
|
0
|
2
|
|
Period 1
Pregnancy
|
1
|
0
|
0
|
0
|
0
|
|
Period 1
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
|
Period 2
Adverse Event
|
0
|
1
|
0
|
0
|
0
|
|
Period 2
Study Terminated By Sponsor
|
3
|
5
|
1
|
3
|
0
|
|
Period 2
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
|
Period 2
Lost to Follow-up
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Study of Efficacy and Safety of CJM112 in Patients With Moderate to Severe Inflammatory Acne
Baseline characteristics by cohort
| Measure |
P1: CJM112 High Dose / P2: CJM112 High Dose
n=21 Participants
CJM112 high dose (300mg) in treatment period 1 (Day 1 - 85) ; CJM112 high dose (300mg) in extension period 2 (Day 86 - 169)
|
P1: CJM112 Low Dose / P2: CJM112 Low Dose
n=13 Participants
CJM112 low dose (75mg) in treatment period 1 (Day 1 - 85) ; CJM112 low dose (75mg) in extension period 2 (Day 86 - 169)
|
P1: Placebo / P2: CJM112 High Dose
n=6 Participants
Placebo in treatment period 1 (Day 1 - 85); CJM112 high dose (300mg) in extension period 2 (Day 86 - 169)
|
P1: Placebo / P2: CJM112 Low Dose
n=8 Participants
Placebo in treatment period 1 (Day 1 - 85) ; CJM112 low dose (75mg) in extension period 2 (Day 86 - 169)
|
P1: Placebo / P2: NA
n=4 Participants
Placebo in treatment period 1 (Day 1 - 85); Patients did not enter extension period 2
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
23.8 years
STANDARD_DEVIATION 4.19 • n=5 Participants
|
25.5 years
STANDARD_DEVIATION 5.99 • n=7 Participants
|
22.5 years
STANDARD_DEVIATION 3.21 • n=5 Participants
|
25 years
STANDARD_DEVIATION 4.66 • n=4 Participants
|
23.75 years
STANDARD_DEVIATION 4.35 • n=21 Participants
|
24.3 years
STANDARD_DEVIATION 4.62 • n=8 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
34 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
18 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White
|
18 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
45 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Day 85Population: Pharmacodynamic analysis set, including only patients completing 12-week assessments.
Total inflammatory facial lesion count was the total count of papules, pustules and nodules assessed at day 85
Outcome measures
| Measure |
P1: CJM112 High Dose / P2: CJM112 High Dose
n=17 Participants
CJM112 high dose (300mg) in treatment period 1 (Day 1 - 85) ; CJM112 high dose (300mg) in extension period 2 (Day 86 - 169)
|
P1: CJM112 Low Dose / P2: CJM112 Low Dose
n=10 Participants
CJM112 low dose (75mg) in treatment period 1 (Day 1 - 85) ; CJM112 low dose (75mg) in extension period 2 (Day 86 - 169)
|
P1: Placebo / P2 CJM112 Low Dose or High Dose
n=15 Participants
Placebo in treatment period 1 (Day 1 - 85) ; CJM112 low dose or CJM112 high dose in extension period 2 (Day 86 - 169)
|
P1: Placebo / P2: CJM112 Low Dose
Placebo in treatment period 1; CJM112 low dose in extension period 2
|
P1: Placebo / P2: NA
Placebo in treatment period 1 (Day 1 - 85); Patients did not enter extension period 2
|
|---|---|---|---|---|---|
|
Total Inflammatory Facial Lesion Count at Day 85
|
21.9 Lesions
Interval 16.58 to 29.14
|
20.3 Lesions
Interval 13.76 to 29.66
|
18.5 Lesions
Interval 13.51 to 25.13
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 to Day 85Population: Safety analysis set
Frequency and severity of adverse events in Period 1
Outcome measures
| Measure |
P1: CJM112 High Dose / P2: CJM112 High Dose
n=21 Participants
CJM112 high dose (300mg) in treatment period 1 (Day 1 - 85) ; CJM112 high dose (300mg) in extension period 2 (Day 86 - 169)
|
P1: CJM112 Low Dose / P2: CJM112 Low Dose
n=13 Participants
CJM112 low dose (75mg) in treatment period 1 (Day 1 - 85) ; CJM112 low dose (75mg) in extension period 2 (Day 86 - 169)
|
P1: Placebo / P2 CJM112 Low Dose or High Dose
n=18 Participants
Placebo in treatment period 1 (Day 1 - 85) ; CJM112 low dose or CJM112 high dose in extension period 2 (Day 86 - 169)
|
P1: Placebo / P2: CJM112 Low Dose
Placebo in treatment period 1; CJM112 low dose in extension period 2
|
P1: Placebo / P2: NA
Placebo in treatment period 1 (Day 1 - 85); Patients did not enter extension period 2
|
|---|---|---|---|---|---|
|
Number and Severity of Adverse Events in Period 1
Number of AEs of mild intensity
|
27 Adverse Events
|
25 Adverse Events
|
20 Adverse Events
|
—
|
—
|
|
Number and Severity of Adverse Events in Period 1
Number of AEs of moderate intensity
|
5 Adverse Events
|
7 Adverse Events
|
9 Adverse Events
|
—
|
—
|
|
Number and Severity of Adverse Events in Period 1
Number of AEs of severe intensity
|
0 Adverse Events
|
1 Adverse Events
|
0 Adverse Events
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 86 to Day 260Population: Safety analysis set
Frequency and severity of adverse events in Period 2
Outcome measures
| Measure |
P1: CJM112 High Dose / P2: CJM112 High Dose
n=17 Participants
CJM112 high dose (300mg) in treatment period 1 (Day 1 - 85) ; CJM112 high dose (300mg) in extension period 2 (Day 86 - 169)
|
P1: CJM112 Low Dose / P2: CJM112 Low Dose
n=10 Participants
CJM112 low dose (75mg) in treatment period 1 (Day 1 - 85) ; CJM112 low dose (75mg) in extension period 2 (Day 86 - 169)
|
P1: Placebo / P2 CJM112 Low Dose or High Dose
n=6 Participants
Placebo in treatment period 1 (Day 1 - 85) ; CJM112 low dose or CJM112 high dose in extension period 2 (Day 86 - 169)
|
P1: Placebo / P2: CJM112 Low Dose
n=8 Participants
Placebo in treatment period 1; CJM112 low dose in extension period 2
|
P1: Placebo / P2: NA
Placebo in treatment period 1 (Day 1 - 85); Patients did not enter extension period 2
|
|---|---|---|---|---|---|
|
Number and Severity of Adverse Events in Period 2
Number of AEs of mild intensity
|
21 Adverse Events
|
20 Adverse Events
|
6 Adverse Events
|
13 Adverse Events
|
—
|
|
Number and Severity of Adverse Events in Period 2
Number of AEs of moderate intensity
|
6 Adverse Events
|
1 Adverse Events
|
3 Adverse Events
|
1 Adverse Events
|
—
|
|
Number and Severity of Adverse Events in Period 2
Number of AEs of severe intensity
|
1 Adverse Events
|
1 Adverse Events
|
0 Adverse Events
|
0 Adverse Events
|
—
|
SECONDARY outcome
Timeframe: Day 1, Day 29, Day 57 and Day 85Population: Pharmacokinetic analysis set
Pharmacokinetics (PK): Serum trough concentrations of CJM112. Concentrations below the lower limit of quantification were reported as 0.
Outcome measures
| Measure |
P1: CJM112 High Dose / P2: CJM112 High Dose
n=21 Participants
CJM112 high dose (300mg) in treatment period 1 (Day 1 - 85) ; CJM112 high dose (300mg) in extension period 2 (Day 86 - 169)
|
P1: CJM112 Low Dose / P2: CJM112 Low Dose
n=12 Participants
CJM112 low dose (75mg) in treatment period 1 (Day 1 - 85) ; CJM112 low dose (75mg) in extension period 2 (Day 86 - 169)
|
P1: Placebo / P2 CJM112 Low Dose or High Dose
Placebo in treatment period 1 (Day 1 - 85) ; CJM112 low dose or CJM112 high dose in extension period 2 (Day 86 - 169)
|
P1: Placebo / P2: CJM112 Low Dose
Placebo in treatment period 1; CJM112 low dose in extension period 2
|
P1: Placebo / P2: NA
Placebo in treatment period 1 (Day 1 - 85); Patients did not enter extension period 2
|
|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Serum Trough Concentrations of CJM112 in Period 1
Period 1 Day 1 (Pre Dose)
|
152 ng/mL
Standard Deviation 663
|
0 ng/mL
Standard Deviation 0
|
—
|
—
|
—
|
|
Pharmacokinetics (PK): Serum Trough Concentrations of CJM112 in Period 1
Period 1 Day 29 (Pre Dose)
|
8670 ng/mL
Standard Deviation 3370
|
802 ng/mL
Standard Deviation 961
|
—
|
—
|
—
|
|
Pharmacokinetics (PK): Serum Trough Concentrations of CJM112 in Period 1
Period 1 Day 57 (Pre Dose)
|
11500 ng/mL
Standard Deviation 5020
|
1550 ng/mL
Standard Deviation 1130
|
—
|
—
|
—
|
|
Pharmacokinetics (PK): Serum Trough Concentrations of CJM112 in Period 1
Period 1 Day 85 (Pre Dose)
|
17000 ng/mL
Standard Deviation 8080
|
2040 ng/mL
Standard Deviation 1570
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 85, Day 113, Day 141 and Day 169Population: Pharmacokinetic analysis set
Pharmacokinetics (PK): Serum trough concentrations of CJM112. Concentrations below the lower limit of quantification were reported as 0.
Outcome measures
| Measure |
P1: CJM112 High Dose / P2: CJM112 High Dose
n=21 Participants
CJM112 high dose (300mg) in treatment period 1 (Day 1 - 85) ; CJM112 high dose (300mg) in extension period 2 (Day 86 - 169)
|
P1: CJM112 Low Dose / P2: CJM112 Low Dose
n=12 Participants
CJM112 low dose (75mg) in treatment period 1 (Day 1 - 85) ; CJM112 low dose (75mg) in extension period 2 (Day 86 - 169)
|
P1: Placebo / P2 CJM112 Low Dose or High Dose
n=6 Participants
Placebo in treatment period 1 (Day 1 - 85) ; CJM112 low dose or CJM112 high dose in extension period 2 (Day 86 - 169)
|
P1: Placebo / P2: CJM112 Low Dose
n=8 Participants
Placebo in treatment period 1; CJM112 low dose in extension period 2
|
P1: Placebo / P2: NA
Placebo in treatment period 1 (Day 1 - 85); Patients did not enter extension period 2
|
|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Serum Trough Concentrations of CJM112 in Period 2
Period 2 Day 113 (Pre Dose)
|
15900 ng/mL
Standard Deviation 8140
|
1890 ng/mL
Standard Deviation 634
|
8260 ng/mL
Standard Deviation 5120
|
1430 ng/mL
Standard Deviation 1190
|
—
|
|
Pharmacokinetics (PK): Serum Trough Concentrations of CJM112 in Period 2
Period 2 Day 85 (Pre Dose)
|
17000 ng/mL
Standard Deviation 8080
|
2040 ng/mL
Standard Deviation 1570
|
713 ng/mL
Standard Deviation 1750
|
0 ng/mL
Standard Deviation 0
|
—
|
|
Pharmacokinetics (PK): Serum Trough Concentrations of CJM112 in Period 2
Period 2 Day 141 (Pre Dose)
|
18700 ng/mL
Standard Deviation 9450
|
3140 ng/mL
Standard Deviation 2180
|
15700 ng/mL
Standard Deviation 10700
|
3700 ng/mL
Standard Deviation 1250
|
—
|
|
Pharmacokinetics (PK): Serum Trough Concentrations of CJM112 in Period 2
Period 2 Day 169 (Pre Dose)
|
19400 ng/mL
Standard Deviation 9650
|
3890 ng/mL
Standard Deviation 1890
|
16600 ng/mL
Standard Deviation 6610
|
2890 ng/mL
Standard Deviation 672
|
—
|
SECONDARY outcome
Timeframe: 38 WeeksPopulation: Safety Analysis Set
Abnormalities were considered clinically significant by the Investigator if they could impact the study conduct or safety of the subjects.
Outcome measures
| Measure |
P1: CJM112 High Dose / P2: CJM112 High Dose
n=21 Participants
CJM112 high dose (300mg) in treatment period 1 (Day 1 - 85) ; CJM112 high dose (300mg) in extension period 2 (Day 86 - 169)
|
P1: CJM112 Low Dose / P2: CJM112 Low Dose
n=13 Participants
CJM112 low dose (75mg) in treatment period 1 (Day 1 - 85) ; CJM112 low dose (75mg) in extension period 2 (Day 86 - 169)
|
P1: Placebo / P2 CJM112 Low Dose or High Dose
n=6 Participants
Placebo in treatment period 1 (Day 1 - 85) ; CJM112 low dose or CJM112 high dose in extension period 2 (Day 86 - 169)
|
P1: Placebo / P2: CJM112 Low Dose
n=8 Participants
Placebo in treatment period 1; CJM112 low dose in extension period 2
|
P1: Placebo / P2: NA
n=4 Participants
Placebo in treatment period 1 (Day 1 - 85); Patients did not enter extension period 2
|
|---|---|---|---|---|---|
|
Number of Patients With Clinically Significant Abnormal Hematology Laboratory Parameters
Period 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Clinically Significant Abnormal Hematology Laboratory Parameters
Period 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 38 WeeksPopulation: Safety Analysis Set
Abnormalities were considered clinically significant by the Investigator if they could impact the study conduct or safety of the subjects.
Outcome measures
| Measure |
P1: CJM112 High Dose / P2: CJM112 High Dose
n=21 Participants
CJM112 high dose (300mg) in treatment period 1 (Day 1 - 85) ; CJM112 high dose (300mg) in extension period 2 (Day 86 - 169)
|
P1: CJM112 Low Dose / P2: CJM112 Low Dose
n=13 Participants
CJM112 low dose (75mg) in treatment period 1 (Day 1 - 85) ; CJM112 low dose (75mg) in extension period 2 (Day 86 - 169)
|
P1: Placebo / P2 CJM112 Low Dose or High Dose
n=6 Participants
Placebo in treatment period 1 (Day 1 - 85) ; CJM112 low dose or CJM112 high dose in extension period 2 (Day 86 - 169)
|
P1: Placebo / P2: CJM112 Low Dose
n=8 Participants
Placebo in treatment period 1; CJM112 low dose in extension period 2
|
P1: Placebo / P2: NA
n=4 Participants
Placebo in treatment period 1 (Day 1 - 85); Patients did not enter extension period 2
|
|---|---|---|---|---|---|
|
Number of Patients With Clinically Significant Abnormal Clinical Chemistry Laboratory Parameters Parameters
Period 1
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Clinically Significant Abnormal Clinical Chemistry Laboratory Parameters Parameters
Period 2
|
0 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: 38 WeeksPopulation: Safety Analysis Set
Abnormalities were considered clinically significant by the Investigator if they could impact the study conduct or safety of the subjects.
Outcome measures
| Measure |
P1: CJM112 High Dose / P2: CJM112 High Dose
n=21 Participants
CJM112 high dose (300mg) in treatment period 1 (Day 1 - 85) ; CJM112 high dose (300mg) in extension period 2 (Day 86 - 169)
|
P1: CJM112 Low Dose / P2: CJM112 Low Dose
n=13 Participants
CJM112 low dose (75mg) in treatment period 1 (Day 1 - 85) ; CJM112 low dose (75mg) in extension period 2 (Day 86 - 169)
|
P1: Placebo / P2 CJM112 Low Dose or High Dose
n=6 Participants
Placebo in treatment period 1 (Day 1 - 85) ; CJM112 low dose or CJM112 high dose in extension period 2 (Day 86 - 169)
|
P1: Placebo / P2: CJM112 Low Dose
n=8 Participants
Placebo in treatment period 1; CJM112 low dose in extension period 2
|
P1: Placebo / P2: NA
n=4 Participants
Placebo in treatment period 1 (Day 1 - 85); Patients did not enter extension period 2
|
|---|---|---|---|---|---|
|
Number of Patients With Clinically Significant Abnormal Urinalysis Laboratory Parameters
Period 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Clinically Significant Abnormal Urinalysis Laboratory Parameters
Period 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
Adverse Events
Period 1: CJM112 High Dose
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Period 1: CJM112 Low Dose
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Period 1: Placebo
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Period 1: Pooled CJM112
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
Period 2: CJM112 High Dose/CJM112 High Dose
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Period 2: CJM112 Low Dose/CJM112 Low Dose
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Period 2: Placebo/ CJM112 High Dose
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Period 2: Placebo/ CJM112 Low Dose
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Period 2: Pooled CJM112 High Dose
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Period 2: Pooled CJM112 Low Dose
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Period 1: CJM112 High Dose
n=21 participants at risk
Period 1: CJM112 high dose (300mg)
|
Period 1: CJM112 Low Dose
n=13 participants at risk
Period 1: CJM112 low dose (75mg)
|
Period 1: Placebo
n=18 participants at risk
Period 1: Placebo
|
Period 1: Pooled CJM112
n=34 participants at risk
Period 1: Pooled CJM112
|
Period 2: CJM112 High Dose/CJM112 High Dose
n=17 participants at risk
CJM112 high dose (300mg) in treatment period 1; CJM112 high dose (300mg) in extension period 2
|
Period 2: CJM112 Low Dose/CJM112 Low Dose
n=10 participants at risk
CJM112 low dose (75mg) in treatment period 1 ; CJM112 low dose (75mg) in extension period 2
|
Period 2: Placebo/ CJM112 High Dose
n=6 participants at risk
Placebo in treatment period 1; CJM112 high dose (300mg) in extension period 2
|
Period 2: Placebo/ CJM112 Low Dose
n=8 participants at risk
Placebo in treatment period 1; CJM112 low dose (75mg) in extension period 2
|
Period 2: Pooled CJM112 High Dose
n=23 participants at risk
Period 2: Pooled CJM112 high dose (300mg)
|
Period 2: Pooled CJM112 Low Dose
n=18 participants at risk
Period 2: Pooled CJM112 low dose (75mg)
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/21 • 38 weeks
|
0.00%
0/13 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
0.00%
0/34 • 38 weeks
|
5.9%
1/17 • 38 weeks
|
0.00%
0/10 • 38 weeks
|
0.00%
0/6 • 38 weeks
|
0.00%
0/8 • 38 weeks
|
4.3%
1/23 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
Other adverse events
| Measure |
Period 1: CJM112 High Dose
n=21 participants at risk
Period 1: CJM112 high dose (300mg)
|
Period 1: CJM112 Low Dose
n=13 participants at risk
Period 1: CJM112 low dose (75mg)
|
Period 1: Placebo
n=18 participants at risk
Period 1: Placebo
|
Period 1: Pooled CJM112
n=34 participants at risk
Period 1: Pooled CJM112
|
Period 2: CJM112 High Dose/CJM112 High Dose
n=17 participants at risk
CJM112 high dose (300mg) in treatment period 1; CJM112 high dose (300mg) in extension period 2
|
Period 2: CJM112 Low Dose/CJM112 Low Dose
n=10 participants at risk
CJM112 low dose (75mg) in treatment period 1 ; CJM112 low dose (75mg) in extension period 2
|
Period 2: Placebo/ CJM112 High Dose
n=6 participants at risk
Placebo in treatment period 1; CJM112 high dose (300mg) in extension period 2
|
Period 2: Placebo/ CJM112 Low Dose
n=8 participants at risk
Placebo in treatment period 1; CJM112 low dose (75mg) in extension period 2
|
Period 2: Pooled CJM112 High Dose
n=23 participants at risk
Period 2: Pooled CJM112 high dose (300mg)
|
Period 2: Pooled CJM112 Low Dose
n=18 participants at risk
Period 2: Pooled CJM112 low dose (75mg)
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.8%
1/21 • 38 weeks
|
7.7%
1/13 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
5.9%
2/34 • 38 weeks
|
0.00%
0/17 • 38 weeks
|
10.0%
1/10 • 38 weeks
|
0.00%
0/6 • 38 weeks
|
12.5%
1/8 • 38 weeks
|
0.00%
0/23 • 38 weeks
|
11.1%
2/18 • 38 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
4.8%
1/21 • 38 weeks
|
0.00%
0/13 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
2.9%
1/34 • 38 weeks
|
0.00%
0/17 • 38 weeks
|
0.00%
0/10 • 38 weeks
|
0.00%
0/6 • 38 weeks
|
0.00%
0/8 • 38 weeks
|
0.00%
0/23 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/21 • 38 weeks
|
15.4%
2/13 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
5.9%
2/34 • 38 weeks
|
0.00%
0/17 • 38 weeks
|
0.00%
0/10 • 38 weeks
|
0.00%
0/6 • 38 weeks
|
0.00%
0/8 • 38 weeks
|
0.00%
0/23 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
4.8%
1/21 • 38 weeks
|
0.00%
0/13 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
2.9%
1/34 • 38 weeks
|
0.00%
0/17 • 38 weeks
|
0.00%
0/10 • 38 weeks
|
0.00%
0/6 • 38 weeks
|
0.00%
0/8 • 38 weeks
|
0.00%
0/23 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/21 • 38 weeks
|
0.00%
0/13 • 38 weeks
|
5.6%
1/18 • 38 weeks
|
0.00%
0/34 • 38 weeks
|
0.00%
0/17 • 38 weeks
|
0.00%
0/10 • 38 weeks
|
0.00%
0/6 • 38 weeks
|
0.00%
0/8 • 38 weeks
|
0.00%
0/23 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
|
Skin and subcutaneous tissue disorders
Diffuse alopecia
|
0.00%
0/21 • 38 weeks
|
0.00%
0/13 • 38 weeks
|
5.6%
1/18 • 38 weeks
|
0.00%
0/34 • 38 weeks
|
0.00%
0/17 • 38 weeks
|
0.00%
0/10 • 38 weeks
|
0.00%
0/6 • 38 weeks
|
0.00%
0/8 • 38 weeks
|
0.00%
0/23 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
9.5%
2/21 • 38 weeks
|
0.00%
0/13 • 38 weeks
|
11.1%
2/18 • 38 weeks
|
5.9%
2/34 • 38 weeks
|
0.00%
0/17 • 38 weeks
|
10.0%
1/10 • 38 weeks
|
0.00%
0/6 • 38 weeks
|
0.00%
0/8 • 38 weeks
|
0.00%
0/23 • 38 weeks
|
5.6%
1/18 • 38 weeks
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/21 • 38 weeks
|
0.00%
0/13 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
0.00%
0/34 • 38 weeks
|
5.9%
1/17 • 38 weeks
|
0.00%
0/10 • 38 weeks
|
0.00%
0/6 • 38 weeks
|
0.00%
0/8 • 38 weeks
|
4.3%
1/23 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/21 • 38 weeks
|
0.00%
0/13 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
0.00%
0/34 • 38 weeks
|
0.00%
0/17 • 38 weeks
|
0.00%
0/10 • 38 weeks
|
0.00%
0/6 • 38 weeks
|
12.5%
1/8 • 38 weeks
|
0.00%
0/23 • 38 weeks
|
5.6%
1/18 • 38 weeks
|
|
Skin and subcutaneous tissue disorders
Pityriasis rosea
|
0.00%
0/21 • 38 weeks
|
7.7%
1/13 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
2.9%
1/34 • 38 weeks
|
0.00%
0/17 • 38 weeks
|
0.00%
0/10 • 38 weeks
|
0.00%
0/6 • 38 weeks
|
0.00%
0/8 • 38 weeks
|
0.00%
0/23 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.8%
1/21 • 38 weeks
|
0.00%
0/13 • 38 weeks
|
16.7%
3/18 • 38 weeks
|
2.9%
1/34 • 38 weeks
|
0.00%
0/17 • 38 weeks
|
0.00%
0/10 • 38 weeks
|
16.7%
1/6 • 38 weeks
|
0.00%
0/8 • 38 weeks
|
4.3%
1/23 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/21 • 38 weeks
|
0.00%
0/13 • 38 weeks
|
5.6%
1/18 • 38 weeks
|
0.00%
0/34 • 38 weeks
|
0.00%
0/17 • 38 weeks
|
0.00%
0/10 • 38 weeks
|
0.00%
0/6 • 38 weeks
|
0.00%
0/8 • 38 weeks
|
0.00%
0/23 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/21 • 38 weeks
|
0.00%
0/13 • 38 weeks
|
5.6%
1/18 • 38 weeks
|
0.00%
0/34 • 38 weeks
|
0.00%
0/17 • 38 weeks
|
0.00%
0/10 • 38 weeks
|
0.00%
0/6 • 38 weeks
|
0.00%
0/8 • 38 weeks
|
0.00%
0/23 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/21 • 38 weeks
|
0.00%
0/13 • 38 weeks
|
5.6%
1/18 • 38 weeks
|
0.00%
0/34 • 38 weeks
|
0.00%
0/17 • 38 weeks
|
0.00%
0/10 • 38 weeks
|
0.00%
0/6 • 38 weeks
|
0.00%
0/8 • 38 weeks
|
0.00%
0/23 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
|
Blood and lymphatic system disorders
Increased tendency to bruise
|
4.8%
1/21 • 38 weeks
|
0.00%
0/13 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
2.9%
1/34 • 38 weeks
|
0.00%
0/17 • 38 weeks
|
0.00%
0/10 • 38 weeks
|
0.00%
0/6 • 38 weeks
|
0.00%
0/8 • 38 weeks
|
0.00%
0/23 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
|
Cardiac disorders
Sinus arrest
|
0.00%
0/21 • 38 weeks
|
0.00%
0/13 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
0.00%
0/34 • 38 weeks
|
5.9%
1/17 • 38 weeks
|
0.00%
0/10 • 38 weeks
|
0.00%
0/6 • 38 weeks
|
0.00%
0/8 • 38 weeks
|
4.3%
1/23 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/21 • 38 weeks
|
0.00%
0/13 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
0.00%
0/34 • 38 weeks
|
5.9%
1/17 • 38 weeks
|
0.00%
0/10 • 38 weeks
|
0.00%
0/6 • 38 weeks
|
0.00%
0/8 • 38 weeks
|
4.3%
1/23 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
|
Eye disorders
Blepharospasm
|
0.00%
0/21 • 38 weeks
|
0.00%
0/13 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
0.00%
0/34 • 38 weeks
|
0.00%
0/17 • 38 weeks
|
0.00%
0/10 • 38 weeks
|
16.7%
1/6 • 38 weeks
|
0.00%
0/8 • 38 weeks
|
4.3%
1/23 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
|
Eye disorders
Dry eye
|
0.00%
0/21 • 38 weeks
|
0.00%
0/13 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
0.00%
0/34 • 38 weeks
|
0.00%
0/17 • 38 weeks
|
0.00%
0/10 • 38 weeks
|
0.00%
0/6 • 38 weeks
|
12.5%
1/8 • 38 weeks
|
0.00%
0/23 • 38 weeks
|
5.6%
1/18 • 38 weeks
|
|
Eye disorders
Eye irritation
|
0.00%
0/21 • 38 weeks
|
0.00%
0/13 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
0.00%
0/34 • 38 weeks
|
5.9%
1/17 • 38 weeks
|
0.00%
0/10 • 38 weeks
|
0.00%
0/6 • 38 weeks
|
0.00%
0/8 • 38 weeks
|
4.3%
1/23 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
|
Eye disorders
Eye pruritus
|
0.00%
0/21 • 38 weeks
|
0.00%
0/13 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
0.00%
0/34 • 38 weeks
|
0.00%
0/17 • 38 weeks
|
0.00%
0/10 • 38 weeks
|
0.00%
0/6 • 38 weeks
|
12.5%
1/8 • 38 weeks
|
0.00%
0/23 • 38 weeks
|
5.6%
1/18 • 38 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
4.8%
1/21 • 38 weeks
|
0.00%
0/13 • 38 weeks
|
11.1%
2/18 • 38 weeks
|
2.9%
1/34 • 38 weeks
|
5.9%
1/17 • 38 weeks
|
10.0%
1/10 • 38 weeks
|
16.7%
1/6 • 38 weeks
|
0.00%
0/8 • 38 weeks
|
8.7%
2/23 • 38 weeks
|
5.6%
1/18 • 38 weeks
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/21 • 38 weeks
|
0.00%
0/13 • 38 weeks
|
5.6%
1/18 • 38 weeks
|
0.00%
0/34 • 38 weeks
|
0.00%
0/17 • 38 weeks
|
0.00%
0/10 • 38 weeks
|
0.00%
0/6 • 38 weeks
|
0.00%
0/8 • 38 weeks
|
0.00%
0/23 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/21 • 38 weeks
|
7.7%
1/13 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
2.9%
1/34 • 38 weeks
|
0.00%
0/17 • 38 weeks
|
0.00%
0/10 • 38 weeks
|
0.00%
0/6 • 38 weeks
|
0.00%
0/8 • 38 weeks
|
0.00%
0/23 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/21 • 38 weeks
|
0.00%
0/13 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
0.00%
0/34 • 38 weeks
|
5.9%
1/17 • 38 weeks
|
0.00%
0/10 • 38 weeks
|
0.00%
0/6 • 38 weeks
|
0.00%
0/8 • 38 weeks
|
4.3%
1/23 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/21 • 38 weeks
|
0.00%
0/13 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
0.00%
0/34 • 38 weeks
|
0.00%
0/17 • 38 weeks
|
10.0%
1/10 • 38 weeks
|
0.00%
0/6 • 38 weeks
|
0.00%
0/8 • 38 weeks
|
0.00%
0/23 • 38 weeks
|
5.6%
1/18 • 38 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/21 • 38 weeks
|
0.00%
0/13 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
0.00%
0/34 • 38 weeks
|
5.9%
1/17 • 38 weeks
|
0.00%
0/10 • 38 weeks
|
0.00%
0/6 • 38 weeks
|
0.00%
0/8 • 38 weeks
|
4.3%
1/23 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
|
Gastrointestinal disorders
Toothache
|
4.8%
1/21 • 38 weeks
|
7.7%
1/13 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
5.9%
2/34 • 38 weeks
|
0.00%
0/17 • 38 weeks
|
0.00%
0/10 • 38 weeks
|
0.00%
0/6 • 38 weeks
|
0.00%
0/8 • 38 weeks
|
0.00%
0/23 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
|
General disorders
Asthenia
|
0.00%
0/21 • 38 weeks
|
0.00%
0/13 • 38 weeks
|
5.6%
1/18 • 38 weeks
|
0.00%
0/34 • 38 weeks
|
0.00%
0/17 • 38 weeks
|
0.00%
0/10 • 38 weeks
|
0.00%
0/6 • 38 weeks
|
0.00%
0/8 • 38 weeks
|
0.00%
0/23 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
|
General disorders
Fatigue
|
0.00%
0/21 • 38 weeks
|
7.7%
1/13 • 38 weeks
|
5.6%
1/18 • 38 weeks
|
2.9%
1/34 • 38 weeks
|
0.00%
0/17 • 38 weeks
|
0.00%
0/10 • 38 weeks
|
0.00%
0/6 • 38 weeks
|
0.00%
0/8 • 38 weeks
|
0.00%
0/23 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
|
General disorders
Influenza like illness
|
4.8%
1/21 • 38 weeks
|
0.00%
0/13 • 38 weeks
|
5.6%
1/18 • 38 weeks
|
2.9%
1/34 • 38 weeks
|
0.00%
0/17 • 38 weeks
|
0.00%
0/10 • 38 weeks
|
0.00%
0/6 • 38 weeks
|
0.00%
0/8 • 38 weeks
|
0.00%
0/23 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
|
General disorders
Injection site bruising
|
4.8%
1/21 • 38 weeks
|
0.00%
0/13 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
2.9%
1/34 • 38 weeks
|
0.00%
0/17 • 38 weeks
|
0.00%
0/10 • 38 weeks
|
0.00%
0/6 • 38 weeks
|
0.00%
0/8 • 38 weeks
|
0.00%
0/23 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
|
General disorders
Injection site reaction
|
0.00%
0/21 • 38 weeks
|
7.7%
1/13 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
2.9%
1/34 • 38 weeks
|
0.00%
0/17 • 38 weeks
|
0.00%
0/10 • 38 weeks
|
0.00%
0/6 • 38 weeks
|
0.00%
0/8 • 38 weeks
|
0.00%
0/23 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/21 • 38 weeks
|
0.00%
0/13 • 38 weeks
|
5.6%
1/18 • 38 weeks
|
0.00%
0/34 • 38 weeks
|
0.00%
0/17 • 38 weeks
|
0.00%
0/10 • 38 weeks
|
0.00%
0/6 • 38 weeks
|
0.00%
0/8 • 38 weeks
|
0.00%
0/23 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
|
General disorders
Sensation of foreign body
|
0.00%
0/21 • 38 weeks
|
0.00%
0/13 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
0.00%
0/34 • 38 weeks
|
5.9%
1/17 • 38 weeks
|
0.00%
0/10 • 38 weeks
|
0.00%
0/6 • 38 weeks
|
0.00%
0/8 • 38 weeks
|
4.3%
1/23 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/21 • 38 weeks
|
0.00%
0/13 • 38 weeks
|
5.6%
1/18 • 38 weeks
|
0.00%
0/34 • 38 weeks
|
0.00%
0/17 • 38 weeks
|
0.00%
0/10 • 38 weeks
|
0.00%
0/6 • 38 weeks
|
0.00%
0/8 • 38 weeks
|
0.00%
0/23 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/21 • 38 weeks
|
0.00%
0/13 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
0.00%
0/34 • 38 weeks
|
0.00%
0/17 • 38 weeks
|
10.0%
1/10 • 38 weeks
|
0.00%
0/6 • 38 weeks
|
0.00%
0/8 • 38 weeks
|
0.00%
0/23 • 38 weeks
|
5.6%
1/18 • 38 weeks
|
|
Infections and infestations
Bacterial vaginosis
|
0.00%
0/21 • 38 weeks
|
7.7%
1/13 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
2.9%
1/34 • 38 weeks
|
0.00%
0/17 • 38 weeks
|
0.00%
0/10 • 38 weeks
|
0.00%
0/6 • 38 weeks
|
0.00%
0/8 • 38 weeks
|
0.00%
0/23 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
|
Infections and infestations
Bronchitis
|
0.00%
0/21 • 38 weeks
|
7.7%
1/13 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
2.9%
1/34 • 38 weeks
|
0.00%
0/17 • 38 weeks
|
0.00%
0/10 • 38 weeks
|
0.00%
0/6 • 38 weeks
|
0.00%
0/8 • 38 weeks
|
0.00%
0/23 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/21 • 38 weeks
|
0.00%
0/13 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
0.00%
0/34 • 38 weeks
|
0.00%
0/17 • 38 weeks
|
0.00%
0/10 • 38 weeks
|
0.00%
0/6 • 38 weeks
|
12.5%
1/8 • 38 weeks
|
0.00%
0/23 • 38 weeks
|
5.6%
1/18 • 38 weeks
|
|
Infections and infestations
Cystitis
|
4.8%
1/21 • 38 weeks
|
7.7%
1/13 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
5.9%
2/34 • 38 weeks
|
0.00%
0/17 • 38 weeks
|
0.00%
0/10 • 38 weeks
|
0.00%
0/6 • 38 weeks
|
0.00%
0/8 • 38 weeks
|
0.00%
0/23 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/21 • 38 weeks
|
0.00%
0/13 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
0.00%
0/34 • 38 weeks
|
5.9%
1/17 • 38 weeks
|
0.00%
0/10 • 38 weeks
|
0.00%
0/6 • 38 weeks
|
0.00%
0/8 • 38 weeks
|
4.3%
1/23 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/21 • 38 weeks
|
7.7%
1/13 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
2.9%
1/34 • 38 weeks
|
5.9%
1/17 • 38 weeks
|
0.00%
0/10 • 38 weeks
|
16.7%
1/6 • 38 weeks
|
0.00%
0/8 • 38 weeks
|
8.7%
2/23 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/21 • 38 weeks
|
7.7%
1/13 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
2.9%
1/34 • 38 weeks
|
0.00%
0/17 • 38 weeks
|
0.00%
0/10 • 38 weeks
|
0.00%
0/6 • 38 weeks
|
0.00%
0/8 • 38 weeks
|
0.00%
0/23 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
|
Infections and infestations
Helicobacter gastritis
|
0.00%
0/21 • 38 weeks
|
0.00%
0/13 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
0.00%
0/34 • 38 weeks
|
5.9%
1/17 • 38 weeks
|
0.00%
0/10 • 38 weeks
|
0.00%
0/6 • 38 weeks
|
0.00%
0/8 • 38 weeks
|
4.3%
1/23 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
|
Infections and infestations
Laryngitis
|
4.8%
1/21 • 38 weeks
|
0.00%
0/13 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
2.9%
1/34 • 38 weeks
|
0.00%
0/17 • 38 weeks
|
0.00%
0/10 • 38 weeks
|
0.00%
0/6 • 38 weeks
|
0.00%
0/8 • 38 weeks
|
0.00%
0/23 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
|
Infections and infestations
Nasopharyngitis
|
14.3%
3/21 • 38 weeks
|
7.7%
1/13 • 38 weeks
|
5.6%
1/18 • 38 weeks
|
11.8%
4/34 • 38 weeks
|
11.8%
2/17 • 38 weeks
|
10.0%
1/10 • 38 weeks
|
0.00%
0/6 • 38 weeks
|
25.0%
2/8 • 38 weeks
|
8.7%
2/23 • 38 weeks
|
16.7%
3/18 • 38 weeks
|
|
Infections and infestations
Oral herpes
|
0.00%
0/21 • 38 weeks
|
0.00%
0/13 • 38 weeks
|
5.6%
1/18 • 38 weeks
|
0.00%
0/34 • 38 weeks
|
0.00%
0/17 • 38 weeks
|
0.00%
0/10 • 38 weeks
|
0.00%
0/6 • 38 weeks
|
0.00%
0/8 • 38 weeks
|
0.00%
0/23 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
|
Infections and infestations
Pharyngitis
|
4.8%
1/21 • 38 weeks
|
7.7%
1/13 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
5.9%
2/34 • 38 weeks
|
0.00%
0/17 • 38 weeks
|
0.00%
0/10 • 38 weeks
|
0.00%
0/6 • 38 weeks
|
0.00%
0/8 • 38 weeks
|
0.00%
0/23 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
|
Infections and infestations
Sinusitis
|
0.00%
0/21 • 38 weeks
|
0.00%
0/13 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
0.00%
0/34 • 38 weeks
|
0.00%
0/17 • 38 weeks
|
0.00%
0/10 • 38 weeks
|
0.00%
0/6 • 38 weeks
|
12.5%
1/8 • 38 weeks
|
0.00%
0/23 • 38 weeks
|
5.6%
1/18 • 38 weeks
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/21 • 38 weeks
|
0.00%
0/13 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
0.00%
0/34 • 38 weeks
|
5.9%
1/17 • 38 weeks
|
0.00%
0/10 • 38 weeks
|
0.00%
0/6 • 38 weeks
|
0.00%
0/8 • 38 weeks
|
4.3%
1/23 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
|
Infections and infestations
Tooth infection
|
0.00%
0/21 • 38 weeks
|
0.00%
0/13 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
0.00%
0/34 • 38 weeks
|
0.00%
0/17 • 38 weeks
|
0.00%
0/10 • 38 weeks
|
16.7%
1/6 • 38 weeks
|
0.00%
0/8 • 38 weeks
|
4.3%
1/23 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
4.8%
1/21 • 38 weeks
|
15.4%
2/13 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
8.8%
3/34 • 38 weeks
|
5.9%
1/17 • 38 weeks
|
20.0%
2/10 • 38 weeks
|
16.7%
1/6 • 38 weeks
|
0.00%
0/8 • 38 weeks
|
8.7%
2/23 • 38 weeks
|
11.1%
2/18 • 38 weeks
|
|
Infections and infestations
Urinary tract infection
|
4.8%
1/21 • 38 weeks
|
7.7%
1/13 • 38 weeks
|
5.6%
1/18 • 38 weeks
|
5.9%
2/34 • 38 weeks
|
11.8%
2/17 • 38 weeks
|
0.00%
0/10 • 38 weeks
|
0.00%
0/6 • 38 weeks
|
12.5%
1/8 • 38 weeks
|
8.7%
2/23 • 38 weeks
|
5.6%
1/18 • 38 weeks
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
4.8%
1/21 • 38 weeks
|
0.00%
0/13 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
2.9%
1/34 • 38 weeks
|
0.00%
0/17 • 38 weeks
|
10.0%
1/10 • 38 weeks
|
0.00%
0/6 • 38 weeks
|
0.00%
0/8 • 38 weeks
|
0.00%
0/23 • 38 weeks
|
5.6%
1/18 • 38 weeks
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/21 • 38 weeks
|
7.7%
1/13 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
2.9%
1/34 • 38 weeks
|
0.00%
0/17 • 38 weeks
|
0.00%
0/10 • 38 weeks
|
0.00%
0/6 • 38 weeks
|
0.00%
0/8 • 38 weeks
|
0.00%
0/23 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/21 • 38 weeks
|
0.00%
0/13 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
0.00%
0/34 • 38 weeks
|
0.00%
0/17 • 38 weeks
|
0.00%
0/10 • 38 weeks
|
16.7%
1/6 • 38 weeks
|
0.00%
0/8 • 38 weeks
|
4.3%
1/23 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/21 • 38 weeks
|
0.00%
0/13 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
0.00%
0/34 • 38 weeks
|
5.9%
1/17 • 38 weeks
|
0.00%
0/10 • 38 weeks
|
0.00%
0/6 • 38 weeks
|
0.00%
0/8 • 38 weeks
|
4.3%
1/23 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/21 • 38 weeks
|
7.7%
1/13 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
2.9%
1/34 • 38 weeks
|
0.00%
0/17 • 38 weeks
|
0.00%
0/10 • 38 weeks
|
0.00%
0/6 • 38 weeks
|
0.00%
0/8 • 38 weeks
|
0.00%
0/23 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/21 • 38 weeks
|
7.7%
1/13 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
2.9%
1/34 • 38 weeks
|
0.00%
0/17 • 38 weeks
|
0.00%
0/10 • 38 weeks
|
0.00%
0/6 • 38 weeks
|
0.00%
0/8 • 38 weeks
|
0.00%
0/23 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
|
Injury, poisoning and procedural complications
Sports injury
|
0.00%
0/21 • 38 weeks
|
0.00%
0/13 • 38 weeks
|
5.6%
1/18 • 38 weeks
|
0.00%
0/34 • 38 weeks
|
0.00%
0/17 • 38 weeks
|
0.00%
0/10 • 38 weeks
|
0.00%
0/6 • 38 weeks
|
0.00%
0/8 • 38 weeks
|
0.00%
0/23 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
|
Injury, poisoning and procedural complications
Wound
|
4.8%
1/21 • 38 weeks
|
0.00%
0/13 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
2.9%
1/34 • 38 weeks
|
0.00%
0/17 • 38 weeks
|
0.00%
0/10 • 38 weeks
|
0.00%
0/6 • 38 weeks
|
0.00%
0/8 • 38 weeks
|
0.00%
0/23 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
|
Investigations
Alanine aminotransferase increased
|
4.8%
1/21 • 38 weeks
|
0.00%
0/13 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
2.9%
1/34 • 38 weeks
|
0.00%
0/17 • 38 weeks
|
0.00%
0/10 • 38 weeks
|
0.00%
0/6 • 38 weeks
|
0.00%
0/8 • 38 weeks
|
0.00%
0/23 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/21 • 38 weeks
|
0.00%
0/13 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
0.00%
0/34 • 38 weeks
|
0.00%
0/17 • 38 weeks
|
0.00%
0/10 • 38 weeks
|
0.00%
0/6 • 38 weeks
|
12.5%
1/8 • 38 weeks
|
0.00%
0/23 • 38 weeks
|
5.6%
1/18 • 38 weeks
|
|
Investigations
Blood creatine phosphokinase increased
|
4.8%
1/21 • 38 weeks
|
0.00%
0/13 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
2.9%
1/34 • 38 weeks
|
0.00%
0/17 • 38 weeks
|
20.0%
2/10 • 38 weeks
|
16.7%
1/6 • 38 weeks
|
12.5%
1/8 • 38 weeks
|
4.3%
1/23 • 38 weeks
|
16.7%
3/18 • 38 weeks
|
|
Investigations
Blood creatinine increased
|
0.00%
0/21 • 38 weeks
|
0.00%
0/13 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
0.00%
0/34 • 38 weeks
|
0.00%
0/17 • 38 weeks
|
10.0%
1/10 • 38 weeks
|
0.00%
0/6 • 38 weeks
|
0.00%
0/8 • 38 weeks
|
0.00%
0/23 • 38 weeks
|
5.6%
1/18 • 38 weeks
|
|
Investigations
Blood triglycerides increased
|
4.8%
1/21 • 38 weeks
|
0.00%
0/13 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
2.9%
1/34 • 38 weeks
|
0.00%
0/17 • 38 weeks
|
0.00%
0/10 • 38 weeks
|
0.00%
0/6 • 38 weeks
|
0.00%
0/8 • 38 weeks
|
0.00%
0/23 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
|
Investigations
Glucose urine present
|
4.8%
1/21 • 38 weeks
|
0.00%
0/13 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
2.9%
1/34 • 38 weeks
|
0.00%
0/17 • 38 weeks
|
0.00%
0/10 • 38 weeks
|
0.00%
0/6 • 38 weeks
|
0.00%
0/8 • 38 weeks
|
0.00%
0/23 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/21 • 38 weeks
|
0.00%
0/13 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
0.00%
0/34 • 38 weeks
|
0.00%
0/17 • 38 weeks
|
0.00%
0/10 • 38 weeks
|
16.7%
1/6 • 38 weeks
|
0.00%
0/8 • 38 weeks
|
4.3%
1/23 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/21 • 38 weeks
|
0.00%
0/13 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
0.00%
0/34 • 38 weeks
|
5.9%
1/17 • 38 weeks
|
0.00%
0/10 • 38 weeks
|
0.00%
0/6 • 38 weeks
|
0.00%
0/8 • 38 weeks
|
4.3%
1/23 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/21 • 38 weeks
|
7.7%
1/13 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
2.9%
1/34 • 38 weeks
|
0.00%
0/17 • 38 weeks
|
10.0%
1/10 • 38 weeks
|
0.00%
0/6 • 38 weeks
|
0.00%
0/8 • 38 weeks
|
0.00%
0/23 • 38 weeks
|
5.6%
1/18 • 38 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/21 • 38 weeks
|
7.7%
1/13 • 38 weeks
|
5.6%
1/18 • 38 weeks
|
2.9%
1/34 • 38 weeks
|
5.9%
1/17 • 38 weeks
|
0.00%
0/10 • 38 weeks
|
0.00%
0/6 • 38 weeks
|
0.00%
0/8 • 38 weeks
|
4.3%
1/23 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/21 • 38 weeks
|
0.00%
0/13 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
0.00%
0/34 • 38 weeks
|
0.00%
0/17 • 38 weeks
|
10.0%
1/10 • 38 weeks
|
0.00%
0/6 • 38 weeks
|
0.00%
0/8 • 38 weeks
|
0.00%
0/23 • 38 weeks
|
5.6%
1/18 • 38 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/21 • 38 weeks
|
0.00%
0/13 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
0.00%
0/34 • 38 weeks
|
0.00%
0/17 • 38 weeks
|
10.0%
1/10 • 38 weeks
|
0.00%
0/6 • 38 weeks
|
12.5%
1/8 • 38 weeks
|
0.00%
0/23 • 38 weeks
|
11.1%
2/18 • 38 weeks
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/21 • 38 weeks
|
7.7%
1/13 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
2.9%
1/34 • 38 weeks
|
0.00%
0/17 • 38 weeks
|
0.00%
0/10 • 38 weeks
|
0.00%
0/6 • 38 weeks
|
0.00%
0/8 • 38 weeks
|
0.00%
0/23 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.8%
1/21 • 38 weeks
|
0.00%
0/13 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
2.9%
1/34 • 38 weeks
|
0.00%
0/17 • 38 weeks
|
0.00%
0/10 • 38 weeks
|
0.00%
0/6 • 38 weeks
|
0.00%
0/8 • 38 weeks
|
0.00%
0/23 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
|
Nervous system disorders
Headache
|
4.8%
1/21 • 38 weeks
|
23.1%
3/13 • 38 weeks
|
5.6%
1/18 • 38 weeks
|
11.8%
4/34 • 38 weeks
|
5.9%
1/17 • 38 weeks
|
0.00%
0/10 • 38 weeks
|
0.00%
0/6 • 38 weeks
|
0.00%
0/8 • 38 weeks
|
4.3%
1/23 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
|
Psychiatric disorders
Depression
|
0.00%
0/21 • 38 weeks
|
0.00%
0/13 • 38 weeks
|
5.6%
1/18 • 38 weeks
|
0.00%
0/34 • 38 weeks
|
0.00%
0/17 • 38 weeks
|
0.00%
0/10 • 38 weeks
|
0.00%
0/6 • 38 weeks
|
0.00%
0/8 • 38 weeks
|
0.00%
0/23 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
|
Renal and urinary disorders
Micturition urgency
|
4.8%
1/21 • 38 weeks
|
0.00%
0/13 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
2.9%
1/34 • 38 weeks
|
0.00%
0/17 • 38 weeks
|
10.0%
1/10 • 38 weeks
|
0.00%
0/6 • 38 weeks
|
0.00%
0/8 • 38 weeks
|
0.00%
0/23 • 38 weeks
|
5.6%
1/18 • 38 weeks
|
|
Renal and urinary disorders
Pollakiuria
|
4.8%
1/21 • 38 weeks
|
0.00%
0/13 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
2.9%
1/34 • 38 weeks
|
0.00%
0/17 • 38 weeks
|
10.0%
1/10 • 38 weeks
|
0.00%
0/6 • 38 weeks
|
0.00%
0/8 • 38 weeks
|
0.00%
0/23 • 38 weeks
|
5.6%
1/18 • 38 weeks
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/21 • 38 weeks
|
0.00%
0/13 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
0.00%
0/34 • 38 weeks
|
0.00%
0/17 • 38 weeks
|
20.0%
2/10 • 38 weeks
|
0.00%
0/6 • 38 weeks
|
12.5%
1/8 • 38 weeks
|
0.00%
0/23 • 38 weeks
|
16.7%
3/18 • 38 weeks
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/21 • 38 weeks
|
7.7%
1/13 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
2.9%
1/34 • 38 weeks
|
0.00%
0/17 • 38 weeks
|
0.00%
0/10 • 38 weeks
|
0.00%
0/6 • 38 weeks
|
0.00%
0/8 • 38 weeks
|
0.00%
0/23 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/21 • 38 weeks
|
7.7%
1/13 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
2.9%
1/34 • 38 weeks
|
0.00%
0/17 • 38 weeks
|
0.00%
0/10 • 38 weeks
|
0.00%
0/6 • 38 weeks
|
0.00%
0/8 • 38 weeks
|
0.00%
0/23 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/21 • 38 weeks
|
0.00%
0/13 • 38 weeks
|
5.6%
1/18 • 38 weeks
|
0.00%
0/34 • 38 weeks
|
0.00%
0/17 • 38 weeks
|
0.00%
0/10 • 38 weeks
|
0.00%
0/6 • 38 weeks
|
0.00%
0/8 • 38 weeks
|
0.00%
0/23 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/21 • 38 weeks
|
0.00%
0/13 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
0.00%
0/34 • 38 weeks
|
5.9%
1/17 • 38 weeks
|
0.00%
0/10 • 38 weeks
|
0.00%
0/6 • 38 weeks
|
0.00%
0/8 • 38 weeks
|
4.3%
1/23 • 38 weeks
|
0.00%
0/18 • 38 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER