Trial Outcomes & Findings for Study to Evaluate the Safety and Efficacy of CTP-543 in Adults With Moderate to Severe Alopecia Areata (NCT NCT03137381)
NCT ID: NCT03137381
Last Updated: 2022-07-19
Results Overview
An adverse event is any untoward medical occurrence that may appear or worsen in a participant 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 patient'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 adverse event. TEAE is defined as any adverse event that occurs after administration of the first dose of study drug.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
149 participants
Primary outcome timeframe
From first dose of study drug up to safety follow up at Week 28
Results posted on
2022-07-19
Participant Flow
Participants were enrolled at 13 study centers in the United States from 09 August 2017 to 08 July 2019.
235 participants were screened, out of which 149 participants who experienced an episode of hair loss due to alopecia areata were enrolled to receive CTP-543 or placebo.
Participant milestones
| Measure |
Combined Placebo
Participants received CTP-543 matched placebo tablets, twice daily for up to 24 weeks in Cohorts 1, 2, and 3.
|
Cohort 1: CTP-543 4 mg BID
Participants received CTP-543 4 mg tablets, twice daily for up to 24 weeks.
|
Cohort 2: CTP-543 8 mg BID
Participants received CTP-543 8 mg tablets, twice daily for up to 24 weeks.
|
Cohort 3: CTP-543 12 mg BID
Participants received CTP-543 12 mg tablets, twice daily for up to 24 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
44
|
30
|
38
|
37
|
|
Overall Study
Safety Population
|
44
|
29
|
38
|
36
|
|
Overall Study
COMPLETED
|
35
|
23
|
30
|
36
|
|
Overall Study
NOT COMPLETED
|
9
|
7
|
8
|
1
|
Reasons for withdrawal
| Measure |
Combined Placebo
Participants received CTP-543 matched placebo tablets, twice daily for up to 24 weeks in Cohorts 1, 2, and 3.
|
Cohort 1: CTP-543 4 mg BID
Participants received CTP-543 4 mg tablets, twice daily for up to 24 weeks.
|
Cohort 2: CTP-543 8 mg BID
Participants received CTP-543 8 mg tablets, twice daily for up to 24 weeks.
|
Cohort 3: CTP-543 12 mg BID
Participants received CTP-543 12 mg tablets, twice daily for up to 24 weeks.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
0
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
1
|
0
|
|
Overall Study
Protocol deviation
|
1
|
1
|
0
|
1
|
|
Overall Study
Withdrawal by Investigator
|
0
|
1
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
4
|
3
|
0
|
|
Overall Study
Pregnancy
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Study to Evaluate the Safety and Efficacy of CTP-543 in Adults With Moderate to Severe Alopecia Areata
Baseline characteristics by cohort
| Measure |
Combined Placebo
n=44 Participants
Participants received CTP-543 matched placebo tablets, twice daily for up to 24 weeks in Cohorts 1, 2, and 3.
|
Cohort 1: CTP-543 4 mg BID
n=30 Participants
Participants received CTP-543 4 mg tablets, twice daily for up to 24 weeks.
|
Cohort 2: CTP-543 8 mg BID
n=38 Participants
Participants received CTP-543 8 mg tablets, twice daily for up to 24 weeks.
|
Cohort 3: CTP-543 12 mg BID
n=37 Participants
Participants received CTP-543 12 mg tablets, twice daily for up to 24 weeks.
|
Total
n=149 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
37.8 years
STANDARD_DEVIATION 13.50 • n=5 Participants
|
35.7 years
STANDARD_DEVIATION 11.01 • n=7 Participants
|
37.3 years
STANDARD_DEVIATION 14.18 • n=5 Participants
|
35.8 years
STANDARD_DEVIATION 12.37 • n=4 Participants
|
36.8 years
STANDARD_DEVIATION 12.85 • n=21 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
105 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
44 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
132 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
33 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
114 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Week 24Population: Efficacy Population included all participants who received study drug and had at least 1 post-treatment SALT assessment during the treatment period. Participants were analyzed according to their randomized treatment group.
The SALT is a quantitative assessment of scalp hair loss. SALT scores range in severity from 0 (no hair loss) to a maximum of 100 (complete hair loss). Responders were defined as participants achieving at least a 50% relative reduction in SALT score from baseline at Week 24.
Outcome measures
| Measure |
Combined Placebo
n=43 Participants
Participants received CTP-543 matched placebo tablets, twice daily for up to 24 weeks in Cohorts 1, 2, and 3.
|
Cohort 1: CTP-543 4 mg BID
n=28 Participants
Participants received CTP-543 4 mg tablets, twice daily for up to 24 weeks.
|
Cohort 2: CTP-543 8 mg BID
n=38 Participants
Participants received CTP-543 8 mg tablets, twice daily for up to 24 weeks.
|
Cohort 3: CTP-543 12 mg BID
n=36 Participants
Participants received CTP-543 12 mg tablets, twice daily for up to 24 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving at Least a 50% Relative Reduction in Severity of Alopecia Tool (SALT) Score From Baseline at Week 24
|
9.3 Percentage of participants
|
21.4 Percentage of participants
|
47.4 Percentage of participants
|
58.3 Percentage of participants
|
PRIMARY outcome
Timeframe: From first dose of study drug up to safety follow up at Week 28Population: Safety Population included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
An adverse event is any untoward medical occurrence that may appear or worsen in a participant 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 patient'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 adverse event. TEAE is defined as any adverse event that occurs after administration of the first dose of study drug.
Outcome measures
| Measure |
Combined Placebo
n=44 Participants
Participants received CTP-543 matched placebo tablets, twice daily for up to 24 weeks in Cohorts 1, 2, and 3.
|
Cohort 1: CTP-543 4 mg BID
n=29 Participants
Participants received CTP-543 4 mg tablets, twice daily for up to 24 weeks.
|
Cohort 2: CTP-543 8 mg BID
n=38 Participants
Participants received CTP-543 8 mg tablets, twice daily for up to 24 weeks.
|
Cohort 3: CTP-543 12 mg BID
n=36 Participants
Participants received CTP-543 12 mg tablets, twice daily for up to 24 weeks.
|
|---|---|---|---|---|
|
Number of Participants Experiencing at Least One Treatment-Emergent Adverse Event (TEAE)
|
31 Participants
|
25 Participants
|
31 Participants
|
30 Participants
|
Adverse Events
Combined Placebo
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
Cohort 1: CTP-543 4 mg BID
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Cohort 2: CTP-543 8 mg BID
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
Cohort 3: CTP-543 12 mg BID
Serious events: 1 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Combined Placebo
n=44 participants at risk
Participants received CTP-543 matched placebo tablets, twice daily for up to 24 weeks in Cohorts 1, 2, and 3.
|
Cohort 1: CTP-543 4 mg BID
n=29 participants at risk
Participants received CTP-543 4 mg tablets, twice daily for up to 24 weeks.
|
Cohort 2: CTP-543 8 mg BID
n=38 participants at risk
Participants received CTP-543 8 mg tablets, twice daily for up to 24 weeks.
|
Cohort 3: CTP-543 12 mg BID
n=36 participants at risk
Participants received CTP-543 12 mg tablets, twice daily for up to 24 weeks.
|
|---|---|---|---|---|
|
Infections and infestations
Cellulitis
|
0.00%
0/44 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
0.00%
0/29 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
0.00%
0/38 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
2.8%
1/36 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
Other adverse events
| Measure |
Combined Placebo
n=44 participants at risk
Participants received CTP-543 matched placebo tablets, twice daily for up to 24 weeks in Cohorts 1, 2, and 3.
|
Cohort 1: CTP-543 4 mg BID
n=29 participants at risk
Participants received CTP-543 4 mg tablets, twice daily for up to 24 weeks.
|
Cohort 2: CTP-543 8 mg BID
n=38 participants at risk
Participants received CTP-543 8 mg tablets, twice daily for up to 24 weeks.
|
Cohort 3: CTP-543 12 mg BID
n=36 participants at risk
Participants received CTP-543 12 mg tablets, twice daily for up to 24 weeks.
|
|---|---|---|---|---|
|
Investigations
Hemoglobin decreased
|
0.00%
0/44 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
3.4%
1/29 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
5.3%
2/38 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
0.00%
0/36 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
15.9%
7/44 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
6.9%
2/29 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
5.3%
2/38 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
19.4%
7/36 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
|
Infections and infestations
Nasopharyngitis
|
2.3%
1/44 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
10.3%
3/29 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
7.9%
3/38 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
25.0%
9/36 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/44 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
10.3%
3/29 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
5.3%
2/38 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
2.8%
1/36 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
|
Infections and infestations
Sinusitis
|
6.8%
3/44 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
0.00%
0/29 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
0.00%
0/38 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
5.6%
2/36 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
|
Infections and infestations
Influenza
|
0.00%
0/44 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
3.4%
1/29 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
0.00%
0/38 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
5.6%
2/36 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
|
Infections and infestations
Body tinea
|
0.00%
0/44 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
6.9%
2/29 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
0.00%
0/38 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
0.00%
0/36 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/44 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
0.00%
0/29 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
5.3%
2/38 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
0.00%
0/36 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/44 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
6.9%
2/29 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
0.00%
0/38 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
0.00%
0/36 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
|
Investigations
Blood creatine phosphokinase increased
|
2.3%
1/44 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
10.3%
3/29 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
5.3%
2/38 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
2.8%
1/36 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
|
Investigations
Red blood cell count decreased
|
0.00%
0/44 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
0.00%
0/29 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
7.9%
3/38 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
5.6%
2/36 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
|
Investigations
Blood triglycerides increased
|
2.3%
1/44 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
0.00%
0/29 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
7.9%
3/38 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
0.00%
0/36 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
|
Investigations
Low density lipoprotein increased
|
0.00%
0/44 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
0.00%
0/29 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
10.5%
4/38 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
0.00%
0/36 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
|
Investigations
Neutrophil count decreased
|
2.3%
1/44 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
0.00%
0/29 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
7.9%
3/38 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
0.00%
0/36 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
|
Investigations
Amylase increased
|
0.00%
0/44 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
0.00%
0/29 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
5.3%
2/38 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
0.00%
0/36 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/44 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
6.9%
2/29 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
0.00%
0/38 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
0.00%
0/36 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
|
Investigations
Hematocrit decreased
|
0.00%
0/44 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
0.00%
0/29 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
5.3%
2/38 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
0.00%
0/36 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
|
Gastrointestinal disorders
Nausea
|
9.1%
4/44 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
13.8%
4/29 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
10.5%
4/38 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
2.8%
1/36 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
|
Gastrointestinal disorders
Diarrhea
|
6.8%
3/44 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
10.3%
3/29 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
2.6%
1/38 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
0.00%
0/36 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.8%
3/44 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
6.9%
2/29 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
0.00%
0/38 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
0.00%
0/36 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/44 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
6.9%
2/29 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
0.00%
0/38 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
2.8%
1/36 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
|
Nervous system disorders
Headache
|
9.1%
4/44 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
17.2%
5/29 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
26.3%
10/38 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
19.4%
7/36 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
|
Nervous system disorders
Migraine
|
2.3%
1/44 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
0.00%
0/29 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
0.00%
0/38 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
8.3%
3/36 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/44 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
3.4%
1/29 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
0.00%
0/38 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
5.6%
2/36 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
|
Skin and subcutaneous tissue disorders
Acne
|
4.5%
2/44 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
13.8%
4/29 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
10.5%
4/38 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
16.7%
6/36 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
2.3%
1/44 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
6.9%
2/29 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
0.00%
0/38 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
2.8%
1/36 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.00%
0/44 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
0.00%
0/29 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
5.3%
2/38 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
0.00%
0/36 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/44 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
13.8%
4/29 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
2.6%
1/38 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
5.6%
2/36 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.3%
1/44 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
10.3%
3/29 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
2.6%
1/38 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
0.00%
0/36 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/44 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
3.4%
1/29 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
0.00%
0/38 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
5.6%
2/36 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.5%
2/44 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
0.00%
0/29 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
0.00%
0/38 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
5.6%
2/36 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/44 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
0.00%
0/29 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
0.00%
0/38 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
8.3%
3/36 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/44 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
0.00%
0/29 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
7.9%
3/38 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
0.00%
0/36 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/44 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
0.00%
0/29 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
5.3%
2/38 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
0.00%
0/36 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
|
General disorders
Fatigue
|
4.5%
2/44 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
6.9%
2/29 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
2.6%
1/38 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
5.6%
2/36 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/44 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
0.00%
0/29 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
7.9%
3/38 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
8.3%
3/36 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/44 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
0.00%
0/29 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
5.3%
2/38 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
0.00%
0/36 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/44 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
0.00%
0/29 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
0.00%
0/38 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
5.6%
2/36 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
|
Eye disorders
Dry eye
|
0.00%
0/44 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
0.00%
0/29 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
0.00%
0/38 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
5.6%
2/36 • From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the Safety Population, included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If an Investigator wants to publish study data or results, the publication or presentation must be provided to Concert for review at least 60 days in advance. If Concert needs to file a patent application prior to publication, the publication can be delayed up to 90 days from Sponsor providing notice to the investigator of such need.
- Publication restrictions are in place
Restriction type: OTHER