Trial Outcomes & Findings for Safety and Efficacy of MMX Mesalamine/Mesalazine in Pediatric Subjects With Mild to Moderate Ulcerative Colitis (NCT NCT02093663)
NCT ID: NCT02093663
Last Updated: 2021-06-09
Results Overview
Clinical response was defined as partial ulcerative colitis disease activity index (UC-DAI) score \< or =1 with rectal bleeding = 0, stool frequency \< or =1, and physician's global assessment (PGA = 0). Number of participants with clinical response were reported.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
107 participants
Primary outcome timeframe
Week 8
Results posted on
2021-06-09
Participant Flow
The study was conducted at 50 study centers and 33 sites consented at least 1 participant between 12 December 2014 (first participant first visit) and 28 November 2018 (last participant last visit).
Study was conducted in three phases as double blind acute (DBA), open label acute (OLA), and double blind maintenance (DBM) phase. Overall, 107 participants were enrolled and entered into DBA or DBM directly and eligible participants entered into DBM phase after DBA or OLA through DBA. Total, 105 participants received treatment and 65 completed.
Participant milestones
| Measure |
Double-Blind Acute (DBA) Phase: Low Dose
Participants with partial UC-DAI \> or =2 and mucosal appearance = 2 or 3 entered the DBA phase. During the DBA low dose phase participants weighing 18 to \< or =23 kg, \>23 to \< or =35 kg, \> 35 to \< or =50 kg, \> 50 to \< or =90 kg received 900, 1200, 1800, and 2400 mg/day of MMX mesalamine/mesalazine tablet orally once daily for 8 weeks respectively.
|
Double-Blind Acute (DBA) Phase: High Dose
Participants with partial UC-DAI \> or =2 and mucosal appearance = 2 or 3 entered the DBA phase. During the DBA high dose phase participants weighing 18 to \< or =23 kg, \> 23 to \< or =35 kg, \> 35 to \< or =50 kg, \> 50 to \< or =90 kg received 1800, 2400, 3600, and 4800 mg/day of MMX mesalamine/mesalazine tablet orally once daily for 8 weeks respectively.
|
Open-Label Acute Phase (OLA): High Dose
During the OLA High dose phase participants weighing 18 to \<=23 kg, \> 23 to \< or =35 kg, \>35 to \< or = 50 kg, \> 50 to \< or = 90 kg received 1800, 2400, 3600, and 4800 mg/day of MMX mesalamine/mesalazine tablet orally once daily for 8 weeks respectively.
|
Double-Blind Maintenance (DBM) Phase: Low Dose
Participants with partial UC-DAI \< or =1 and mucosal appearance = 0 or 1 entered the DBM phase directly. Also, participants with a clinical response (partial UC-DAI \< or =1) after completion of DBA phase or OLA phase entered into the DBM phase. During the DBM low dose phase participants weighing 18 to \< or =23 kg, \> 23 to \< or =35 kg, \> 35 to \< or =50 kg, \> 50 to \< or =90 kg received 900, 1200, 1800, and 2400 mg/day of MMX mesalamine/mesalazine tablet orally once daily for 26 weeks respectively.
|
Double-Blind Maintenance (DBM) Phase: High Dose
Participants with partial UC-DAI \< or =1 and mucosal appearance = 0 or 1 entered the DBM phase directly. Also, participants with a clinical response (partial UC-DAI \< or =1) after completion of DBA phase or OLA phase entered into the DBM phase. During the DBM high dose phase participants weighing 18 to \<=23 kg, \> 23 to \< or =35 kg, \>35 to \< or = 50 kg, \> 50 to \< or = 90 kg received 1800, 2400, 3600, and 4800 mg/day of MMX mesalamine/mesalazine tablet orally once daily for 26 weeks respectively.
|
|---|---|---|---|---|---|
|
Double Blind Acute Phase (8 Weeks)
STARTED
|
27
|
26
|
0
|
0
|
0
|
|
Double Blind Acute Phase (8 Weeks)
COMPLETED
|
19
|
22
|
0
|
0
|
0
|
|
Double Blind Acute Phase (8 Weeks)
NOT COMPLETED
|
8
|
4
|
0
|
0
|
0
|
|
Open Label Acute Phase (8 Weeks)
STARTED
|
0
|
0
|
18
|
0
|
0
|
|
Open Label Acute Phase (8 Weeks)
Participants Entered OLA Via DBA
|
0
|
0
|
18
|
0
|
0
|
|
Open Label Acute Phase (8 Weeks)
COMPLETED
|
0
|
0
|
12
|
0
|
0
|
|
Open Label Acute Phase (8 Weeks)
NOT COMPLETED
|
0
|
0
|
6
|
0
|
0
|
|
Double Blind Maintenance Phase(26 Weeks)
STARTED
|
0
|
0
|
0
|
42
|
45
|
|
Double Blind Maintenance Phase(26 Weeks)
Participants Entered Directly to DBM
|
0
|
0
|
0
|
26
|
26
|
|
Double Blind Maintenance Phase(26 Weeks)
Participants Entered DBM Via DBA
|
0
|
0
|
0
|
12
|
15
|
|
Double Blind Maintenance Phase(26 Weeks)
Participants Entered DBM Via OLA
|
0
|
0
|
0
|
4
|
4
|
|
Double Blind Maintenance Phase(26 Weeks)
COMPLETED
|
0
|
0
|
0
|
32
|
34
|
|
Double Blind Maintenance Phase(26 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
10
|
11
|
Reasons for withdrawal
| Measure |
Double-Blind Acute (DBA) Phase: Low Dose
Participants with partial UC-DAI \> or =2 and mucosal appearance = 2 or 3 entered the DBA phase. During the DBA low dose phase participants weighing 18 to \< or =23 kg, \>23 to \< or =35 kg, \> 35 to \< or =50 kg, \> 50 to \< or =90 kg received 900, 1200, 1800, and 2400 mg/day of MMX mesalamine/mesalazine tablet orally once daily for 8 weeks respectively.
|
Double-Blind Acute (DBA) Phase: High Dose
Participants with partial UC-DAI \> or =2 and mucosal appearance = 2 or 3 entered the DBA phase. During the DBA high dose phase participants weighing 18 to \< or =23 kg, \> 23 to \< or =35 kg, \> 35 to \< or =50 kg, \> 50 to \< or =90 kg received 1800, 2400, 3600, and 4800 mg/day of MMX mesalamine/mesalazine tablet orally once daily for 8 weeks respectively.
|
Open-Label Acute Phase (OLA): High Dose
During the OLA High dose phase participants weighing 18 to \<=23 kg, \> 23 to \< or =35 kg, \>35 to \< or = 50 kg, \> 50 to \< or = 90 kg received 1800, 2400, 3600, and 4800 mg/day of MMX mesalamine/mesalazine tablet orally once daily for 8 weeks respectively.
|
Double-Blind Maintenance (DBM) Phase: Low Dose
Participants with partial UC-DAI \< or =1 and mucosal appearance = 0 or 1 entered the DBM phase directly. Also, participants with a clinical response (partial UC-DAI \< or =1) after completion of DBA phase or OLA phase entered into the DBM phase. During the DBM low dose phase participants weighing 18 to \< or =23 kg, \> 23 to \< or =35 kg, \> 35 to \< or =50 kg, \> 50 to \< or =90 kg received 900, 1200, 1800, and 2400 mg/day of MMX mesalamine/mesalazine tablet orally once daily for 26 weeks respectively.
|
Double-Blind Maintenance (DBM) Phase: High Dose
Participants with partial UC-DAI \< or =1 and mucosal appearance = 0 or 1 entered the DBM phase directly. Also, participants with a clinical response (partial UC-DAI \< or =1) after completion of DBA phase or OLA phase entered into the DBM phase. During the DBM high dose phase participants weighing 18 to \<=23 kg, \> 23 to \< or =35 kg, \>35 to \< or = 50 kg, \> 50 to \< or = 90 kg received 1800, 2400, 3600, and 4800 mg/day of MMX mesalamine/mesalazine tablet orally once daily for 26 weeks respectively.
|
|---|---|---|---|---|---|
|
Double Blind Acute Phase (8 Weeks)
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
|
Double Blind Acute Phase (8 Weeks)
Lack of Efficacy
|
5
|
0
|
0
|
0
|
0
|
|
Double Blind Acute Phase (8 Weeks)
Subjects who Continued in the Study
|
2
|
4
|
0
|
0
|
0
|
|
Open Label Acute Phase (8 Weeks)
Adverse Event
|
0
|
0
|
1
|
0
|
0
|
|
Open Label Acute Phase (8 Weeks)
Lack of Efficacy
|
0
|
0
|
5
|
0
|
0
|
|
Double Blind Maintenance Phase(26 Weeks)
Adverse Event
|
0
|
0
|
0
|
3
|
2
|
|
Double Blind Maintenance Phase(26 Weeks)
Lack of Efficacy
|
0
|
0
|
0
|
6
|
7
|
|
Double Blind Maintenance Phase(26 Weeks)
Other (unspecified)
|
0
|
0
|
0
|
1
|
1
|
|
Double Blind Maintenance Phase(26 Weeks)
Missing
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Safety and Efficacy of MMX Mesalamine/Mesalazine in Pediatric Subjects With Mild to Moderate Ulcerative Colitis
Baseline characteristics by cohort
| Measure |
Overall Study
n=105 Participants
Participants with partial UC-DAI \> or =2 and mucosal appearance = 2 or 3 entered the DBA phase; with UC-DAI between 1 and 2 entered the OLA phase, after completing DBA phase; with UC-DAI \< or = 1 and mucosal appearance = 0 or 1 entered the DBM phase directly. Also, participants who had a clinical response (partial UC-DAI \< or =1) after completion of DBA phase or OLA phase entered into the DBM phase. During the DBA and DBM phase, participants received 900 to 2400 mg/day (low dose) and 1800 to 4800 mg/day (high dose) of MMX mesalamine/mesalazine tablet orally once daily for 8 and 26 weeks respectively. During OLA phase, participants received the high dose for 8 weeks.
|
|---|---|
|
Age, Continuous
|
14.1 years
STANDARD_DEVIATION 2.55 • n=5 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
104 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
101 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 8Population: Double-blind acute phase safety analysis set consisted of randomized participants who had taken at least 1 dose of investigational product during the double-blind acute phase.
Clinical response was defined as partial ulcerative colitis disease activity index (UC-DAI) score \< or =1 with rectal bleeding = 0, stool frequency \< or =1, and physician's global assessment (PGA = 0). Number of participants with clinical response were reported.
Outcome measures
| Measure |
Double-Blind Acute (DBA) Phase: Low Dose
n=27 Participants
Participants with partial UC-DAI \> or =2 and mucosal appearance = 2 or 3 entered the DBA phase. During the DBA low dose phase participants weighing 18 to \< or =23 kg, \>23 to \< or =35 kg, \> 35 to \< or =50 kg, \> 50 to \< or =90 kg received 900, 1200, 1800, and 2400 mg/day of MMX mesalamine/mesalazine tablet orally once daily for 8 weeks respectively.
|
Double-Blind Acute (DBA) Phase: High Dose
n=26 Participants
Participants with partial UC-DAI \> or =2 and mucosal appearance = 2 or 3 entered the DBA phase. During the DBA high dose phase participants weighing 18 to \< or =23 kg, \> 23 to \< or =35 kg, \> 35 to \< or =50 kg, \> 50 to \< or =90 kg received 1800, 2400, 3600, and 4800 mg/day of MMX mesalamine/mesalazine tablet orally once daily for 8 weeks respectively.
|
|---|---|---|
|
Number of Participants With Clinical Response During Double-Blind Acute Phase at Week 8
|
10 Participants
|
17 Participants
|
PRIMARY outcome
Timeframe: Week 26Population: Double-blind maintenance phase safety analysis set consisted of randomized participants who had taken at least 1 dose of investigational product during the double-blind maintenance phase.
Clinical response was defined as partial UC-DAI \<=1 with (rectal bleeding = 0, stool frequency \< or =1, and PGA = 0). Number of participants who had maintained clinical response were reported.
Outcome measures
| Measure |
Double-Blind Acute (DBA) Phase: Low Dose
n=42 Participants
Participants with partial UC-DAI \> or =2 and mucosal appearance = 2 or 3 entered the DBA phase. During the DBA low dose phase participants weighing 18 to \< or =23 kg, \>23 to \< or =35 kg, \> 35 to \< or =50 kg, \> 50 to \< or =90 kg received 900, 1200, 1800, and 2400 mg/day of MMX mesalamine/mesalazine tablet orally once daily for 8 weeks respectively.
|
Double-Blind Acute (DBA) Phase: High Dose
n=45 Participants
Participants with partial UC-DAI \> or =2 and mucosal appearance = 2 or 3 entered the DBA phase. During the DBA high dose phase participants weighing 18 to \< or =23 kg, \> 23 to \< or =35 kg, \> 35 to \< or =50 kg, \> 50 to \< or =90 kg received 1800, 2400, 3600, and 4800 mg/day of MMX mesalamine/mesalazine tablet orally once daily for 8 weeks respectively.
|
|---|---|---|
|
Number of Participants With Clinical Response During Double-blind Maintenance Phase at Week 26
|
23 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: Week 8Population: Double-blind acute phase safety analysis set consisted of randomized participants who had taken at least 1 dose of investigational product during the double-blind acute phase.
Clinical and endoscopic response was defined as UC-DAI \<=2 with rectal bleeding = 0 and stool frequency \<=1, and PGA = 0, and with mucosal healing (endoscopy score \<=1) at least a 1 point reduction in endoscopy score from baseline based on central reading. Participants with missing data at week 8 were assumed not to had a clinical response. Participants who completed week 8 but did not have central reading endoscopies at both baseline and week 8 were excluded. Number of participants with clinical and endoscopic response were reported.
Outcome measures
| Measure |
Double-Blind Acute (DBA) Phase: Low Dose
n=27 Participants
Participants with partial UC-DAI \> or =2 and mucosal appearance = 2 or 3 entered the DBA phase. During the DBA low dose phase participants weighing 18 to \< or =23 kg, \>23 to \< or =35 kg, \> 35 to \< or =50 kg, \> 50 to \< or =90 kg received 900, 1200, 1800, and 2400 mg/day of MMX mesalamine/mesalazine tablet orally once daily for 8 weeks respectively.
|
Double-Blind Acute (DBA) Phase: High Dose
n=26 Participants
Participants with partial UC-DAI \> or =2 and mucosal appearance = 2 or 3 entered the DBA phase. During the DBA high dose phase participants weighing 18 to \< or =23 kg, \> 23 to \< or =35 kg, \> 35 to \< or =50 kg, \> 50 to \< or =90 kg received 1800, 2400, 3600, and 4800 mg/day of MMX mesalamine/mesalazine tablet orally once daily for 8 weeks respectively.
|
|---|---|---|
|
Number of Participants With Clinical and Endoscopic Response During Double Blind Acute Phase at Week 8 Using Central Reading
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Week 8Population: Double-blind acute phase safety analysis set consisted of randomized participants who had taken at least 1 dose of investigational product during the double-blind acute phase.
Clinical and endoscopic response was defined as UC-DAI \< or =2 with rectal bleeding = 0 and stool frequency \< or =1, and PGA = 0, and with mucosal healing (endoscopy score \< or =1) at least a 1 point reduction in endoscopy score from baseline based on local reading. Participants with missing data at week 8 were assumed not to had a clinical response. Participants who completed week 8 but did not have local reading endoscopies at both baseline and week 8 were excluded. Number of participants with clinical and endoscopic response were reported.
Outcome measures
| Measure |
Double-Blind Acute (DBA) Phase: Low Dose
n=27 Participants
Participants with partial UC-DAI \> or =2 and mucosal appearance = 2 or 3 entered the DBA phase. During the DBA low dose phase participants weighing 18 to \< or =23 kg, \>23 to \< or =35 kg, \> 35 to \< or =50 kg, \> 50 to \< or =90 kg received 900, 1200, 1800, and 2400 mg/day of MMX mesalamine/mesalazine tablet orally once daily for 8 weeks respectively.
|
Double-Blind Acute (DBA) Phase: High Dose
n=26 Participants
Participants with partial UC-DAI \> or =2 and mucosal appearance = 2 or 3 entered the DBA phase. During the DBA high dose phase participants weighing 18 to \< or =23 kg, \> 23 to \< or =35 kg, \> 35 to \< or =50 kg, \> 50 to \< or =90 kg received 1800, 2400, 3600, and 4800 mg/day of MMX mesalamine/mesalazine tablet orally once daily for 8 weeks respectively.
|
|---|---|---|
|
Number of Participants With Clinical and Endoscopic Response During Double Blind Acute Phase at Week 8 Using Local Reading
|
1 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 8Population: Double-blind acute phase safety analysis set consisted of randomized participants who had taken at least 1 dose of investigational product during the double-blind acute phase. Here, number of participants analyzed signifies participants who were evaluable for this measure category.
DUCS score was to measure 7 specific signs or symptom and one impact (abdominal pain, nocturnal stool, daytime stool, blood in stool, diarrhea, urgency, tiredness) of UC with each item score ranged from 0 (worst) to 10 (best) with the overall score ranged from 0 (worst) to 70 (best) based on the responses. Change in the DUCS score from baseline to Week 8 during DBA phase were reported.
Outcome measures
| Measure |
Double-Blind Acute (DBA) Phase: Low Dose
n=27 Participants
Participants with partial UC-DAI \> or =2 and mucosal appearance = 2 or 3 entered the DBA phase. During the DBA low dose phase participants weighing 18 to \< or =23 kg, \>23 to \< or =35 kg, \> 35 to \< or =50 kg, \> 50 to \< or =90 kg received 900, 1200, 1800, and 2400 mg/day of MMX mesalamine/mesalazine tablet orally once daily for 8 weeks respectively.
|
Double-Blind Acute (DBA) Phase: High Dose
n=26 Participants
Participants with partial UC-DAI \> or =2 and mucosal appearance = 2 or 3 entered the DBA phase. During the DBA high dose phase participants weighing 18 to \< or =23 kg, \> 23 to \< or =35 kg, \> 35 to \< or =50 kg, \> 50 to \< or =90 kg received 1800, 2400, 3600, and 4800 mg/day of MMX mesalamine/mesalazine tablet orally once daily for 8 weeks respectively.
|
|---|---|---|
|
Change From Baseline in Daily Ulcerative Colitis Scale (DUCS) Score During Double-Blind Acute Phase
Baseline
|
32.2 Score on the scale
Standard Error 2.86
|
31.6 Score on the scale
Standard Error 2.88
|
|
Change From Baseline in Daily Ulcerative Colitis Scale (DUCS) Score During Double-Blind Acute Phase
Week 2
|
-14.1 Score on the scale
Standard Error 3.80
|
-13.2 Score on the scale
Standard Error 3.50
|
|
Change From Baseline in Daily Ulcerative Colitis Scale (DUCS) Score During Double-Blind Acute Phase
Week 4
|
-15.6 Score on the scale
Standard Error 3.96
|
-16.7 Score on the scale
Standard Error 4.01
|
|
Change From Baseline in Daily Ulcerative Colitis Scale (DUCS) Score During Double-Blind Acute Phase
Week 8
|
-18.2 Score on the scale
Standard Error 4.40
|
-23.1 Score on the scale
Standard Error 3.59
|
SECONDARY outcome
Timeframe: Week 8Population: Double-blind acute phase safety analysis set consisted of randomized participants who had taken at least 1 dose of investigational product during the double-blind acute phase.
PUCAI was a physician-administered measure that focuses on 6 key signs and symptoms of UC and activity limitations producing a total score ranging from 0-85 with higher scores being worse. Recommended cut-off scores to differentiate disease activity are \< 10 (remission); 11-30 (mild); 31-64 (moderate) and \> 65 (severe). Participants with an improvement (change of greater than or equal to \[\> or =\] 20 points) in PUCAI score. Number of participants with improvement in PUCAI score during Double-blind Acute Phase at Week 8 were reported.
Outcome measures
| Measure |
Double-Blind Acute (DBA) Phase: Low Dose
n=27 Participants
Participants with partial UC-DAI \> or =2 and mucosal appearance = 2 or 3 entered the DBA phase. During the DBA low dose phase participants weighing 18 to \< or =23 kg, \>23 to \< or =35 kg, \> 35 to \< or =50 kg, \> 50 to \< or =90 kg received 900, 1200, 1800, and 2400 mg/day of MMX mesalamine/mesalazine tablet orally once daily for 8 weeks respectively.
|
Double-Blind Acute (DBA) Phase: High Dose
n=26 Participants
Participants with partial UC-DAI \> or =2 and mucosal appearance = 2 or 3 entered the DBA phase. During the DBA high dose phase participants weighing 18 to \< or =23 kg, \> 23 to \< or =35 kg, \> 35 to \< or =50 kg, \> 50 to \< or =90 kg received 1800, 2400, 3600, and 4800 mg/day of MMX mesalamine/mesalazine tablet orally once daily for 8 weeks respectively.
|
|---|---|---|
|
Number of Participants With Improvement in Pediatric Ulcerative Colitis Activity Index (PUCAI) Score During Double-blind Acute Phase at Week 8
|
10 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: Week 26Population: Double-blind maintenance phase safety analysis set consisted of randomized participants who had taken at least 1 dose of investigational product during the double-blind maintenance phase.
Clinical and endoscopic response was defined as UC-DAI \< or =2 with rectal bleeding=0, stool frequency \< or =1, PGA=0, and with mucosal healing (endoscopy score \< or =1) based on central reading at Week 26. Number of participants with clinical and endoscopic response during double-blind maintenance phase at Week 26 using central reading were reported.
Outcome measures
| Measure |
Double-Blind Acute (DBA) Phase: Low Dose
n=42 Participants
Participants with partial UC-DAI \> or =2 and mucosal appearance = 2 or 3 entered the DBA phase. During the DBA low dose phase participants weighing 18 to \< or =23 kg, \>23 to \< or =35 kg, \> 35 to \< or =50 kg, \> 50 to \< or =90 kg received 900, 1200, 1800, and 2400 mg/day of MMX mesalamine/mesalazine tablet orally once daily for 8 weeks respectively.
|
Double-Blind Acute (DBA) Phase: High Dose
n=45 Participants
Participants with partial UC-DAI \> or =2 and mucosal appearance = 2 or 3 entered the DBA phase. During the DBA high dose phase participants weighing 18 to \< or =23 kg, \> 23 to \< or =35 kg, \> 35 to \< or =50 kg, \> 50 to \< or =90 kg received 1800, 2400, 3600, and 4800 mg/day of MMX mesalamine/mesalazine tablet orally once daily for 8 weeks respectively.
|
|---|---|---|
|
Number of Participants With Clinical and Endoscopic Response During Double-Blind Maintenance Phase at Week 26 Using Central Reading
|
13 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Week 26Population: Double-blind maintenance phase safety analysis set consisted of randomized participants who had taken at least 1 dose of investigational product during the double-blind maintenance phase.
Clinical and endoscopic response was defined as UC-DAI \< or = 2 with rectal bleeding=0, stool frequency \< or = 1, PGA=0, and with mucosal healing (endoscopy score \< or = 1) based on local reading. Number of participants who had maintained clinical and endoscopic response during double-blind maintenance phase at week 26 using local reading were reported.
Outcome measures
| Measure |
Double-Blind Acute (DBA) Phase: Low Dose
n=42 Participants
Participants with partial UC-DAI \> or =2 and mucosal appearance = 2 or 3 entered the DBA phase. During the DBA low dose phase participants weighing 18 to \< or =23 kg, \>23 to \< or =35 kg, \> 35 to \< or =50 kg, \> 50 to \< or =90 kg received 900, 1200, 1800, and 2400 mg/day of MMX mesalamine/mesalazine tablet orally once daily for 8 weeks respectively.
|
Double-Blind Acute (DBA) Phase: High Dose
n=45 Participants
Participants with partial UC-DAI \> or =2 and mucosal appearance = 2 or 3 entered the DBA phase. During the DBA high dose phase participants weighing 18 to \< or =23 kg, \> 23 to \< or =35 kg, \> 35 to \< or =50 kg, \> 50 to \< or =90 kg received 1800, 2400, 3600, and 4800 mg/day of MMX mesalamine/mesalazine tablet orally once daily for 8 weeks respectively.
|
|---|---|---|
|
Number of Participants With Clinical and Endoscopic Response During Double-Blind Maintenance Phase at Week 26 Using Local Reading
|
18 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 13, and Week 26Population: Double-blind maintenance phase safety analysis set consisted of randomized participants who had taken at least 1 dose of investigational product during the double-blind maintenance phase. Here, number of participants analyzed signifies participants who were evaluable for this measure category.
DUCS score was to measure 7 specific signs or symptom and one impact (abdominal pain, nocturnal stool, daytime stool, blood in stool, diarrhea, urgency, tiredness) of UC with each score range from 0 (worst) to 10 (best) with the overall score ranging from 0 (worst) to 70 (best) based on the responses. Change from Baseline in DUCS score during double-blind maintenance phase at week 13 and Week 26 wwere reported.
Outcome measures
| Measure |
Double-Blind Acute (DBA) Phase: Low Dose
n=42 Participants
Participants with partial UC-DAI \> or =2 and mucosal appearance = 2 or 3 entered the DBA phase. During the DBA low dose phase participants weighing 18 to \< or =23 kg, \>23 to \< or =35 kg, \> 35 to \< or =50 kg, \> 50 to \< or =90 kg received 900, 1200, 1800, and 2400 mg/day of MMX mesalamine/mesalazine tablet orally once daily for 8 weeks respectively.
|
Double-Blind Acute (DBA) Phase: High Dose
n=45 Participants
Participants with partial UC-DAI \> or =2 and mucosal appearance = 2 or 3 entered the DBA phase. During the DBA high dose phase participants weighing 18 to \< or =23 kg, \> 23 to \< or =35 kg, \> 35 to \< or =50 kg, \> 50 to \< or =90 kg received 1800, 2400, 3600, and 4800 mg/day of MMX mesalamine/mesalazine tablet orally once daily for 8 weeks respectively.
|
|---|---|---|
|
Change From Baseline in Daily Ulcerative Colitis Scale (DUCS) Score During Double-Blind Maintenance Phase
Baseline
|
5.8 Score on the scale
Standard Error 1.37
|
4.6 Score on the scale
Standard Error 0.79
|
|
Change From Baseline in Daily Ulcerative Colitis Scale (DUCS) Score During Double-Blind Maintenance Phase
Week 13
|
1.7 Score on the scale
Standard Error 1.61
|
-0.1 Score on the scale
Standard Error 0.89
|
|
Change From Baseline in Daily Ulcerative Colitis Scale (DUCS) Score During Double-Blind Maintenance Phase
Week 26
|
1.3 Score on the scale
Standard Error 1.19
|
4.4 Score on the scale
Standard Error 1.79
|
SECONDARY outcome
Timeframe: Week 26Population: Double-blind maintenance phase safety analysis set consisted of randomized participants who had taken at least 1 dose of investigational product during the double-blind maintenance phase.
PUCAI was a physician-administered measure that focuses on 6 key signs and symptoms of UC and activity limitations producing a total score ranging from 0-85 with higher scores being worse. Recommended cut-off scores to differentiate disease activity are \< 10 (remission); 11-30 (mild); 31-64 (moderate) and \> 65 (severe). Number of participants with remission at PUCAI score during double-blind maintenance phase at week 26 were reported.
Outcome measures
| Measure |
Double-Blind Acute (DBA) Phase: Low Dose
n=42 Participants
Participants with partial UC-DAI \> or =2 and mucosal appearance = 2 or 3 entered the DBA phase. During the DBA low dose phase participants weighing 18 to \< or =23 kg, \>23 to \< or =35 kg, \> 35 to \< or =50 kg, \> 50 to \< or =90 kg received 900, 1200, 1800, and 2400 mg/day of MMX mesalamine/mesalazine tablet orally once daily for 8 weeks respectively.
|
Double-Blind Acute (DBA) Phase: High Dose
n=45 Participants
Participants with partial UC-DAI \> or =2 and mucosal appearance = 2 or 3 entered the DBA phase. During the DBA high dose phase participants weighing 18 to \< or =23 kg, \> 23 to \< or =35 kg, \> 35 to \< or =50 kg, \> 50 to \< or =90 kg received 1800, 2400, 3600, and 4800 mg/day of MMX mesalamine/mesalazine tablet orally once daily for 8 weeks respectively.
|
|---|---|---|
|
Number of Participants With Remission at Pediatric Ulcerative Colitis Activity Index (PUCAI) Score During Double-Blind Maintenance Phase at Week 26
|
29 Participants
|
27 Participants
|
Adverse Events
Double-Blind Acute (DBA) Phase: Low Dose
Serious events: 4 serious events
Other events: 15 other events
Deaths: 0 deaths
Double-Blind Acute (DBA) Phase: High Dose
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Open-Label Acute (OLA) Phase: High Dose
Serious events: 3 serious events
Other events: 12 other events
Deaths: 0 deaths
Double-Blind Maintenance (DBM) Phase: Low Dose
Serious events: 3 serious events
Other events: 25 other events
Deaths: 0 deaths
Double-Blind Maintenance (DBM) Phase: High Dose
Serious events: 2 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Double-Blind Acute (DBA) Phase: Low Dose
n=27 participants at risk
Participants with partial UC-DAI \>=2 and mucosal appearance = 2 or 3 entered the DBA phase. During the DBA low dose phase participants weighing 18 to \<=23 kg, \>23 to \<=35 kg, \>35 to \<=50 kg, \>50 to \<=90 kg received 900, 1200, 1800, and 2400 mg/day of MMX mesalamine/mesalazine tablet orally once daily for 8 weeks respectively.
|
Double-Blind Acute (DBA) Phase: High Dose
n=26 participants at risk
Participants with partial UC-DAI \>=2 and mucosal appearance = 2 or 3 entered the DBA phase. During the DBA high dose phase participants weighing 18 to \<=23 kg, \>23 to \<=35 kg, \>35 to \<=50 kg, \>50 to \<=90 kg received 1800, 2400, 3600, and 4800 mg/day of MMX mesalamine/mesalazine tablet orally once daily for 8 weeks respectively.
|
Open-Label Acute (OLA) Phase: High Dose
n=18 participants at risk
Participants with partial UC-DAI between 1 and 2 entered the OLA phase, after completing DBA phase. Participants weighing 18 to \<=23 kg, \>23 to \<=35 kg, \>35 to \<=50 kg, \>50 to \<=90 kg received 1800, 2400, 3600, and 4800 mg/day of MMX mesalamine/mesalazine tablet orally once daily for 8 weeks respectively during the high dose OLA phase.
|
Double-Blind Maintenance (DBM) Phase: Low Dose
n=42 participants at risk
Participants with partial UC-DAI \<=1 and mucosal appearance = 0 or 1 entered the DBM phase directly. Also, participants with a clinical response (partial UC-DAI \<=1) after completion of DBA phase or OLA phase entered into the DBM phase. During the DBM low dose phase participants weighing 18 to \<=23 kg, \>23 to \<=35 kg, \>35 to \<=50 kg, \>50 to \<=90 kg received 900, 1200, 1800, and 2400 mg/day of MMX mesalamine/mesalazine tablet orally once daily for 26 weeks respectively.
|
Double-Blind Maintenance (DBM) Phase: High Dose
n=45 participants at risk
Participants with partial UC-DAI \<=1 and mucosal appearance = 0 or 1 entered the DBM phase directly. Also, participants with a clinical response (partial UC-DAI \<=1) after completion of DBA phase or OLA phase entered into the DBM phase. During the DBM high dose phase participants weighing 18 to \<=3 kg, \>23 to \<=35 kg, \>35 to \<=50 kg, \>50 to \<=90 kg received 1800, 2400, 3600, and 4800 mg/day of MMX mesalamine/mesalazine tablet orally once daily for 26 weeks respectively.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.7%
1/27 • Number of events 1 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
5.6%
1/18 • Number of events 1 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/42 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/45 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/27 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/18 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/42 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
2.2%
1/45 • Number of events 2 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
7.4%
2/27 • Number of events 2 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
5.6%
1/18 • Number of events 1 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
2.4%
1/42 • Number of events 2 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/45 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/27 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/18 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/42 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
2.2%
1/45 • Number of events 1 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
|
Gastrointestinal disorders
Enteritis
|
3.7%
1/27 • Number of events 1 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/18 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/42 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/45 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
|
General disorders
Chest pain
|
0.00%
0/27 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
5.6%
1/18 • Number of events 1 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/42 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/45 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
|
Infections and infestations
Pyelonephritis
|
3.7%
1/27 • Number of events 1 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/18 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/42 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/45 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
|
Injury, poisoning and procedural complications
Injury corneal
|
0.00%
0/27 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/18 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
2.4%
1/42 • Number of events 1 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/45 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
|
Injury, poisoning and procedural complications
Retinal injury
|
0.00%
0/27 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/18 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
2.4%
1/42 • Number of events 1 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/45 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/27 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/18 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
2.4%
1/42 • Number of events 1 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/45 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/27 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/18 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
2.4%
1/42 • Number of events 1 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/45 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.7%
1/27 • Number of events 1 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/18 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/42 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/45 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
Other adverse events
| Measure |
Double-Blind Acute (DBA) Phase: Low Dose
n=27 participants at risk
Participants with partial UC-DAI \>=2 and mucosal appearance = 2 or 3 entered the DBA phase. During the DBA low dose phase participants weighing 18 to \<=23 kg, \>23 to \<=35 kg, \>35 to \<=50 kg, \>50 to \<=90 kg received 900, 1200, 1800, and 2400 mg/day of MMX mesalamine/mesalazine tablet orally once daily for 8 weeks respectively.
|
Double-Blind Acute (DBA) Phase: High Dose
n=26 participants at risk
Participants with partial UC-DAI \>=2 and mucosal appearance = 2 or 3 entered the DBA phase. During the DBA high dose phase participants weighing 18 to \<=23 kg, \>23 to \<=35 kg, \>35 to \<=50 kg, \>50 to \<=90 kg received 1800, 2400, 3600, and 4800 mg/day of MMX mesalamine/mesalazine tablet orally once daily for 8 weeks respectively.
|
Open-Label Acute (OLA) Phase: High Dose
n=18 participants at risk
Participants with partial UC-DAI between 1 and 2 entered the OLA phase, after completing DBA phase. Participants weighing 18 to \<=23 kg, \>23 to \<=35 kg, \>35 to \<=50 kg, \>50 to \<=90 kg received 1800, 2400, 3600, and 4800 mg/day of MMX mesalamine/mesalazine tablet orally once daily for 8 weeks respectively during the high dose OLA phase.
|
Double-Blind Maintenance (DBM) Phase: Low Dose
n=42 participants at risk
Participants with partial UC-DAI \<=1 and mucosal appearance = 0 or 1 entered the DBM phase directly. Also, participants with a clinical response (partial UC-DAI \<=1) after completion of DBA phase or OLA phase entered into the DBM phase. During the DBM low dose phase participants weighing 18 to \<=23 kg, \>23 to \<=35 kg, \>35 to \<=50 kg, \>50 to \<=90 kg received 900, 1200, 1800, and 2400 mg/day of MMX mesalamine/mesalazine tablet orally once daily for 26 weeks respectively.
|
Double-Blind Maintenance (DBM) Phase: High Dose
n=45 participants at risk
Participants with partial UC-DAI \<=1 and mucosal appearance = 0 or 1 entered the DBM phase directly. Also, participants with a clinical response (partial UC-DAI \<=1) after completion of DBA phase or OLA phase entered into the DBM phase. During the DBM high dose phase participants weighing 18 to \<=3 kg, \>23 to \<=35 kg, \>35 to \<=50 kg, \>50 to \<=90 kg received 1800, 2400, 3600, and 4800 mg/day of MMX mesalamine/mesalazine tablet orally once daily for 26 weeks respectively.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/27 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
3.8%
1/26 • Number of events 1 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
5.6%
1/18 • Number of events 1 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
2.4%
1/42 • Number of events 1 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
2.2%
1/45 • Number of events 1 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/27 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
3.8%
1/26 • Number of events 1 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
11.1%
2/18 • Number of events 2 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/42 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/45 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/27 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
5.6%
1/18 • Number of events 1 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/42 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/45 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
|
Musculoskeletal and connective tissue disorders
Torticollis
|
0.00%
0/27 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
5.6%
1/18 • Number of events 1 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/42 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/45 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.7%
1/27 • Number of events 1 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
7.7%
2/26 • Number of events 2 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
5.6%
1/18 • Number of events 1 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
7.1%
3/42 • Number of events 5 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
11.1%
5/45 • Number of events 6 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/27 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
3.8%
1/26 • Number of events 1 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/18 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
7.1%
3/42 • Number of events 3 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
2.2%
1/45 • Number of events 1 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
22.2%
6/27 • Number of events 6 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
5.6%
1/18 • Number of events 1 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
11.9%
5/42 • Number of events 5 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
17.8%
8/45 • Number of events 9 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/27 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
5.6%
1/18 • Number of events 1 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/42 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/45 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
|
Gastrointestinal disorders
Dyspepsia
|
3.7%
1/27 • Number of events 1 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
11.5%
3/26 • Number of events 3 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/18 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/42 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
2.2%
1/45 • Number of events 2 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/27 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
3.8%
1/26 • Number of events 1 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
5.6%
1/18 • Number of events 1 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
4.8%
2/42 • Number of events 2 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
2.2%
1/45 • Number of events 1 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
|
Gastrointestinal disorders
Vomiting
|
7.4%
2/27 • Number of events 2 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
3.8%
1/26 • Number of events 1 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
5.6%
1/18 • Number of events 1 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/42 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
6.7%
3/45 • Number of events 8 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
|
General disorders
Pyrexia
|
7.4%
2/27 • Number of events 2 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
3.8%
1/26 • Number of events 1 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/18 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/42 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
2.2%
1/45 • Number of events 1 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/27 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
5.6%
1/18 • Number of events 1 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/42 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/45 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/27 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
5.6%
1/18 • Number of events 1 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/42 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
2.2%
1/45 • Number of events 1 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/27 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/18 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
7.1%
3/42 • Number of events 4 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
13.3%
6/45 • Number of events 6 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
|
Infections and infestations
Pharyngitis
|
3.7%
1/27 • Number of events 1 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
7.7%
2/26 • Number of events 2 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/18 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/42 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
2.2%
1/45 • Number of events 1 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.7%
1/27 • Number of events 1 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
11.1%
2/18 • Number of events 2 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
2.4%
1/42 • Number of events 1 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
2.2%
1/45 • Number of events 1 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
|
Infections and infestations
Urinary tract infection
|
3.7%
1/27 • Number of events 2 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
5.6%
1/18 • Number of events 1 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
2.4%
1/42 • Number of events 1 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
2.2%
1/45 • Number of events 1 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
|
Infections and infestations
Viral infection
|
3.7%
1/27 • Number of events 1 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
7.7%
2/26 • Number of events 2 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/18 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
4.8%
2/42 • Number of events 2 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
2.2%
1/45 • Number of events 1 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/27 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
5.6%
1/18 • Number of events 1 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/42 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/45 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/27 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
5.6%
1/18 • Number of events 1 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/42 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/45 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
|
Nervous system disorders
Headache
|
7.4%
2/27 • Number of events 2 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
7.7%
2/26 • Number of events 2 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/18 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
4.8%
2/42 • Number of events 3 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
4.4%
2/45 • Number of events 6 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/27 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
5.6%
1/18 • Number of events 1 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/42 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/45 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.4%
2/27 • Number of events 2 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/18 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
2.4%
1/42 • Number of events 1 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
2.2%
1/45 • Number of events 1 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.4%
2/27 • Number of events 2 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
5.6%
1/18 • Number of events 1 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
2.4%
1/42 • Number of events 1 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
6.7%
3/45 • Number of events 3 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/27 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/18 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/42 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
6.7%
3/45 • Number of events 3 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/27 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
5.6%
1/18 • Number of events 1 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/42 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/45 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/27 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/26 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
5.6%
1/18 • Number of events 1 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/42 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
0.00%
0/45 • From start of study drug administration up to follow-up (up to Week 27)
Overall safety analysis set consisted of randomized participants who had taken at least 1 dose of IP.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
- Publication restrictions are in place
Restriction type: OTHER