Trial Outcomes & Findings for Efficacy, Safety, and Pharmacokinetics of APT-1011 in Subjects With Eosinophilic Esophagitis (EoE) (NCT NCT03191864)
NCT ID: NCT03191864
Last Updated: 2023-04-26
Results Overview
Histology (eosinophils per high power field \[HPF\]): percentage of subjects with ≤6 PEAK eosinophils/HPF after assessing at least 5-6 biopsies from the proximal and distal esophagus (\~3 each) where the HPF area is 235 square microns (40 magnification lens with a 22 mm ocular).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
106 participants
Primary outcome timeframe
Week 12
Results posted on
2023-04-26
Participant Flow
Recruitment in 6 countries (United States, Canada, Belgium, Germany, Spain, and Switzerland) took place between 22-Jun-2017 (First Subject Enrolled) until 23-Aug-2018 (Last Subject Enrolled).
The Screening Period was 4 weeks (28 days) and utilized a single-blind placebo run-in period. Along with the reports confirming the subject's primary diagnosis of EoE, the Investigator assessed eligibility criteria of the subject based on screening results. The Global EoE Symptom Score had to be \>3 for the subject to continue in the study. Patients who were screened (308) are presented under Baseline Symptom Assessment, those enrolled (106) are presented in Part 1 - Induction.
Participant milestones
| Measure |
APT-1011 1.5 mg HS
Placebo after breakfast, APT-1011 1.5 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
APT-1011 1.5 mg BID
APT-1011 1.5 mg after breakfast, APT-1011 1.5 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
APT-1011 3 mg HS
Placebo after breakfast, APT-1011 3 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
APT-1011 3 mg BID
APT-1011 3 mg after breakfast, APT-1011 3 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
Single-blind APT-1011 3mg BID
APT-1011 3 mg after breakfast, APT-1011 3 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
Placebo BID
Placebo 30 minutes after breakfast and HS
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
|---|---|---|---|---|---|---|
|
Baseline Symptom Assessment
STARTED
|
0
|
0
|
0
|
0
|
0
|
308
|
|
Baseline Symptom Assessment
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
106
|
|
Baseline Symptom Assessment
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
202
|
|
Part 1 - Induction
STARTED
|
21
|
22
|
22
|
20
|
0
|
21
|
|
Part 1 - Induction
COMPLETED
|
18
|
19
|
20
|
19
|
0
|
16
|
|
Part 1 - Induction
NOT COMPLETED
|
3
|
3
|
2
|
1
|
0
|
5
|
|
Part 2 - Maintenance
STARTED
|
10
|
19
|
14
|
16
|
34
|
0
|
|
Part 2 - Maintenance
COMPLETED
|
5
|
17
|
11
|
14
|
19
|
0
|
|
Part 2 - Maintenance
NOT COMPLETED
|
5
|
2
|
3
|
2
|
15
|
0
|
Reasons for withdrawal
| Measure |
APT-1011 1.5 mg HS
Placebo after breakfast, APT-1011 1.5 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
APT-1011 1.5 mg BID
APT-1011 1.5 mg after breakfast, APT-1011 1.5 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
APT-1011 3 mg HS
Placebo after breakfast, APT-1011 3 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
APT-1011 3 mg BID
APT-1011 3 mg after breakfast, APT-1011 3 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
Single-blind APT-1011 3mg BID
APT-1011 3 mg after breakfast, APT-1011 3 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
Placebo BID
Placebo 30 minutes after breakfast and HS
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
|---|---|---|---|---|---|---|
|
Baseline Symptom Assessment
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Baseline Symptom Assessment
Patient Diary Unavailable at Site
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Baseline Symptom Assessment
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
2
|
|
Baseline Symptom Assessment
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
19
|
|
Baseline Symptom Assessment
Violation of inclusion/exclusion criteria
|
0
|
0
|
0
|
0
|
0
|
179
|
|
Part 1 - Induction
Violation of inclusion/exclusion criteria
|
0
|
0
|
1
|
0
|
0
|
1
|
|
Part 1 - Induction
Adverse Event
|
0
|
2
|
0
|
1
|
0
|
2
|
|
Part 1 - Induction
Randomized but never dosed
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Part 1 - Induction
Withdrawal by Subject
|
3
|
1
|
0
|
0
|
0
|
2
|
|
Part 2 - Maintenance
Refused EGD at Week 26
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Part 2 - Maintenance
Subject Could Not Transfer Site to Complete the Study
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Part 2 - Maintenance
Physician Decision
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Part 2 - Maintenance
Lack of Efficacy
|
1
|
2
|
2
|
2
|
10
|
0
|
|
Part 2 - Maintenance
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Part 2 - Maintenance
Withdrawal by Subject
|
2
|
0
|
0
|
0
|
3
|
0
|
|
Part 2 - Maintenance
Unresponsive - Patient missed multiple appointments
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Efficacy, Safety, and Pharmacokinetics of APT-1011 in Subjects With Eosinophilic Esophagitis (EoE)
Baseline characteristics by cohort
| Measure |
APT-1011 1.5 mg HS
n=21 Participants
Placebo after breakfast, APT-1011 1.5 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
APT-1011 1.5 mg BID
n=22 Participants
APT-1011 1.5 mg after breakfast, APT-1011 1.5 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
APT-1011 3 mg HS
n=22 Participants
Placebo after breakfast, APT-1011 3 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
APT-1011 3 mg BID
n=20 Participants
APT-1011 3 mg after breakfast, APT-1011 3 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
Placebo BID
n=21 Participants
Placebo 30 minutes after breakfast and HS
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
Total
n=106 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
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
|
0 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
104 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Age, Continuous
|
36.8 years
STANDARD_DEVIATION 11.65 • n=5 Participants
|
41.3 years
STANDARD_DEVIATION 12.24 • n=7 Participants
|
41.9 years
STANDARD_DEVIATION 12.09 • n=5 Participants
|
36.8 years
STANDARD_DEVIATION 9.19 • n=4 Participants
|
38.7 years
STANDARD_DEVIATION 13.94 • n=21 Participants
|
39.2 years
STANDARD_DEVIATION 11.92 • n=10 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
33 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
73 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
16 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
87 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
|
Race (NIH/OMB)
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
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
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
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
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
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
103 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
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
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
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
|
0 Participants
n=10 Participants
|
|
Region of Enrollment
North America
|
15 participants
n=5 Participants
|
16 participants
n=7 Participants
|
18 participants
n=5 Participants
|
13 participants
n=4 Participants
|
17 participants
n=21 Participants
|
79 participants
n=10 Participants
|
|
Region of Enrollment
Europe
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
4 participants
n=5 Participants
|
7 participants
n=4 Participants
|
4 participants
n=21 Participants
|
27 participants
n=10 Participants
|
|
Smoking Status
Never
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
87 Participants
n=10 Participants
|
|
Smoking Status
Former
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
16 Participants
n=10 Participants
|
|
Smoking Status
Current
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
|
Smoking Status
Missing
|
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
|
0 Participants
n=10 Participants
|
|
History of esophageal stricture(s)
Yes
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
46 Participants
n=10 Participants
|
|
History of esophageal stricture(s)
No
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
60 Participants
n=10 Participants
|
|
History of esophageal stricture(s)
Missing
|
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
|
0 Participants
n=10 Participants
|
|
Current esophageal stricture(s) based on the study EGD
Yes
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
23 Participants
n=10 Participants
|
|
Current esophageal stricture(s) based on the study EGD
No
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
83 Participants
n=10 Participants
|
|
Current esophageal stricture(s) based on the study EGD
Missing
|
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
|
0 Participants
n=10 Participants
|
|
History of positive steroid response to EOE
Yes
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
21 Participants
n=10 Participants
|
|
History of positive steroid response to EOE
No
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
85 Participants
n=10 Participants
|
|
History of positive steroid response to EOE
Missing
|
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
|
0 Participants
n=10 Participants
|
|
Proton pump inhibitor status
Continuing into study
|
12 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
66 Participants
n=10 Participants
|
|
Proton pump inhibitor status
Not continuing into study
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
40 Participants
n=10 Participants
|
|
Proton pump inhibitor status
Missing
|
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
|
0 Participants
n=10 Participants
|
|
Height
|
175.4 cm
STANDARD_DEVIATION 8.55 • n=5 Participants
|
173.0 cm
STANDARD_DEVIATION 8.56 • n=7 Participants
|
171.0 cm
STANDARD_DEVIATION 9.62 • n=5 Participants
|
176.7 cm
STANDARD_DEVIATION 8.61 • n=4 Participants
|
174.8 cm
STANDARD_DEVIATION 7.20 • n=21 Participants
|
174.1 cm
STANDARD_DEVIATION 8.63 • n=10 Participants
|
|
Weight
|
87.45 kg
STANDARD_DEVIATION 17.69 • n=5 Participants
|
83.72 kg
STANDARD_DEVIATION 14.72 • n=7 Participants
|
83.47 kg
STANDARD_DEVIATION 18.45 • n=5 Participants
|
79.72 kg
STANDARD_DEVIATION 14.93 • n=4 Participants
|
85.45 kg
STANDARD_DEVIATION 19.79 • n=21 Participants
|
83.96 kg
STANDARD_DEVIATION 17.09 • n=10 Participants
|
|
BMI
|
28.27 kg/m^2
STANDARD_DEVIATION 5.19 • n=5 Participants
|
27.39 kg/m^2
STANDARD_DEVIATION 4.34 • n=7 Participants
|
28.68 kg/m^2
STANDARD_DEVIATION 6.74 • n=5 Participants
|
25.54 kg/m^2
STANDARD_DEVIATION 4.45 • n=4 Participants
|
28.02 kg/m^2
STANDARD_DEVIATION 6.53 • n=21 Participants
|
27.60 kg/m^2
STANDARD_DEVIATION 5.57 • n=10 Participants
|
|
Global EOE Symptom Score prior to randomization
|
5.14 units on a scale
STANDARD_DEVIATION 1.62 • n=5 Participants
|
4.50 units on a scale
STANDARD_DEVIATION 2.13 • n=7 Participants
|
5.00 units on a scale
STANDARD_DEVIATION 1.95 • n=5 Participants
|
4.25 units on a scale
STANDARD_DEVIATION 1.94 • n=4 Participants
|
4.95 units on a scale
STANDARD_DEVIATION 1.66 • n=21 Participants
|
4.77 units on a scale
STANDARD_DEVIATION 1.87 • n=10 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: Full Analysis Set Population
Histology (eosinophils per high power field \[HPF\]): percentage of subjects with ≤6 PEAK eosinophils/HPF after assessing at least 5-6 biopsies from the proximal and distal esophagus (\~3 each) where the HPF area is 235 square microns (40 magnification lens with a 22 mm ocular).
Outcome measures
| Measure |
APT-1011 1.5 mg HS
n=21 Participants
Placebo after breakfast, APT-1011 1.5 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
APT-1011 1.5 mg BID
n=22 Participants
APT-1011 1.5 mg after breakfast, APT-1011 1.5 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
APT-1011 3 mg HS
n=21 Participants
Placebo after breakfast, APT-1011 3 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
APT-1011 3 mg BID
n=20 Participants
APT-1011 3 mg after breakfast, APT-1011 3 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
Placebo BID
n=19 Participants
Placebo 30 minutes after breakfast and HS
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
Placebo BID, APT-1011 3 mg BID (Part 2)
Placebo 30 minutes after breakfast and HS
All Non-responders at Week 12 received 3 mg BID Week 14 to Week 52
|
Total APT-1011 3 mg BID
The Total APT-1011 3 mg BID group comprises all subjects who received double-blind or single-blind APT-1011 3 mg BID during Part 2
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With ≤6 Peak Eosinophils/High-power Field (HPF)
Responder
|
10 Participants
|
19 Participants
|
14 Participants
|
16 Participants
|
0 Participants
|
—
|
—
|
|
Percentage of Subjects With ≤6 Peak Eosinophils/High-power Field (HPF)
Non-Responder
|
11 Participants
|
3 Participants
|
7 Participants
|
4 Participants
|
19 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 26, and Week 52Population: Full Analysis Set Population
Percentage of subjects who entered Part 2 - Maintenance and met the primary endpoint (histology) at Week 12 and maintained the primary endpoint at Week 26 and Week 52. Note: Following Week 14, all patients in the placebo group were given APT-1011 3mg BID and results reflect percentage of subjects who met the primary endpoint following 12 or 38 weeks of treatment.
Outcome measures
| Measure |
APT-1011 1.5 mg HS
n=10 Participants
Placebo after breakfast, APT-1011 1.5 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
APT-1011 1.5 mg BID
n=19 Participants
APT-1011 1.5 mg after breakfast, APT-1011 1.5 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
APT-1011 3 mg HS
n=14 Participants
Placebo after breakfast, APT-1011 3 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
APT-1011 3 mg BID
n=16 Participants
APT-1011 3 mg after breakfast, APT-1011 3 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
Placebo BID
n=18 Participants
Placebo 30 minutes after breakfast and HS
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
Placebo BID, APT-1011 3 mg BID (Part 2)
n=16 Participants
Placebo 30 minutes after breakfast and HS
All Non-responders at Week 12 received 3 mg BID Week 14 to Week 52
|
Total APT-1011 3 mg BID
The Total APT-1011 3 mg BID group comprises all subjects who received double-blind or single-blind APT-1011 3 mg BID during Part 2
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
|---|---|---|---|---|---|---|---|
|
Percentage of Subjects Who Met the Primary Endpoint at Week 12 and Maintained the Primary Endpoint at Weeks 26 and 52
Week 26 Responders
|
7 Participants
|
17 Participants
|
11 Participants
|
14 Participants
|
7 Participants
|
12 Participants
|
—
|
|
Percentage of Subjects Who Met the Primary Endpoint at Week 12 and Maintained the Primary Endpoint at Weeks 26 and 52
Week 52 Responders
|
3 Participants
|
16 Participants
|
9 Participants
|
11 Participants
|
5 Participants
|
10 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 12, Week 26, and Week 52Population: Full Analysis Set Population receiving double-blind study medication
Endoscopic changes will be assessed as per the EREFs evaluation based on the following endoscopic features: edema \[Grade {Gr} 0 (absent) or Gr 1 (present)\], strictures \[Gr 0 (absent) or Gr 1 (present)\], rings \[Gr 0 (none), Gr 1 (mild), Gr 2 (moderate), Gr 3 (severe)\], exudates \[Gr 0 (none), Gr 1 (mild), Gr (severe)\], furrows \[Gr 0 (none), Gr 1 (mild), Gr 2 (severe)\], crepe paper esophagus \[Gr 0 (absent) or Gr 1 (present)\], narrow caliber esophagus \[Gr 0 (absent) or Gr 1 (present)\], and esophageal erosions \[Normal (0), Gr A (1), Gr B (2), Gr C (3), or Gr D (4)\]. EREFs: 0 (best) to 15 (worst) based on the sum of the subscores listed above. Population used are those who entered Part 1 - Induction. The number of participants analyzed for each timepoint reflect the actual number of participants with data at that timepoint. Note: Following Week 14, all patients in the placebo group were given APT-1011 3 mg BID and results reflect EREF evaluation following 12 or 38 weeks of treatment.
Outcome measures
| Measure |
APT-1011 1.5 mg HS
n=18 Participants
Placebo after breakfast, APT-1011 1.5 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
APT-1011 1.5 mg BID
n=20 Participants
APT-1011 1.5 mg after breakfast, APT-1011 1.5 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
APT-1011 3 mg HS
n=20 Participants
Placebo after breakfast, APT-1011 3 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
APT-1011 3 mg BID
n=19 Participants
APT-1011 3 mg after breakfast, APT-1011 3 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
Placebo BID
n=17 Participants
Placebo 30 minutes after breakfast and HS
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
Placebo BID, APT-1011 3 mg BID (Part 2)
Placebo 30 minutes after breakfast and HS
All Non-responders at Week 12 received 3 mg BID Week 14 to Week 52
|
Total APT-1011 3 mg BID
The Total APT-1011 3 mg BID group comprises all subjects who received double-blind or single-blind APT-1011 3 mg BID during Part 2
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline Eosinophilic Esophagitis Endoscopic Reference Score (EREFs) at Week 12, 26, and 52
Week 12 Change From Baseline
|
-2.4 units on a scale
Standard Deviation 2.04
|
-2.7 units on a scale
Standard Deviation 2.66
|
-3.3 units on a scale
Standard Deviation 2.36
|
-2.2 units on a scale
Standard Deviation 2.15
|
-0.9 units on a scale
Standard Deviation 1.62
|
—
|
—
|
|
Change From Baseline Eosinophilic Esophagitis Endoscopic Reference Score (EREFs) at Week 12, 26, and 52
Week 26 Change From Baseline
|
-3.1 units on a scale
Standard Deviation 1.25
|
-3.2 units on a scale
Standard Deviation 2.77
|
-4.2 units on a scale
Standard Deviation 2.61
|
-3.0 units on a scale
Standard Deviation 1.67
|
—
|
—
|
—
|
|
Change From Baseline Eosinophilic Esophagitis Endoscopic Reference Score (EREFs) at Week 12, 26, and 52
Week 52 Change From Baseline
|
-3.4 units on a scale
Standard Deviation 1.82
|
-3.5 units on a scale
Standard Deviation 3.08
|
-3.8 units on a scale
Standard Deviation 3.19
|
-2.9 units on a scale
Standard Deviation 1.29
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 12, Week 26, and Week 52Population: Full Analysis Set Population receiving double-blind study medication
Percentage of subjects with a peak eosinophils/HPF \<1 and \<15 at Week 12, 26 and 52. Population used are those who entered Part 1 - Induction. The number of participants analyzed for each timepoint reflect the actual number of participants with data at that timepoint. Note: Following Week 14, all patients in the placebo group were given APT-1011 3mg BID and results reflect peak eosinophils/HPF following 12 or 38 weeks of treatment.
Outcome measures
| Measure |
APT-1011 1.5 mg HS
n=18 Participants
Placebo after breakfast, APT-1011 1.5 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
APT-1011 1.5 mg BID
n=20 Participants
APT-1011 1.5 mg after breakfast, APT-1011 1.5 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
APT-1011 3 mg HS
n=20 Participants
Placebo after breakfast, APT-1011 3 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
APT-1011 3 mg BID
n=19 Participants
APT-1011 3 mg after breakfast, APT-1011 3 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
Placebo BID
n=17 Participants
Placebo 30 minutes after breakfast and HS
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
Placebo BID, APT-1011 3 mg BID (Part 2)
Placebo 30 minutes after breakfast and HS
All Non-responders at Week 12 received 3 mg BID Week 14 to Week 52
|
Total APT-1011 3 mg BID
The Total APT-1011 3 mg BID group comprises all subjects who received double-blind or single-blind APT-1011 3 mg BID during Part 2
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With a Peak Eosinophils/HPF Number <1 and <15
Week 12 : <1/HPF
|
7 Participants
|
14 Participants
|
12 Participants
|
15 Participants
|
0 Participants
|
—
|
—
|
|
Percentage of Subjects With a Peak Eosinophils/HPF Number <1 and <15
Week 12 : <15/HPF
|
12 Participants
|
19 Participants
|
15 Participants
|
16 Participants
|
1 Participants
|
—
|
—
|
|
Percentage of Subjects With a Peak Eosinophils/HPF Number <1 and <15
Week 26 : <1/HPF
|
4 Participants
|
15 Participants
|
9 Participants
|
13 Participants
|
—
|
—
|
—
|
|
Percentage of Subjects With a Peak Eosinophils/HPF Number <1 and <15
Week 26 : <15/HPF
|
8 Participants
|
18 Participants
|
12 Participants
|
14 Participants
|
—
|
—
|
—
|
|
Percentage of Subjects With a Peak Eosinophils/HPF Number <1 and <15
Week 52 : <1/HPF
|
1 Participants
|
12 Participants
|
7 Participants
|
10 Participants
|
—
|
—
|
—
|
|
Percentage of Subjects With a Peak Eosinophils/HPF Number <1 and <15
Week 52 : <15/HPF
|
3 Participants
|
17 Participants
|
10 Participants
|
12 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 4, 8, 12, 14, 18, 22, 26, 28, 36, 44, and 52Population: Full Analysis Set Population receiving double-blind study medication
Change from baseline global EOE symptom score assessed prior to randomization to scores for 7-day recall at Week 4, 8, 12, 14, 18, 22, 26, 28, 36, 44, and 52 visits. Global Eosinophilic Esophagitis Symptom Score: On a scale from 0 (no symptoms) to 10 (most severe symptoms), how severe were your EoE symptoms over the past 7 days? Patients were asked to think of all their symptoms due to EoE and make an overall statement by selecting a number. Population used are those who entered Part 1 - Induction. The number of participants analyzed for each timepoint reflect the actual number of participants with data at that timepoint. Note: Following Week 14, all patients in the placebo group were given APT-1011 3mg BID and results reflect change from baseline global EOE symptom score following 4, 8, 12, 14, 22, 30 or 38 weeks of treatment.
Outcome measures
| Measure |
APT-1011 1.5 mg HS
n=21 Participants
Placebo after breakfast, APT-1011 1.5 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
APT-1011 1.5 mg BID
n=21 Participants
APT-1011 1.5 mg after breakfast, APT-1011 1.5 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
APT-1011 3 mg HS
n=20 Participants
Placebo after breakfast, APT-1011 3 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
APT-1011 3 mg BID
n=20 Participants
APT-1011 3 mg after breakfast, APT-1011 3 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
Placebo BID
n=17 Participants
Placebo 30 minutes after breakfast and HS
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
Placebo BID, APT-1011 3 mg BID (Part 2)
Placebo 30 minutes after breakfast and HS
All Non-responders at Week 12 received 3 mg BID Week 14 to Week 52
|
Total APT-1011 3 mg BID
The Total APT-1011 3 mg BID group comprises all subjects who received double-blind or single-blind APT-1011 3 mg BID during Part 2
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline Global EoE Symptom Score
Week 4 Change from Baseline
|
-1.8 units on a scale
Standard Deviation 2.64
|
-1.3 units on a scale
Standard Deviation 2.15
|
-2.5 units on a scale
Standard Deviation 3.12
|
-1.6 units on a scale
Standard Deviation 1.39
|
-1.0 units on a scale
Standard Deviation 1.67
|
—
|
—
|
|
Change From Baseline Global EoE Symptom Score
Week 8 Change from Baseline
|
-2.6 units on a scale
Standard Deviation 2.12
|
-1.7 units on a scale
Standard Deviation 1.94
|
-3.1 units on a scale
Standard Deviation 2.64
|
-2.1 units on a scale
Standard Deviation 1.92
|
-1.4 units on a scale
Standard Deviation 2.21
|
—
|
—
|
|
Change From Baseline Global EoE Symptom Score
Week 12 Change from Baseline
|
-3.1 units on a scale
Standard Deviation 2.17
|
-1.5 units on a scale
Standard Deviation 2.20
|
-3.1 units on a scale
Standard Deviation 2.74
|
-1.7 units on a scale
Standard Deviation 2.42
|
-1.7 units on a scale
Standard Deviation 1.83
|
—
|
—
|
|
Change From Baseline Global EoE Symptom Score
Week 14 Change from Baseline
|
-2.7 units on a scale
Standard Deviation 2.26
|
-2.3 units on a scale
Standard Deviation 2.45
|
-3.9 units on a scale
Standard Deviation 2.81
|
-2.8 units on a scale
Standard Deviation 1.77
|
—
|
—
|
—
|
|
Change From Baseline Global EoE Symptom Score
Week 18 Change from Baseline
|
-4.1 units on a scale
Standard Deviation 1.36
|
-2.7 units on a scale
Standard Deviation 2.58
|
-4.1 units on a scale
Standard Deviation 2.92
|
-3.1 units on a scale
Standard Deviation 2.17
|
—
|
—
|
—
|
|
Change From Baseline Global EoE Symptom Score
Week 22 Change from Baseline
|
-4.0 units on a scale
Standard Deviation 1.41
|
-3.2 units on a scale
Standard Deviation 2.46
|
-3.8 units on a scale
Standard Deviation 2.97
|
-3.0 units on a scale
Standard Deviation 2.76
|
—
|
—
|
—
|
|
Change From Baseline Global EoE Symptom Score
Week 26 Change from Baseline
|
-3.8 units on a scale
Standard Deviation 1.39
|
-3.1 units on a scale
Standard Deviation 2.52
|
-4.0 units on a scale
Standard Deviation 2.68
|
-3.8 units on a scale
Standard Deviation 2.57
|
—
|
—
|
—
|
|
Change From Baseline Global EoE Symptom Score
Week 28 Change from Baseline
|
-4.3 units on a scale
Standard Deviation 1.38
|
-3.3 units on a scale
Standard Deviation 2.42
|
-4.8 units on a scale
Standard Deviation 2.44
|
-3.9 units on a scale
Standard Deviation 2.09
|
—
|
—
|
—
|
|
Change From Baseline Global EoE Symptom Score
Week 36 Change from Baseline
|
-4.2 units on a scale
Standard Deviation 1.47
|
-3.9 units on a scale
Standard Deviation 2.25
|
-4.8 units on a scale
Standard Deviation 2.09
|
-3.9 units on a scale
Standard Deviation 2.07
|
—
|
—
|
—
|
|
Change From Baseline Global EoE Symptom Score
Week 44 Change from Baseline
|
-4.8 units on a scale
Standard Deviation 2.39
|
-3.7 units on a scale
Standard Deviation 2.41
|
-4.4 units on a scale
Standard Deviation 3.20
|
-4.4 units on a scale
Standard Deviation 1.95
|
—
|
—
|
—
|
|
Change From Baseline Global EoE Symptom Score
Week 52 Change from Baseline
|
-3.3 units on a scale
Standard Deviation 1.71
|
-3.1 units on a scale
Standard Deviation 2.40
|
-4.2 units on a scale
Standard Deviation 2.66
|
-4.7 units on a scale
Standard Deviation 2.27
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 12, Week 26 and Week 52Population: Full Analysis Set Population receiving double-blind study medication
Change in the number of dysphagia episodes at baseline (14-day period prior to randomization) compared with the 14-day period prior to the time point of interest. Population used are those who entered Part 1 - Induction. The number of participants analyzed for each timepoint reflect the actual number of participants with data at that timepoint. Note: Following Week 14, all patients in the placebo group were given APT-1011 3mg BID and results reflect the change in the number of dysphagia episodes following 12 or 38 weeks of treatment.
Outcome measures
| Measure |
APT-1011 1.5 mg HS
n=18 Participants
Placebo after breakfast, APT-1011 1.5 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
APT-1011 1.5 mg BID
n=21 Participants
APT-1011 1.5 mg after breakfast, APT-1011 1.5 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
APT-1011 3 mg HS
n=20 Participants
Placebo after breakfast, APT-1011 3 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
APT-1011 3 mg BID
n=19 Participants
APT-1011 3 mg after breakfast, APT-1011 3 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
Placebo BID
n=17 Participants
Placebo 30 minutes after breakfast and HS
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
Placebo BID, APT-1011 3 mg BID (Part 2)
Placebo 30 minutes after breakfast and HS
All Non-responders at Week 12 received 3 mg BID Week 14 to Week 52
|
Total APT-1011 3 mg BID
The Total APT-1011 3 mg BID group comprises all subjects who received double-blind or single-blind APT-1011 3 mg BID during Part 2
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
|---|---|---|---|---|---|---|---|
|
Change in the Number of Dysphagia Episodes
Week 12 Change from Baseline
|
-8.2 change in episodes per 14-day period
Standard Deviation 5.48
|
-4.4 change in episodes per 14-day period
Standard Deviation 9.41
|
-9.3 change in episodes per 14-day period
Standard Deviation 7.37
|
-9.1 change in episodes per 14-day period
Standard Deviation 11.01
|
-5.5 change in episodes per 14-day period
Standard Deviation 7.89
|
—
|
—
|
|
Change in the Number of Dysphagia Episodes
Week 26 Change from Baseline
|
-12.8 change in episodes per 14-day period
Standard Deviation 5.65
|
-10.0 change in episodes per 14-day period
Standard Deviation 10.97
|
-9.8 change in episodes per 14-day period
Standard Deviation 7.82
|
-13.4 change in episodes per 14-day period
Standard Deviation 11.78
|
—
|
—
|
—
|
|
Change in the Number of Dysphagia Episodes
Week 52 Change from Baseline
|
-11.2 change in episodes per 14-day period
Standard Deviation 5.26
|
-13.0 change in episodes per 14-day period
Standard Deviation 10.79
|
-9.5 change in episodes per 14-day period
Standard Deviation 9.66
|
-14.5 change in episodes per 14-day period
Standard Deviation 11.68
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 12, 26 and 52Population: Full Analysis Set Population
Change from Baseline 7-Day EEsAI total score assessed prior to randomization and those assessed at Weeks 12, 26 and 52 (Total score 100). Eosinophilic Esophagitis Activity Index Total Score: 0 (best) to 100 (worst) based on the sum of the categorized subscores for frequency of trouble swallowing \[never (0), 1-3x (15) or 4-6x (27) per week\]; duration of trouble swallowing \[≤5 min (0), \>5 min (6)\]; pain when swallowing \[no (0), yes (15)\]; Visual Dysphagia Question score \[0 (best),12,19, 21, or 23 (worst)\]; avoidance modification and slow eating score \[0 (best), 9, or 25 (worst)\]. A higher score means a worse outcome. Population used are those who entered Part 1 - Induction. The number of participants analyzed for each timepoint reflect the actual number of participants with data at that timepoint. Note: Following Week 14, all patients in the placebo group were given APT-1011 3mg BID and results reflect the change from baseline 7-day EEs
Outcome measures
| Measure |
APT-1011 1.5 mg HS
n=18 Participants
Placebo after breakfast, APT-1011 1.5 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
APT-1011 1.5 mg BID
n=20 Participants
APT-1011 1.5 mg after breakfast, APT-1011 1.5 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
APT-1011 3 mg HS
n=20 Participants
Placebo after breakfast, APT-1011 3 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
APT-1011 3 mg BID
n=19 Participants
APT-1011 3 mg after breakfast, APT-1011 3 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
Placebo BID
n=17 Participants
Placebo 30 minutes after breakfast and HS
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
Placebo BID, APT-1011 3 mg BID (Part 2)
Placebo 30 minutes after breakfast and HS
All Non-responders at Week 12 received 3 mg BID Week 14 to Week 52
|
Total APT-1011 3 mg BID
The Total APT-1011 3 mg BID group comprises all subjects who received double-blind or single-blind APT-1011 3 mg BID during Part 2
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline 7-Day Eosinophilic Esophagitis Activity Index (EEsAI) Total Score
EEsAI Total Score Week 12 Change from Baseline
|
-20.4 units on a scale
Standard Deviation 15.90
|
-15.6 units on a scale
Standard Deviation 21.02
|
-22.7 units on a scale
Standard Deviation 16.60
|
-22.6 units on a scale
Standard Deviation 21.11
|
-9.6 units on a scale
Standard Deviation 14.07
|
—
|
—
|
|
Change From Baseline 7-Day Eosinophilic Esophagitis Activity Index (EEsAI) Total Score
EEsAI Total Score Week 26 Change from Baseline
|
-25.6 units on a scale
Standard Deviation 21.11
|
-29.6 units on a scale
Standard Deviation 25.48
|
-28.8 units on a scale
Standard Deviation 21.10
|
-34.6 units on a scale
Standard Deviation 25.43
|
—
|
—
|
—
|
|
Change From Baseline 7-Day Eosinophilic Esophagitis Activity Index (EEsAI) Total Score
EEsAI Total Score Week 52 Change from Baseline
|
-39.8 units on a scale
Standard Deviation 28.42
|
-37.4 units on a scale
Standard Deviation 27.02
|
-37.0 units on a scale
Standard Deviation 23.72
|
-41.1 units on a scale
Standard Deviation 20.56
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 12, 26 and 52Population: Full Analysis Set Population
The Avoidance, Modification and Slow Eating (AMS) Score and Visual Dysphagia Question (VDQ) Score are components of the EEsAI. AMS: Answers to three items determining the pattern of behavioral adaptation were scored for each food consistency consumed by the subject (avoidance, modification, and eating slowly). The AMS score ranges from 0 (best) to 25 (worst). VDG: The degree of perceived difficulty when eating 8 different food consistencies was assessed. The VDQ score ranges from 0 (best) to 23 (worst). A higher score for either subscore means a worse outcome. Negative change from baseline represents a worsening in quality of life for the total score or subscore. Population used are those who entered Part 1 - Induction. The number of participants analyzed for each timepoint reflect the actual number of participants with data at that timepoint. Note: Following Week 14, all patients in the placebo group were given APT-1011 3mg BID and results reflect change from baseline.
Outcome measures
| Measure |
APT-1011 1.5 mg HS
n=18 Participants
Placebo after breakfast, APT-1011 1.5 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
APT-1011 1.5 mg BID
n=20 Participants
APT-1011 1.5 mg after breakfast, APT-1011 1.5 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
APT-1011 3 mg HS
n=20 Participants
Placebo after breakfast, APT-1011 3 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
APT-1011 3 mg BID
n=19 Participants
APT-1011 3 mg after breakfast, APT-1011 3 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
Placebo BID
n=17 Participants
Placebo 30 minutes after breakfast and HS
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
Placebo BID, APT-1011 3 mg BID (Part 2)
Placebo 30 minutes after breakfast and HS
All Non-responders at Week 12 received 3 mg BID Week 14 to Week 52
|
Total APT-1011 3 mg BID
The Total APT-1011 3 mg BID group comprises all subjects who received double-blind or single-blind APT-1011 3 mg BID during Part 2
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline 7-Day Eosinophilic Esophagitis Activity Index (EEsAI) Subscores
VDQ Score Week 12 Change from Baseline
|
-3.9 units on a scale
Standard Deviation 6.53
|
-2.5 units on a scale
Standard Deviation 3.24
|
-5.0 units on a scale
Standard Deviation 6.00
|
-4.1 units on a scale
Standard Deviation 8.03
|
-2.7 units on a scale
Standard Deviation 3.41
|
—
|
—
|
|
Change From Baseline 7-Day Eosinophilic Esophagitis Activity Index (EEsAI) Subscores
VDQ Score Week 26 Change from Baseline
|
-3.1 units on a scale
Standard Deviation 4.36
|
-6.8 units on a scale
Standard Deviation 7.03
|
-6.8 units on a scale
Standard Deviation 6.46
|
-7.7 units on a scale
Standard Deviation 9.47
|
—
|
—
|
—
|
|
Change From Baseline 7-Day Eosinophilic Esophagitis Activity Index (EEsAI) Subscores
VDQ Score Week 52 Change from Baseline
|
-9.4 units on a scale
Standard Deviation 9.50
|
-9.4 units on a scale
Standard Deviation 8.25
|
-12.6 units on a scale
Standard Deviation 9.67
|
-9.6 units on a scale
Standard Deviation 7.27
|
—
|
—
|
—
|
|
Change From Baseline 7-Day Eosinophilic Esophagitis Activity Index (EEsAI) Subscores
AMS Score Week 12 Change from Baseline
|
0.0 units on a scale
Standard Deviation 0.00
|
-3.0 units on a scale
Standard Deviation 7.80
|
-1.4 units on a scale
Standard Deviation 3.30
|
-1.3 units on a scale
Standard Deviation 6.47
|
1.5 units on a scale
Standard Deviation 6.85
|
—
|
—
|
|
Change From Baseline 7-Day Eosinophilic Esophagitis Activity Index (EEsAI) Subscores
AMS Score Week 26 Change from Baseline
|
0.0 units on a scale
Standard Deviation 0.00
|
-2.2 units on a scale
Standard Deviation 8.31
|
-0.7 units on a scale
Standard Deviation 4.44
|
-3.3 units on a scale
Standard Deviation 7.54
|
—
|
—
|
—
|
|
Change From Baseline 7-Day Eosinophilic Esophagitis Activity Index (EEsAI) Subscores
AMS Score Week 52 Change from Baseline
|
0.0 units on a scale
Standard Deviation 0.00
|
-3.5 units on a scale
Standard Deviation 8.39
|
-0.8 units on a scale
Standard Deviation 2.71
|
-2.6 units on a scale
Standard Deviation 7.17
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 12, 26, and 52Population: Full Analysis Set population
Percentage of subjects with mean 7-day EEsAI total score \<20 to those assessed at Weeks 12, 26 and 52. Eosinophilic Esophagitis Activity Index Total Score: 0 (best) to 100 (worst) based on the sum of the categorized subscores for frequency of trouble swallowing \[never (0), 1-3x (15) or 4-6x (27) per week\]; duration of trouble swallowing \[\<= 5 min (0), \>5 min (6)\]; pain when swallowing \[no (0), yes (15)\]; Visual Dysphagia Question score \[0 (best),12,19,21, or 23 (worst)\]; avoidance modification and slow eating score \[0 (best), 9, or 25 (worst)\]. Population used are those who entered Part 1 - Induction. The number of participants analyzed for each timepoint reflect the actual number of participants with data at that timepoint. Note: Following Week 14, all patients in the placebo group were given APT-1011 3mg BID and results reflect change from baseline global EOE symptom score following 12 or 38 weeks of treatment
Outcome measures
| Measure |
APT-1011 1.5 mg HS
n=18 Participants
Placebo after breakfast, APT-1011 1.5 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
APT-1011 1.5 mg BID
n=20 Participants
APT-1011 1.5 mg after breakfast, APT-1011 1.5 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
APT-1011 3 mg HS
n=20 Participants
Placebo after breakfast, APT-1011 3 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
APT-1011 3 mg BID
n=19 Participants
APT-1011 3 mg after breakfast, APT-1011 3 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
Placebo BID
n=17 Participants
Placebo 30 minutes after breakfast and HS
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
Placebo BID, APT-1011 3 mg BID (Part 2)
Placebo 30 minutes after breakfast and HS
All Non-responders at Week 12 received 3 mg BID Week 14 to Week 52
|
Total APT-1011 3 mg BID
The Total APT-1011 3 mg BID group comprises all subjects who received double-blind or single-blind APT-1011 3 mg BID during Part 2
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With Mean 7-day EEsAI Total Score <20
Week 12 EEsAI Total Score <20
|
4 Participants
|
1 Participants
|
6 Participants
|
5 Participants
|
2 Participants
|
—
|
—
|
|
Percentage of Subjects With Mean 7-day EEsAI Total Score <20
Week 26 EEsAI Total Score <20
|
3 Participants
|
5 Participants
|
7 Participants
|
7 Participants
|
—
|
—
|
—
|
|
Percentage of Subjects With Mean 7-day EEsAI Total Score <20
Week 52 EEsAI Total Score <20
|
3 Participants
|
7 Participants
|
7 Participants
|
10 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 14, 18, 22, 26, 28, 36, 44, and 52Population: Full Analysis Set
Change From Baseline PGIS for EoE Symptoms as Assessed Prior to Randomization at Weeks 4, 8, 12, 14, 18, 22, 26, 28, 36, 44, and 52. Population used are those who entered Part 1 - Induction. The number of participants analyzed for each timepoint reflect the actual number of participants with data at that timepoint. Note: Following Week 14, all patients in the placebo group were given APT-1011 3mg BID and results reflect change from baseline global EOE symptoms following 4, 8, 12, 14, 22, 30 or 38 weeks of treatment.
Outcome measures
| Measure |
APT-1011 1.5 mg HS
n=20 Participants
Placebo after breakfast, APT-1011 1.5 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
APT-1011 1.5 mg BID
n=21 Participants
APT-1011 1.5 mg after breakfast, APT-1011 1.5 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
APT-1011 3 mg HS
n=20 Participants
Placebo after breakfast, APT-1011 3 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
APT-1011 3 mg BID
n=19 Participants
APT-1011 3 mg after breakfast, APT-1011 3 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
Placebo BID
n=17 Participants
Placebo 30 minutes after breakfast and HS
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
Placebo BID, APT-1011 3 mg BID (Part 2)
Placebo 30 minutes after breakfast and HS
All Non-responders at Week 12 received 3 mg BID Week 14 to Week 52
|
Total APT-1011 3 mg BID
The Total APT-1011 3 mg BID group comprises all subjects who received double-blind or single-blind APT-1011 3 mg BID during Part 2
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 18 · Moderate to Very Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 22 · Mild to Mild
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 4 · Mild to None
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 4 · Mild to Mild
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 4 · Mild to Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 4 · Mild to Severe
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 4 · Mild to Very Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 4 · Moderate to None
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 4 · Moderate to Mild
|
8 Participants
|
7 Participants
|
5 Participants
|
6 Participants
|
5 Participants
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 4 · Moderate to Moderate
|
5 Participants
|
5 Participants
|
4 Participants
|
7 Participants
|
3 Participants
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 4 · Moderate to Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 4 · Moderate to Very Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 4 · Severe to None
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 4 · Severe to Mild
|
3 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 4 · Severe to Moderate
|
1 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
2 Participants
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 4 · Severe to Severe
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 4 · Severe to Very Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 4 · Very Severe to None
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 18 · Severe to None
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 4 · Very Severe to Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 4 · Very Severe to Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 4 · Very Severe to Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 4 · Very Severe to Very Severe
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 8 · Mild to None
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 8 · Mild to Mild
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 8 · Mild to Moderate
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 8 · Mild to Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 8 · Mild to Very Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 8 · Moderate to None
|
1 Participants
|
1 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 8 · Moderate to Mild
|
8 Participants
|
6 Participants
|
5 Participants
|
6 Participants
|
7 Participants
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 8 · Moderate to Moderate
|
3 Participants
|
6 Participants
|
3 Participants
|
6 Participants
|
2 Participants
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 8 · Moderate to Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 8 · Moderate to Very Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 8 · Severe to None
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 8 · Severe to Mild
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 8 · Severe to Moderate
|
1 Participants
|
6 Participants
|
1 Participants
|
4 Participants
|
5 Participants
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 8 · Severe to Severe
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 8 · Severe to Very Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 8 · Very Severe to None
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 8 · Very Severe to Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 8 · Very Severe to Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 8 · Very Severe to Severe
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 8 · Very Severe to Very Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 12 · Mild to None
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 12 · Mild to Mild
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 12 · Mild to Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 12 · Mild to Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 12 · Mild to Very Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 12 · Moderate to None
|
1 Participants
|
0 Participants
|
5 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 12 · Moderate to Mild
|
10 Participants
|
7 Participants
|
5 Participants
|
6 Participants
|
6 Participants
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 12 · Moderate to Moderate
|
2 Participants
|
5 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 12 · Moderate to Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 12 · Moderate to Very Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 12 · Severe to None
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 12 · Severe to Mild
|
1 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 12 · Severe to Moderate
|
0 Participants
|
4 Participants
|
4 Participants
|
2 Participants
|
4 Participants
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 12 · Severe to Severe
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 12 · Severe to Very Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 12 · Very Severe to None
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 12 · Very Severe to Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 12 · Very Severe to Moderate
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 12 · Very Severe to Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 12 · Very Severe to Very Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 14 · Mild to None
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 14 · Mild to Mild
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 14 · Mild to Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 14 · Mild to Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 14 · Mild to Very Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 14 · Moderate to None
|
0 Participants
|
1 Participants
|
5 Participants
|
4 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 14 · Moderate to Mild
|
7 Participants
|
8 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 14 · Moderate to Moderate
|
0 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 14 · Moderate to Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 14 · Moderate to Very Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 14 · Severe to None
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 14 · Severe to Mild
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 14 · Severe to Moderate
|
0 Participants
|
5 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 14 · Severe to Severe
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 14 · Severe to Very Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 14 · Very Severe to None
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 14 · Very Severe to Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 14 · Very Severe to Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 14 · Very Severe to Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 14 · Very Severe to Very Severe
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 18 · Mild to None
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 18 · Mild to Mild
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 18 · Mild to Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 18 · Mild to Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 18 · Mild to Very Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 18 · Moderate to None
|
0 Participants
|
1 Participants
|
5 Participants
|
5 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 18 · Moderate to Mild
|
6 Participants
|
9 Participants
|
2 Participants
|
4 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 18 · Moderate to Moderate
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 18 · Moderate to Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 18 · Severe to Mild
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 18 · Severe to Moderate
|
0 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 18 · Severe to Severe
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 18 · Severe to Very Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 18 · Very Severe to None
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 18 · Very Severe to Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 18 · Very Severe to Moderate
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 18 · Very Severe to Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 22 · Mild to Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 22 · Mild to Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 22 · Mild to Very Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 22 · Moderate to None
|
1 Participants
|
2 Participants
|
3 Participants
|
4 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 22 · Moderate to Mild
|
6 Participants
|
8 Participants
|
2 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 22 · Moderate to Moderate
|
0 Participants
|
1 Participants
|
2 Participants
|
5 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 22 · Moderate to Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 22 · Moderate to Very Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 18 · Very Severe to Very Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 22 · Mild to None
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 26 · Moderate to None
|
2 Participants
|
1 Participants
|
4 Participants
|
5 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 26 · Moderate to Moderate
|
2 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 26 · Severe to None
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 28 · Mild to Very Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 52 · Mild to Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 52 · Mild to Very Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 36 · Mild to Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 36 · Mild to Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 26 · Moderate to Mild
|
2 Participants
|
8 Participants
|
2 Participants
|
5 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 44 · Severe to Very Severe
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 44 · Very Severe to None
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 36 · Mild to None
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 36 · Mild to Mild
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 36 · Mild to Very Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 36 · Moderate to None
|
0 Participants
|
2 Participants
|
5 Participants
|
4 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 36 · Moderate to Mild
|
4 Participants
|
7 Participants
|
1 Participants
|
5 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 36 · Moderate to Moderate
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 36 · Moderate to Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 36 · Moderate to Very Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 36 · Severe to None
|
0 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 36 · Severe to Mild
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 36 · Severe to Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 36 · Severe to Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 36 · Severe to Very Severe
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 36 · Very Severe to None
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 36 · Very Severe to Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 36 · Very Severe to Moderate
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 36 · Very Severe to Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 36 · Very Severe to Very Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 44 · Mild to None
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 44 · Mild to Mild
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 44 · Mild to Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 44 · Mild to Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 44 · Mild to Very Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 44 · Moderate to None
|
1 Participants
|
1 Participants
|
3 Participants
|
5 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 44 · Moderate to Mild
|
2 Participants
|
8 Participants
|
1 Participants
|
4 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 44 · Moderate to Moderate
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 44 · Moderate to Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 44 · Moderate to Very Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 44 · Severe to None
|
0 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 44 · Severe to Mild
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 44 · Severe to Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 44 · Severe to Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 44 · Very Severe to Mild
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 44 · Very Severe to Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 44 · Very Severe to Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 44 · Very Severe to Very Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 52 · Mild to None
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 52 · Mild to Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 52 · Mild to Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 52 · Moderate to None
|
0 Participants
|
3 Participants
|
5 Participants
|
8 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 52 · Moderate to Mild
|
3 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 52 · Moderate to Moderate
|
0 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 52 · Moderate to Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 52 · Moderate to Very Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 52 · Severe to None
|
0 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 52 · Severe to Mild
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 52 · Severe to Moderate
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 52 · Severe to Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 52 · Severe to Very Severe
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 52 · Very Severe to None
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 52 · Very Severe to Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 52 · Very Severe to Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 22 · Severe to None
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 22 · Severe to Mild
|
1 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 22 · Severe to Moderate
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 22 · Severe to Severe
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 22 · Severe to Very Severe
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 22 · Very Severe to None
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 22 · Very Severe to Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 22 · Very Severe to Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 22 · Very Severe to Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 22 · Very Severe to Very Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 26 · Mild to None
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 26 · Mild to Mild
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 26 · Mild to Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 26 · Mild to Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 26 · Mild to Very Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 26 · Moderate to Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 26 · Moderate to Very Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 26 · Severe to Mild
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 26 · Severe to Moderate
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 26 · Severe to Severe
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 26 · Severe to Very Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 26 · Very Severe to None
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 26 · Very Severe to Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 26 · Very Severe to Moderate
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 26 · Very Severe to Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 26 · Very Severe to Very Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 28 · Mild to None
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 28 · Mild to Mild
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 28 · Mild to Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 28 · Mild to Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 28 · Moderate to None
|
2 Participants
|
1 Participants
|
4 Participants
|
4 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 28 · Moderate to Mild
|
3 Participants
|
7 Participants
|
1 Participants
|
5 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 28 · Moderate to Moderate
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 28 · Moderate to Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 28 · Moderate to Very Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 28 · Severe to None
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 28 · Severe to Mild
|
1 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 28 · Severe to Moderate
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 28 · Severe to Severe
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 28 · Severe to Very Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 28 · Very Severe to None
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 28 · Very Severe to Mild
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 28 · Very Severe to Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 28 · Very Severe to Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 28 · Very Severe to Very Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 52 · Very Severe to Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 52 · Very Severe to Very Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 14, 18, 22, 26, 28, 36, 44, and 52Population: Full Analysis Set
Change From Baseline PGIS for Difficulty with Food or Pills Going Down as Assessed Prior to Randomization at Weeks 4, 8, 12, 14, 18, 22, 26, 28, 36, 44, and 52. Population used are those who entered Part 1 - Induction. The number of participants analyzed for each timepoint reflect the actual number of participants with data at that timepoint. Note: Following Week 14, all patients in the placebo group were given APT-1011 3mg BID and results reflect change from baseline PGIS for difficulty with food or pills going down following 4, 8, 12, 14, 22, 30 or 38 weeks of treatment.
Outcome measures
| Measure |
APT-1011 1.5 mg HS
n=20 Participants
Placebo after breakfast, APT-1011 1.5 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
APT-1011 1.5 mg BID
n=21 Participants
APT-1011 1.5 mg after breakfast, APT-1011 1.5 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
APT-1011 3 mg HS
n=20 Participants
Placebo after breakfast, APT-1011 3 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
APT-1011 3 mg BID
n=19 Participants
APT-1011 3 mg after breakfast, APT-1011 3 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
Placebo BID
n=17 Participants
Placebo 30 minutes after breakfast and HS
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
Placebo BID, APT-1011 3 mg BID (Part 2)
Placebo 30 minutes after breakfast and HS
All Non-responders at Week 12 received 3 mg BID Week 14 to Week 52
|
Total APT-1011 3 mg BID
The Total APT-1011 3 mg BID group comprises all subjects who received double-blind or single-blind APT-1011 3 mg BID during Part 2
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 18 · Mild to Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 8 · Severe to Mild
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 8 · Severe to Moderate
|
0 Participants
|
7 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 8 · Severe to Severe
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 8 · Severe to Very Severe
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 8 · Very Severe to None
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 8 · Very Severe to Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 8 · Very Severe to Moderate
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 8 · Very Severe to Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 8 · Very Severe to Very Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 12 · Mild to None
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 4 · Mild to None
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 4 · Mild to Mild
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 4 · Mild to Moderate
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 4 · Mild to Very Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 4 · Moderate to None
|
0 Participants
|
0 Participants
|
6 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 4 · Moderate to Mild
|
6 Participants
|
6 Participants
|
4 Participants
|
7 Participants
|
5 Participants
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 4 · Moderate to Severe
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 4 · Moderate to Very Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 4 · Severe to None
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 4 · Severe to Mild
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 4 · Severe to Moderate
|
2 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 4 · Severe to Very Severe
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 4 · Very Severe to None
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 4 · Very Severe to Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 4 · Very Severe to Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 8 · Moderate to None
|
1 Participants
|
1 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 8 · Moderate to Moderate
|
1 Participants
|
6 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 12 · Very Severe to Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 12 · Very Severe to Moderate
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 14 · Mild to Mild
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 14 · Moderate to None
|
1 Participants
|
0 Participants
|
4 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 14 · Moderate to Mild
|
7 Participants
|
7 Participants
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 14 · Moderate to Moderate
|
0 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 14 · Severe to Mild
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 18 · Mild to Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 14 · Severe to Moderate
|
0 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 14 · Severe to Severe
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 14 · Severe to Very Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 18 · Mild to Very Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 18 · Moderate to None
|
0 Participants
|
1 Participants
|
5 Participants
|
4 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 18 · Moderate to Moderate
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 18 · Moderate to Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 18 · Severe to None
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 18 · Severe to Mild
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 18 · Severe to Moderate
|
0 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 18 · Severe to Very Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 18 · Very Severe to None
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 18 · Very Severe to Moderate
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 18 · Very Severe to Very Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 22 · Mild to None
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 22 · Mild to Mild
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 22 · Mild to Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 22 · Mild to Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 22 · Mild to Very Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 22 · Moderate to None
|
2 Participants
|
1 Participants
|
3 Participants
|
4 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 22 · Moderate to Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 22 · Severe to Mild
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 22 · Severe to Moderate
|
0 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 22 · Severe to Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 22 · Severe to Very Severe
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 22 · Very Severe to None
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 22 · Very Severe to Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 22 · Very Severe to Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 22 · Very Severe to Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 22 · Very Severe to Very Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 26 · Mild to None
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 26 · Mild to Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 26 · Mild to Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 26 · Mild to Very Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 26 · Moderate to None
|
3 Participants
|
0 Participants
|
4 Participants
|
5 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 26 · Moderate to Mild
|
3 Participants
|
7 Participants
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 26 · Moderate to Moderate
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 26 · Moderate to Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 26 · Severe to None
|
0 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 26 · Severe to Mild
|
0 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 26 · Severe to Moderate
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 26 · Severe to Severe
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 26 · Severe to Very Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 26 · Very Severe to Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 26 · Very Severe to Moderate
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 26 · Very Severe to Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 26 · Very Severe to Very Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 28 · Mild to None
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 28 · Mild to Mild
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 28 · Mild to Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 28 · Mild to Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 28 · Mild to Very Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 28 · Moderate to None
|
4 Participants
|
0 Participants
|
4 Participants
|
4 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 28 · Moderate to Mild
|
2 Participants
|
7 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 28 · Moderate to Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 28 · Severe to Mild
|
0 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 28 · Severe to Moderate
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 28 · Severe to Very Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 28 · Very Severe to Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 28 · Very Severe to Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 36 · Mild to None
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 36 · Mild to Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 36 · Moderate to Moderate
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 36 · Moderate to Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 36 · Severe to None
|
0 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 36 · Severe to Mild
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 36 · Severe to Very Severe
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 36 · Very Severe to None
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 36 · Very Severe to Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 36 · Very Severe to Very Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 44 · Mild to Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 44 · Mild to Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 44 · Mild to Very Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 44 · Moderate to Mild
|
2 Participants
|
6 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 44 · Moderate to Moderate
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 44 · Moderate to Severe
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 52 · Mild to Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 52 · Mild to Very Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 52 · Moderate to Mild
|
2 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 52 · Very Severe to Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 4 · Mild to Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 4 · Moderate to Moderate
|
5 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 4 · Severe to Severe
|
1 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 4 · Very Severe to Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 4 · Very Severe to Very Severe
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 8 · Mild to Mild
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 8 · Mild to None
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 8 · Mild to Moderate
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 8 · Mild to Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 8 · Mild to Very Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 8 · Moderate to Mild
|
8 Participants
|
5 Participants
|
5 Participants
|
5 Participants
|
6 Participants
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 8 · Moderate to Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 8 · Moderate to Very Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 8 · Severe to None
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 12 · Mild to Mild
|
2 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 12 · Mild to Moderate
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 12 · Mild to Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 12 · Mild to Very Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 12 · Moderate to None
|
3 Participants
|
0 Participants
|
5 Participants
|
3 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 12 · Moderate to Mild
|
4 Participants
|
5 Participants
|
6 Participants
|
2 Participants
|
6 Participants
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 12 · Moderate to Moderate
|
3 Participants
|
6 Participants
|
3 Participants
|
5 Participants
|
4 Participants
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 12 · Moderate to Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 12 · Moderate to Very Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 12 · Severe to None
|
3 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 12 · Severe to Mild
|
0 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 12 · Severe to Moderate
|
0 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 12 · Severe to Severe
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 12 · Severe to Very Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 12 · Very Severe to None
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 14 · Moderate to Severe
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 12 · Very Severe to Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 12 · Very Severe to Very Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 14 · Mild to None
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 14 · Moderate to Very Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 44 · Mild to Mild
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 44 · Mild to None
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 14 · Mild to Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 14 · Mild to Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 14 · Mild to Very Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 14 · Severe to None
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 14 · Very Severe to None
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 14 · Very Severe to Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 14 · Very Severe to Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 14 · Very Severe to Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 14 · Very Severe to Very Severe
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 18 · Mild to None
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 18 · Mild to Mild
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 36 · Very Severe to Severe
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 18 · Moderate to Mild
|
8 Participants
|
7 Participants
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 18 · Moderate to Very Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 18 · Severe to Severe
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 22 · Moderate to Mild
|
6 Participants
|
7 Participants
|
3 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 18 · Very Severe to Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 18 · Very Severe to Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 44 · Moderate to None
|
2 Participants
|
1 Participants
|
3 Participants
|
4 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 22 · Moderate to Moderate
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 44 · Severe to Mild
|
0 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 22 · Moderate to Very Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 22 · Severe to None
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 26 · Mild to Mild
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 26 · Moderate to Very Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 26 · Very Severe to None
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 44 · Moderate to Very Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 44 · Severe to None
|
0 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 44 · Severe to Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 44 · Severe to Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 52 · Mild to Moderate
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 44 · Severe to Very Severe
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 44 · Very Severe to None
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 44 · Very Severe to Mild
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 44 · Very Severe to Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 44 · Very Severe to Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 44 · Very Severe to Very Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 52 · Mild to None
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 52 · Mild to Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 52 · Moderate to None
|
2 Participants
|
2 Participants
|
5 Participants
|
6 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 52 · Moderate to Moderate
|
0 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 52 · Moderate to Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 52 · Moderate to Very Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 52 · Severe to None
|
0 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 52 · Severe to Mild
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 52 · Severe to Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 52 · Severe to Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 52 · Severe to Very Severe
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 52 · Very Severe to None
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 52 · Very Severe to Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 52 · Very Severe to Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 52 · Very Severe to Very Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 28 · Moderate to Moderate
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 28 · Moderate to Very Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 28 · Severe to None
|
0 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 28 · Severe to Severe
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 28 · Very Severe to None
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 28 · Very Severe to Mild
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 28 · Very Severe to Very Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 36 · Mild to Mild
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 36 · Mild to Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 36 · Mild to Very Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 36 · Moderate to None
|
2 Participants
|
2 Participants
|
5 Participants
|
4 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 36 · Moderate to Mild
|
3 Participants
|
5 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 36 · Moderate to Very Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 36 · Severe to Moderate
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 36 · Severe to Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
Week 36 · Very Severe to Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 14, 18, 22, 26, 36, 44, and 52Population: Full Analysis Set
Change From Baseline PGIC for EoE Symptoms as Assessed Prior to Randomization at Weeks 4, 8, 12, 14, 18, 22, 26, 28, 36, 44, and 52. Population used are those who entered Part 1 - Induction. The number of participants analyzed for each timepoint reflect the actual number of participants with data at that timepoint. Note: Following Week 14, all patients in the placebo group were given APT-1011 3mg BID and results reflect change from baseline PGIC for EoE symptoms following 4, 8, 12, 14, 22, 30 or 38 weeks of treatment.
Outcome measures
| Measure |
APT-1011 1.5 mg HS
n=21 Participants
Placebo after breakfast, APT-1011 1.5 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
APT-1011 1.5 mg BID
n=22 Participants
APT-1011 1.5 mg after breakfast, APT-1011 1.5 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
APT-1011 3 mg HS
n=20 Participants
Placebo after breakfast, APT-1011 3 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
APT-1011 3 mg BID
n=20 Participants
APT-1011 3 mg after breakfast, APT-1011 3 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
Placebo BID
n=17 Participants
Placebo 30 minutes after breakfast and HS
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
Placebo BID, APT-1011 3 mg BID (Part 2)
Placebo 30 minutes after breakfast and HS
All Non-responders at Week 12 received 3 mg BID Week 14 to Week 52
|
Total APT-1011 3 mg BID
The Total APT-1011 3 mg BID group comprises all subjects who received double-blind or single-blind APT-1011 3 mg BID during Part 2
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline Patient Global Impression of Change (PGIC) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 4 · A Little Worse
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Change (PGIC) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 14 · Moderately Improved
|
5 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Change (PGIC) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 18 · Moderately Improved
|
6 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Change (PGIC) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 52 · Moderately Improved
|
2 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Change (PGIC) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 52 · A Little Improved
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Change (PGIC) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 52 · Much Improved
|
1 Participants
|
10 Participants
|
8 Participants
|
11 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Change (PGIC) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 4 · Much Worse
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Change (PGIC) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 4 · Moderately Worse
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Change (PGIC) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 4 · Stayed the Same
|
4 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
6 Participants
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Change (PGIC) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 4 · A Little Improved
|
9 Participants
|
9 Participants
|
4 Participants
|
10 Participants
|
4 Participants
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Change (PGIC) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 4 · Moderately Improved
|
4 Participants
|
3 Participants
|
6 Participants
|
2 Participants
|
4 Participants
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Change (PGIC) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 4 · Much Improved
|
3 Participants
|
4 Participants
|
5 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Change (PGIC) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 8 · Much Worse
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Change (PGIC) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 8 · Moderately Worse
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Change (PGIC) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 8 · A Little Worse
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Change (PGIC) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 8 · Stayed the Same
|
2 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Change (PGIC) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 8 · A Little Improved
|
4 Participants
|
9 Participants
|
5 Participants
|
7 Participants
|
6 Participants
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Change (PGIC) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 8 · Moderately Improved
|
7 Participants
|
4 Participants
|
4 Participants
|
6 Participants
|
5 Participants
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Change (PGIC) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 8 · Much Improved
|
3 Participants
|
6 Participants
|
6 Participants
|
4 Participants
|
2 Participants
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Change (PGIC) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 12 · Much Worse
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Change (PGIC) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 12 · Moderately Worse
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Change (PGIC) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 12 · A Little Worse
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Change (PGIC) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 12 · Stayed the Same
|
1 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Change (PGIC) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 12 · A Little Improved
|
6 Participants
|
5 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Change (PGIC) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 12 · Moderately Improved
|
5 Participants
|
5 Participants
|
4 Participants
|
3 Participants
|
8 Participants
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Change (PGIC) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 12 · Much Improved
|
6 Participants
|
8 Participants
|
9 Participants
|
5 Participants
|
2 Participants
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Change (PGIC) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 14 · Much Worse
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Change (PGIC) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 14 · Moderately Worse
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Change (PGIC) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 14 · A Little Worse
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Change (PGIC) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 14 · Stayed the Same
|
0 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Change (PGIC) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 14 · A Little Improved
|
3 Participants
|
4 Participants
|
1 Participants
|
5 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Change (PGIC) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 14 · Much Improved
|
2 Participants
|
8 Participants
|
7 Participants
|
5 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Change (PGIC) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 18 · Much Worse
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Change (PGIC) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 18 · Moderately Worse
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Change (PGIC) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 18 · A Little Worse
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Change (PGIC) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 18 · Stayed the Same
|
0 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Change (PGIC) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 18 · A Little Improved
|
2 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Change (PGIC) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 18 · Much Improved
|
1 Participants
|
11 Participants
|
10 Participants
|
6 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Change (PGIC) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 22 · Much Worse
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Change (PGIC) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 22 · Moderately Worse
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Change (PGIC) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 22 · A Little Worse
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Change (PGIC) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 22 · Stayed the Same
|
0 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Change (PGIC) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 22 · A Little Improved
|
2 Participants
|
1 Participants
|
2 Participants
|
5 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Change (PGIC) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 22 · Moderately Improved
|
2 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Change (PGIC) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 22 · Much Improved
|
4 Participants
|
11 Participants
|
7 Participants
|
8 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Change (PGIC) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 26 · Much Worse
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Change (PGIC) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 26 · Moderately Worse
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Change (PGIC) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 26 · A Little Worse
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Change (PGIC) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 26 · Stayed the Same
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Change (PGIC) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 26 · A Little Improved
|
3 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Change (PGIC) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 26 · Moderately Improved
|
1 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Change (PGIC) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 26 · Much Improved
|
4 Participants
|
13 Participants
|
9 Participants
|
10 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Change (PGIC) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 28 · Much Worse
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Change (PGIC) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 28 · Moderately Worse
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Change (PGIC) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 28 · A Little Worse
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Change (PGIC) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 28 · Stayed the Same
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Change (PGIC) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 28 · A Little Improved
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Change (PGIC) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 28 · Moderately Improved
|
2 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Change (PGIC) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 28 · Much Improved
|
4 Participants
|
11 Participants
|
8 Participants
|
10 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Change (PGIC) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 36 · Much Worse
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Change (PGIC) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 36 · Moderately Worse
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Change (PGIC) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 36 · A Little Worse
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Change (PGIC) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 36 · Stayed the Same
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Change (PGIC) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 36 · A Little Improved
|
1 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Change (PGIC) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 36 · Moderately Improved
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Change (PGIC) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 36 · Much Improved
|
3 Participants
|
14 Participants
|
10 Participants
|
9 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Change (PGIC) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 44 · Much Worse
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Change (PGIC) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 44 · Moderately Worse
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Change (PGIC) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 44 · A Little Worse
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Change (PGIC) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 44 · Stayed the Same
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Change (PGIC) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 44 · A Little Improved
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Change (PGIC) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 44 · Moderately Improved
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Change (PGIC) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 44 · Much Improved
|
3 Participants
|
12 Participants
|
8 Participants
|
10 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Change (PGIC) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 52 · Much Worse
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Change (PGIC) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 52 · Moderately Worse
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Change (PGIC) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 52 · A Little Worse
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline Patient Global Impression of Change (PGIC) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
Week 52 · Stayed the Same
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 14, 18, 22, 26, 36, 44, and 52Population: Full Analysis Set
Change From Baseline PGIC of Difficulty with Food or Pills as Assessed Prior to Randomization at Weeks 4, 8, 12, 14, 18, 22, 26, 28, 36, 44, and 52. Population used are those who entered Part 1 - Induction. The number of participants analyzed for each timepoint reflect the actual number of participants with data at that timepoint. Note: Following Week 14, all patients in the placebo group were given APT-1011 3mg BID and results reflect change from baseline PGIC of difficulty with food or pills following 4, 8, 12, 14, 22, 30 or 38 weeks of treatment.
Outcome measures
| Measure |
APT-1011 1.5 mg HS
n=21 Participants
Placebo after breakfast, APT-1011 1.5 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
APT-1011 1.5 mg BID
n=22 Participants
APT-1011 1.5 mg after breakfast, APT-1011 1.5 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
APT-1011 3 mg HS
n=20 Participants
Placebo after breakfast, APT-1011 3 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
APT-1011 3 mg BID
n=20 Participants
APT-1011 3 mg after breakfast, APT-1011 3 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
Placebo BID
n=17 Participants
Placebo 30 minutes after breakfast and HS
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
Placebo BID, APT-1011 3 mg BID (Part 2)
Placebo 30 minutes after breakfast and HS
All Non-responders at Week 12 received 3 mg BID Week 14 to Week 52
|
Total APT-1011 3 mg BID
The Total APT-1011 3 mg BID group comprises all subjects who received double-blind or single-blind APT-1011 3 mg BID during Part 2
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline PGIC of Difficulty With Food or Pills as Assessed Prior to Randomization Post-Baseline Visit
Week 4 · Much Worse
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline PGIC of Difficulty With Food or Pills as Assessed Prior to Randomization Post-Baseline Visit
Week 4 · Moderately Worse
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline PGIC of Difficulty With Food or Pills as Assessed Prior to Randomization Post-Baseline Visit
Week 4 · A Little Worse
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Change From Baseline PGIC of Difficulty With Food or Pills as Assessed Prior to Randomization Post-Baseline Visit
Week 4 · Stayed the Same
|
4 Participants
|
3 Participants
|
4 Participants
|
5 Participants
|
5 Participants
|
—
|
—
|
|
Change From Baseline PGIC of Difficulty With Food or Pills as Assessed Prior to Randomization Post-Baseline Visit
Week 4 · A Little Improved
|
8 Participants
|
10 Participants
|
4 Participants
|
9 Participants
|
7 Participants
|
—
|
—
|
|
Change From Baseline PGIC of Difficulty With Food or Pills as Assessed Prior to Randomization Post-Baseline Visit
Week 4 · Moderately Improved
|
6 Participants
|
5 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
|
Change From Baseline PGIC of Difficulty With Food or Pills as Assessed Prior to Randomization Post-Baseline Visit
Week 4 · Much Improved
|
2 Participants
|
2 Participants
|
6 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
|
Change From Baseline PGIC of Difficulty With Food or Pills as Assessed Prior to Randomization Post-Baseline Visit
Week 8 · Much Worse
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline PGIC of Difficulty With Food or Pills as Assessed Prior to Randomization Post-Baseline Visit
Week 8 · Moderately Worse
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline PGIC of Difficulty With Food or Pills as Assessed Prior to Randomization Post-Baseline Visit
Week 12 · Much Improved
|
6 Participants
|
9 Participants
|
9 Participants
|
6 Participants
|
2 Participants
|
—
|
—
|
|
Change From Baseline PGIC of Difficulty With Food or Pills as Assessed Prior to Randomization Post-Baseline Visit
Week 8 · A Little Worse
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Change From Baseline PGIC of Difficulty With Food or Pills as Assessed Prior to Randomization Post-Baseline Visit
Week 8 · Stayed the Same
|
2 Participants
|
5 Participants
|
1 Participants
|
4 Participants
|
4 Participants
|
—
|
—
|
|
Change From Baseline PGIC of Difficulty With Food or Pills as Assessed Prior to Randomization Post-Baseline Visit
Week 8 · A Little Improved
|
3 Participants
|
5 Participants
|
5 Participants
|
5 Participants
|
5 Participants
|
—
|
—
|
|
Change From Baseline PGIC of Difficulty With Food or Pills as Assessed Prior to Randomization Post-Baseline Visit
Week 8 · Moderately Improved
|
6 Participants
|
4 Participants
|
3 Participants
|
7 Participants
|
5 Participants
|
—
|
—
|
|
Change From Baseline PGIC of Difficulty With Food or Pills as Assessed Prior to Randomization Post-Baseline Visit
Week 8 · Much Improved
|
4 Participants
|
8 Participants
|
8 Participants
|
4 Participants
|
1 Participants
|
—
|
—
|
|
Change From Baseline PGIC of Difficulty With Food or Pills as Assessed Prior to Randomization Post-Baseline Visit
Week 12 · Much Worse
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline PGIC of Difficulty With Food or Pills as Assessed Prior to Randomization Post-Baseline Visit
Week 12 · Moderately Worse
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline PGIC of Difficulty With Food or Pills as Assessed Prior to Randomization Post-Baseline Visit
Week 12 · A Little Worse
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Change From Baseline PGIC of Difficulty With Food or Pills as Assessed Prior to Randomization Post-Baseline Visit
Week 12 · Stayed the Same
|
1 Participants
|
4 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
—
|
—
|
|
Change From Baseline PGIC of Difficulty With Food or Pills as Assessed Prior to Randomization Post-Baseline Visit
Week 12 · A Little Improved
|
5 Participants
|
5 Participants
|
5 Participants
|
5 Participants
|
6 Participants
|
—
|
—
|
|
Change From Baseline PGIC of Difficulty With Food or Pills as Assessed Prior to Randomization Post-Baseline Visit
Week 12 · Moderately Improved
|
6 Participants
|
4 Participants
|
2 Participants
|
3 Participants
|
6 Participants
|
—
|
—
|
|
Change From Baseline PGIC of Difficulty With Food or Pills as Assessed Prior to Randomization Post-Baseline Visit
Week 14 · Much Worse
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIC of Difficulty With Food or Pills as Assessed Prior to Randomization Post-Baseline Visit
Week 14 · Moderately Worse
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIC of Difficulty With Food or Pills as Assessed Prior to Randomization Post-Baseline Visit
Week 14 · A Little Worse
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIC of Difficulty With Food or Pills as Assessed Prior to Randomization Post-Baseline Visit
Week 14 · Stayed the Same
|
0 Participants
|
4 Participants
|
0 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIC of Difficulty With Food or Pills as Assessed Prior to Randomization Post-Baseline Visit
Week 14 · A Little Improved
|
3 Participants
|
3 Participants
|
1 Participants
|
4 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIC of Difficulty With Food or Pills as Assessed Prior to Randomization Post-Baseline Visit
Week 14 · Moderately Improved
|
4 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIC of Difficulty With Food or Pills as Assessed Prior to Randomization Post-Baseline Visit
Week 14 · Much Improved
|
3 Participants
|
8 Participants
|
8 Participants
|
5 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIC of Difficulty With Food or Pills as Assessed Prior to Randomization Post-Baseline Visit
Week 18 · Much Worse
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIC of Difficulty With Food or Pills as Assessed Prior to Randomization Post-Baseline Visit
Week 18 · Moderately Worse
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIC of Difficulty With Food or Pills as Assessed Prior to Randomization Post-Baseline Visit
Week 18 · A Little Worse
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIC of Difficulty With Food or Pills as Assessed Prior to Randomization Post-Baseline Visit
Week 18 · Stayed the Same
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIC of Difficulty With Food or Pills as Assessed Prior to Randomization Post-Baseline Visit
Week 18 · A Little Improved
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIC of Difficulty With Food or Pills as Assessed Prior to Randomization Post-Baseline Visit
Week 18 · Moderately Improved
|
6 Participants
|
4 Participants
|
2 Participants
|
4 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIC of Difficulty With Food or Pills as Assessed Prior to Randomization Post-Baseline Visit
Week 18 · Much Improved
|
2 Participants
|
9 Participants
|
9 Participants
|
7 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIC of Difficulty With Food or Pills as Assessed Prior to Randomization Post-Baseline Visit
Week 22 · Much Worse
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIC of Difficulty With Food or Pills as Assessed Prior to Randomization Post-Baseline Visit
Week 22 · Moderately Worse
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIC of Difficulty With Food or Pills as Assessed Prior to Randomization Post-Baseline Visit
Week 22 · A Little Worse
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIC of Difficulty With Food or Pills as Assessed Prior to Randomization Post-Baseline Visit
Week 22 · Stayed the Same
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIC of Difficulty With Food or Pills as Assessed Prior to Randomization Post-Baseline Visit
Week 22 · A Little Improved
|
2 Participants
|
2 Participants
|
2 Participants
|
5 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIC of Difficulty With Food or Pills as Assessed Prior to Randomization Post-Baseline Visit
Week 22 · Moderately Improved
|
2 Participants
|
5 Participants
|
3 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIC of Difficulty With Food or Pills as Assessed Prior to Randomization Post-Baseline Visit
Week 22 · Much Improved
|
4 Participants
|
9 Participants
|
7 Participants
|
9 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIC of Difficulty With Food or Pills as Assessed Prior to Randomization Post-Baseline Visit
Week 26 · Much Worse
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIC of Difficulty With Food or Pills as Assessed Prior to Randomization Post-Baseline Visit
Week 26 · Moderately Worse
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIC of Difficulty With Food or Pills as Assessed Prior to Randomization Post-Baseline Visit
Week 26 · A Little Worse
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIC of Difficulty With Food or Pills as Assessed Prior to Randomization Post-Baseline Visit
Week 26 · Stayed the Same
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIC of Difficulty With Food or Pills as Assessed Prior to Randomization Post-Baseline Visit
Week 26 · A Little Improved
|
2 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIC of Difficulty With Food or Pills as Assessed Prior to Randomization Post-Baseline Visit
Week 26 · Moderately Improved
|
4 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIC of Difficulty With Food or Pills as Assessed Prior to Randomization Post-Baseline Visit
Week 26 · Much Improved
|
2 Participants
|
12 Participants
|
9 Participants
|
10 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIC of Difficulty With Food or Pills as Assessed Prior to Randomization Post-Baseline Visit
Week 28 · Much Worse
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIC of Difficulty With Food or Pills as Assessed Prior to Randomization Post-Baseline Visit
Week 28 · Moderately Worse
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIC of Difficulty With Food or Pills as Assessed Prior to Randomization Post-Baseline Visit
Week 28 · A Little Worse
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIC of Difficulty With Food or Pills as Assessed Prior to Randomization Post-Baseline Visit
Week 28 · Stayed the Same
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIC of Difficulty With Food or Pills as Assessed Prior to Randomization Post-Baseline Visit
Week 28 · A Little Improved
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIC of Difficulty With Food or Pills as Assessed Prior to Randomization Post-Baseline Visit
Week 28 · Moderately Improved
|
2 Participants
|
3 Participants
|
0 Participants
|
4 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIC of Difficulty With Food or Pills as Assessed Prior to Randomization Post-Baseline Visit
Week 28 · Much Improved
|
4 Participants
|
11 Participants
|
8 Participants
|
9 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIC of Difficulty With Food or Pills as Assessed Prior to Randomization Post-Baseline Visit
Week 36 · Much Worse
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIC of Difficulty With Food or Pills as Assessed Prior to Randomization Post-Baseline Visit
Week 36 · A Little Worse
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIC of Difficulty With Food or Pills as Assessed Prior to Randomization Post-Baseline Visit
Week 36 · Moderately Worse
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIC of Difficulty With Food or Pills as Assessed Prior to Randomization Post-Baseline Visit
Week 36 · Stayed the Same
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIC of Difficulty With Food or Pills as Assessed Prior to Randomization Post-Baseline Visit
Week 36 · A Little Improved
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIC of Difficulty With Food or Pills as Assessed Prior to Randomization Post-Baseline Visit
Week 36 · Moderately Improved
|
3 Participants
|
3 Participants
|
0 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIC of Difficulty With Food or Pills as Assessed Prior to Randomization Post-Baseline Visit
Week 36 · Much Improved
|
2 Participants
|
12 Participants
|
10 Participants
|
9 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIC of Difficulty With Food or Pills as Assessed Prior to Randomization Post-Baseline Visit
Week 44 · Much Worse
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIC of Difficulty With Food or Pills as Assessed Prior to Randomization Post-Baseline Visit
Week 44 · Moderately Worse
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIC of Difficulty With Food or Pills as Assessed Prior to Randomization Post-Baseline Visit
Week 44 · A Little Worse
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIC of Difficulty With Food or Pills as Assessed Prior to Randomization Post-Baseline Visit
Week 44 · Stayed the Same
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIC of Difficulty With Food or Pills as Assessed Prior to Randomization Post-Baseline Visit
Week 44 · A Little Improved
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIC of Difficulty With Food or Pills as Assessed Prior to Randomization Post-Baseline Visit
Week 44 · Moderately Improved
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIC of Difficulty With Food or Pills as Assessed Prior to Randomization Post-Baseline Visit
Week 44 · Much Improved
|
3 Participants
|
13 Participants
|
8 Participants
|
10 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIC of Difficulty With Food or Pills as Assessed Prior to Randomization Post-Baseline Visit
Week 52 · Much Worse
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIC of Difficulty With Food or Pills as Assessed Prior to Randomization Post-Baseline Visit
Week 52 · Moderately Worse
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIC of Difficulty With Food or Pills as Assessed Prior to Randomization Post-Baseline Visit
Week 52 · A Little Worse
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIC of Difficulty With Food or Pills as Assessed Prior to Randomization Post-Baseline Visit
Week 52 · Stayed the Same
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIC of Difficulty With Food or Pills as Assessed Prior to Randomization Post-Baseline Visit
Week 52 · A Little Improved
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIC of Difficulty With Food or Pills as Assessed Prior to Randomization Post-Baseline Visit
Week 52 · Moderately Improved
|
1 Participants
|
5 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Change From Baseline PGIC of Difficulty With Food or Pills as Assessed Prior to Randomization Post-Baseline Visit
Week 52 · Much Improved
|
2 Participants
|
8 Participants
|
8 Participants
|
9 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 12, 26 and 52Population: Full Analysis Set Population
Percentage of histologic non-responders by dose at Weeks 12, 26, and 52. Note: Following Week 14, all patients in the placebo group were given APT-1011 3mg BID and results reflect non-response following 12 or 38 weeks of treatment.
Outcome measures
| Measure |
APT-1011 1.5 mg HS
n=21 Participants
Placebo after breakfast, APT-1011 1.5 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
APT-1011 1.5 mg BID
n=22 Participants
APT-1011 1.5 mg after breakfast, APT-1011 1.5 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
APT-1011 3 mg HS
n=21 Participants
Placebo after breakfast, APT-1011 3 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
APT-1011 3 mg BID
n=20 Participants
APT-1011 3 mg after breakfast, APT-1011 3 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
Placebo BID
n=19 Participants
Placebo 30 minutes after breakfast and HS
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
Placebo BID, APT-1011 3 mg BID (Part 2)
Placebo 30 minutes after breakfast and HS
All Non-responders at Week 12 received 3 mg BID Week 14 to Week 52
|
Total APT-1011 3 mg BID
The Total APT-1011 3 mg BID group comprises all subjects who received double-blind or single-blind APT-1011 3 mg BID during Part 2
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
|---|---|---|---|---|---|---|---|
|
Percentage of Histologic Non-responders by Dose at Weeks 12, 26, and 52
Week 26
|
11 Participants
|
5 Participants
|
7 Participants
|
5 Participants
|
7 Participants
|
—
|
—
|
|
Percentage of Histologic Non-responders by Dose at Weeks 12, 26, and 52
Week 52
|
16 Participants
|
6 Participants
|
10 Participants
|
8 Participants
|
9 Participants
|
—
|
—
|
|
Percentage of Histologic Non-responders by Dose at Weeks 12, 26, and 52
Week 12
|
11 Participants
|
2 Participants
|
7 Participants
|
4 Participants
|
19 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: before Week 14, between Week 14 and Week 28, between Week 28 and Week 52Population: Full Analysis Set Population
Percentage of subjects requiring emergency endoscopic food dis-impaction by dose before Week 14, between Week 14 and Week 28, and between Week 28 and Week 52. Note: There were no patients in the placebo group after Week 14.
Outcome measures
| Measure |
APT-1011 1.5 mg HS
n=21 Participants
Placebo after breakfast, APT-1011 1.5 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
APT-1011 1.5 mg BID
n=22 Participants
APT-1011 1.5 mg after breakfast, APT-1011 1.5 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
APT-1011 3 mg HS
n=21 Participants
Placebo after breakfast, APT-1011 3 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
APT-1011 3 mg BID
n=20 Participants
APT-1011 3 mg after breakfast, APT-1011 3 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
Placebo BID
n=19 Participants
Placebo 30 minutes after breakfast and HS
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
Placebo BID, APT-1011 3 mg BID (Part 2)
Placebo 30 minutes after breakfast and HS
All Non-responders at Week 12 received 3 mg BID Week 14 to Week 52
|
Total APT-1011 3 mg BID
The Total APT-1011 3 mg BID group comprises all subjects who received double-blind or single-blind APT-1011 3 mg BID during Part 2
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
|---|---|---|---|---|---|---|---|
|
Percentage of Subjects Requiring Emergency Endoscopic Food Dis-impaction
Before Week 14
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Percentage of Subjects Requiring Emergency Endoscopic Food Dis-impaction
Between Week 14 and Week 28
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Percentage of Subjects Requiring Emergency Endoscopic Food Dis-impaction
Between Week 28 and Week 52
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: baseline to Week 52Population: Full Analysis Set Population
Percentage of subjects requiring esophageal dilation by dosing group and part of the study. Note: There were no patients in the placebo group after Week 14.
Outcome measures
| Measure |
APT-1011 1.5 mg HS
n=21 Participants
Placebo after breakfast, APT-1011 1.5 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
APT-1011 1.5 mg BID
n=22 Participants
APT-1011 1.5 mg after breakfast, APT-1011 1.5 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
APT-1011 3 mg HS
n=21 Participants
Placebo after breakfast, APT-1011 3 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
APT-1011 3 mg BID
n=20 Participants
APT-1011 3 mg after breakfast, APT-1011 3 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
Placebo BID
n=19 Participants
Placebo 30 minutes after breakfast and HS
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
Placebo BID, APT-1011 3 mg BID (Part 2)
Placebo 30 minutes after breakfast and HS
All Non-responders at Week 12 received 3 mg BID Week 14 to Week 52
|
Total APT-1011 3 mg BID
The Total APT-1011 3 mg BID group comprises all subjects who received double-blind or single-blind APT-1011 3 mg BID during Part 2
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
|---|---|---|---|---|---|---|---|
|
Percentage of Subjects Requiring Esophageal Dilation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline to Week 52Population: Safety Analysis Population
Number of subjects discontinuing due to HPA axis suppression. Note: There were no patients in the placebo group after Week 14.
Outcome measures
| Measure |
APT-1011 1.5 mg HS
n=21 Participants
Placebo after breakfast, APT-1011 1.5 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
APT-1011 1.5 mg BID
n=23 Participants
APT-1011 1.5 mg after breakfast, APT-1011 1.5 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
APT-1011 3 mg HS
n=21 Participants
Placebo after breakfast, APT-1011 3 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
APT-1011 3 mg BID
n=20 Participants
APT-1011 3 mg after breakfast, APT-1011 3 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
Placebo BID
n=19 Participants
Placebo 30 minutes after breakfast and HS
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
Placebo BID, APT-1011 3 mg BID (Part 2)
Placebo 30 minutes after breakfast and HS
All Non-responders at Week 12 received 3 mg BID Week 14 to Week 52
|
Total APT-1011 3 mg BID
The Total APT-1011 3 mg BID group comprises all subjects who received double-blind or single-blind APT-1011 3 mg BID during Part 2
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
|---|---|---|---|---|---|---|---|
|
Number of Subjects Discontinuing Due to HPA Axis Suppression
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline to Week 52Population: Safety Analysis Population
Frequency of oral and esophageal candidiasis. Note: There were no patients in the placebo group after Week 14.
Outcome measures
| Measure |
APT-1011 1.5 mg HS
n=21 Participants
Placebo after breakfast, APT-1011 1.5 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
APT-1011 1.5 mg BID
n=23 Participants
APT-1011 1.5 mg after breakfast, APT-1011 1.5 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
APT-1011 3 mg HS
n=21 Participants
Placebo after breakfast, APT-1011 3 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
APT-1011 3 mg BID
n=20 Participants
APT-1011 3 mg after breakfast, APT-1011 3 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
Placebo BID
n=19 Participants
Placebo 30 minutes after breakfast and HS
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
Placebo BID, APT-1011 3 mg BID (Part 2)
n=34 Participants
Placebo 30 minutes after breakfast and HS
All Non-responders at Week 12 received 3 mg BID Week 14 to Week 52
|
Total APT-1011 3 mg BID
n=51 Participants
The Total APT-1011 3 mg BID group comprises all subjects who received double-blind or single-blind APT-1011 3 mg BID during Part 2
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
|---|---|---|---|---|---|---|---|
|
Number of Subjects With Oral and Esophageal Candidiasis
Oesophageal candidiasis
|
0 Participants
|
2 Participants
|
0 Participants
|
8 Participants
|
0 Participants
|
1 Participants
|
9 Participants
|
|
Number of Subjects With Oral and Esophageal Candidiasis
Oral candidiasis
|
0 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline to Week 12Population: Safety Analysis Population
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) Leading to Study Discontinuation in Part 1.
Outcome measures
| Measure |
APT-1011 1.5 mg HS
n=21 Participants
Placebo after breakfast, APT-1011 1.5 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
APT-1011 1.5 mg BID
n=23 Participants
APT-1011 1.5 mg after breakfast, APT-1011 1.5 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
APT-1011 3 mg HS
n=21 Participants
Placebo after breakfast, APT-1011 3 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
APT-1011 3 mg BID
n=20 Participants
APT-1011 3 mg after breakfast, APT-1011 3 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
Placebo BID
n=20 Participants
Placebo 30 minutes after breakfast and HS
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
Placebo BID, APT-1011 3 mg BID (Part 2)
n=85 Participants
Placebo 30 minutes after breakfast and HS
All Non-responders at Week 12 received 3 mg BID Week 14 to Week 52
|
Total APT-1011 3 mg BID
The Total APT-1011 3 mg BID group comprises all subjects who received double-blind or single-blind APT-1011 3 mg BID during Part 2
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
|---|---|---|---|---|---|---|---|
|
Number of Subjects With Treatment-Emergent Adverse Events Leading to Study Discontinuation in Part 1
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 12 to 52Population: Safety Analysis Population
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) Leading to Study Discontinuation in Part 2.
Outcome measures
| Measure |
APT-1011 1.5 mg HS
n=10 Participants
Placebo after breakfast, APT-1011 1.5 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
APT-1011 1.5 mg BID
n=19 Participants
APT-1011 1.5 mg after breakfast, APT-1011 1.5 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
APT-1011 3 mg HS
n=14 Participants
Placebo after breakfast, APT-1011 3 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
APT-1011 3 mg BID
n=16 Participants
APT-1011 3 mg after breakfast, APT-1011 3 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
Placebo BID
Placebo 30 minutes after breakfast and HS
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
Placebo BID, APT-1011 3 mg BID (Part 2)
n=34 Participants
Placebo 30 minutes after breakfast and HS
All Non-responders at Week 12 received 3 mg BID Week 14 to Week 52
|
Total APT-1011 3 mg BID
n=50 Participants
The Total APT-1011 3 mg BID group comprises all subjects who received double-blind or single-blind APT-1011 3 mg BID during Part 2
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
|---|---|---|---|---|---|---|---|
|
Number of Subjects With Treatment-Emergent Adverse Events Leading to Study Discontinuation in Part 2
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 12 to 52Population: Safety Analysis Population
Percentage of subjects with serum cortisol level ≤5 μg/dL (≤138 nmol/L) or abnormal adrenocorticotropic hormone (ACTH) stimulation test (serum cortisol \<16 μg/dL \[≤440 nmol/L\] at 60 minutes). Population used are those who entered Part 2 - Maintenance. The number of participants analyzed for each timepoint reflect the actual number of participants with data at that timepoint.
Outcome measures
| Measure |
APT-1011 1.5 mg HS
n=9 Participants
Placebo after breakfast, APT-1011 1.5 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
APT-1011 1.5 mg BID
n=19 Participants
APT-1011 1.5 mg after breakfast, APT-1011 1.5 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
APT-1011 3 mg HS
n=14 Participants
Placebo after breakfast, APT-1011 3 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
APT-1011 3 mg BID
n=16 Participants
APT-1011 3 mg after breakfast, APT-1011 3 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
Placebo BID
Placebo 30 minutes after breakfast and HS
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
Placebo BID, APT-1011 3 mg BID (Part 2)
Placebo 30 minutes after breakfast and HS
All Non-responders at Week 12 received 3 mg BID Week 14 to Week 52
|
Total APT-1011 3 mg BID
The Total APT-1011 3 mg BID group comprises all subjects who received double-blind or single-blind APT-1011 3 mg BID during Part 2
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With Serum Cortisol Level ≤5 μg/dL or Abnormal Adrenocorticotropic Hormone (ACTH) Stimulation Test
Serum cortisol level <=5 ug/dL (<=138 mmol/L)
|
4 Participants
|
1 Participants
|
4 Participants
|
6 Participants
|
0 Participants
|
—
|
—
|
|
Percentage of Subjects With Serum Cortisol Level ≤5 μg/dL or Abnormal Adrenocorticotropic Hormone (ACTH) Stimulation Test
Abnormal ACTH stimulation test result serum cortisol level <16ug/Dl (<=440 nmol/L)
|
0 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
—
|
—
|
Adverse Events
APT-1011 1.5 mg HS Part 1
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
APT-1011 1.5 mg BID Part 1
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
APT-1011 3 mg HS Part 1
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
APT-1011 3 mg BID Part 1
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Placebo BID Part 1
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Double-blind APT-1011 1.5 mg HS Part 2
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Double-blind APT-1011 1.5 mg BID Part 2
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Double-blind APT-1011 3 mg HS Part 2
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Double-blind APT-1011 3 mg BID Part 2
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Single-blind APT-1011 3mg BID Part 2
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Total APT-1011 3 mg BID Part 2
Serious events: 0 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
APT-1011 1.5 mg HS Part 1
n=21 participants at risk
Placebo after breakfast, APT-1011 1.5 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
APT-1011 1.5 mg BID Part 1
n=23 participants at risk
APT-1011 1.5 mg after breakfast, APT-1011 1.5 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
APT-1011 3 mg HS Part 1
n=21 participants at risk
Placebo after breakfast, APT-1011 3 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
APT-1011 3 mg BID Part 1
n=20 participants at risk
APT-1011 3 mg after breakfast, APT-1011 3 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
Placebo BID Part 1
n=20 participants at risk
Placebo 30 minutes after breakfast and HS
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
Double-blind APT-1011 1.5 mg HS Part 2
n=10 participants at risk
Placebo after breakfast, APT-1011 1.5 mg HS
Histologic responders at Week 12 who continued in Part 2 are included in double-blind dosing groups.
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
Double-blind APT-1011 1.5 mg BID Part 2
n=19 participants at risk
APT-1011 1.5 mg after breakfast, APT-1011 1.5 mg HS
Histologic responders at Week 12 who continued in Part 2 are included in double-blind dosing groups.
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
Double-blind APT-1011 3 mg HS Part 2
n=14 participants at risk
Placebo after breakfast, APT-1011 3 mg HS
Histologic responders at Week 12 who continued in Part 2 are included in double-blind dosing groups.
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
Double-blind APT-1011 3 mg BID Part 2
n=16 participants at risk
APT-1011 3 mg after breakfast, APT-1011 3 mg HS
Histologic responders at Week 12 who continued in Part 2 are included in double-blind dosing groups.
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
Single-blind APT-1011 3mg BID Part 2
n=34 participants at risk
APT-1011 3 mg after breakfast, APT-1011 3 mg HS
Histologic non-responders at Week 12 who continued in Part 2 are included in the single-blind APT-1011 3 mg BID group.
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
Total APT-1011 3 mg BID Part 2
n=50 participants at risk
The Total APT-1011 3 mg BID group comprises all subjects who received double-blind or single-blind APT-1011 3 mg BID during Part 2
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
10.0%
1/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Nervous system disorders
Status epilepticus
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
7.1%
1/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
4.8%
1/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
Other adverse events
| Measure |
APT-1011 1.5 mg HS Part 1
n=21 participants at risk
Placebo after breakfast, APT-1011 1.5 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
APT-1011 1.5 mg BID Part 1
n=23 participants at risk
APT-1011 1.5 mg after breakfast, APT-1011 1.5 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
APT-1011 3 mg HS Part 1
n=21 participants at risk
Placebo after breakfast, APT-1011 3 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
APT-1011 3 mg BID Part 1
n=20 participants at risk
APT-1011 3 mg after breakfast, APT-1011 3 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
Placebo BID Part 1
n=20 participants at risk
Placebo 30 minutes after breakfast and HS
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
Double-blind APT-1011 1.5 mg HS Part 2
n=10 participants at risk
Placebo after breakfast, APT-1011 1.5 mg HS
Histologic responders at Week 12 who continued in Part 2 are included in double-blind dosing groups.
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
Double-blind APT-1011 1.5 mg BID Part 2
n=19 participants at risk
APT-1011 1.5 mg after breakfast, APT-1011 1.5 mg HS
Histologic responders at Week 12 who continued in Part 2 are included in double-blind dosing groups.
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
Double-blind APT-1011 3 mg HS Part 2
n=14 participants at risk
Placebo after breakfast, APT-1011 3 mg HS
Histologic responders at Week 12 who continued in Part 2 are included in double-blind dosing groups.
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
|
Double-blind APT-1011 3 mg BID Part 2
n=16 participants at risk
APT-1011 3 mg after breakfast, APT-1011 3 mg HS
Histologic responders at Week 12 who continued in Part 2 are included in double-blind dosing groups.
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
Single-blind APT-1011 3mg BID Part 2
n=34 participants at risk
APT-1011 3 mg after breakfast, APT-1011 3 mg HS
Histologic non-responders at Week 12 who continued in Part 2 are included in the single-blind APT-1011 3 mg BID group.
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
Total APT-1011 3 mg BID Part 2
n=50 participants at risk
The Total APT-1011 3 mg BID group comprises all subjects who received double-blind or single-blind APT-1011 3 mg BID during Part 2
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Bacterial vaginosis
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
4.8%
1/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Infections and infestations
Bronchitis
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
4.3%
1/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Infections and infestations
Cellulitis
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
5.0%
1/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Infections and infestations
Conjunctivitis viral
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
5.0%
1/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Infections and infestations
Ear infection
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
10.0%
1/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Infections and infestations
Epididymitis
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
5.0%
1/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Infections and infestations
Fungal infection
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.9%
1/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.0%
1/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.9%
1/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.0%
1/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Infections and infestations
Genital infection fungal
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
10.0%
1/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
4.8%
1/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Infections and infestations
Impetigo
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.9%
1/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.0%
1/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Infections and infestations
Infectious mononucleosis
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
10.0%
1/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Infections and infestations
Kidney infection
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
7.1%
1/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Infections and infestations
Oral infection
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
5.3%
1/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Infections and infestations
Otitis media
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
7.1%
1/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
5.3%
1/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Infections and infestations
Tinea infection
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
5.0%
1/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
5.0%
1/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Infections and infestations
Viral infection
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
10.0%
1/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Gastrointestinal disorders
Dyspepsia
|
4.8%
1/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
4.3%
1/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
9.5%
2/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
5.0%
1/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
5.0%
1/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
5.3%
1/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
5.9%
2/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
4.0%
2/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
9.5%
2/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
5.0%
1/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
5.0%
1/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
10.0%
1/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
6.2%
1/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.0%
1/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
4.3%
1/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
4.8%
1/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
5.0%
1/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
5.0%
1/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
5.3%
1/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.9%
1/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.0%
1/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Gastrointestinal disorders
Flatulence
|
4.8%
1/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
4.3%
1/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
5.3%
1/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
6.2%
1/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.9%
1/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
4.0%
2/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Gastrointestinal disorders
Erosive oesophagitis
|
4.8%
1/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.9%
1/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.0%
1/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
4.8%
1/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
5.0%
1/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
10.0%
1/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
5.3%
1/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
7.1%
1/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
4.8%
1/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
5.0%
1/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.9%
1/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.0%
1/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
4.3%
1/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
10.0%
1/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.9%
1/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.0%
1/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
9.5%
2/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
6.2%
1/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.0%
1/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
4.3%
1/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
5.9%
2/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
4.0%
2/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
6.2%
1/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.9%
1/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
4.0%
2/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
5.0%
1/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
5.3%
1/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
6.2%
1/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.9%
1/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
4.0%
2/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
5.0%
1/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.9%
1/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.0%
1/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
4.8%
1/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
5.3%
1/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
5.3%
1/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Gastrointestinal disorders
Abdominal distension
|
4.8%
1/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
7.1%
1/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Gastrointestinal disorders
Angular cheilitis
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.9%
1/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.0%
1/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
6.2%
1/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.0%
1/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Gastrointestinal disorders
Faeces pale
|
4.8%
1/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Gastrointestinal disorders
Faeces soft
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
5.0%
1/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
6.2%
1/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.0%
1/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Gastrointestinal disorders
Gastric mucosa erythema
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.9%
1/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.0%
1/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Gastrointestinal disorders
Gastric polyps
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.9%
1/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.0%
1/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.9%
1/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.0%
1/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
4.3%
1/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
5.3%
1/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Gastrointestinal disorders
Haemorrhoids thrombosed
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.9%
1/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.0%
1/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Gastrointestinal disorders
Oesophageal food impaction
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
4.3%
1/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.9%
1/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.0%
1/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Gastrointestinal disorders
Oral pain
|
4.8%
1/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
4.3%
1/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.9%
1/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.0%
1/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.5%
2/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
4.8%
1/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
10.0%
2/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
10.5%
2/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
6.2%
1/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.9%
1/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
4.0%
2/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
6.2%
1/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.0%
1/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
10.0%
1/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
12.5%
2/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
4.0%
2/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
6.2%
1/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.9%
1/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
4.0%
2/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.8%
1/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
10.0%
1/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
5.3%
1/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
10.0%
1/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
10.0%
1/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
6.2%
1/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.0%
1/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
4.3%
1/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
4.3%
1/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
5.3%
1/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
7.1%
1/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis stenosans
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
7.1%
1/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Investigations
Cortisol decreased
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
8.7%
2/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
4.8%
1/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
10.0%
1/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
7.1%
1/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
6.2%
1/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
5.9%
2/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
6.0%
3/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Investigations
Aspartate aminotransferase increased
|
4.8%
1/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
5.0%
1/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
7.1%
1/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Investigations
Alanine aminotransferase increased
|
4.8%
1/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
7.1%
1/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Investigations
Blood glucose increased
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
5.0%
1/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
7.1%
1/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Investigations
Protein urine present
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
4.3%
1/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
5.0%
1/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
5.3%
1/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.9%
1/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.0%
1/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Investigations
ACTH stimulation test abnormal
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
7.1%
1/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Investigations
Blood bilirubin increased
|
4.8%
1/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Investigations
Blood creatinine increased
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
7.1%
1/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Investigations
Blood pressure increased
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
6.2%
1/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.0%
1/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Investigations
Electrocardiogram QRS complex prolonged
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
6.2%
1/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.0%
1/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
5.0%
1/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Investigations
Heart rate increased
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
5.0%
1/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.9%
1/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.0%
1/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.9%
1/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.0%
1/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Investigations
Neutrophil percentage decreased
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
5.0%
1/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
6.2%
1/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.0%
1/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Investigations
Weight increased
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
6.2%
1/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.0%
1/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Nervous system disorders
Headache
|
4.8%
1/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
4.3%
1/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
4.8%
1/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
15.0%
3/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
10.0%
2/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
10.0%
1/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
5.3%
1/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
14.3%
2/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
6.2%
1/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
5.9%
2/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
6.0%
3/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Nervous system disorders
Migraine
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
10.0%
1/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
5.3%
1/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
7.1%
1/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Nervous system disorders
Cervical radiculopathy
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
5.3%
1/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
5.0%
1/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Nervous system disorders
Somnolence
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
4.8%
1/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Nervous system disorders
Syncope
|
4.8%
1/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
5.3%
1/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
9.5%
2/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
5.0%
1/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
6.2%
1/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.0%
1/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
9.5%
2/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
10.0%
1/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
5.3%
1/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
7.1%
1/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.9%
1/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.0%
1/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
7.1%
1/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
6.2%
1/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.0%
1/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
5.0%
1/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.9%
1/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.0%
1/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal spasm
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
5.0%
1/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
4.8%
1/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
10.0%
1/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillolith
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
5.0%
1/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
General disorders
Fatigue
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
5.0%
1/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
15.0%
3/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
General disorders
Chills
|
4.8%
1/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
General disorders
Early satiety
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.9%
1/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.0%
1/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
General disorders
Face oedema
|
4.8%
1/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
General disorders
Gait disturbance
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
4.8%
1/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
General disorders
Generalized oedema
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.9%
1/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.0%
1/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
General disorders
Influenza like illness
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.9%
1/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.0%
1/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
5.0%
1/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
General disorders
Oedema peripheral
|
4.8%
1/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
General disorders
Pain
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
6.2%
1/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.0%
1/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
General disorders
Peripheral swelling
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
7.1%
1/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
General disorders
Pyrexia
|
4.8%
1/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
General disorders
Temperature regulation disorder
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
6.2%
1/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.0%
1/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
4.8%
1/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
5.0%
1/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
7.1%
1/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.0%
1/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
5.0%
1/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
7.1%
1/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.0%
1/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
4.8%
1/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Injury, poisoning and procedural complications
Back injury
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.9%
1/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.0%
1/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
4.3%
1/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.9%
1/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.0%
1/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.9%
1/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.0%
1/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
5.0%
1/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.9%
1/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.0%
1/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
4.8%
1/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
6.2%
1/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.0%
1/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
7.1%
1/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
6.2%
1/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.0%
1/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
7.1%
1/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
6.2%
1/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.0%
1/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
6.2%
1/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.9%
1/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
4.0%
2/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
4.8%
1/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Skin and subcutaneous tissue disorders
Cutaneous calcification
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
5.0%
1/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.9%
1/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.0%
1/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Skin and subcutaneous tissue disorders
Pityriasis rosea
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
4.3%
1/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Skin and subcutaneous tissue disorders
Pruritus allergic
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
5.0%
1/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Skin and subcutaneous tissue disorders
Rash vesicular
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.9%
1/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.0%
1/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
10.0%
1/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
5.3%
1/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
6.2%
1/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.0%
1/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
6.2%
1/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.0%
1/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Reproductive system and breast disorders
Epididymal cyst
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
5.0%
1/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
5.0%
1/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Reproductive system and breast disorders
Genital rash
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
10.0%
1/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
7.1%
1/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Endocrine disorders
Adrenal suppression
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
6.2%
1/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.0%
1/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
7.1%
1/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Reproductive system and breast disorders
Pelvic discomfort
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.9%
1/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.0%
1/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Reproductive system and breast disorders
Peyronie's disease
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.9%
1/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.0%
1/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
12.5%
2/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
4.0%
2/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Psychiatric disorders
Depression
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
5.0%
1/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
7.1%
1/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
6.2%
1/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.0%
1/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
5.0%
1/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
6.2%
1/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.9%
1/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
4.0%
2/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
5.0%
1/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Psychiatric disorders
Libido decreased
|
4.8%
1/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Psychiatric disorders
Post-traumatic stress disorder
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
4.8%
1/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Psychiatric disorders
Stress
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.9%
1/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.0%
1/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Metabolism and nutrition disorders
Appetite disorder
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
5.0%
1/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
5.0%
1/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
6.2%
1/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.0%
1/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
7.1%
1/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Metabolism and nutrition disorders
Hypovitaminosis
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
7.1%
1/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
4.8%
1/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Renal and urinary disorders
Hypertonic bladder
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
4.8%
1/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.9%
1/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.0%
1/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
5.0%
1/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
5.0%
1/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Cardiac disorders
Bundle branch block right
|
4.8%
1/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Cardiac disorders
Palpitations
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
4.8%
1/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Ear and labyrinth disorders
Deafness bilateral
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
5.3%
1/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.9%
1/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.0%
1/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Ear and labyrinth disorders
Middle ear effusion
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.9%
1/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.0%
1/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Vascular disorders
Hypertension
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
4.3%
1/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
10.5%
2/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
7.1%
1/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
7.1%
1/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
6.2%
1/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.9%
1/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
4.0%
2/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cartilage neoplasm
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
6.2%
1/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.0%
1/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.9%
1/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.0%
1/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.9%
1/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.0%
1/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Congenital, familial and genetic disorders
Gilbert's syndrome
|
4.8%
1/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Hepatobiliary disorders
Hepatic steatosis
|
4.8%
1/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Infections and infestations
Nasopharyngitis
|
14.3%
3/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
13.0%
3/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
9.5%
2/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
10.0%
2/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
20.0%
2/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
5.3%
1/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
31.2%
5/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
11.8%
4/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
18.0%
9/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Infections and infestations
Oeseophageal candidiasis
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
8.7%
2/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
30.0%
6/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
5.3%
1/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
18.8%
3/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.9%
1/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
8.0%
4/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
8.7%
2/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
4.8%
1/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
10.0%
2/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
10.5%
2/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
12.5%
2/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.9%
1/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
6.0%
3/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
4.3%
1/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
4.8%
1/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
10.5%
2/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
7.1%
1/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
12.5%
2/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
4.0%
2/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
4.8%
1/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
10.0%
1/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
10.5%
2/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
6.2%
1/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.0%
1/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
4.3%
1/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
4.8%
1/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
10.0%
1/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
5.3%
1/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.9%
1/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.0%
1/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Infections and infestations
Viral upper respiratory tract infection
|
4.8%
1/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
5.0%
1/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
14.3%
2/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.9%
1/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.0%
1/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Infections and infestations
Influenza
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
4.3%
1/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
4.8%
1/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
10.5%
2/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
5.0%
1/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
5.3%
1/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
12.5%
2/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
4.0%
2/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Infections and infestations
Sinusitis
|
4.8%
1/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
4.8%
1/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
6.2%
1/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.0%
1/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
10.0%
2/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
10.0%
1/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Infections and infestations
Gastroenteritis viral
|
4.8%
1/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.9%
1/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
2.0%
1/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Infections and infestations
Oropharyngeal candidiasis
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
5.0%
1/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
7.1%
1/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/23 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/21 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/20 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/10 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/19 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
7.1%
1/14 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/16 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/34 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
0.00%
0/50 • to Week 14 (Part 1) to Week 52 (Part 2)
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration. One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
|
Additional Information
Senior Director Clinical Operations and Medical Affairs
Ellodi Pharmaceuticals (Formerly Adare Pharmaceuticals)
Phone: (609) 450-1312
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60