Efficacy, Safety, and Pharmacokinetics of APT-1011 in Sub... | NCT03191864 | Trialant
NCT03191864
Sponsor
Adare Pharmaceuticals, Inc.
Status
Completed
Last Update Posted
Apr 26, 2023Actual
Enrollment
106Actual
Phase
Phase 2
Conditions
Eosinophilic Esophagitis
Interventions
APT-1011
Placebo
Countries
United States
Belgium
Canada
Germany
Spain
Switzerland
Protocol Section
Identification Module
NCT ID
NCT03191864
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
SP-1011-002
Secondary IDs
ID
Type
Description
Link
2016-004749-10
EudraCT Number
Brief Title
Efficacy, Safety, and Pharmacokinetics of APT-1011 in Subjects With Eosinophilic Esophagitis (EoE)
Official Title
FLUTicasone in Eosinophilic Esophagitis (FLUTE): A Randomized, Double-blind, Placebo-controlled, Dose-ranging, and Maintenance Study of APT-1011 in Subjects With Eosinophilic Esophagitis
Acronym
FLUTE
Organization
Adare Pharmaceuticals, Inc.INDUSTRY
Status Module
Record Verification Date
Apr 2023
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jun 22, 2017Actual
Primary Completion Date
Jan 3, 2019Actual
Completion Date
Oct 23, 2019Actual
First Submitted Date
Jun 15, 2017
First Submission Date that Met QC Criteria
Jun 16, 2017
First Posted Date
Jun 19, 2017Actual
Results Waived
Not provided
Results First Submitted Date
Oct 3, 2022
Results First Submitted that Met QC Criteria
Apr 4, 2023
Results First Posted Date
Apr 26, 2023Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Jan 27, 2021
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Apr 26, 2023Actual
Last Update Submitted Date
Apr 4, 2023
Last Update Posted Date
Apr 26, 2023Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Adare Pharmaceuticals, Inc.INDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
Eosinophilic esophagitis (EoE) is an inflammatory disease of the esophagus, characterized by eosinophilic infiltration and gastrointestinal symptoms. Swallowed, topically acting corticosteroids, such as fluticasone, appear to be effective in resolving acute clinical and pathological features of EoE.
APT-1011 is an orally disintegrating tablet (ODT) formulation of fluticasone propionate. This study is designed to compare the efficacy and safety of APT-1011 with placebo in adults with EoE for an initial 12-week treatment period, followed by an additional 40-week maintenance treatment phase. Histologic response, pharmacokinetics, and dysphagia will be assessed.
Detailed Description
FLUTE is a phase 2b randomized, double-blind, placebo-controlled dose-ranging clinical trial of APT-1011 versus placebo in 100 adult subjects (≥18 years of age) diagnosed with EoE. Efficacy (including histologic, endoscopic, and symptomatic response), safety, and PK of APT-1011 will be examined. Participants will be given an electronic diary to record symptoms and medication intake daily.
FLUTE will be conducted in several parts (Screening [4 weeks], followed by a 4-week Baseline Symptom Assessment, and 2 treatment parts [Part 1: 14-week Induction and Part 2: 38-week Maintenance]), with a follow-up visit to occur 2 weeks after the final dose of study drug.
In Part 1 of the study, approximately 100 subjects will be randomized 1:1:1:1:1 to receive placebo or one of 4 active doses of APT-1011. All subjects will receive one tablet 30 minutes after breakfast and one tablet at bedtime (HS). The dosing groups include: 1.5 mg HS APT-1011, 1.5 mg twice daily (BID) (total daily dose of 3 mg) APT-1011, 3 mg HS APT-1011, and 3 mg BID (total daily dose of 6 mg) APT-1011, and placebo BID.
In Part 2, all subjects classified as histologic responders at Week 12 will continue to be treated according to the dosing group to which they were randomized, and non-responders will receive single-blind 3 mg BID. All subjects who are histologic non-responders at Week 26 will stop treatment at Week 28 and enter the 2-week follow-up and exit the study. Histologic responders at Week 26 will continue on the same dose until end-of-study at Week 52.
Subjects will complete a follow-up visit 2 weeks after the final dose of study drug. All subjects must have a final EGD within 3 weeks prior to completing the Follow-up Visit unless the subject withdraws consent or has a contraindication to EGD.
Conditions Module
Conditions
Eosinophilic Esophagitis
Keywords
Esophagitis
Eosinophilic Esophagitis
Fluticasone
Dysphagia
Safety
Efficacy
Pharmacokinetics
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Glucocorticoids
Orally Disintegrating Tablet
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
106Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
APT-1011 1.5 mg HS
Experimental
Placebo after breakfast, APT-1011 1.5 mg HS
Drug: APT-1011
Drug: Placebo
APT-1011 1.5 mg BID
Experimental
APT-1011 1.5 mg after breakfast, APT-1011 1.5 mg HS
Drug: APT-1011
APT-1011 3 mg HS
Experimental
Placebo after breakfast, APT-1011 3 mg HS
Drug: APT-1011
Drug: Placebo
APT-1011 3 mg BID
Experimental
APT-1011 3 mg after breakfast, APT-1011 3 mg HS
Drug: APT-1011
Placebo BID
Placebo Comparator
Placebo 30 minutes after breakfast and HS
Drug: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
APT-1011
Drug
APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
APT-1011 1.5 mg BID
APT-1011 1.5 mg HS
APT-1011 3 mg BID
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Subjects With ≤6 Peak Eosinophils/High-power Field (HPF)
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).
Week 12
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Subjects Who Met the Primary Endpoint at Week 12 and Maintained the Primary Endpoint at Weeks 26 and 52
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.
Other Outcomes
Measure
Description
Time Frame
Number of Subjects Discontinuing Due to HPA Axis Suppression
Number of subjects discontinuing due to HPA axis suppression.
Note: There were no patients in the placebo group after Week 14.
baseline to Week 52
Number of Subjects With Oral and Esophageal Candidiasis
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Male or female between ≥18 and ≤75 years of age at the time of informed consent
Signed informed consent
Evidence of EoE defined by ≥15 peak eosinophils per HPF as measured from proximal and distal biopsies
Subject-reported history of ≥3 episodes of dysphagia in the 7 days prior to Screening
7-day Global EoE Symptom Score >3 at baseline and at screening
Willing and able to adhere to study-related treatment regimens, procedures, and visit schedule
Exclusion Criteria:
Have known contraindication, hypersensitivity, or intolerance to corticosteroids;
Have any physical, mental, or social condition or history of illness or laboratory abnormality that in the Investigator's judgment might interfere with study procedures or the ability of the subject to adhere to and complete the study;
Presence of oral or esophageal mucosal infection of any type;
Have any mouth or dental condition that prevents normal eating;
Have any condition affecting the esophageal mucosa or altering esophageal motility other than EoE;
Use of systemic corticosteroids within 60 days prior to Screening, use of inhaled/swallowed corticosteroids within 30 days prior to Screening, or extended use of high-potency dermal topical corticosteroids within 30 days prior to Screening;
Initiation of an elimination diet or elemental diet within 30 days before Screening (diet must remain stable after signing ICF);
Use of biologic immunomodulators in the 24 weeks prior to Screening;
Use of calcineurin inhibitors or purine analogues, or potent cytochrome P450 (CYP) 3A4 inhibitors in the 12 weeks prior to Screening;
Have a contraindication to or factors that substantially increase the risk of EGD or esophageal biopsy or have narrowing of the esophagus that precludes EGD with a standard 9 mm endoscope;
Have a history of an esophageal stricture requiring dilatation within the previous 12 weeks prior to Screening;
Have initiated, discontinued or changed dosage regimen of PPIs, H2 antagonists, antacids or antihistamines for any condition such as GERD or allergic rhinitis within 4 weeks prior to qualifying endoscopy. These drugs must remain constant throughout the study.
A serum cortisol level <18 μg/dL (497 nmol/L) at 60 minutes with adrenocorticotropic hormone (ACTH) stimulation test using 250 μg cosyntropin (i.e., a positive result on the ACTH stimulation test).
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.
Recruitment Details
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).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
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.
FG001
APT-1011 1.5 mg BID
Periods
Title
Milestones
Reasons Not Completed
Baseline Symptom Assessment
Type
Comment
Milestone Data
STARTED
Due to the high placebo response rates, the study utilized a 4-week single-blind placebo run-in period to not only establish the baseline symptoms for the study, but also to ensure that all subjects enrolled had sufficient severity of EoE to warrant inclusion in the study.
Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
APT-1011 1.5 mg HS
APT-1011 3 mg HS
Placebo BID
Matching placebo dose
Week 26, and Week 52
Change From Baseline Eosinophilic Esophagitis Endoscopic Reference Score (EREFs) at Week 12, 26, and 52
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.
Week 12, Week 26, and Week 52
Percentage of Subjects With a Peak Eosinophils/HPF Number <1 and <15
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.
Week 12, Week 26, and Week 52
Change From Baseline Global EoE Symptom Score
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.
Week 4, 8, 12, 14, 18, 22, 26, 28, 36, 44, and 52
Change in the Number of Dysphagia Episodes
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.
Week 12, Week 26 and Week 52
Change From Baseline 7-Day Eosinophilic Esophagitis Activity Index (EEsAI) Total Score
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
Weeks 12, 26 and 52
Change From Baseline 7-Day Eosinophilic Esophagitis Activity Index (EEsAI) Subscores
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.
Weeks 12, 26 and 52
Percentage of Subjects With Mean 7-day EEsAI Total Score <20
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
Weeks 12, 26, and 52
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
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.
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
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.
Change From Baseline Patient Global Impression of Change (PGIC) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
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.
Weeks 4, 8, 12, 14, 18, 22, 26, 36, 44, and 52
Change From Baseline PGIC of Difficulty With Food or Pills as Assessed Prior to Randomization Post-Baseline Visit
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.
Weeks 4, 8, 12, 14, 18, 22, 26, 36, 44, and 52
Percentage of Histologic Non-responders by Dose at Weeks 12, 26, and 52
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.
Weeks 12, 26 and 52
Percentage of Subjects Requiring Emergency Endoscopic Food Dis-impaction
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.
before Week 14, between Week 14 and Week 28, between Week 28 and Week 52
Percentage of Subjects Requiring Esophageal Dilation
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.
baseline to Week 52
Frequency of oral and esophageal candidiasis.
Note: There were no patients in the placebo group after Week 14.
baseline to Week 52
Number of Subjects With Treatment-Emergent Adverse Events Leading to Study Discontinuation in Part 1
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) Leading to Study Discontinuation in Part 1.
baseline to Week 12
Number of Subjects With Treatment-Emergent Adverse Events Leading to Study Discontinuation in Part 2
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) Leading to Study Discontinuation in Part 2.
Week 12 to 52
Percentage of Subjects With Serum Cortisol Level ≤5 μg/dL or Abnormal Adrenocorticotropic Hormone (ACTH) Stimulation Test
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.
Week 12 to 52
Tucson
Arizona
85710
United States
Arkansas Gastroenterology, P.A.
Sherwood
Arkansas
72120
United States
Hope Clinical Research
Canoga Park
California
91303
United States
TriWest Research Associates, LLC
El Cajon
California
92020-4124
United States
SC Clinical Research, Inc.
Garden Grove
California
92844
United States
Beverly Hills Center for Digestive Health
Los Angeles
California
90048
United States
Focilmed
Oxnard
California
93030
United States
Precision Research Institute, LLC
San Diego
California
92114
United States
Medical Associates Research Group, Inc.
San Diego
California
92123
United States
Care Access Research LLC
San Pablo
California
94806
United States
Stanford University School of Medicine
Stanford
California
94305-2200
United States
St. Jude Healthcare
Yorba Linda
California
92886
United States
Western Connecticut Health Network
Danbury
Connecticut
06810
United States
Medical Research Center of Connecticut, LLC
Hamden
Connecticut
06518
United States
Eastern Research, Inc.
Hialeah
Florida
33013
United States
Nature Coast Clinical Research, LLC
Inverness
Florida
34452
United States
Sunrise Medical Research
Lauderdale Lakes
Florida
33319
United States
DBC Research, Corp
Pembroke Pines
Florida
33029
United States
Northwestern Medical Faculty Foundation
Chicago
Illinois
60611
United States
Southwest Gastroenterology
Oak Lawn
Illinois
60453-3767
United States
Rockford Gastroenterology Associates, Ltd.
Rockford
Illinois
61107
United States
MediSphere Medical Research Center, an AMR affiliate
Evansville
Indiana
47714
United States
Cotton-O'Neil Clinical Research Center, Digestive Health
Topeka
Kansas
66606
United States
Gastroenterology Associates
Hazard
Kentucky
41701
United States
Clinical Trials of America, Inc.
West Monroe
Louisiana
71291
United States
Henry Ford Medical Center
Novi
Michigan
48377-3600
United States
Metro Health
Wyoming
Michigan
49519
United States
St. Louis Center for Clinical Research
St Louis
Missouri
63128
United States
Long Island Gastrointestinal Research Group, LLP
Great Neck
New York
11023
United States
Weill Cornell Medical College
New York
New York
10021
United States
University of North Carolina at Chapel Hill
Chapel Hill
North Carolina
27514
United States
Research Institute of the Carolinas, PLC
Mooresville
North Carolina
28117
United States
Carolina's GI Research, LLC
Raleigh
North Carolina
27607
United States
Wake Research Associates, LLC
Raleigh
North Carolina
27612
United States
PMG Research of Salisbury, LLC
Salisbury
North Carolina
28144
United States
Bernstein Clinical Research Center, LLC
Cincinnati
Ohio
45231
United States
Aventiv Research Inc.
Columbus
Ohio
43231
United States
Unity Clinical Research
Oklahoma City
Oklahoma
73118
United States
Allergy and Asthma Center of South Oregon
Medford
Oregon
97504
United States
University of Pennsylvania
Philadelphia
Pennsylvania
19104
United States
Digestive Disease Associates, Ltd.
Wyomissing
Pennsylvania
19610
United States
Rapid City Medical Center, LLP
Rapid City
South Dakota
57701
United States
Advanced Gastroenterology
Union City
Tennessee
38261
United States
Avant Research Associates, LLC - Austin
Austin
Texas
78704
United States
Avant Research Associates, LLC
Beaumont
Texas
77702
United States
DHAT Research Institute
Richardson
Texas
75082
United States
Advanced Research Institute
Ogden
Utah
84405
United States
University of Utah
Salt Lake City
Utah
84108
United States
Care Access Research LLC
Salt Lake City
Utah
84124
United States
Verity Research Inc
Fairfax
Virginia
22031
United States
AZ Sint-Lucas
Bruges
8310
Belgium
Universitair Ziekenhuis Gent
Ghent
9000
Belgium
AZ Groeninge - Kennedylaan
Kortrijk
8500
Belgium
UZ Leuven
Leuven
3000
Belgium
(G.I.R.I.) GI Research Institute
Vancouver
British Columbia
V6Z 2K5
Canada
Viable Clinical Research
Bridgewater
Nova Scotia
B4V 3N2
Canada
Viable Clinical Research
Lindsay
Ontario
K9V 5G6
Canada
London Health Science Centre
London
Ontario
N6A 5A5
Canada
Taunton Surgical Centre
Oshawa
Ontario
L1H 7K4
Canada
Klinikum rechts der Isar der TU Muenchen
Munich
Bavaria
81675
Germany
Staedisches Klinikum Brandenburg
Brandenburg an der Havel
Brandenburg
14770
Germany
Praxis am Germania
Münster
North Rhine-Westphalia
48159
Germany
Universitaetsklinikum Leipzig AoeR
Leipzig
Saxony
4103
Germany
Universitaetsklinikum Schleswig-Holstein
Kiel
Schleswig-Holstein
24105
Germany
Hospital General de Tomelloso
Tomelloso
Ciudad Real
13700
Spain
Hospital General Universitario de Alicante
Alicante
3010
Spain
Hospital de la Santa Creu i Sant Pau
Barcelona
08025
Spain
Hospital Universitari Vall d'Hebron
Barcelona
Spain
Hospital Universitario de La Princesa
Madrid
28006
Spain
Hospital Universitario Virgen del Rocio
Seville
41013
Spain
Hospital Clinico Universitario de Valencia
Valencia
46010
Spain
Hospital Clinico Universitario Lozano Blesa
Zaragoza
50009
Spain
Hospital Universitario Miguel Servet
Zaragoza
50009
Spain
Centre Hospitalier Universitaire Vaudois
Lausanne
1011
Switzerland
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
FG002
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.
FG003
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
FG004
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
FG005
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.
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG005308 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG005106 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG005202 subjects
Type
Comment
Reasons
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
Patient Diary Unavailable at Site
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Violation of inclusion/exclusion criteria
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Part 1 - Induction
Type
Comment
Milestone Data
STARTED
FG00021 subjects
FG00122 subjects
FG00222 subjects
FG00320 subjects
FG0040 subjects
FG00521 subjects
COMPLETED
FG00018 subjects
FG00119 subjects
FG00220 subjects
FG00319 subjects
FG004
NOT COMPLETED
FG0003 subjects
FG0013 subjects
FG0022 subjects
FG0031 subjects
FG004
Type
Comment
Reasons
Violation of inclusion/exclusion criteria
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG003
Part 2 - Maintenance
Type
Comment
Milestone Data
STARTED
Note that those subjects that were non-responders at Week 12 were switched from another arm to the Single-blind APT-1011 3 mg BID arm. This arm was a single-blinded arm for the subjects only.
FG00010 subjects
FG00119 subjects
FG00214 subjects
FG00316 subjects
FG00434 subjects
FG0050 subjects
COMPLETED
FG0005 subjects
FG00117 subjects
FG00211 subjects
FG00314 subjects
FG004
NOT COMPLETED
FG0005 subjects
FG0012 subjects
FG0023 subjects
FG0032 subjects
FG004
Type
Comment
Reasons
Refused EGD at Week 26
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
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.
BG001
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
BG002
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.
BG003
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
BG004
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.
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00021
BG00122
BG00222
BG00320
BG00421
BG005106
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00036.8± 11.65
BG00141.3± 12.24
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0007
BG0017
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0004
BG0015
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
North America
Title
Measurements
BG00015
BG00116
BG002
Smoking Status
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Never
BG00018
BG00117
BG002
History of esophageal stricture(s)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Yes
BG00011
BG00110
BG002
Current esophageal stricture(s) based on the study EGD
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Yes
BG0004
BG0015
BG002
History of positive steroid response to EOE
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Yes
BG0003
BG0015
BG002
Proton pump inhibitor status
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Continuing into study
BG00012
BG00116
BG002
Height
Mean
Standard Deviation
cm
Title
Denominators
Categories
Title
Measurements
BG000175.4± 8.55
BG001173.0± 8.56
BG002
Weight
Mean
Standard Deviation
kg
Title
Denominators
Categories
Title
Measurements
BG00087.45± 17.69
BG00183.72± 14.72
BG002
BMI
Mean
Standard Deviation
kg/m^2
Title
Denominators
Categories
Title
Measurements
BG00028.27± 5.19
BG00127.39± 4.34
BG002
Global EOE Symptom Score prior to randomization
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.
Mean
Standard Deviation
units on a scale
Title
Denominators
Categories
Title
Measurements
BG0005.14± 1.62
BG001
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Subjects With ≤6 Peak Eosinophils/High-power Field (HPF)
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).
Full Analysis Set Population
Posted
Count of Participants
Participants
Week 12
ID
Title
Description
OG000
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.
OG001
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
OG002
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.
OG003
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
OG004
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.
Units
Counts
Participants
OG00021
OG00122
OG00221
OG003
Title
Denominators
Categories
Responder
Title
Measurements
OG00010
OG00119
OG00214
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
Cochran-Mantel-Haenszel
0.001
Superiority
OG001
OG004
Cochran-Mantel-Haenszel
<0.001
Secondary
Percentage of Subjects Who Met the Primary Endpoint at Week 12 and Maintained the Primary Endpoint at Weeks 26 and 52
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.
Full Analysis Set Population
Posted
Count of Participants
Participants
Week 26, and Week 52
ID
Title
Description
OG000
Responder 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.
OG001
Responder 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
OG002
Responder 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.
Secondary
Change From Baseline Eosinophilic Esophagitis Endoscopic Reference Score (EREFs) at Week 12, 26, and 52
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.
Full Analysis Set Population receiving double-blind study medication
Posted
Mean
Standard Deviation
units on a scale
Week 12, Week 26, and Week 52
ID
Title
Description
OG000
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.
OG001
Secondary
Percentage of Subjects With a Peak Eosinophils/HPF Number <1 and <15
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.
Full Analysis Set Population receiving double-blind study medication
Posted
Count of Participants
Participants
Week 12, Week 26, and Week 52
ID
Title
Description
OG000
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.
OG001
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
OG002
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.
Secondary
Change From Baseline Global EoE Symptom Score
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.
Full Analysis Set Population receiving double-blind study medication
Posted
Mean
Standard Deviation
units on a scale
Week 4, 8, 12, 14, 18, 22, 26, 28, 36, 44, and 52
ID
Title
Description
OG000
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.
OG001
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
Secondary
Change in the Number of Dysphagia Episodes
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.
Full Analysis Set Population receiving double-blind study medication
Posted
Mean
Standard Deviation
change in episodes per 14-day period
Week 12, Week 26 and Week 52
ID
Title
Description
OG000
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.
OG001
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
OG002
APT-1011 3 mg HS
Secondary
Change From Baseline 7-Day Eosinophilic Esophagitis Activity Index (EEsAI) Total Score
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
Full Analysis Set Population
Posted
Mean
Standard Deviation
units on a scale
Weeks 12, 26 and 52
ID
Title
Description
OG000
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.
OG001
APT-1011 1.5 mg BID
Secondary
Change From Baseline 7-Day Eosinophilic Esophagitis Activity Index (EEsAI) Subscores
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.
Full Analysis Set Population
Posted
Mean
Standard Deviation
units on a scale
Weeks 12, 26 and 52
ID
Title
Description
OG000
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.
OG001
APT-1011 1.5 mg BID
Secondary
Percentage of Subjects With Mean 7-day EEsAI Total Score <20
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
Full Analysis Set population
Posted
Count of Participants
Participants
Weeks 12, 26, and 52
ID
Title
Description
OG000
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.
OG001
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
Secondary
Change From Baseline Patient Global Impression of Severity (PGIS) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
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.
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.
OG001
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
OG002
APT-1011 3 mg HS
Secondary
Change From Baseline PGIS for Difficulty With Food or Pills Going Down as Assessed Prior to Randomization Post-Baseline Visit
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.
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.
OG001
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
OG002
APT-1011 3 mg HS
Secondary
Change From Baseline Patient Global Impression of Change (PGIC) for EoE Symptoms as Assessed Prior to Randomization Post-Baseline Visit
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.
Full Analysis Set
Posted
Count of Participants
Participants
Weeks 4, 8, 12, 14, 18, 22, 26, 36, 44, and 52
ID
Title
Description
OG000
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.
OG001
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
OG002
APT-1011 3 mg HS
Secondary
Change From Baseline PGIC of Difficulty With Food or Pills as Assessed Prior to Randomization Post-Baseline Visit
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.
Full Analysis Set
Posted
Count of Participants
Participants
Weeks 4, 8, 12, 14, 18, 22, 26, 36, 44, and 52
ID
Title
Description
OG000
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.
OG001
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
OG002
APT-1011 3 mg HS
Secondary
Percentage of Histologic Non-responders by Dose at Weeks 12, 26, and 52
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.
Full Analysis Set Population
Posted
Count of Participants
Participants
Weeks 12, 26 and 52
ID
Title
Description
OG000
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.
OG001
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
OG002
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.
Secondary
Percentage of Subjects Requiring Emergency Endoscopic Food Dis-impaction
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.
Full Analysis Set Population
Posted
Count of Participants
Participants
before Week 14, between Week 14 and Week 28, between Week 28 and Week 52
ID
Title
Description
OG000
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.
OG001
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
OG002
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.
Secondary
Percentage of Subjects Requiring Esophageal Dilation
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.
Full Analysis Set Population
Posted
Count of Participants
Participants
baseline to Week 52
ID
Title
Description
OG000
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.
OG001
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
OG002
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.
OG003
Other Pre-specified
Number of Subjects Discontinuing Due to HPA Axis Suppression
Number of subjects discontinuing due to HPA axis suppression.
Note: There were no patients in the placebo group after Week 14.
Safety Analysis Population
Posted
Count of Participants
Participants
baseline to Week 52
ID
Title
Description
OG000
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.
OG001
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
OG002
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.
OG003
APT-1011 3 mg BID
Other Pre-specified
Number of Subjects With Oral and Esophageal Candidiasis
Frequency of oral and esophageal candidiasis.
Note: There were no patients in the placebo group after Week 14.
Safety Analysis Population
Posted
Count of Participants
Participants
baseline to Week 52
ID
Title
Description
OG000
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.
OG001
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
OG002
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.
OG003
APT-1011 3 mg BID
Other Pre-specified
Number of Subjects With Treatment-Emergent Adverse Events Leading to Study Discontinuation in Part 1
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) Leading to Study Discontinuation in Part 1.
Safety Analysis Population
Posted
Count of Participants
Participants
baseline to Week 12
ID
Title
Description
OG000
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.
OG001
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
OG002
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.
OG003
Other Pre-specified
Number of Subjects With Treatment-Emergent Adverse Events Leading to Study Discontinuation in Part 2
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) Leading to Study Discontinuation in Part 2.
Safety Analysis Population
Posted
Count of Participants
Participants
Week 12 to 52
ID
Title
Description
OG000
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.
OG001
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
OG002
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.
OG003
Other Pre-specified
Percentage of Subjects With Serum Cortisol Level ≤5 μg/dL or Abnormal Adrenocorticotropic Hormone (ACTH) Stimulation Test
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.
Safety Analysis Population
Posted
Count of Participants
Participants
Week 12 to 52
ID
Title
Description
OG000
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.
OG001
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
OG002
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.
Time Frame
to Week 14 (Part 1) to Week 52 (Part 2)
Description
Adverse events were collected and reported from the time of signature on the ICF to the last study visit. All SAEs were collected and reported from the ICF signature to 30 days after the last study procedure or study drug administration.
One subject randomized to placebo was erroneously dispensed APT-1011 1.5 mg BID therefore this subject is included in the APT-1011 1.5mg BID arm for safety reporting (FAS). This subject is included in the placebo arm for efficacy reporting (ITT).
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
APT-1011 1.5 mg HS Part 1
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.
0
21
0
21
13
21
EG001
APT-1011 1.5 mg BID Part 1
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
0
23
0
23
17
23
EG002
APT-1011 3 mg HS Part 1
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.
0
21
1
21
16
21
EG003
APT-1011 3 mg BID Part 1
APT-1011 3 mg after breakfast, APT-1011 3 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
0
20
0
20
17
20
EG004
Placebo BID Part 1
Placebo 30 minutes after breakfast and HS
Placebo: Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
0
20
0
20
13
20
EG005
Double-blind APT-1011 1.5 mg HS Part 2
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.
0
10
1
10
7
10
EG006
Double-blind APT-1011 1.5 mg BID Part 2
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
0
19
0
19
14
19
EG007
Double-blind APT-1011 3 mg HS Part 2
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.
0
14
1
14
13
14
EG008
Double-blind APT-1011 3 mg BID Part 2
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
0
16
0
16
12
16
EG009
Single-blind APT-1011 3mg BID Part 2
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
0
34
0
34
22
34
EG010
Total APT-1011 3 mg BID Part 2
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
0
50
0
50
34
50
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Hodgkin's disease
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG0030 affected20 at risk
EG004
Status epilepticus
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Ureterolithiasis
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0021 affected21 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Nasopharyngitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0003 affected21 at risk
EG0013 affected23 at risk
EG0022 affected21 at risk
EG0030 affected20 at risk
EG0042 affected20 at risk
EG0052 affected10 at risk
EG0061 affected19 at risk
EG0070 affected14 at risk
EG0085 affected16 at risk
EG0094 affected34 at risk
EG0109 affected50 at risk
Oeseophageal candidiasis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0012 affected23 at risk
EG0020 affected21 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0012 affected23 at risk
EG0021 affected21 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0011 affected23 at risk
EG0021 affected21 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0021 affected21 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0011 affected23 at risk
EG0021 affected21 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0001 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Influenza
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0011 affected23 at risk
EG0021 affected21 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0001 affected21 at risk
EG0010 affected23 at risk
EG0021 affected21 at risk
EG003
Vulvovaginal mycotic infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0001 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Oropharyngeal candidiasis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Acute sinusitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Bacterial vaginosis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0021 affected21 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0011 affected23 at risk
EG0020 affected21 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Conjunctivitis viral
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Ear infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Epididymitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Fungal infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Gastrointestinal viral infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Genital infection fungal
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Helicobacter infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0021 affected21 at risk
EG003
Impetigo
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Infectious mononucleosis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Kidney infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Oral infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Otitis media
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Tinea infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Viral infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected21 at risk
EG0011 affected23 at risk
EG0022 affected21 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0022 affected21 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0011 affected23 at risk
EG0021 affected21 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected21 at risk
EG0011 affected23 at risk
EG0020 affected21 at risk
EG003
Erosive oesophagitis
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0021 affected21 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0021 affected21 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0011 affected23 at risk
EG0020 affected21 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0022 affected21 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0011 affected23 at risk
EG0020 affected21 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Gastritis erosive
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Hiatus hernia
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Odynophagia
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0021 affected21 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Angular cheilitis
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Diarrhoea haemorrhagic
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Faeces pale
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Faeces soft
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Gastric mucosa erythema
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Gastric polyps
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Gastritis haemorrhagic
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Glossodynia
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0011 affected23 at risk
EG0020 affected21 at risk
EG003
Haemorrhoids thrombosed
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Oesophageal food impaction
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0011 affected23 at risk
EG0020 affected21 at risk
EG003
Oesophageal ulcer
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Paraesthesia oral
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0011 affected23 at risk
EG0020 affected21 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0002 affected21 at risk
EG0010 affected23 at risk
EG0021 affected21 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Joint effusion
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0011 affected23 at risk
EG0020 affected21 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0011 affected23 at risk
EG0020 affected21 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Tenosynovitis stenosans
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Cortisol decreased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0012 affected23 at risk
EG0021 affected21 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0001 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0001 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Blood glucose increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Protein urine present
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0011 affected23 at risk
EG0020 affected21 at risk
EG003
ACTH stimulation test abnormal
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0001 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Blood pressure increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Electrocardiogram QRS complex prolonged
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Heart rate increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Lymphocyte count increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Neutrophil percentage decreased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Weight increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Headache
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected21 at risk
EG0011 affected23 at risk
EG0021 affected21 at risk
EG003
Migraine
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Carpal tunnel syndrome
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Cervical radiculopathy
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0021 affected21 at risk
EG003
Syncope
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Taste disorder
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0002 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0002 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Hyperventilation
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Laryngeal inflammation
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Oropharyngeal spasm
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Pulmonary congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Tonsillolith
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Fatigue
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Chills
General disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Early satiety
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Face oedema
General disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Gait disturbance
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0021 affected21 at risk
EG003
Generalized oedema
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Influenza like illness
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Oedema peripheral
General disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Pain
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Peripheral swelling
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Pyrexia
General disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Temperature regulation disorder
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0021 affected21 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0001 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Back injury
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Concussion
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0011 affected23 at risk
EG0020 affected21 at risk
EG003
Corneal abrasion
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Eye injury
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Hand fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Muscle rupture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0021 affected21 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Tooth fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Wound
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Ingrowing nail
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0021 affected21 at risk
EG003
Cutaneous calcification
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Pityriasis rosea
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0011 affected23 at risk
EG0020 affected21 at risk
EG003
Pruritus allergic
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Rash vesicular
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Rosacea
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Prostatitis
Reproductive system and breast disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Benign prostatic hyperplasia
Reproductive system and breast disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Epididymal cyst
Reproductive system and breast disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Erectile dysfunction
Reproductive system and breast disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Genital rash
Reproductive system and breast disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Gynaecomastia
Reproductive system and breast disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Menstruation irregular
Reproductive system and breast disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Pelvic discomfort
Reproductive system and breast disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Peyronie's disease
Reproductive system and breast disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Depression
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Depressed mood
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Libido decreased
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Post-traumatic stress disorder
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0021 affected21 at risk
EG003
Stress
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Appetite disorder
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Glucose tolerance impaired
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Hypovitaminosis
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Hypertonic bladder
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0021 affected21 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Atrioventricular block first degree
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Bundle branch block right
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0021 affected21 at risk
EG003
Deafness bilateral
Ear and labyrinth disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Middle ear effusion
Ear and labyrinth disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Hypertension
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0011 affected23 at risk
EG0020 affected21 at risk
EG003
Adrenal suppression
Endocrine disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Cartilage neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Gilbert's syndrome
Congenital, familial and genetic disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Hepatic steatosis
Hepatobiliary disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected21 at risk
EG0010 affected23 at risk
EG0020 affected21 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
LTE60
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Not provided
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Director Clinical Operations and Medical Affairs
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
OG004
Non-Responder APT-1011, APT-1011 3mg BID (Part 2)
APT-1011 3 mg after breakfast, APT-1011 3 mg HS
All Non-responders at Week 12 received 3 mg BID Week 14 to Week 52
OG005
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
Units
Counts
Participants
OG00010
OG00119
OG00214
OG00316
OG00418
OG00516
Title
Denominators
Categories
Week 26 Responders
Title
Measurements
OG0007
OG00117
OG00211
OG00314
OG0047
OG00512
Week 52 Responders
Title
Measurements
OG0003
OG00116
OG0029
OG003
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
OG002
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.
OG003
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
OG004
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.
Units
Counts
Participants
OG00018
OG00120
OG00220
OG00319
OG00417
Title
Denominators
Categories
Week 12 Change From Baseline
ParticipantsOG00018
ParticipantsOG00120
ParticipantsOG00220
ParticipantsOG00319
ParticipantsOG00417
Title
Measurements
OG000-2.4± 2.04
OG001-2.7± 2.66
OG002-3.3± 2.36
OG003
Week 26 Change From Baseline
ParticipantsOG0008
ParticipantsOG00119
ParticipantsOG00213
ParticipantsOG00316
Week 52 Change From Baseline
ParticipantsOG0005
ParticipantsOG00117
ParticipantsOG00211
ParticipantsOG00314
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
Least-squares Mean differences, 90% confidence intervals and 1-sided p-values for comparisons of each APT-1011 dose group to Placebo at Week 12 are from an ANCOVA model
ANCOVA
0.020
Mean Difference (Final Values)
-1.28
2-Sided
90
-2.29
-0.26
Other
OG001
OG004
Least-squares Mean differences, 90% confidence intervals and 1-sided p-values for comparisons of each APT-1011 dose group to Placebo at Week 12 are from an ANCOVA model
ANCOVA
<0.001
Mean Difference (Final Values)
-2.08
2-Sided
90
-3.07
-1.10
Other
OG002
OG004
Least-squares Mean differences, 90% confidence intervals and 1-sided p-values for comparisons of each APT-1011 dose group to Placebo at Week 12 are from an ANCOVA model
ANCOVA
<0.001
Mean Difference (Final Values)
-2.25
2-Sided
90
-3.23
-1.26
Other
OG003
OG004
Least-squares Mean differences, 90% confidence intervals and 1-sided p-values for comparisons of each APT-1011 dose group to Placebo at Week 12 are from an ANCOVA model
ANCOVA
0.005
Mean Difference (Final Values)
-1.59
2-Sided
90
-2.59
-0.59
Other
OG003
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
OG004
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.
Units
Counts
Participants
OG00018
OG00120
OG00220
OG00319
OG00417
Title
Denominators
Categories
Week 12 : <1/HPF
ParticipantsOG00018
ParticipantsOG00120
ParticipantsOG00220
ParticipantsOG00319
ParticipantsOG00417
Title
Measurements
OG0007
OG00114
OG00212
OG003
Week 12 : <15/HPF
ParticipantsOG00018
ParticipantsOG00120
ParticipantsOG00220
ParticipantsOG00319
Week 26 : <1/HPF
ParticipantsOG0008
ParticipantsOG00119
ParticipantsOG00213
ParticipantsOG00316
Week 26 : <15/HPF
ParticipantsOG0008
ParticipantsOG00119
ParticipantsOG00213
ParticipantsOG00319
Week 52 : <1/HPF
ParticipantsOG0005
ParticipantsOG00117
ParticipantsOG00211
ParticipantsOG00314
Week 52 : <15/HPF
ParticipantsOG0005
ParticipantsOG00117
ParticipantsOG00211
ParticipantsOG00314
OG002
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.
OG003
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
OG004
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.
Units
Counts
Participants
OG00021
OG00121
OG00220
OG00320
OG00417
Title
Denominators
Categories
Week 4 Change from Baseline
ParticipantsOG00021
ParticipantsOG00120
ParticipantsOG00220
ParticipantsOG00320
ParticipantsOG00416
Title
Measurements
OG000-1.8± 2.64
OG001-1.3± 2.15
OG002-2.5± 3.12
OG003
Week 8 Change from Baseline
ParticipantsOG00018
ParticipantsOG00121
ParticipantsOG00219
ParticipantsOG00320
Week 12 Change from Baseline
ParticipantsOG00018
ParticipantsOG00121
ParticipantsOG00220
ParticipantsOG00319
Week 14 Change from Baseline
ParticipantsOG00010
ParticipantsOG00118
ParticipantsOG00213
ParticipantsOG00316
Week 18 Change from Baseline
ParticipantsOG0009
ParticipantsOG00119
ParticipantsOG00214
ParticipantsOG00315
Week 22 Change from Baseline
ParticipantsOG0008
ParticipantsOG00119
ParticipantsOG00214
ParticipantsOG00316
Week 26 Change from Baseline
ParticipantsOG0008
ParticipantsOG00118
ParticipantsOG00213
ParticipantsOG00316
Week 28 Change from Baseline
ParticipantsOG0007
ParticipantsOG00118
ParticipantsOG00210
ParticipantsOG00314
Week 36 Change from Baseline
ParticipantsOG0006
ParticipantsOG00116
ParticipantsOG00211
ParticipantsOG00314
Week 44 Change from Baseline
ParticipantsOG0005
ParticipantsOG00115
ParticipantsOG00211
ParticipantsOG00314
Week 52 Change from Baseline
ParticipantsOG0004
ParticipantsOG00114
ParticipantsOG00210
ParticipantsOG00314
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
Least-squares Mean differences, 90% confidence intervals and 1-sided p-values for comparison of each APT-1011 dose group to placebo at Week 12 are from an ANCOVA model.
ANCOVA
0.067
Mean Difference (Final Values)
-1.19
2-Sided
90
-2.49
0.12
Other
OG001
OG004
Least-squares Mean differences, 90% confidence intervals and 1-sided p-values for comparison of each APT-1011 dose group to placebo at Week 12 are from an ANCOVA model.
ANCOVA
0.672
Mean Difference (Final Values)
0.34
2-Sided
90
-0.91
1.59
Other
OG002
OG004
Least-squares Mean differences, 90% confidence intervals and 1-sided p-values for comparison of each APT-1011 dose group to placebo at Week 12 are from an ANCOVA model.
ANCOVA
0.048
Mean Difference (Final Values)
-1.28
2-Sided
90
-2.55
-0.01
Other
OG003
OG004
Least-squares Mean differences, 90% confidence intervals and 1-sided p-values for comparison of each APT-1011 dose group to placebo at Week 12 are from an ANCOVA model.
ANCOVA
0.653
Mean Difference (Final Values)
0.31
2-Sided
90
-0.98
1.59
Other
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.
OG003
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
OG004
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.
Units
Counts
Participants
OG00018
OG00121
OG00220
OG00319
OG00417
Title
Denominators
Categories
Week 12 Change from Baseline
ParticipantsOG00018
ParticipantsOG00121
ParticipantsOG00220
ParticipantsOG00319
ParticipantsOG00417
Title
Measurements
OG000-8.2± 5.48
OG001-4.4± 9.41
OG002-9.3± 7.37
OG003
Week 26 Change from Baseline
ParticipantsOG0008
ParticipantsOG00119
ParticipantsOG00213
ParticipantsOG00315
Week 52 Change from Baseline
ParticipantsOG0005
ParticipantsOG00116
ParticipantsOG00210
ParticipantsOG00314
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
OG002
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.
OG003
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
OG004
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.
Units
Counts
Participants
OG00018
OG00120
OG00220
OG00319
OG00417
Title
Denominators
Categories
EEsAI Total Score Week 12 Change from Baseline
ParticipantsOG00018
ParticipantsOG00120
ParticipantsOG00220
ParticipantsOG00319
ParticipantsOG00417
Title
Measurements
OG000-20.4± 15.90
OG001-15.6± 21.02
OG002-22.7± 16.60
OG003
EEsAI Total Score Week 26 Change from Baseline
ParticipantsOG0008
ParticipantsOG00119
ParticipantsOG00213
ParticipantsOG00316
EEsAI Total Score Week 52 Change from Baseline
ParticipantsOG0005
ParticipantsOG00117
ParticipantsOG00211
ParticipantsOG00314
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
EEsAI Total Score Change from Baseline Week 12
ANCOVA
0.079
Mean Difference (Final Values)
-8.81
2-Sided
90
-19.06
1.45
Superiority
OG001
OG004
EEsAI Total Score Change from Baseline Week 12
ANCOVA
0.195
Mean Difference (Final Values)
-5.18
2-Sided
90
-15.14
4.78
Superiority
OG002
OG004
EEsAI Total Score Change from Baseline Week 12
ANCOVA
0.020
Mean Difference (Final Values)
-12.56
2-Sided
90
-22.55
-2.58
Superiority
OG003
OG004
EEsAI Total Score Change from Baseline Week 12
ANCOVA
0.043
Mean Difference (Final Values)
-10.61
2-Sided
90
-20.74
-0.48
Superiority
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
OG002
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.
OG003
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
OG004
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.
Units
Counts
Participants
OG00018
OG00120
OG00220
OG00319
OG00417
Title
Denominators
Categories
VDQ Score Week 12 Change from Baseline
ParticipantsOG00018
ParticipantsOG00119
ParticipantsOG00220
ParticipantsOG00319
ParticipantsOG00417
Title
Measurements
OG000-3.9± 6.53
OG001-2.5± 3.24
OG002-5.0± 6.00
OG003
VDQ Score Week 26 Change from Baseline
ParticipantsOG0008
ParticipantsOG00118
ParticipantsOG00213
ParticipantsOG00316
VDQ Score Week 52 Change from Baseline
ParticipantsOG0005
ParticipantsOG00116
ParticipantsOG00211
ParticipantsOG00314
AMS Score Week 12 Change from Baseline
ParticipantsOG00018
ParticipantsOG00120
ParticipantsOG00220
ParticipantsOG00319
AMS Score Week 26 Change from Baseline
ParticipantsOG0008
ParticipantsOG00119
ParticipantsOG00213
ParticipantsOG00315
AMS Score Week 52 Change from Baseline
ParticipantsOG0005
ParticipantsOG00117
ParticipantsOG00211
ParticipantsOG00313
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
VDQ Score Change from Baseline Week 12
ANCOVA
0.459
Mean Difference (Final Values)
-0.21
2-Sided
90
-3.49
3.08
Superiority
OG001
OG004
VDQ Score Change from Baseline Week 12
ANCOVA
0.617
Mean Difference (Final Values)
0.58
2-Sided
90
-2.65
3.80
Superiority
OG002
OG004
VDQ Score Change from Baseline Week 12
ANCOVA
0.167
Mean Difference (Final Values)
-1.87
2-Sided
90
-5.07
1.33
Superiority
OG003
OG004
VDQ Score Change from Baseline Week 12
ANCOVA
0.373
Mean Difference (Final Values)
-0.63
2-Sided
90
-3.88
2.61
Superiority
OG000
OG004
AMS Score Change from Baseline Week 12
ANCOVA
0.203
Mean Difference (Final Values)
-1.66
2-Sided
90
-4.96
1.64
Superiority
OG001
OG004
AMS Score Change from Baseline Week 12
ANCOVA
0.014
Mean Difference (Final Values)
-4.33
2-Sided
90
-7.54
-1.13
Superiority
OG002
OG004
AMS Score Change from Baseline Week 12
ANCOVA
0.061
Mean Difference (Final Values)
-3.02
2-Sided
90
-6.23
0.20
Superiority
OG003
OG004
AMS Score Change from Baseline Week 12
ANCOVA
0.097
Mean Difference (Final Values)
-2.57
2-Sided
90
-5.83
0.69
Superiority
OG002
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.
OG003
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
OG004
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.
Units
Counts
Participants
OG00018
OG00120
OG00220
OG00319
OG00417
Title
Denominators
Categories
Week 12 EEsAI Total Score <20
ParticipantsOG00018
ParticipantsOG00120
ParticipantsOG00220
ParticipantsOG00319
ParticipantsOG00417
Title
Measurements
OG0004
OG0011
OG0026
OG003
Week 26 EEsAI Total Score <20
ParticipantsOG0008
ParticipantsOG00119
ParticipantsOG00213
ParticipantsOG00316
Week 52 EEsAI Total Score <20
ParticipantsOG0005
ParticipantsOG00117
ParticipantsOG00211
ParticipantsOG00314
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.
OG003
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
OG004
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.
Units
Counts
Participants
OG00020
OG00121
OG00220
OG00319
OG00417
Title
Denominators
Categories
Week 4
ParticipantsOG00020
ParticipantsOG00119
ParticipantsOG00220
ParticipantsOG00319
ParticipantsOG00415
Title
Measurements
Mild to None
OG0001
OG0010
OG0020
OG003
Week 8
ParticipantsOG00017
ParticipantsOG00121
ParticipantsOG00219
ParticipantsOG00319
Week 12
ParticipantsOG00018
ParticipantsOG00120
ParticipantsOG00220
ParticipantsOG00318
Week 14
ParticipantsOG00010
ParticipantsOG00118
ParticipantsOG00213
ParticipantsOG00315
Week 18
ParticipantsOG0009
ParticipantsOG00118
ParticipantsOG00214
ParticipantsOG00314
Week 22
ParticipantsOG0008
ParticipantsOG00118
ParticipantsOG00213
ParticipantsOG00316
Week 26
ParticipantsOG0008
ParticipantsOG00117
ParticipantsOG00213
ParticipantsOG00316
Week 28
ParticipantsOG0007
ParticipantsOG00116
ParticipantsOG00210
ParticipantsOG00314
Week 36
ParticipantsOG0006
ParticipantsOG00115
ParticipantsOG00211
ParticipantsOG00314
Week 44
ParticipantsOG0005
ParticipantsOG00115
ParticipantsOG00210
ParticipantsOG00314
Week 52
ParticipantsOG0004
ParticipantsOG00114
ParticipantsOG00210
ParticipantsOG00314
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.
OG003
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
OG004
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.
Units
Counts
Participants
OG00020
OG00121
OG00220
OG00319
OG00417
Title
Denominators
Categories
Week 4
ParticipantsOG00020
ParticipantsOG00119
ParticipantsOG00220
ParticipantsOG00319
ParticipantsOG00415
Title
Measurements
Mild to None
OG0002
OG0010
OG0020
OG003
Week 8
ParticipantsOG00017
ParticipantsOG00121
ParticipantsOG00219
ParticipantsOG00319
Week 12
ParticipantsOG00018
ParticipantsOG00120
ParticipantsOG00220
ParticipantsOG00318
Week 14
ParticipantsOG00010
ParticipantsOG00118
ParticipantsOG00213
ParticipantsOG00315
Week 18
ParticipantsOG0009
ParticipantsOG00118
ParticipantsOG00214
ParticipantsOG00314
Week 22
ParticipantsOG0008
ParticipantsOG00118
ParticipantsOG00213
ParticipantsOG00316
Week 26
ParticipantsOG0008
ParticipantsOG00117
ParticipantsOG00213
ParticipantsOG00316
Week 28
ParticipantsOG0007
ParticipantsOG00116
ParticipantsOG00210
ParticipantsOG00314
Week 36
ParticipantsOG0006
ParticipantsOG00115
ParticipantsOG00211
ParticipantsOG00314
Week 44
ParticipantsOG0005
ParticipantsOG00115
ParticipantsOG00210
ParticipantsOG00314
Week 52
ParticipantsOG0004
ParticipantsOG00114
ParticipantsOG00210
ParticipantsOG00314
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.
OG003
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
OG004
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.
Units
Counts
Participants
OG00021
OG00122
OG00220
OG00320
OG00417
Title
Denominators
Categories
Week 4
ParticipantsOG00021
ParticipantsOG00120
ParticipantsOG00220
ParticipantsOG00320
ParticipantsOG00416
Title
Measurements
Much Worse
OG0000
OG0010
OG0020
OG003
Week 8
ParticipantsOG00017
ParticipantsOG00122
ParticipantsOG00219
ParticipantsOG00320
Week 12
ParticipantsOG00018
ParticipantsOG00122
ParticipantsOG00220
ParticipantsOG00319
Week 14
ParticipantsOG00010
ParticipantsOG00118
ParticipantsOG00213
ParticipantsOG00315
Week 18
ParticipantsOG0009
ParticipantsOG00118
ParticipantsOG00214
ParticipantsOG00314
Week 22
ParticipantsOG0008
ParticipantsOG00118
ParticipantsOG00214
ParticipantsOG00316
Week 26
ParticipantsOG0008
ParticipantsOG00118
ParticipantsOG00213
ParticipantsOG00316
Week 28
ParticipantsOG0007
ParticipantsOG00117
ParticipantsOG00210
ParticipantsOG00314
Week 36
ParticipantsOG0006
ParticipantsOG00116
ParticipantsOG00211
ParticipantsOG00314
Week 44
ParticipantsOG0005
ParticipantsOG00115
ParticipantsOG00211
ParticipantsOG00314
Week 52
ParticipantsOG0004
ParticipantsOG00114
ParticipantsOG00210
ParticipantsOG00314
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.
OG003
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
OG004
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.
Units
Counts
Participants
OG00021
OG00122
OG00220
OG00320
OG00417
Title
Denominators
Categories
Week 4
ParticipantsOG00021
ParticipantsOG00120
ParticipantsOG00220
ParticipantsOG00320
ParticipantsOG00416
Title
Measurements
Much Worse
OG0000
OG0010
OG0020
OG003
Week 8
ParticipantsOG00017
ParticipantsOG00122
ParticipantsOG00219
ParticipantsOG00320
Week 12
ParticipantsOG00018
ParticipantsOG00122
ParticipantsOG00220
ParticipantsOG00319
Week 14
ParticipantsOG00010
ParticipantsOG00118
ParticipantsOG00213
ParticipantsOG00315
Week 18
ParticipantsOG0009
ParticipantsOG00118
ParticipantsOG00214
ParticipantsOG00314
Week 22
ParticipantsOG0008
ParticipantsOG00118
ParticipantsOG00214
ParticipantsOG00316
Week 26
ParticipantsOG0008
ParticipantsOG00118
ParticipantsOG00213
ParticipantsOG00316
Week 28
ParticipantsOG0007
ParticipantsOG00117
ParticipantsOG00210
ParticipantsOG00314
Week 36
ParticipantsOG0006
ParticipantsOG00116
ParticipantsOG00211
ParticipantsOG00314
Week 44
ParticipantsOG0005
ParticipantsOG00115
ParticipantsOG00211
ParticipantsOG00314
Week 52
ParticipantsOG0004
ParticipantsOG00114
ParticipantsOG00210
ParticipantsOG00314
OG003
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
OG004
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.
Units
Counts
Participants
OG00021
OG00122
OG00221
OG00320
OG00419
Title
Denominators
Categories
Week 12
Title
Measurements
OG00011
OG0012
OG0027
OG0034
OG00419
Week 26
Title
Measurements
OG00011
OG0015
OG0027
OG003
Week 52
Title
Measurements
OG00016
OG0016
OG00210
OG003
OG003
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
OG004
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.
Units
Counts
Participants
OG00021
OG00122
OG00221
OG00320
OG00419
Title
Denominators
Categories
Before Week 14
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
Between Week 14 and Week 28
Title
Measurements
OG0000
OG0010
OG0020
OG003
Between Week 28 and Week 52
Title
Measurements
OG0000
OG0010
OG0020
OG003
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
OG004
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.
Units
Counts
Participants
OG00021
OG00122
OG00221
OG00320
OG00419
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
APT-1011 3 mg after breakfast, APT-1011 3 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
OG004
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.
Units
Counts
Participants
OG00021
OG00123
OG00221
OG00320
OG00419
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
APT-1011 3 mg after breakfast, APT-1011 3 mg HS
APT-1011: APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
OG004
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.
OG005
Single-blind 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
OG006
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
Units
Counts
Participants
OG00021
OG00123
OG00221
OG00320
OG00419
OG00534
OG00651
Title
Denominators
Categories
Oesophageal candidiasis
Title
Measurements
OG0000
OG0012
OG0020
OG0038
OG0040
OG0051
OG0069
Oral candidiasis
Title
Measurements
OG0000
OG0013
OG0021
OG003
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
OG004
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.
OG005
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
Units
Counts
Participants
OG00021
OG00123
OG00221
OG00320
OG00420
OG00585
Title
Denominators
Categories
Title
Measurements
OG0000
OG0012
OG0020
OG0031
OG0042
OG0053
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
OG004
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.
OG005
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
OG006
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
Units
Counts
Participants
OG00010
OG00119
OG00214
OG00316
OG0040
OG00534
OG00650
Title
Denominators
Categories
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0050
OG0060
OG003
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
OG004
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.
Units
Counts
Participants
OG0009
OG00119
OG00214
OG00316
OG0040
Title
Denominators
Categories
Serum cortisol level <=5 ug/dL (<=138 mmol/L)
ParticipantsOG0009
ParticipantsOG00119
ParticipantsOG00214
ParticipantsOG00316
ParticipantsOG0040
Title
Measurements
OG0004
OG0011
OG0024
OG003
Abnormal ACTH stimulation test result serum cortisol level <16ug/Dl (<=440 nmol/L)