Dose-finding Study to Assess the Efficacy, Safety and Tol... | NCT02712983 | Trialant
NCT02712983
Sponsor
Novartis Pharmaceuticals
Status
Completed
Last Update Posted
Aug 25, 2020Actual
Enrollment
107Actual
Phase
Phase 2
Conditions
Non-cystic Fibrosis Bronchiectasis
Interventions
TIP
TIP and placebo
Placebo
Countries
Belgium
France
Germany
Italy
Spain
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT02712983
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CTBM100G2202
Secondary IDs
ID
Type
Description
Link
2015-003040-39
EudraCT Number
Brief Title
Dose-finding Study to Assess the Efficacy, Safety and Tolerability of Tobramycin Inhalation Powder in Patients With Non-Cystic Fibrosis Bronchiectasis and Pulmonary P. Aeruginosa Infection
Official Title
A Randomized, Blinded, Parallel Group, Multi-center Dose-finding Study, to Assess the Efficacy, Safety and Tolerability of Different Doses of Tobramycin Inhalation Powder in Patients With Non-Cystic Fibrosis Bronchiectasis and Pulmonary P. Aeruginosa Infection
Acronym
iBEST-1
Organization
NovartisINDUSTRY
Status Module
Record Verification Date
Aug 2020
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
Feb 8, 2017Actual
Primary Completion Date
Mar 20, 2019Actual
Completion Date
Mar 20, 2019Actual
First Submitted Date
Feb 5, 2016
First Submission Date that Met QC Criteria
Mar 14, 2016
First Posted Date
Mar 18, 2016Estimated
Results Waived
Not provided
Results First Submitted Date
Mar 17, 2020
Results First Submitted that Met QC Criteria
Aug 13, 2020
Results First Posted Date
Aug 14, 2020Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Aug 24, 2020
Last Update Posted Date
Aug 25, 2020Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Novartis PharmaceuticalsINDUSTRY
Collaborators
Name
Class
Queen's University, Belfast
OTHER
University Hospital, Antwerp
OTHER
University of Milan
OTHER
Fundacion Clinic per a la Recerca Biomédica
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
No
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
The purpose of this study was to support the selection of a safe and tolerable tobramycin inhalation powder (TIP) dose, and regimen that exhibits effective bacterial reduction of P. aeruginosa in non-cystic fibrosis bronchiectasis (BE) patients with P. aeruginosa colonization.
Detailed Description
This was a blinded, randomized, dose and regimen finding trial utilizing a three treatment cohort design where active TIP and TIP/Placebo cyclical (3 capsules o.d [Cohort A], 5 capsules o.d. [Cohort B] or 4 capsules b.i.d. [Cohort C]) versus Placebo were administered for a total of 112 days.
Novartis decided to close the recruitment of new subjects into this study earlier than scheduled. Subjects who had a signed informed consent form and entered screening by 10-Sep-2018 still participated in the study. The latest possible randomization was on 08-Oct-2018. All subjects enrolled in the study (107 enrolled subjects out of 180 planned) continued as planned through to their last scheduled visit. The early recruitment halt of the study was not due to safety or lack of efficacy.
Conditions Module
Conditions
Non-cystic Fibrosis Bronchiectasis
Keywords
Inhaled tobramycin
tobramycin inhalation powder
bronchiectasis
pulmonary Pseudomonas aeruginosa infection
dose-finding study
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
107Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Cohort A (3 capsules o.d.): TIP
Experimental
Cohort A (3 capsules o.d.): Tobramycin inhalation powder (TIP)
Drug: TIP
Cohort A (3 capsules o.d.): TIP/PBO
Experimental
Cohort A (3 capsules o.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
Drug: TIP and placebo
Cohort A (3 capsules o.d.): PBO
Placebo Comparator
Cohort A (3 capsules o.d.): Inhaled placebo (PBO)
Drug: Placebo
Cohort B (5 capsules o.d.): TIP
Experimental
Cohort B (5 capsules o.d.): Tobramycin inhalation powder (TIP)
Drug: TIP
Cohort B (5 capsules o.d.): TIP/PBO
Experimental
Cohort B (5 capsules o.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
Drug: TIP and placebo
Cohort B (5 capsules o.d.): PBO
Placebo Comparator
Interventions
Name
Type
Description
Arm Group Labels
Other Names
TIP
Drug
TIP dose regimen
Cohort A (3 capsules o.d.): TIP
Cohort B (5 capsules o.d.): TIP
Cohort C (4 capsules b.i.d.): TIP
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Change From Baseline to Day 29 in Pseudomonas Aeruginosa (P. Aeruginosa) Density in Sputum (log10 CFUs)
Microbiological data was collected to understand the direct impact of the drug on the pathogens. Sputum samples were cultured for the presence of three Pseudomonas aeruginosa (P. aeruginosa) biotypes measured were mucoid, dry and small colony variant. Change was determined using the formula = (Post-baseline value - baseline value). If no P. aeruginosa was isolated for a visit, log10 colony forming units (CFU) was imputed with log10 (19) for all biotypes. Only values for all morphotypes presented.
Change From Baseline to Each Post-baseline Visit in Pseudomonas Aeruginosa (P. Aeruginosa) Density in Sputum (log10 CFUs)
Microbiological data was collected to understand the direct impact of the drug on the pathogens. Sputum samples were cultured for the presence of three Pseudomonas aeruginosa (P. aeruginosa) biotypes measured were mucoid, dry and small colony variant. Change was determined using the formula = (Post-baseline value - baseline value). If no P. aeruginosa was isolated for a visit, log10 colony forming units (CFU) was imputed with log10 (19) for all biotypes. Only values for all morphotypes are presented.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Key Inclusion Criteria:
Written informed consent must be obtained before any assessment is performed.
Male and female patients of ≥ 18 years of age at screening (Visit 1).
Proven diagnosis of non-CF BE as documented by computed tomography or high-resolution computed tomography
At least 2 or more exacerbations treated with oral antibiotics OR 1 or more exacerbation requiring intravenous antibiotic treatment within 12 months prior to screening.
FEV1 ≥ 30% predicted at screening (Visit 1).
P. aeruginosa, must be documented in a respiratory sample at least 1 time within 12 months and also present in the expectorated sputum culture at Visit 1.
Key Exclusion Criteria:
Patients with a history of cystic fibrosis.
Patients with a primary diagnosis of bronchial asthma.
Patients with a primary diagnosis of COPD associated with at least a 20 pack year smoking history.
Any significant medical condition that is either recently diagnosed or was not stable during the last 3 months, other than pulmonary exacerbations, and that in the opinion of the investigator makes participation in the trial against the patients' best interests.
Clinically significant (in the opinion of the investigator) hearing loss that interferes with patients' daily activities (such as normal conversations) or chronic tinnitus. Patients with a past history of clinically significant hearing loss in the opinion of the investigator may be eligible only if their hearing threshold at screening audiometry is 25dB or lower at frequencies 0.5-4 kHz. The use of a hearing device is reflective of a clinically significant hearing loss; hence patients using hearing aids at screening are not eligible.
Patients with active pulmonary tuberculosis.
Patients currently receiving treatment for nontuberculous mycobacterial (NTM) pulmonary disease.
Patients who are regularly receiving inhaled anti-pseudomonal antibiotic (during the study inhaled anti-pseudomonal antibiotics are not allowed other than the study drug).
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This study planned to recruit approximately 180 subjects to one of the 3 cohorts in a ratio of 1:1:1. The subjects within each cohort were randomized to blinded TIP or placebo with the following randomization scheme: TIP:TIP/Placebo cyclical:Placebo, in a 2:2:1 ratio.
Recruitment Details
A total of 107 subjects were enrolled in the trial from 6 countries (Belgium [2 sites], France [4 sites], Germany [5 sites], Italy [6 sites], Spain [8 sites] and United Kingdom [9 sites]).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Cohort A (3 Capsules o.d.): TIP
Cohort A (3 capsules o.d.): Tobramycin inhalation powder (TIP)
FG001
Cohort A (3 Capsules o.d.): TIP/PBO
Cohort A (3 capsules o.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
Periods
Title
Milestones
Reasons Not Completed
Treatment Phase
Type
Comment
Milestone Data
STARTED
All randomized patients (Full Analysis Set and Safety Set)
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Jun 21, 2018
Mar 17, 2020
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Netherlands
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
OTHER
Erasmus Medical Center
OTHER
Papworth Hospital NHS Foundation Trust
OTHER_GOV
Royal Brompton & Harefield NHS Foundation Trust
OTHER
University of Dundee
OTHER
University of Edinburgh
OTHER
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Cohort B (5 capsules o.d.): inhaled placebo (PBO)
Drug: Placebo
Cohort C (4 capsules b.i.d.): TIP
Experimental
Cohort C (4 capsules b.i.d.): Tobramycin inhalation powder (TIP)
Drug: TIP
Cohort C (4 capsules b.i.d.): TIP/PBO
Experimental
Cohort C (4 capsules b.i.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
Drug: TIP and placebo
Cohort C (4 capsules b.i.d.): PBO
Placebo Comparator
Cohort C (4 capsules b.i.d.): inhaled placebo (PBO)
Time to First Onset of Pulmonary Exacerbation by Exacerbation Category
The time to first onset of pulmonary exacerbation compared to placebo was analyzed. Participants with pulmonary exacerbation were categorized as: a) Overall, b) Category 1 (Oral): treated with oral antibiotics only and c) Category 2 (Parenteral): treated with parenteral Antibiotics and/or requiring hospitalization. Participants were censored at the time of completion of study or early discontinuation if they did not have a pulmonary exacerbation during the study period.
Baseline (Visit 101/Day 1) to Visit 202 (Day 169)
Duration of Pulmonary Exacerbation by Exacerbation Category
The duration of pulmonary exacerbation compared to placebo was analyzed. Participants with pulmonary exacerbation were categorized as: a) Overall, b) Category 1 (Oral): treated with oral antibiotics only and c) Category 2 (Parenteral): treated with parenteral Antibiotics and/or requiring hospitalization.
Baseline (Visit 101/Day 1) to Visit 202 (Day 169)
Exposure Adjusted Rate of Pulmonary Exacerbations (PE) Over the Entire Study Period
The exposure adjusted rate of pulmonary exacerbation compared to placebo was analyzed. Participants with pulmonary exacerbation were categorized as: a) Overall, b) Category 1 (Oral): treated with oral antibiotics only and c) Category 2 (Parenteral): treated with parenteral Antibiotics and/or requiring hospitalization. The Exposure adjusted rate = (Number of pulmonary exacerbations reported during the study period) / (sum of study duration in days for all participants/ 365.25). Only descriptive analysis performed.
Baseline (Visit 101/Day 1) to Visit 202 (Day 169)
Percentage of Participants With at Least One Pulmonary Exacerbation by Exacerbation Category
Pulmonary exacerbations are defined as events requiring antibiotic therapy AND for which at least 3 of the following 6 symptoms, signs, or findings were present outside of normal variation: 1. Increased sputum volume, or change in viscosity/consistency or purulence for more than 24 hours; 2. Increased shortness of breath at rest or on exercise for more than 24 hours; 3. Increased cough for more than 24 hours; 4. Fever of ≥38° Celsius within the last 24 hours; 5. Increased malaise/fatigue/lethargy for more than 24 hours; 6. A reduction in forced expiratory volume in the first second of expiration (FEV1) or forced vital capacity (FVC) of least 10% from screening.
Participants were categorized as: a) Overall, b) Category 1: treated with oral antibiotics only and c) Category 2: treated with parenteral Antibiotics and/or requiring hospitalization.
Only descriptive analysis performed.
Baseline (Visit 101/Day 1) to Visit 202 (Day 169)
Percentage of Participants Who Permanently Discontinued Study Drug Due to Pulmonary Exacerbation
The percentage of participants who permanently discontinued study drug due to pulmonary exacerbation compared to placebo was analyzed.
Baseline (Visit 101/Day 1) to Visit 202 (Day 169)
Time to Permanent Study Drug Discontinuation Due to Pulmonary Exacerbation
The time to permanent study drug discontinuation due to Pulmonary exacerbation. Participants were censored at the time of last contact if they did not permanently discontinue study drug due to pulmonary exacerbation requiring during the study period. Only descriptive analysis performed.
Baseline (Visit 101/Day 1) to Visit 202 (Day 169)
Time to First Use (Overall, Oral, and Parenteral) of Anti-pseudomonal Antibiotics Usage
The time to first use of anti-pseudomonal antibiotics administered compared to placebo was analyzed. Participants were censored at the time of last contact if they did not have anti-pseudomonal antibiotics over the entire study period.
From Baseline (Visit 101/Day 1) up to approximately Day 173
Percentage of Participants Requiring Anti-pseudomonal Antibiotics
The percentage of participants requiring anti-pseudomonal antibiotics compared to placebo was analyzed. Only descriptive analysis performed.
Baseline (Visit 101/Day 1) to Visit 202 (Day 169)
Duration of Anti-pseudomonal Antibiotics Usage
The total number of days of new anti-pseudomonal antibiotic use compared to placebo was analyzed. Only descriptive analysis
Baseline (Visit 101/Day 1) to Visit 202 (Day 169)
Percentage of Participants Requiring Hospitalization Due to Serious Respiratory-related Adverse Events
The percentage of participants requiring hospitalization due to serious respiratory-related adverse events (other than those regularly scheduled hospitalization that were planned prior to study start) was analyzed to define severity of pulmonary exacerbations compared to placebo. Only descriptive analysis performed.
Baseline (Visit 101/Day 1) to Visit 202 (Day 169)
Duration of Hospitalization Due to Serious Respiratory-related Adverse Events
The duration of hospitalization due to serious respiratory-related adverse events (other than those regularly scheduled hospitalization that were planned prior to study start) was analyzed to define severity of pulmonary exacerbations compared to placebo. Only descriptive analysis performed.
Baseline (Visit 101/Day 1) to Visit 202 (Day 169)
Number of Hospitalization Due to Serious Respiratory-related Adverse Events
The number of hospitalization due to serious respiratory-related AEs was analyzed to define severity of pulmonary exacerbations compared to placebo. Respiratory related adverse events were identified using the AEs captured under system organ class 'Respiratory, thoracic and mediastinal disorders' and 'Infections and infestations'.
Baseline (Visit 101/Day 1) to Visit 202 (Day 169)
Time to First Hospitalization Due to Serious Respiratory-related Adverse Events
Time to first hospitalization due to serious respiratory-related AEs was analyzed to define severity of pulmonary exacerbations compared to placebo. Participants were censored at the time of last contact if they did not have a hospitalization due to serious respiratory-related adverse events over the entire study period.
Baseline (Visit 101/Day 1) to Visit 202 (Day 169)
Serum Tobramycin Concentration
The serum pharmacokinetic (PK) properties of tobramycin were assessed by evaluating tobramycin concentrations in serum collected from the non-cystic fibrosis bronchiectasis population post administration of o.d. or b.i.d. doses of TIP. Serum specimens for PK tobramycin concentration were assessed at Visit 101 (Day 1/start of treatment) 0 to 1 and 1 to 2 hours post-dose and Visit 102 (Day 8) 0 to 1 and 1 to 2 hours post-dose. Prior to protocol amendment #2, PK samples were assessed on Visits 103 (Day 29) rather than Visit 102. Only descriptive analysis performed.
Baseline (Visit 101/Day 1), Visit 102 (Day 8) and Visits 103 (Day 29): 0-1 hours and 1-2 hours post-dose.
Sputum Tobramycin Concentration
The sputum pharmacokinetic (PK) properties of tobramycin were assessed by evaluating tobramycin concentrations in sputum collected from the non-cystic fibrosis bronchiectasis population post administration of o.d. or b.i.d. doses of TIP. Only descriptive analysis performed.
Baseline (Visit 101/Day 1): 0-1 hours and 1-2 hours post-dose; Visit 102 (Day 8):0-2 hours and 5-6 hours post-dose; Visits 103 (Day 29): 5 to 6 hours post-dose, Visit 104 (Day 57) and Visit 105 (Day 85): 3-4 hours post-dose.
Change From Baseline in Quality of Life Questionnaire for Bronchiectasis (QOL-B)-Physical Functioning
The QoL-B consists of 37 items across 8 domains: Physical Functioning (PF), Role Functioning (RF), Vitality, Emotional Function (EF), Social Functioning (SF), Treatment Burden (TB), Health Perception (HP) and Respiratory Symptoms (RS). Each of the 37 items is scored from 1 to 4, and each of the 8 scale scores is standardized on a 0-100 point scale, with higher scores representing fewer symptoms or better functioning and HRQoL. A total score is not calculated since functioning can vary greatly from one domain to another. Only descriptive analysis performed.
Baseline, Visit 102 (Day 8), Visit 103 (Day 29), End of Treatment (Day 113) and Visit 202 (Day 169)
Change From Baseline in Quality of Life Questionnaire for Bronchiectasis (QOL-B)-Role Functioning
The QoL-B consists of 37 items across 8 domains: Physical Functioning (PF), Role Functioning (RF), Vitality, Emotional Function (EF), Social Functioning (SF), Treatment Burden (TB), Health Perception (HP) and Respiratory Symptoms (RS). Each of the 37 items is scored from 1 to 4, and each of the 8 scale scores is standardized on a 0-100 point scale, with higher scores representing fewer symptoms or better functioning and HRQoL. A total score is not calculated since functioning can vary greatly from one domain to another. Only descriptive analysis performed.
Baseline, Visit 102 (Day 8), Visit 103 (Day 29), End of Treatment (Day 113) and Visit 202 (Day 169)
Change From Baseline in Quality of Life Questionnaire for Bronchiectasis (QOL-B)-Vitality
The QoL-B consists of 37 items across 8 domains: Physical Functioning (PF), Role Functioning (RF), Vitality, Emotional Function (EF), Social Functioning (SF), Treatment Burden (TB), Health Perception (HP) and Respiratory Symptoms (RS). Each of the 37 items is scored from 1 to 4, and each of the 8 scale scores is standardized on a 0-100 point scale, with higher scores representing fewer symptoms or better functioning and HRQoL. A total score is not calculated since functioning can vary greatly from one domain to another. Only descriptive analysis performed.
Baseline, Visit 102 (Day 8), Visit 103 (Day 29), End of Treatment (Day 113) and Visit 202 (Day 169)
Change From Baseline in Quality of Life Questionnaire for Bronchiectasis (QOL-B)-Emotional Functioning
The QoL-B consists of 37 items across 8 domains: Physical Functioning (PF), Role Functioning (RF), Vitality, Emotional Function (EF), Social Functioning (SF), Treatment Burden (TB), Health Perception (HP) and Respiratory Symptoms (RS). Each of the 37 items is scored from 1 to 4, and each of the 8 scale scores is standardized on a 0-100 point scale, with higher scores representing fewer symptoms or better functioning and HRQoL. A total score is not calculated since functioning can vary greatly from one domain to another. Only descriptive analysis performed.
Baseline, Visit 102 (Day 8), Visit 103 (Day 29), End of Treatment (Day 113) and Visit 202 (Day 169)
Change From Baseline in Quality of Life Questionnaire for Bronchiectasis (QOL-B)-Social Functioning
The QoL-B consists of 37 items across 8 domains: Physical Functioning (PF), Role Functioning (RF), Vitality, Emotional Function (EF), Social Functioning (SF), Treatment Burden (TB), Health Perception (HP) and Respiratory Symptoms (RS). Each of the 37 items is scored from 1 to 4, and each of the 8 scale scores is standardized on a 0-100 point scale, with higher scores representing fewer symptoms or better functioning and HRQoL. A total score is not calculated since functioning can vary greatly from one domain to another. Only descriptive analysis performed.
Baseline, Visit 102 (Day 8), Visit 103 (Day 29), End of Treatment (Day 113) and Visit 202 (Day 169)
Change From Baseline in Quality of Life Questionnaire for Bronchiectasis (QOL-B)-Treatment Burden
The QoL-B consists of 37 items across 8 domains: Physical Functioning (PF), Role Functioning (RF), Vitality, Emotional Function (EF), Social Functioning (SF), Treatment Burden (TB), Health Perception (HP) and Respiratory Symptoms (RS). Each of the 37 items is scored from 1 to 4, and each of the 8 scale scores is standardized on a 0-100 point scale, with higher scores representing fewer symptoms or better functioning and HRQoL. A total score is not calculated since functioning can vary greatly from one domain to another. Only descriptive analysis performed.
Baseline, Visit 102 (Day 8), Visit 103 (Day 29), End of Treatment (Day 113) and Visit 202 (Day 169)
Change From Baseline in Quality of Life Questionnaire for Bronchiectasis (QOL-B)-Health Perceptions
The QoL-B consists of 37 items across 8 domains: Physical Functioning (PF), Role Functioning (RF), Vitality, Emotional Function (EF), Social Functioning (SF), Treatment Burden (TB), Health Perception (HP) and Respiratory Symptoms (RS). Each of the 37 items is scored from 1 to 4, and each of the 8 scale scores is standardized on a 0-100 point scale, with higher scores representing fewer symptoms or better functioning and HRQoL. A total score is not calculated since functioning can vary greatly from one domain to another. Only descriptive analysis performed.
Baseline, Visit 102 (Day 8), Visit 103 (Day 29), End of Treatment (Day 113) and Visit 202 (Day 169)
Change From Baseline in Quality of Life Questionnaire for Bronchiectasis (QOL-B)-Respiratory Symptoms
The QoL-B consists of 37 items across 8 domains: Physical Functioning (PF), Role Functioning (RF), Vitality, Emotional Function (EF), Social Functioning (SF), Treatment Burden (TB), Health Perception (HP) and Respiratory Symptoms (RS). Each of the 37 items is scored from 1 to 4, and each of the 8 scale scores is standardized on a 0-100 point scale, with higher scores representing fewer symptoms or better functioning and HRQoL. A total score is not calculated since functioning can vary greatly from one domain to another. Only descriptive analysis performed.
Baseline, Visit 102 (Day 8), Visit 103 (Day 29), End of Treatment (Day 113) and Visit 202 (Day 169)
Leuven
3000
Belgium
Novartis Investigative Site
Nice
Cedex1
06001
France
Novartis Investigative Site
Montpellier
Herault
34059
France
Novartis Investigative Site
Grenoble
38043
France
Novartis Investigative Site
Toulouse
31059
France
Novartis Investigative Site
Essen
North Rhine-Westphalia
45239
Germany
Novartis Investigative Site
Berlin
14059
Germany
Novartis Investigative Site
Frankfurt
60596
Germany
Novartis Investigative Site
Hanover
30625
Germany
Novartis Investigative Site
Leipzig
04357
Germany
Novartis Investigative Site
Monza
MB
20900
Italy
Novartis Investigative Site
Pisa
PI
56124
Italy
Novartis Investigative Site
Pordenone
PN
33170
Italy
Novartis Investigative Site
Milan
20112
Italy
Novartis Investigative Site
Pavia
27100
Italy
Novartis Investigative Site
Scafati
84018
Italy
Novartis Investigative Site
Barcelona
Catalonia
08035
Spain
Novartis Investigative Site
Barcelona
Catalonia
08036
Spain
Novartis Investigative Site
Barcelona
Catalonia
08041
Spain
Novartis Investigative Site
Valencia
Comunitat Valencia
46014
Spain
Novartis Investigative Site
Baracaldo - Vizcaya
48903
Spain
Novartis Investigative Site
Barcelona
08003
Spain
Novartis Investigative Site
Valencia
46009
Spain
Novartis Investigative Site
Valladolid
47003
Spain
Novartis Investigative Site
Cambridge
Cambridgeshire
CB23 3RE
United Kingdom
Novartis Investigative Site
Dundee
Perthshire
DD1 9SY
United Kingdom
Novartis Investigative Site
Birmingham
B15 2TH
United Kingdom
Novartis Investigative Site
Edinburgh
ED16 4SA
United Kingdom
Novartis Investigative Site
Lancaster
LA1 4RP
United Kingdom
Novartis Investigative Site
Leeds
LS9 7TF
United Kingdom
Novartis Investigative Site
London
SW 6NP
United Kingdom
Novartis Investigative Site
Newcastle upon Tyne
NE7 7DN
United Kingdom
Novartis Investigative Site
Southampton
SO16 6YD
United Kingdom
Derived
Loebinger MR, Polverino E, Blasi F, Elborn SJ, Chalmers JD, Tiddens HA, Goossens H, Tunney M, Zhou W, Angyalosi G, Hill AT, Haworth CS; iBEST-1 Trial Team. Efficacy and safety of tobramycin inhalation powder in bronchiectasis patients with P. aeruginosa infection: Design of a dose-finding study (iBEST-1). Pulm Pharmacol Ther. 2019 Oct;58:101834. doi: 10.1016/j.pupt.2019.101834. Epub 2019 Aug 18.
FG002
Cohort A (3 Capsules o.d.): PBO
Cohort A (3 capsules o.d.): Inhaled placebo (PBO)
FG003
Cohort B (5 Capsules o.d.): TIP
Cohort B (5 capsules o.d.): Tobramycin inhalation powder (TIP)
FG004
Cohort B (5 Capsules o.d.): TIP/PBO
Cohort B (5 capsules o.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
FG005
Cohort B (5 Capsules o.d.): PBO
Cohort B (5 capsules o.d.): inhaled placebo (PBO)
FG006
Cohort C (4 Capsules b.i.d.): TIP
Cohort C (4 capsules b.i.d.): Tobramycin inhalation powder (TIP)
FG007
Cohort C (4 Capsules b.i.d.): TIP/PBO
Cohort C (4 capsules b.i.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
FG008
Cohort C (4 Capsules b.i.d.): PBO
Cohort C (4 capsules b.i.d.): inhaled placebo (PBO)
FG00014 subjects
FG00113 subjects
FG0027 subjects
FG00315 subjects
FG00414 subjects
FG0057 subjects
FG00615 subjects
FG00715 subjects
FG0087 subjects
Pharmacokinetic Analysis Set
FG00014 subjects
FG00113 subjects
FG0020 subjects
FG00315 subjects
FG00414 subjects
FG0050 subjects
FG00615 subjects
FG00714 subjects
FG0080 subjects
COMPLETED
FG0009 subjects
FG00112 subjects
FG0026 subjects
FG0037 subjects
FG00410 subjects
FG0057 subjects
FG0066 subjects
FG0076 subjects
FG0085 subjects
NOT COMPLETED
FG0005 subjects
FG0011 subjects
FG0021 subjects
FG0038 subjects
FG0044 subjects
FG0050 subjects
FG0069 subjects
FG0079 subjects
FG0082 subjects
Type
Comment
Reasons
Adverse Event
FG0003 subjects
FG0011 subjects
FG0021 subjects
FG0034 subjects
FG0043 subjects
FG0050 subjects
FG0066 subjects
FG0076 subjects
FG0081 subjects
Protocol Deviation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
FG004
Technical Problems
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Subject Decision
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
FG004
Post-Treatment Efficacy Follow-Up Phase
Type
Comment
Milestone Data
STARTED
All patients who discontinued treatment and entered Post-Treatment Efficacy Follow-Up Phase
FG0000 subjectsAll patients who entered Post-Treatment Efficacy Fup Phase
FG0011 subjectsAll patients who entered Post-Treatment Efficacy Fup Phase
FG0020 subjectsAll patients who entered Post-Treatment Efficacy Fup Phase
FG0031 subjectsAll patients who entered Post-Treatment Efficacy Fup Phase
FG0042 subjectsAll patients who entered Post-Treatment Efficacy Fup Phase
FG0051 subjectsAll patients who entered Post-Treatment Efficacy Fup Phase
FG0062 subjectsAll patients who entered Post-Treatment Efficacy Fup Phase
FG0073 subjectsAll patients who entered Post-Treatment Efficacy Fup Phase
FG0080 subjectsAll patients who entered Post-Treatment Efficacy Fup Phase
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Cohort A (3 Capsules o.d.): TIP
Cohort A (3 capsules o.d.): Tobramycin inhalation powder (TIP)
BG001
Cohort A (3 Capsules o.d.): TIP/PBO
Cohort A (3 capsules o.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
BG002
Cohort A (3 Capsules o.d.): PBO
Cohort A (3 capsules o.d.): Inhaled placebo (PBO)
BG003
Cohort B (5 Capsules o.d.): TIP
Cohort B (5 capsules o.d.): Tobramycin inhalation powder (TIP)
BG004
Cohort B (5 Capsules o.d.): TIP/PBO
Cohort B (5 capsules o.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
BG005
Cohort B (5 Capsules o.d.): PBO
Cohort B (5 capsules o.d.): inhaled placebo (PBO)
BG006
Cohort C (4 Capsules b.i.d.): TIP
Cohort C (4 capsules b.i.d.): Tobramycin inhalation powder (TIP)
BG007
Cohort C (4 Capsules b.i.d.): TIP/PBO
Cohort C (4 capsules b.i.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
BG008
Cohort C (4 Capsules b.i.d.): PBO
Cohort C (4 capsules b.i.d.): inhaled placebo (PBO)
BG009
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00014
BG00113
BG0027
BG00315
BG00414
BG0057
BG00615
BG00715
BG0087
BG009107
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00063.4± 12.66
BG00157.5± 11.83
BG00261.3± 7.45
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0009
BG00110
BG002
Race/Ethnicity, Customized
Number
Participants
Title
Denominators
Categories
Caucasian
Title
Measurements
BG00012
BG00111
BG002
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
Change From Baseline to Day 29 in Pseudomonas Aeruginosa (P. Aeruginosa) Density in Sputum (log10 CFUs)
Microbiological data was collected to understand the direct impact of the drug on the pathogens. Sputum samples were cultured for the presence of three Pseudomonas aeruginosa (P. aeruginosa) biotypes measured were mucoid, dry and small colony variant. Change was determined using the formula = (Post-baseline value - baseline value). If no P. aeruginosa was isolated for a visit, log10 colony forming units (CFU) was imputed with log10 (19) for all biotypes. Only values for all morphotypes presented.
Full Analysis Set. Only the participants who had microbiological data at specified time points were included.
Cohort A (3 capsules o.d.): Tobramycin inhalation powder (TIP)
OG001
Cohort A (3 Capsules o.d.): TIP/PBO
Cohort A (3 capsules o.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
OG002
Cohort B (5 Capsules o.d.): TIP
Cohort B (5 capsules o.d.): Tobramycin inhalation powder (TIP)
OG003
Cohort B (5 Capsules o.d.): TIP/PBO
Cohort B (5 capsules o.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
OG004
Cohort C (4 Capsules b.i.d.): TIP
Cohort C (4 capsules b.i.d.): Tobramycin inhalation powder (TIP)
OG005
Cohort C (4 Capsules b.i.d.): TIP/PBO
Cohort C (4 capsules b.i.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
OG006
Pooled TIP
Pooled Tobramycin inhalation powder (TIP): For efficacy analysis, subjects assigned to TIP groups were pooled across the 3 cohorts.
OG007
Pooled TIP/PBO
Pooled Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical: For efficacy analysis, subjects assigned to TIP/PBO groups were pooled across the 3 cohorts.
OG008
Pooled PBO
Pooled inhaled placebo (PBO): For efficacy analysis, subjects assigned to Placebo groups were pooled across the 3 cohorts, as the number of placebo capsules was not expected to impact the efficacy assessments.
Units
Counts
Participants
OG00014
OG00113
OG00215
OG003
Title
Denominators
Categories
Baseline
ParticipantsOG00014
ParticipantsOG00113
ParticipantsOG00214
ParticipantsOG003
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
OG008
Day 8 Cohort A: TIP, Pooled PBO
LS Mean Diff (SE) vs pooled placebo
-2.4
Standard Error of the Mean
0.60
2-Sided
95
-3.62
-1.22
Other
OG001
OG008
Day 8 Cohort A: TIP/PBO, Pooled PBO
Secondary
Change From Baseline to Each Post-baseline Visit in Pseudomonas Aeruginosa (P. Aeruginosa) Density in Sputum (log10 CFUs)
Microbiological data was collected to understand the direct impact of the drug on the pathogens. Sputum samples were cultured for the presence of three Pseudomonas aeruginosa (P. aeruginosa) biotypes measured were mucoid, dry and small colony variant. Change was determined using the formula = (Post-baseline value - baseline value). If no P. aeruginosa was isolated for a visit, log10 colony forming units (CFU) was imputed with log10 (19) for all biotypes. Only values for all morphotypes are presented.
Full Analysis Set. Only the participants who had microbiological data at specified time points were included.
Cohort A (3 capsules o.d.): Tobramycin inhalation powder (TIP)
OG001
Cohort A (3 Capsules o.d.): TIP/PBO
Cohort A (3 capsules o.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
OG002
Cohort B (5 Capsules o.d.): TIP
Secondary
Time to First Onset of Pulmonary Exacerbation by Exacerbation Category
The time to first onset of pulmonary exacerbation compared to placebo was analyzed. Participants with pulmonary exacerbation were categorized as: a) Overall, b) Category 1 (Oral): treated with oral antibiotics only and c) Category 2 (Parenteral): treated with parenteral Antibiotics and/or requiring hospitalization. Participants were censored at the time of completion of study or early discontinuation if they did not have a pulmonary exacerbation during the study period.
Full Analysis Set
Posted
Median
Full Range
Days
Baseline (Visit 101/Day 1) to Visit 202 (Day 169)
ID
Title
Description
OG000
Cohort A (3 Capsules o.d.): TIP
Cohort A (3 capsules o.d.): Tobramycin inhalation powder (TIP)
OG001
Cohort A (3 Capsules o.d.): TIP/PBO
Cohort A (3 capsules o.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
OG002
Cohort B (5 Capsules o.d.): TIP
Cohort B (5 capsules o.d.): Tobramycin inhalation powder (TIP)
OG003
Cohort B (5 Capsules o.d.): TIP/PBO
Secondary
Duration of Pulmonary Exacerbation by Exacerbation Category
The duration of pulmonary exacerbation compared to placebo was analyzed. Participants with pulmonary exacerbation were categorized as: a) Overall, b) Category 1 (Oral): treated with oral antibiotics only and c) Category 2 (Parenteral): treated with parenteral Antibiotics and/or requiring hospitalization.
Full Analysis Set
Posted
Mean
Standard Deviation
Days
Baseline (Visit 101/Day 1) to Visit 202 (Day 169)
ID
Title
Description
OG000
Cohort A (3 Capsules o.d.): TIP
Cohort A (3 capsules o.d.): Tobramycin inhalation powder (TIP)
OG001
Cohort A (3 Capsules o.d.): TIP/PBO
Cohort A (3 capsules o.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
OG002
Cohort B (5 Capsules o.d.): TIP
Cohort B (5 capsules o.d.): Tobramycin inhalation powder (TIP)
OG003
Cohort B (5 Capsules o.d.): TIP/PBO
Cohort B (5 capsules o.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
Secondary
Exposure Adjusted Rate of Pulmonary Exacerbations (PE) Over the Entire Study Period
The exposure adjusted rate of pulmonary exacerbation compared to placebo was analyzed. Participants with pulmonary exacerbation were categorized as: a) Overall, b) Category 1 (Oral): treated with oral antibiotics only and c) Category 2 (Parenteral): treated with parenteral Antibiotics and/or requiring hospitalization. The Exposure adjusted rate = (Number of pulmonary exacerbations reported during the study period) / (sum of study duration in days for all participants/ 365.25). Only descriptive analysis performed.
Full Analysis Set
Posted
Number
95% Confidence Interval
pulmonary exacerbation per study years
Baseline (Visit 101/Day 1) to Visit 202 (Day 169)
ID
Title
Description
OG000
Cohort A (3 Capsules o.d.): TIP
Cohort A (3 capsules o.d.): Tobramycin inhalation powder (TIP)
OG001
Cohort A (3 Capsules o.d.): TIP/PBO
Cohort A (3 capsules o.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
OG002
Cohort B (5 Capsules o.d.): TIP
Cohort B (5 capsules o.d.): Tobramycin inhalation powder (TIP)
Secondary
Percentage of Participants With at Least One Pulmonary Exacerbation by Exacerbation Category
Pulmonary exacerbations are defined as events requiring antibiotic therapy AND for which at least 3 of the following 6 symptoms, signs, or findings were present outside of normal variation: 1. Increased sputum volume, or change in viscosity/consistency or purulence for more than 24 hours; 2. Increased shortness of breath at rest or on exercise for more than 24 hours; 3. Increased cough for more than 24 hours; 4. Fever of ≥38° Celsius within the last 24 hours; 5. Increased malaise/fatigue/lethargy for more than 24 hours; 6. A reduction in forced expiratory volume in the first second of expiration (FEV1) or forced vital capacity (FVC) of least 10% from screening.
Participants were categorized as: a) Overall, b) Category 1: treated with oral antibiotics only and c) Category 2: treated with parenteral Antibiotics and/or requiring hospitalization.
Only descriptive analysis performed.
Full Analysis Set
Posted
Count of Participants
Participants
Baseline (Visit 101/Day 1) to Visit 202 (Day 169)
ID
Title
Description
OG000
Cohort A (3 Capsules o.d.): TIP
Cohort A (3 capsules o.d.): Tobramycin inhalation powder (TIP)
OG001
Cohort A (3 Capsules o.d.): TIP/PBO
Cohort A (3 capsules o.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
Secondary
Percentage of Participants Who Permanently Discontinued Study Drug Due to Pulmonary Exacerbation
The percentage of participants who permanently discontinued study drug due to pulmonary exacerbation compared to placebo was analyzed.
Full Analysis Set
Posted
Count of Participants
Participants
Baseline (Visit 101/Day 1) to Visit 202 (Day 169)
ID
Title
Description
OG000
Cohort A (3 Capsules o.d.): TIP
Cohort A (3 capsules o.d.): Tobramycin inhalation powder (TIP)
OG001
Cohort A (3 Capsules o.d.): TIP/PBO
Cohort A (3 capsules o.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
OG002
Cohort B (5 Capsules o.d.): TIP
Cohort B (5 capsules o.d.): Tobramycin inhalation powder (TIP)
OG003
Cohort B (5 Capsules o.d.): TIP/PBO
Cohort B (5 capsules o.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
Secondary
Time to Permanent Study Drug Discontinuation Due to Pulmonary Exacerbation
The time to permanent study drug discontinuation due to Pulmonary exacerbation. Participants were censored at the time of last contact if they did not permanently discontinue study drug due to pulmonary exacerbation requiring during the study period. Only descriptive analysis performed.
Full Analysis Set
Posted
Median
95% Confidence Interval
Days
Baseline (Visit 101/Day 1) to Visit 202 (Day 169)
ID
Title
Description
OG000
Cohort A (3 Capsules o.d.): TIP
Cohort A (3 capsules o.d.): Tobramycin inhalation powder (TIP)
OG001
Cohort A (3 Capsules o.d.): TIP/PBO
Cohort A (3 capsules o.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
OG002
Cohort B (5 Capsules o.d.): TIP
Cohort B (5 capsules o.d.): Tobramycin inhalation powder (TIP)
OG003
Cohort B (5 Capsules o.d.): TIP/PBO
Cohort B (5 capsules o.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
Secondary
Time to First Use (Overall, Oral, and Parenteral) of Anti-pseudomonal Antibiotics Usage
The time to first use of anti-pseudomonal antibiotics administered compared to placebo was analyzed. Participants were censored at the time of last contact if they did not have anti-pseudomonal antibiotics over the entire study period.
Full Analysis Set. Only the participants who required antipseudomonal antibiotics were included.
Posted
Median
Full Range
Days
From Baseline (Visit 101/Day 1) up to approximately Day 173
ID
Title
Description
OG000
Cohort A (3 Capsules o.d.): TIP
Cohort A (3 capsules o.d.): Tobramycin inhalation powder (TIP)
OG001
Cohort A (3 Capsules o.d.): TIP/PBO
Cohort A (3 capsules o.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
OG002
Cohort B (5 Capsules o.d.): TIP
Cohort B (5 capsules o.d.): Tobramycin inhalation powder (TIP)
OG003
Cohort B (5 Capsules o.d.): TIP/PBO
Cohort B (5 capsules o.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
Secondary
Percentage of Participants Requiring Anti-pseudomonal Antibiotics
The percentage of participants requiring anti-pseudomonal antibiotics compared to placebo was analyzed. Only descriptive analysis performed.
Full Analysis Set
Posted
Count of Participants
Participants
Baseline (Visit 101/Day 1) to Visit 202 (Day 169)
ID
Title
Description
OG000
Cohort A (3 Capsules o.d.): TIP
Cohort A (3 capsules o.d.): Tobramycin inhalation powder (TIP)
OG001
Cohort A (3 Capsules o.d.): TIP/PBO
Cohort A (3 capsules o.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
OG002
Cohort B (5 Capsules o.d.): TIP
Cohort B (5 capsules o.d.): Tobramycin inhalation powder (TIP)
OG003
Cohort B (5 Capsules o.d.): TIP/PBO
Cohort B (5 capsules o.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
OG004
Secondary
Duration of Anti-pseudomonal Antibiotics Usage
The total number of days of new anti-pseudomonal antibiotic use compared to placebo was analyzed. Only descriptive analysis
Full Analysis Set
Posted
Mean
Standard Deviation
Days
Baseline (Visit 101/Day 1) to Visit 202 (Day 169)
ID
Title
Description
OG000
Cohort A (3 Capsules o.d.): TIP
Cohort A (3 capsules o.d.): Tobramycin inhalation powder (TIP)
OG001
Cohort A (3 Capsules o.d.): TIP/PBO
Cohort A (3 capsules o.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
OG002
Cohort B (5 Capsules o.d.): TIP
Cohort B (5 capsules o.d.): Tobramycin inhalation powder (TIP)
OG003
Cohort B (5 Capsules o.d.): TIP/PBO
Cohort B (5 capsules o.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
OG004
Secondary
Percentage of Participants Requiring Hospitalization Due to Serious Respiratory-related Adverse Events
The percentage of participants requiring hospitalization due to serious respiratory-related adverse events (other than those regularly scheduled hospitalization that were planned prior to study start) was analyzed to define severity of pulmonary exacerbations compared to placebo. Only descriptive analysis performed.
Full Analysis Set
Posted
Count of Participants
Participants
Baseline (Visit 101/Day 1) to Visit 202 (Day 169)
ID
Title
Description
OG000
Cohort A (3 Capsules o.d.): TIP
Cohort A (3 capsules o.d.): Tobramycin inhalation powder (TIP)
OG001
Cohort A (3 Capsules o.d.): TIP/PBO
Cohort A (3 capsules o.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
OG002
Cohort B (5 Capsules o.d.): TIP
Cohort B (5 capsules o.d.): Tobramycin inhalation powder (TIP)
OG003
Cohort B (5 Capsules o.d.): TIP/PBO
Secondary
Duration of Hospitalization Due to Serious Respiratory-related Adverse Events
The duration of hospitalization due to serious respiratory-related adverse events (other than those regularly scheduled hospitalization that were planned prior to study start) was analyzed to define severity of pulmonary exacerbations compared to placebo. Only descriptive analysis performed.
Full Analysis Set. Only the participants with at least one hospitalization are included in the analysis
Posted
Mean
Standard Deviation
Days
Baseline (Visit 101/Day 1) to Visit 202 (Day 169)
ID
Title
Description
OG000
Cohort A (3 Capsules o.d.): TIP
Cohort A (3 capsules o.d.): Tobramycin inhalation powder (TIP)
OG001
Cohort A (3 Capsules o.d.): TIP/PBO
Cohort A (3 capsules o.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
OG002
Cohort B (5 Capsules o.d.): TIP
Cohort B (5 capsules o.d.): Tobramycin inhalation powder (TIP)
OG003
Cohort B (5 Capsules o.d.): TIP/PBO
Secondary
Number of Hospitalization Due to Serious Respiratory-related Adverse Events
The number of hospitalization due to serious respiratory-related AEs was analyzed to define severity of pulmonary exacerbations compared to placebo. Respiratory related adverse events were identified using the AEs captured under system organ class 'Respiratory, thoracic and mediastinal disorders' and 'Infections and infestations'.
Full Analysis Set
Posted
Number
Hospitalization
Baseline (Visit 101/Day 1) to Visit 202 (Day 169)
ID
Title
Description
OG000
Cohort A (3 Capsules o.d.): TIP
Cohort A (3 capsules o.d.): Tobramycin inhalation powder (TIP)
OG001
Cohort A (3 Capsules o.d.): TIP/PBO
Cohort A (3 capsules o.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
OG002
Cohort B (5 Capsules o.d.): TIP
Cohort B (5 capsules o.d.): Tobramycin inhalation powder (TIP)
OG003
Cohort B (5 Capsules o.d.): TIP/PBO
Cohort B (5 capsules o.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
Secondary
Time to First Hospitalization Due to Serious Respiratory-related Adverse Events
Time to first hospitalization due to serious respiratory-related AEs was analyzed to define severity of pulmonary exacerbations compared to placebo. Participants were censored at the time of last contact if they did not have a hospitalization due to serious respiratory-related adverse events over the entire study period.
Full Analysis Set
Posted
Median
95% Confidence Interval
Day
Baseline (Visit 101/Day 1) to Visit 202 (Day 169)
ID
Title
Description
OG000
Cohort A (3 Capsules o.d.): TIP
Cohort A (3 capsules o.d.): Tobramycin inhalation powder (TIP)
OG001
Cohort A (3 Capsules o.d.): TIP/PBO
Cohort A (3 capsules o.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
OG002
Cohort B (5 Capsules o.d.): TIP
Cohort B (5 capsules o.d.): Tobramycin inhalation powder (TIP)
OG003
Cohort B (5 Capsules o.d.): TIP/PBO
Cohort B (5 capsules o.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
Secondary
Serum Tobramycin Concentration
The serum pharmacokinetic (PK) properties of tobramycin were assessed by evaluating tobramycin concentrations in serum collected from the non-cystic fibrosis bronchiectasis population post administration of o.d. or b.i.d. doses of TIP. Serum specimens for PK tobramycin concentration were assessed at Visit 101 (Day 1/start of treatment) 0 to 1 and 1 to 2 hours post-dose and Visit 102 (Day 8) 0 to 1 and 1 to 2 hours post-dose. Prior to protocol amendment #2, PK samples were assessed on Visits 103 (Day 29) rather than Visit 102. Only descriptive analysis performed.
Pharmacokinetic Analysis Set. Prior to protocol amendment #2, PK samples were assessed on Visit 103 (Day 29) rather than Visit 102 (Day 8).
Posted
Mean
Standard Deviation
microgram/milliliter
Baseline (Visit 101/Day 1), Visit 102 (Day 8) and Visits 103 (Day 29): 0-1 hours and 1-2 hours post-dose.
ID
Title
Description
OG000
Cohort A (3 Capsules o.d.): TIP
Cohort A (3 capsules o.d.): Tobramycin inhalation powder (TIP)
OG001
Cohort A (3 Capsules o.d.): TIP/PBO
Cohort A (3 capsules o.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
OG002
Cohort B (5 Capsules o.d.): TIP
Secondary
Sputum Tobramycin Concentration
The sputum pharmacokinetic (PK) properties of tobramycin were assessed by evaluating tobramycin concentrations in sputum collected from the non-cystic fibrosis bronchiectasis population post administration of o.d. or b.i.d. doses of TIP. Only descriptive analysis performed.
Pharmacokinetic Analysis Set. Prior to protocol amendment #2, Sputum specimens for PK assessments were collected at Visit 103 (Day 29) 5 to 6 hours rather than Visit 102 (Day 8) 0 to 2 and 5 to 6 hours and on Visit 105 (Day 85) 3 to 4 hours rather than Visit 104 (Day 57) 3 to 4 hours.
Posted
Mean
Standard Deviation
microgram/milliliter
Baseline (Visit 101/Day 1): 0-1 hours and 1-2 hours post-dose; Visit 102 (Day 8):0-2 hours and 5-6 hours post-dose; Visits 103 (Day 29): 5 to 6 hours post-dose, Visit 104 (Day 57) and Visit 105 (Day 85): 3-4 hours post-dose.
ID
Title
Description
OG000
Cohort A (3 Capsules o.d.): TIP
Cohort A (3 capsules o.d.): Tobramycin inhalation powder (TIP)
OG001
Cohort A (3 Capsules o.d.): TIP/PBO
Cohort A (3 capsules o.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
OG002
Cohort B (5 Capsules o.d.): TIP
Cohort B (5 capsules o.d.): Tobramycin inhalation powder (TIP)
Secondary
Change From Baseline in Quality of Life Questionnaire for Bronchiectasis (QOL-B)-Physical Functioning
The QoL-B consists of 37 items across 8 domains: Physical Functioning (PF), Role Functioning (RF), Vitality, Emotional Function (EF), Social Functioning (SF), Treatment Burden (TB), Health Perception (HP) and Respiratory Symptoms (RS). Each of the 37 items is scored from 1 to 4, and each of the 8 scale scores is standardized on a 0-100 point scale, with higher scores representing fewer symptoms or better functioning and HRQoL. A total score is not calculated since functioning can vary greatly from one domain to another. Only descriptive analysis performed.
Full Analysis Set
Posted
Mean
Standard Deviation
Score on Scale
Baseline, Visit 102 (Day 8), Visit 103 (Day 29), End of Treatment (Day 113) and Visit 202 (Day 169)
ID
Title
Description
OG000
Cohort A (3 Capsules o.d.): TIP
Cohort A (3 capsules o.d.): Tobramycin inhalation powder (TIP)
OG001
Cohort A (3 Capsules o.d.): TIP/PBO
Cohort A (3 capsules o.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
OG002
Cohort B (5 Capsules o.d.): TIP
Cohort B (5 capsules o.d.): Tobramycin inhalation powder (TIP)
Secondary
Change From Baseline in Quality of Life Questionnaire for Bronchiectasis (QOL-B)-Role Functioning
The QoL-B consists of 37 items across 8 domains: Physical Functioning (PF), Role Functioning (RF), Vitality, Emotional Function (EF), Social Functioning (SF), Treatment Burden (TB), Health Perception (HP) and Respiratory Symptoms (RS). Each of the 37 items is scored from 1 to 4, and each of the 8 scale scores is standardized on a 0-100 point scale, with higher scores representing fewer symptoms or better functioning and HRQoL. A total score is not calculated since functioning can vary greatly from one domain to another. Only descriptive analysis performed.
Full Analysis Set
Posted
Mean
Standard Deviation
Score on Scale
Baseline, Visit 102 (Day 8), Visit 103 (Day 29), End of Treatment (Day 113) and Visit 202 (Day 169)
ID
Title
Description
OG000
Cohort A (3 Capsules o.d.): TIP
Cohort A (3 capsules o.d.): Tobramycin inhalation powder (TIP)
OG001
Cohort A (3 Capsules o.d.): TIP/PBO
Cohort A (3 capsules o.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
OG002
Cohort B (5 Capsules o.d.): TIP
Cohort B (5 capsules o.d.): Tobramycin inhalation powder (TIP)
Secondary
Change From Baseline in Quality of Life Questionnaire for Bronchiectasis (QOL-B)-Vitality
The QoL-B consists of 37 items across 8 domains: Physical Functioning (PF), Role Functioning (RF), Vitality, Emotional Function (EF), Social Functioning (SF), Treatment Burden (TB), Health Perception (HP) and Respiratory Symptoms (RS). Each of the 37 items is scored from 1 to 4, and each of the 8 scale scores is standardized on a 0-100 point scale, with higher scores representing fewer symptoms or better functioning and HRQoL. A total score is not calculated since functioning can vary greatly from one domain to another. Only descriptive analysis performed.
Full Analysis Set
Posted
Mean
Standard Deviation
Score on Scale
Baseline, Visit 102 (Day 8), Visit 103 (Day 29), End of Treatment (Day 113) and Visit 202 (Day 169)
ID
Title
Description
OG000
Cohort A (3 Capsules o.d.): TIP
Cohort A (3 capsules o.d.): Tobramycin inhalation powder (TIP)
OG001
Cohort A (3 Capsules o.d.): TIP/PBO
Cohort A (3 capsules o.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
OG002
Cohort B (5 Capsules o.d.): TIP
Cohort B (5 capsules o.d.): Tobramycin inhalation powder (TIP)
Secondary
Change From Baseline in Quality of Life Questionnaire for Bronchiectasis (QOL-B)-Emotional Functioning
The QoL-B consists of 37 items across 8 domains: Physical Functioning (PF), Role Functioning (RF), Vitality, Emotional Function (EF), Social Functioning (SF), Treatment Burden (TB), Health Perception (HP) and Respiratory Symptoms (RS). Each of the 37 items is scored from 1 to 4, and each of the 8 scale scores is standardized on a 0-100 point scale, with higher scores representing fewer symptoms or better functioning and HRQoL. A total score is not calculated since functioning can vary greatly from one domain to another. Only descriptive analysis performed.
Full Analysis Set
Posted
Mean
Standard Deviation
Score on Scale
Baseline, Visit 102 (Day 8), Visit 103 (Day 29), End of Treatment (Day 113) and Visit 202 (Day 169)
ID
Title
Description
OG000
Cohort A (3 Capsules o.d.): TIP
Cohort A (3 capsules o.d.): Tobramycin inhalation powder (TIP)
OG001
Cohort A (3 Capsules o.d.): TIP/PBO
Cohort A (3 capsules o.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
OG002
Cohort B (5 Capsules o.d.): TIP
Cohort B (5 capsules o.d.): Tobramycin inhalation powder (TIP)
Secondary
Change From Baseline in Quality of Life Questionnaire for Bronchiectasis (QOL-B)-Social Functioning
The QoL-B consists of 37 items across 8 domains: Physical Functioning (PF), Role Functioning (RF), Vitality, Emotional Function (EF), Social Functioning (SF), Treatment Burden (TB), Health Perception (HP) and Respiratory Symptoms (RS). Each of the 37 items is scored from 1 to 4, and each of the 8 scale scores is standardized on a 0-100 point scale, with higher scores representing fewer symptoms or better functioning and HRQoL. A total score is not calculated since functioning can vary greatly from one domain to another. Only descriptive analysis performed.
Full Analysis Set
Posted
Mean
Standard Deviation
Score on Scale
Baseline, Visit 102 (Day 8), Visit 103 (Day 29), End of Treatment (Day 113) and Visit 202 (Day 169)
ID
Title
Description
OG000
Cohort A (3 Capsules o.d.): TIP
Cohort A (3 capsules o.d.): Tobramycin inhalation powder (TIP)
OG001
Cohort A (3 Capsules o.d.): TIP/PBO
Cohort A (3 capsules o.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
OG002
Cohort B (5 Capsules o.d.): TIP
Cohort B (5 capsules o.d.): Tobramycin inhalation powder (TIP)
Secondary
Change From Baseline in Quality of Life Questionnaire for Bronchiectasis (QOL-B)-Treatment Burden
The QoL-B consists of 37 items across 8 domains: Physical Functioning (PF), Role Functioning (RF), Vitality, Emotional Function (EF), Social Functioning (SF), Treatment Burden (TB), Health Perception (HP) and Respiratory Symptoms (RS). Each of the 37 items is scored from 1 to 4, and each of the 8 scale scores is standardized on a 0-100 point scale, with higher scores representing fewer symptoms or better functioning and HRQoL. A total score is not calculated since functioning can vary greatly from one domain to another. Only descriptive analysis performed.
Full Analysis Set
Posted
Mean
Standard Deviation
Score on Scale
Baseline, Visit 102 (Day 8), Visit 103 (Day 29), End of Treatment (Day 113) and Visit 202 (Day 169)
ID
Title
Description
OG000
Cohort A (3 Capsules o.d.): TIP
Cohort A (3 capsules o.d.): Tobramycin inhalation powder (TIP)
OG001
Cohort A (3 Capsules o.d.): TIP/PBO
Cohort A (3 capsules o.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
OG002
Cohort B (5 Capsules o.d.): TIP
Cohort B (5 capsules o.d.): Tobramycin inhalation powder (TIP)
Secondary
Change From Baseline in Quality of Life Questionnaire for Bronchiectasis (QOL-B)-Health Perceptions
The QoL-B consists of 37 items across 8 domains: Physical Functioning (PF), Role Functioning (RF), Vitality, Emotional Function (EF), Social Functioning (SF), Treatment Burden (TB), Health Perception (HP) and Respiratory Symptoms (RS). Each of the 37 items is scored from 1 to 4, and each of the 8 scale scores is standardized on a 0-100 point scale, with higher scores representing fewer symptoms or better functioning and HRQoL. A total score is not calculated since functioning can vary greatly from one domain to another. Only descriptive analysis performed.
Full Analysis Set
Posted
Mean
Standard Deviation
Score on Scale
Baseline, Visit 102 (Day 8), Visit 103 (Day 29), End of Treatment (Day 113) and Visit 202 (Day 169)
ID
Title
Description
OG000
Cohort A (3 Capsules o.d.): TIP
Cohort A (3 capsules o.d.): Tobramycin inhalation powder (TIP)
OG001
Cohort A (3 Capsules o.d.): TIP/PBO
Cohort A (3 capsules o.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
OG002
Cohort B (5 Capsules o.d.): TIP
Cohort B (5 capsules o.d.): Tobramycin inhalation powder (TIP)
Secondary
Change From Baseline in Quality of Life Questionnaire for Bronchiectasis (QOL-B)-Respiratory Symptoms
The QoL-B consists of 37 items across 8 domains: Physical Functioning (PF), Role Functioning (RF), Vitality, Emotional Function (EF), Social Functioning (SF), Treatment Burden (TB), Health Perception (HP) and Respiratory Symptoms (RS). Each of the 37 items is scored from 1 to 4, and each of the 8 scale scores is standardized on a 0-100 point scale, with higher scores representing fewer symptoms or better functioning and HRQoL. A total score is not calculated since functioning can vary greatly from one domain to another. Only descriptive analysis performed.
Full Analysis Set
Posted
Mean
Standard Deviation
Score on Scale
Baseline, Visit 102 (Day 8), Visit 103 (Day 29), End of Treatment (Day 113) and Visit 202 (Day 169)
ID
Title
Description
OG000
Cohort A (3 Capsules o.d.): TIP
Cohort A (3 capsules o.d.): Tobramycin inhalation powder (TIP)
OG001
Cohort A (3 Capsules o.d.): TIP/PBO
Cohort A (3 capsules o.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
OG002
Cohort B (5 Capsules o.d.): TIP
Cohort B (5 capsules o.d.): Tobramycin inhalation powder (TIP)
Time Frame
Adverse events were collected from first dose of study drug treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 134 days.
Description
Any sign or symptom that occurs during study treatment plus the 30 days post treatment.
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
Cohort A (3 Capsules o.d.): TIP
Cohort A (3 capsules o.d.): Tobramycin inhalation powder (TIP)
0
14
4
14
12
14
EG001
Cohort A (3 Capsules o.d.): TIP/PBO
Cohort A (3 capsules o.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
0
13
2
13
12
13
EG002
Cohort A (3 Capsules o.d.): PBO
Cohort A (3 capsules o.d.): Inhaled placebo (PBO)
0
7
0
7
6
7
EG003
Cohort B (5 Capsules o.d.): TIP
Cohort B (5 capsules o.d.): Tobramycin inhalation powder (TIP)
0
15
4
15
10
15
EG004
Cohort B (5 Capsules o.d.): TIP/PBO
Cohort B (5 capsules o.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
0
14
3
14
10
14
EG005
Cohort B (5 Capsules o.d.): PBO
Cohort B (5 capsules o.d.): inhaled placebo (PBO)
0
7
2
7
7
7
EG006
Cohort C:4 Capsules b.i.d. TIP
Cohort C (4 capsules b.i.d.): Tobramycin inhalation powder (TIP)
0
15
2
15
13
15
EG007
Cohort C (4 Capsules b.i.d.): TIP/PBO
Cohort C (4 capsules b.i.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
0
15
4
15
14
15
EG008
Cohort C (4 Capsules b.i.d.): PBO
Cohort C (4 capsules b.i.d.): inhaled placebo (PBO)
0
7
1
7
5
7
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Acute myocardial infarction
Cardiac disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG0030 affected15 at risk
EG0041 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
Atrial fibrillation
Cardiac disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Asthenia
General disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Bile duct stone
Hepatobiliary disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0011 affected13 at risk
EG0020 affected7 at risk
EG003
Bacterial disease carrier
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Infective exacerbation of bronchiectasis
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0003 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Blood creatinine abnormal
Investigations
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Glomerular filtration rate decreased
Investigations
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Syncope
Nervous system disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0011 affected13 at risk
EG0020 affected7 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA (21.1)
Systematic Assessment
EG0001 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA (21.1)
Systematic Assessment
EG0001 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG0030 affected15 at risk
EG0041 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
Eosinophilia
Blood and lymphatic system disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Cerumen impaction
Ear and labyrinth disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Deafness
Ear and labyrinth disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Eustachian tube dysfunction
Ear and labyrinth disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Middle ear effusion
Ear and labyrinth disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0011 affected13 at risk
EG0020 affected7 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA (21.1)
Systematic Assessment
EG0001 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Eye pain
Eye disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0001 affected14 at risk
EG0011 affected13 at risk
EG0020 affected7 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Aerophagia
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Cheilitis
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0011 affected13 at risk
EG0020 affected7 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0013 affected13 at risk
EG0022 affected7 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0011 affected13 at risk
EG0020 affected7 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0011 affected13 at risk
EG0020 affected7 at risk
EG003
Gastric polyps
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0011 affected13 at risk
EG0020 affected7 at risk
EG003
Gastrointestinal disorder
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0021 affected7 at risk
EG003
Glossodynia
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Lip swelling
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0011 affected13 at risk
EG0021 affected7 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0021 affected7 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0001 affected14 at risk
EG0011 affected13 at risk
EG0020 affected7 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0001 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Paraesthesia oral
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0011 affected13 at risk
EG0020 affected7 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0011 affected13 at risk
EG0020 affected7 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0001 affected14 at risk
EG0011 affected13 at risk
EG0021 affected7 at risk
EG003
Asthenia
General disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Chest discomfort
General disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0021 affected7 at risk
EG003
Chest pain
General disorders
MedDRA (21.1)
Systematic Assessment
EG0001 affected14 at risk
EG0012 affected13 at risk
EG0020 affected7 at risk
EG003
Discomfort
General disorders
MedDRA (21.1)
Systematic Assessment
EG0001 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Exercise tolerance decreased
General disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Fatigue
General disorders
MedDRA (21.1)
Systematic Assessment
EG0001 affected14 at risk
EG0012 affected13 at risk
EG0020 affected7 at risk
EG003
Influenza like illness
General disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0011 affected13 at risk
EG0020 affected7 at risk
EG003
Oedema peripheral
General disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0021 affected7 at risk
EG003
Peripheral swelling
General disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0021 affected7 at risk
EG003
Pyrexia
General disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Hepatic function abnormal
Hepatobiliary disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Hepatotoxicity
Hepatobiliary disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Food allergy
Immune system disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0021 affected7 at risk
EG003
Bronchitis
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0001 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Candida infection
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0001 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Cystitis
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0001 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Ear infection
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0021 affected7 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0021 affected7 at risk
EG003
Herpes simplex
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Hordeolum
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0001 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Infective exacerbation of bronchiectasis
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0004 affected14 at risk
EG0014 affected13 at risk
EG0026 affected7 at risk
EG003
Influenza
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Joint abscess
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Labyrinthitis
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0001 affected14 at risk
EG0011 affected13 at risk
EG0020 affected7 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Oral fungal infection
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Oral herpes
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Respiratory tract infection viral
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Rhinitis
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0001 affected14 at risk
EG0011 affected13 at risk
EG0020 affected7 at risk
EG003
Sinusitis
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0011 affected13 at risk
EG0021 affected7 at risk
EG003
Sputum purulent
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0001 affected14 at risk
EG0011 affected13 at risk
EG0020 affected7 at risk
EG003
Tooth infection
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0011 affected13 at risk
EG0020 affected7 at risk
EG003
Viral infection
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0021 affected7 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0021 affected7 at risk
EG003
Vulvovaginal candidiasis
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0021 affected7 at risk
EG003
Airway complication of anaesthesia
Injury, poisoning and procedural complications
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0011 affected13 at risk
EG0020 affected7 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA (21.1)
Systematic Assessment
EG0001 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Hypobarism
Injury, poisoning and procedural complications
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0011 affected13 at risk
EG0020 affected7 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0011 affected13 at risk
EG0020 affected7 at risk
EG003
Blood cholesterol increased
Investigations
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Blood creatinine increased
Investigations
MedDRA (21.1)
Systematic Assessment
EG0001 affected14 at risk
EG0011 affected13 at risk
EG0020 affected7 at risk
EG003
Blood electrolytes decreased
Investigations
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0011 affected13 at risk
EG0020 affected7 at risk
EG003
Blood urea increased
Investigations
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
C-reactive protein increased
Investigations
MedDRA (21.1)
Systematic Assessment
EG0001 affected14 at risk
EG0010 affected13 at risk
EG0021 affected7 at risk
EG003
Eosinophil count abnormal
Investigations
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Forced expiratory volume decreased
Investigations
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0011 affected13 at risk
EG0020 affected7 at risk
EG003
Forced vital capacity decreased
Investigations
MedDRA (21.1)
Systematic Assessment
EG0001 affected14 at risk
EG0011 affected13 at risk
EG0020 affected7 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Glomerular filtration rate decreased
Investigations
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Liver function test abnormal
Investigations
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Neutrophil count increased
Investigations
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Protein urine present
Investigations
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Sputum abnormal
Investigations
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Urine albumin/creatinine ratio increased
Investigations
MedDRA (21.1)
Systematic Assessment
EG0001 affected14 at risk
EG0011 affected13 at risk
EG0020 affected7 at risk
EG003
Urine protein/creatinine ratio increased
Investigations
MedDRA (21.1)
Systematic Assessment
EG0001 affected14 at risk
EG0011 affected13 at risk
EG0020 affected7 at risk
EG003
Weight decreased
Investigations
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0011 affected13 at risk
EG0020 affected7 at risk
EG003
White blood cell count increased
Investigations
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Acidosis
Metabolism and nutrition disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0011 affected13 at risk
EG0020 affected7 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0011 affected13 at risk
EG0020 affected7 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Joint contracture
Musculoskeletal and connective tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0001 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Limb discomfort
Musculoskeletal and connective tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Muscle contracture
Musculoskeletal and connective tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0001 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Muscle tightness
Musculoskeletal and connective tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0021 affected7 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Periarthritis
Musculoskeletal and connective tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0011 affected13 at risk
EG0020 affected7 at risk
EG003
Ageusia
Nervous system disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0021 affected7 at risk
EG003
Anosmia
Nervous system disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0021 affected7 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (21.1)
Systematic Assessment
EG0001 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Headache
Nervous system disorders
MedDRA (21.1)
Systematic Assessment
EG0002 affected14 at risk
EG0014 affected13 at risk
EG0020 affected7 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0011 affected13 at risk
EG0020 affected7 at risk
EG003
Migraine
Nervous system disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0011 affected13 at risk
EG0020 affected7 at risk
EG003
Muscle spasticity
Nervous system disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0011 affected13 at risk
EG0020 affected7 at risk
EG003
Sciatica
Nervous system disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Tremor
Nervous system disorders
MedDRA (21.1)
Systematic Assessment
EG0001 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0011 affected13 at risk
EG0020 affected7 at risk
EG003
Calculus urinary
Renal and urinary disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0011 affected13 at risk
EG0020 affected7 at risk
EG003
Glycosuria
Renal and urinary disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA (21.1)
Systematic Assessment
EG0001 affected14 at risk
EG0011 affected13 at risk
EG0020 affected7 at risk
EG003
Renal cyst
Renal and urinary disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0011 affected13 at risk
EG0020 affected7 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Renal impairment
Renal and urinary disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0011 affected13 at risk
EG0020 affected7 at risk
EG003
Benign prostatic hyperplasia
Reproductive system and breast disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Prostatitis
Reproductive system and breast disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Bronchiectasis
Respiratory, thoracic and mediastinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Bronchospasm
Respiratory, thoracic and mediastinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0021 affected7 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (21.1)
Systematic Assessment
EG0002 affected14 at risk
EG0013 affected13 at risk
EG0021 affected7 at risk
EG003
Dry throat
Respiratory, thoracic and mediastinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0011 affected13 at risk
EG0020 affected7 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (21.1)
Systematic Assessment
EG0002 affected14 at risk
EG0012 affected13 at risk
EG0021 affected7 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0011 affected13 at risk
EG0020 affected7 at risk
EG003
Dyspnoea paroxysmal nocturnal
Respiratory, thoracic and mediastinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA (21.1)
Systematic Assessment
EG0001 affected14 at risk
EG0011 affected13 at risk
EG0020 affected7 at risk
EG003
Increased bronchial secretion
Respiratory, thoracic and mediastinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0021 affected7 at risk
EG003
Increased viscosity of bronchial secretion
Respiratory, thoracic and mediastinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0011 affected13 at risk
EG0020 affected7 at risk
EG003
Nasal discomfort
Respiratory, thoracic and mediastinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0011 affected13 at risk
EG0020 affected7 at risk
EG003
Pulmonary pain
Respiratory, thoracic and mediastinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Rales
Respiratory, thoracic and mediastinal disorders
MedDRA (21.1)
Systematic Assessment
EG0001 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Respiratory symptom
Respiratory, thoracic and mediastinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Sputum discoloured
Respiratory, thoracic and mediastinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0021 affected7 at risk
EG003
Sputum increased
Respiratory, thoracic and mediastinal disorders
MedDRA (21.1)
Systematic Assessment
EG0003 affected14 at risk
EG0011 affected13 at risk
EG0021 affected7 at risk
EG003
Throat irritation
Respiratory, thoracic and mediastinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA (21.1)
Systematic Assessment
EG0001 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0011 affected13 at risk
EG0020 affected7 at risk
EG003
Dermatitis allergic
Skin and subcutaneous tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0001 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Skin exfoliation
Skin and subcutaneous tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Swelling face
Skin and subcutaneous tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0021 affected7 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Hot flush
Vascular disorders
MedDRA (21.1)
Systematic Assessment
EG0001 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Hypertension
Vascular disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected13 at risk
EG0020 affected7 at risk
EG003
Novartis decided to close the recruitment of new subjects into this study earlier than scheduled. The early recruitment halt of the study was not due to safety or lack of efficacy.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
Cohort B (5 capsules o.d.): Tobramycin inhalation powder (TIP)
OG003
Cohort B (5 Capsules o.d.): TIP/PBO
Cohort B (5 capsules o.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
OG004
Cohort C (4 Capsules b.i.d.): TIP
Cohort C (4 capsules b.i.d.): Tobramycin inhalation powder (TIP)
OG005
Cohort C (4 Capsules b.i.d.): TIP/PBO
Cohort C (4 capsules b.i.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
OG006
Pooled TIP
Pooled Tobramycin inhalation powder (TIP): For efficacy analysis, subjects assigned to TIP groups were pooled across the 3 cohorts.
OG007
Pooled TIP/PBO
Pooled Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical: For efficacy analysis, subjects assigned to TIP/PBO groups were pooled across the 3 cohorts.
OG008
Pooled PBO
Pooled inhaled placebo (PBO): For efficacy analysis, subjects assigned to Placebo groups were pooled across the 3 cohorts, as the number of placebo capsules was not expected to impact the efficacy assessments.
Units
Counts
Participants
OG00014
OG00113
OG00215
OG00314
OG00415
OG00515
OG00644
OG00742
OG00821
Title
Denominators
Categories
Baseline (BL)
ParticipantsOG00014
ParticipantsOG00113
ParticipantsOG00214
ParticipantsOG00313
ParticipantsOG00415
ParticipantsOG00515
ParticipantsOG00643
ParticipantsOG00741
ParticipantsOG00821
Title
Measurements
OG0006.80± 1.202
OG0017.67± 1.507
OG0026.10± 2.419
OG003
Change from BL at Day 57
ParticipantsOG00011
ParticipantsOG00111
ParticipantsOG0028
ParticipantsOG00311
Change from BL at Day 85
ParticipantsOG00011
ParticipantsOG0019
ParticipantsOG0026
ParticipantsOG00310
Change from BL at Day 113
ParticipantsOG0008
ParticipantsOG00110
ParticipantsOG0024
ParticipantsOG0039
Change from BL at EOT
ParticipantsOG00012
ParticipantsOG00111
ParticipantsOG00211
ParticipantsOG00312
Change from BL at Day 141
ParticipantsOG00011
ParticipantsOG00111
ParticipantsOG0026
ParticipantsOG00311
Change from BL at Day 169
ParticipantsOG00010
ParticipantsOG00110
ParticipantsOG0027
ParticipantsOG0038
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
OG008
Day 57 Cohort A: TIP, Pooled PBO
LS Mean Diff (SE) vs pooled placebo
-2.1
Standard Error of the Mean
0.87
2-Sided
95
-3.82
-0.36
Other
OG001
OG008
Day 57 Cohort A: TIP/PBO, Pooled PBO
LS Mean Diff (SE) vs pooled placebo
-0.5
Standard Error of the Mean
0.88
2-Sided
95
-2.21
1.29
Other
OG002
OG008
Day 57 Cohort B: TIP, Pooled PBO
LS Mean Diff (SE) vs pooled placebo
-1.9
Standard Error of the Mean
0.99
2-Sided
95
-3.87
0.08
Other
OG003
OG008
Day 57 Cohort B: TIP/PBO, Pooled PBO
LS Mean Diff (SE) vs pooled placebo
-1.6
Standard Error of the Mean
0.88
2-Sided
95
-3.34
0.16
Other
OG004
OG008
Day 57 Cohort C: TIP, Pooled PBO
LS Mean Diff (SE) vs pooled placebo
-3.9
Standard Error of the Mean
0.82
2-Sided
95
-5.50
-2.22
Other
OG005
OG008
Day 57 Cohort C: TIP/PBO, Pooled PBO
LS Mean Diff (SE) vs pooled placebo
-1.4
Standard Error of the Mean
0.92
2-Sided
95
-3.26
0.41
Other
OG006
OG008
Day 57: Pooled TIP, Pooled PBO
LS Mean Diff (SE) vs pooled placebo
-2.6
Standard Error of the Mean
0.68
2-Sided
95
-3.98
-1.25
Other
OG007
OG008
Day 57: Pooled TIP/PBO, Pooled PBO
LS Mean Diff (SE) vs pooled placebo
-1.2
Standard Error of the Mean
0.67
2-Sided
95
-2.50
0.19
Other
OG000
OG008
Day 85 Cohort A: TIP, Pooled PBO
LS Mean Diff (SE) vs pooled placebo
-2.2
Standard Error of the Mean
0.90
2-Sided
95
-4.00
-0.38
Other
OG001
OG008
Day 85 Cohort A: TIP/PBO, Pooled PBO
LS Mean Diff (SE) vs pooled placebo
-1.8
Standard Error of the Mean
0.99
2-Sided
95
-3.81
0.13
Other
OG002
OG008
Day 85 Cohort B: TIP, Pooled PBO
LS Mean Diff (SE) vs pooled placebo
-2.7
Standard Error of the Mean
1.11
2-Sided
95
-4.96
-0.53
Other
OG003
OG008
Day 85 Cohort B: TIP/PBO, Pooled PBO
LS Mean Diff (SE) vs pooled placebo
-3.6
Standard Error of the Mean
0.93
2-Sided
95
-5.44
-1.73
Other
OG004
OG008
Day 85 Cohort C: TIP, Pooled PBO
LS Mean Diff (SE) vs pooled placebo
-3.0
Standard Error of the Mean
0.96
2-Sided
95
-4.90
-1.07
Other
OG005
OG008
Day 85 Cohort C: TIP/PBO, Pooled PBO
LS Mean Diff (SE) vs pooled placebo
-2.6
Standard Error of the Mean
1.03
2-Sided
95
-4.66
-0.53
Other
OG006
OG008
Day 85: Pooled TIP, Pooled PBO
LS Mean Diff (SE) vs pooled placebo
-2.6
Standard Error of the Mean
0.74
2-Sided
95
-4.11
-1.17
Other
OG007
OG008
Day 85: Pooled TIP/PBO, Pooled PBO
LS Mean Diff (SE) vs pooled placebo
-2.7
Standard Error of the Mean
0.72
2-Sided
95
-4.12
-1.23
Other
OG000
OG008
Day 113 Cohort A: TIP, Pooled PBO
LS Mean Diff (SE) vs pooled placebo
-2.8
Standard Error of the Mean
0.87
2-Sided
95
-4.55
-1.08
Other
OG001
OG008
Day 113 Cohort A: TIP/PBO, Pooled PBO
LS Mean Diff (SE) vs pooled placebo
0.1
Standard Error of the Mean
0.83
2-Sided
95
-1.61
1.71
Other
OG002
OG008
Day 113 Cohort B: TIP, Pooled PBO
LS Mean Diff (SE) vs pooled placebo
-2.6
Standard Error of the Mean
1.16
2-Sided
95
-4.93
-0.29
Other
OG003
OG008
Day 113 Cohort B: TIP/PBO, Pooled PBO
LS Mean Diff (SE) vs pooled placebo
-1.9
Standard Error of the Mean
0.84
2-Sided
95
-3.62
-0.25
Other
OG004
OG008
Day 113 Cohort C: TIP, Pooled PBO
LS Mean Diff (SE) vs pooled placebo
-3.1
Standard Error of the Mean
0.91
2-Sided
95
-4.94
-1.30
Other
OG005
OG008
Day 113 Cohort C: TIP/PBO, Pooled PBO
LS Mean Diff (SE) vs pooled placebo
-2.4
Standard Error of the Mean
0.98
2-Sided
95
-4.37
-0.43
Other
OG006
OG008
Day 113: Pooled TIP, Pooled PBO
LS Mean Diff (SE) vs pooled placebo
-2.8
Standard Error of the Mean
0.70
2-Sided
95
-4.24
-1.45
Other
OG007
OG008
Day 113: Pooled TIP/PBO, Pooled PBO
LS Mean Diff (SE) vs pooled placebo
-1.4
Standard Error of the Mean
0.65
2-Sided
95
-2.73
-0.13
Other
OG000
OG008
EoT Cohort A: TIP, Pooled PBO
LS Mean Diff (SE) vs pooled placebo
-2.2
Standard Error of the Mean
0.73
2-Sided
95
-3.64
-0.73
Other
OG001
OG008
EoT Cohort A: TIP/PBO, Pooled PBO
LS Mean Diff (SE) vs pooled placebo
-0.1
Standard Error of the Mean
0.76
2-Sided
95
-1.61
1.43
Other
OG002
OG008
EoT Cohort B: TIP, Pooled PBO
LS Mean Diff (SE) vs pooled placebo
-1.3
Standard Error of the Mean
0.77
2-Sided
95
-2.81
0.25
Other
OG003
OG008
EoT Cohort B: TIP/PBO, Pooled PBO
LS Mean Diff (SE) vs pooled placebo
-1.7
Standard Error of the Mean
0.73
2-Sided
95
-3.14
-0.22
Other
OG004
OG008
EoT Cohort C: TIP, Pooled PBO
LS Mean Diff (SE) vs pooled placebo
-2.4
Standard Error of the Mean
0.73
2-Sided
95
-3.89
-0.98
Other
OG005
OG008
EoT Cohort C: TIP/PBO, Pooled PBO
LS Mean Diff (SE) vs pooled placebo
-1.7
Standard Error of the Mean
0.73
2-Sided
95
-3.12
-0.22
Other
OG006
OG008
EoT: Pooled TIP, Pooled PBO
LS Mean Diff (SE) vs pooled placebo
-2.0
Standard Error of the Mean
0.56
2-Sided
95
-3.08
-0.85
Other
OG007
OG008
EoT: Pooled TIP/PBO, Pooled PBO
LS Mean Diff (SE) vs pooled placebo
-1.1
Standard Error of the Mean
0.56
2-Sided
95
-2.25
-0.04
Other
OG000
OG008
Day 141 Cohort A: TIP, Pooled PBO
LS Mean Diff (SE) vs pooled placebo
-0.8
Standard Error of the Mean
0.91
2-Sided
95
-2.63
0.99
Other
OG001
OG008
Day 141 Cohort A: TIP/PBO, Pooled PBO
LS Mean Diff (SE) vs pooled placebo
0.1
Standard Error of the Mean
0.95
2-Sided
95
-1.83
1.98
Other
OG002
OG008
Day 141 Cohort B: TIP, Pooled PBO
LS Mean Diff (SE) vs pooled placebo
0.2
Standard Error of the Mean
1.11
2-Sided
95
-2.03
2.41
Other
OG003
OG008
Day 141 Cohort B: TIP/PBO, Pooled PBO
LS Mean Diff (SE) vs pooled placebo
-1.8
Standard Error of the Mean
0.92
2-Sided
95
-3.68
-0.01
Other
OG004
OG008
Day 141 Cohort C (4 capsules b.i.d.): TIP, Pooled PBO
LS Mean Diff (SE) vs pooled placebo
-0.9
Standard Error of the Mean
0.96
2-Sided
95
-2.78
1.07
Other
OG005
OG008
Day 141 Cohort C: TIP/PBO, Pooled PBO
LS Mean Diff (SE) vs pooled placebo
-1.2
Standard Error of the Mean
1.06
2-Sided
95
-3.36
0.89
Other
OG006
OG008
Day 141: Pooled TIP, Pooled PBO
LS Mean Diff (SE) vs pooled placebo
-0.5
Standard Error of the Mean
0.74
2-Sided
95
-1.97
0.98
Other
OG007
OG008
Day 141: Pooled TIP/PBO, Pooled PBO
LS Mean Diff (SE) vs pooled placebo
-1.0
Standard Error of the Mean
0.73
2-Sided
95
-2.45
0.45
Other
OG000
OG008
Day 169 Cohort A: TIP, Pooled PBO
LS Mean Diff (SE) vs pooled placebo
-1.3
Standard Error of the Mean
0.96
2-Sided
95
-3.24
0.61
Other
OG001
OG008
Day 169 Cohort A: TIP/PBO, Pooled PBO
LS Mean Diff (SE) vs pooled placebo
-1.1
Standard Error of the Mean
0.99
2-Sided
95
-3.05
0.91
Other
OG002
OG008
Day 169 Cohort B: TIP, Pooled PBO
LS Mean Diff (SE) vs pooled placebo
-0.6
Standard Error of the Mean
1.09
2-Sided
95
-2.73
1.62
Other
OG003
OG008
Day 169 Cohort B: TIP/PBO, Pooled PBO
LS Mean Diff (SE) vs pooled placebo
-2.1
Standard Error of the Mean
1.03
2-Sided
95
-4.22
-0.08
Other
OG004
OG008
Day 169 Cohort C: TIP, Pooled PBO
LS Mean Diff (SE) vs pooled placebo
-0.2
Standard Error of the Mean
1.14
2-Sided
95
-2.48
2.10
Other
OG005
OG008
Day 169 Cohort C: TIP/PBO, Pooled PBO
LS Mean Diff (SE) vs pooled placebo
-0.1
Standard Error of the Mean
1.12
2-Sided
95
-2.33
2.13
Other
OG006
OG008
Day 169: Pooled TIP, Pooled PBO
LS Mean Diff (SE) vs pooled placebo
-0.7
Standard Error of the Mean
0.77
2-Sided
95
-2.24
0.86
Other
OG007
OG008
Day 169: Pooled TIP/PBO, Pooled PBO
LS Mean Diff (SE) vs pooled placebo
-1.1
Standard Error of the Mean
0.75
2-Sided
95
-2.61
0.40
Other
Cohort B (5 capsules o.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
OG004
Cohort C (4 Capsules b.i.d.): TIP
Cohort C (4 capsules b.i.d.): Tobramycin inhalation powder (TIP)
OG005
Cohort C (4 Capsules b.i.d.): TIP/PBO
Cohort C (4 capsules b.i.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
OG006
Pooled TIP
Pooled Tobramycin inhalation powder (TIP): For efficacy analysis, subjects assigned to TIP groups were pooled across the 3 cohorts.
OG007
Pooled TIP/PBO
Pooled Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical: For efficacy analysis, subjects assigned to TIP/PBO groups were pooled across the 3 cohorts.
OG008
Pooled PBO
Pooled inhaled placebo (PBO): For efficacy analysis, subjects assigned to Placebo groups were pooled across the 3 cohorts, as the number of placebo capsules was not expected to impact the efficacy assessments.
Units
Counts
Participants
OG00014
OG00113
OG00215
OG00314
OG00415
OG00515
OG00644
OG00742
OG00821
Title
Denominators
Categories
Overall
ParticipantsOG0006
ParticipantsOG0014
ParticipantsOG0025
ParticipantsOG0035
ParticipantsOG0044
ParticipantsOG0056
ParticipantsOG00615
ParticipantsOG00715
ParticipantsOG00810
Title
Measurements
OG000NA(39.00 to NA)NA: Not estimable due to insufficient number of participants with events
OG001NA(48.00 to NA)NA: Not estimable due to insufficient number of participants with events
OG002NA(15.00 to NA)NA: Not estimable due to insufficient number of participants with events
OG003
Oral
ParticipantsOG0002
ParticipantsOG0014
ParticipantsOG0023
ParticipantsOG0034
Parenteral
ParticipantsOG0004
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0032
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
OG008
Overall Cohort A: TIP, Pooled PBO
Hazard Ratio (HR)
1.14
2-Sided
95
0.14
3.18
Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.
Other
OG001
OG008
Overall Cohort A: TIP/PBO, Pooled PBO
Hazard Ratio (HR)
0.57
2-Sided
95
0.18
1.85
Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.
Other
OG002
OG008
Overall Cohort B: TIP, Pooled PBO
Hazard Ratio (HR)
1.26
2-Sided
95
0.42
3.77
Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.
Other
OG003
OG008
Overall Cohort B: TIP/PBO, Pooled PBO
Hazard Ratio (HR)
0.61
2-Sided
95
0.20
1.83
Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.
Other
OG004
OG008
Overall Cohort C: TIP, Pooled PBO
Hazard Ratio (HR)
0.67
2-Sided
95
0.21
2.17
Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.
Other
OG005
OG008
Overall Cohort C: TIP/PBO, Pooled PBO
Hazard Ratio (HR)
1.27
2-Sided
95
0.44
3.62
Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.
Other
OG006
OG008
Overall Pooled TIP, Pooled PBO
Hazard Ratio (HR)
0.99
2-Sided
95
0.44
2.23
Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.
Other
OG007
OG008
Overall Pooled TIP/PBO, Pooled PBO
Hazard Ratio (HR)
0.76
2-Sided
95
0.34
1.71
Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.
Other
OG000
OG008
Oral Cohort A: TIP, Pooled PBO
Hazard Ratio (HR)
0.39
2-Sided
95
0.08
1.83
Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.
Other
OG001
OG008
Oral Cohort A: TIP/PBO, Pooled PBO
Hazard Ratio (HR)
0.85
2-Sided
95
0.25
2.89
Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.
Other
OG002
OG008
Oral Cohort B: TIP, Pooled PBO
Hazard Ratio (HR)
0.98
2-Sided
95
0.25
3.93
Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.
Other
OG003
OG008
Oral Cohort B: TIP/PBO, Pooled PBO
Hazard Ratio (HR)
0.67
2-Sided
95
0.19
2.36
Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.
Other
OG004
OG008
Oral Cohort C: TIP, Pooled PBO
Hazard Ratio (HR)
0.19
2-Sided
95
0.02
1.57
Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.
Other
OG005
OG008
Oral Cohort C: TIP/PBO, Pooled PBO
Hazard Ratio (HR)
0.62
2-Sided
95
0.16
2.41
Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.
Other
OG006
OG008
Oral Pooled TIP, Pooled PBO
Hazard Ratio (HR)
0.42
2-Sided
95
0.13
1.31
Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.
Other
OG007
OG008
Oral Pooled TIP/PBO, Pooled PBO
Hazard Ratio (HR)
0.71
2-Sided
95
0.28
1.80
Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.
Other
OG000
OG008
Parenteral Cohort A: TIP, Pooled PBO
Hazard Ratio (HR)
10.71
2-Sided
95
1.10
104.19
Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.
Other
OG002
OG008
Parenteral Cohort B: TIP, Pooled PBO
Hazard Ratio (HR)
4.62
2-Sided
95
0.41
52.29
Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.
Other
OG003
OG008
Parenteral Cohort B: TIP/PBO, Pooled PBO
Hazard Ratio (HR)
3.23
2-Sided
95
0.28
37.06
Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.
Other
OG004
OG008
Parenteral Cohort C: TIP, Pooled PBO
Hazard Ratio (HR)
1.61
2-Sided
95
0.10
25.94
Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.
Other
OG005
OG008
Parenteral Cohort C: TIP/PBO, Pooled PBO
Hazard Ratio (HR)
11.30
2-Sided
95
1.09
117.34
Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.
Other
OG006
OG008
Parenteral Pooled TIP, Pooled PBO
Hazard Ratio (HR)
4.30
2-Sided
95
0.50
37.32
Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.
Other
OG004
Cohort C (4 Capsules b.i.d.): TIP
Cohort C (4 capsules b.i.d.): Tobramycin inhalation powder (TIP)
OG005
Cohort C (4 Capsules b.i.d.): TIP/PBO
Cohort C (4 capsules b.i.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
OG006
Pooled TIP
Pooled Tobramycin inhalation powder (TIP): For efficacy analysis, subjects assigned to TIP groups were pooled across the 3 cohorts.
OG007
Pooled TIP/PBO
Pooled Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical: For efficacy analysis, subjects assigned to TIP/PBO groups were pooled across the 3 cohorts.
OG008
Pooled PBO
Pooled inhaled placebo (PBO): For efficacy analysis, subjects assigned to Placebo groups were pooled across the 3 cohorts, as the number of placebo capsules was not expected to impact the efficacy assessments.
Units
Counts
Participants
OG00014
OG00113
OG00215
OG00314
OG00415
OG00515
OG00644
OG00742
OG00821
Title
Denominators
Categories
Overall
ParticipantsOG00010
ParticipantsOG0018
ParticipantsOG0026
ParticipantsOG0037
ParticipantsOG0044
ParticipantsOG0058
ParticipantsOG00620
ParticipantsOG00723
ParticipantsOG00813
Title
Measurements
OG00015.7± 6.22
OG00118.0± 8.26
OG00220.2± 6.37
OG003
Oral
ParticipantsOG0002
ParticipantsOG0017
ParticipantsOG0024
ParticipantsOG0035
Parenteral
ParticipantsOG0005
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0032
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
OG008
Overall Cohort A: TIP, Pooled PBO
LS Mean Diff (SE) vs pooled placebo
9.8
Standard Error of the Mean
18.15
2-Sided
95
-27.15
46.81
ANCOVA model includes treatment as a fixed-effect factor and number of pulmonary exacerbations in the 12 months prior to screening as a covariate.
Other
OG001
OG008
Overall Cohort A: TIP/PBO, Pooled PBO
LS Mean Diff (SE) vs pooled placebo
19.8
Standard Error of the Mean
20.81
2-Sided
95
-22.63
62.14
ANCOVA model includes treatment as a fixed-effect factor and number of pulmonary exacerbations in the 12 months prior to screening as a covariate.
Other
OG002
OG008
Overall Cohort B: TIP, Pooled PBO
LS Mean Diff (SE) vs pooled placebo
8.0
Standard Error of the Mean
19.29
2-Sided
95
-31.32
47.26
ANCOVA model includes treatment as a fixed-effect factor and number of pulmonary exacerbations in the 12 months prior to screening as a covariate.
Other
OG003
OG008
Overall Cohort B: TIP/PBO, Pooled PBO
LS Mean Diff (SE) vs pooled placebo
12.7
Standard Error of the Mean
19.24
2-Sided
95
-26.49
51.89
ANCOVA model includes treatment as a fixed-effect factor and number of pulmonary exacerbations in the 12 months prior to screening as a covariate.
Other
OG004
OG008
Overall Cohort C: TIP, Pooled PBO
LS Mean Diff (SE) vs pooled placebo
46.5
Standard Error of the Mean
21.17
2-Sided
95
3.37
89.61
ANCOVA model includes treatment as a fixed-effect factor and number of pulmonary exacerbations in the 12 months prior to screening as a covariate.
Other
OG005
OG008
Overall Cohort C: TIP/PBO, Pooled PBO
LS Mean Diff (SE) vs pooled placebo
3.2
Standard Error of the Mean
18.37
2-Sided
95
-34.21
40.64
ANCOVA model includes treatment as a fixed-effect factor and number of pulmonary exacerbations in the 12 months prior to screening as a covariate.
Other
OG006
OG008
Overall Pooled TIP, Pooled PBO
LS Mean Diff (SE) vs pooled placebo
21.4
Standard Error of the Mean
14.46
2-Sided
95
-8.03
50.89
ANCOVA model includes treatment as a fixed-effect factor and number of pulmonary exacerbations in the 12 months prior to screening as a covariate.
Other
OG007
OG008
Overall Pooled TIP/PBO, Pooled PBO
LS Mean Diff (SE) vs pooled placebo
11.9
Standard Error of the Mean
14.44
2-Sided
95
-17.52
41.29
ANCOVA model includes treatment as a fixed-effect factor and number of pulmonary exacerbations in the 12 months prior to screening as a covariate.
Other
OG003
Cohort B (5 Capsules o.d.): TIP/PBO
Cohort B (5 capsules o.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
OG004
Cohort C (4 Capsules b.i.d.): TIP
Cohort C (4 capsules b.i.d.): Tobramycin inhalation powder (TIP)
OG005
Cohort C (4 Capsules b.i.d.): TIP/PBO
Cohort C (4 capsules b.i.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
OG006
Pooled TIP
Pooled Tobramycin inhalation powder (TIP): For efficacy analysis, subjects assigned to TIP groups were pooled across the 3 cohorts.
OG007
Pooled TIP/PBO
Pooled Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical: For efficacy analysis, subjects assigned to TIP/PBO groups were pooled across the 3 cohorts.
OG008
Pooled PBO
Pooled inhaled placebo (PBO): For efficacy analysis, subjects assigned to Placebo groups were pooled across the 3 cohorts, as the number of placebo capsules was not expected to impact the efficacy assessments.
Units
Counts
Participants
OG00014
OG00113
OG00215
OG00314
OG00415
OG00515
OG00644
OG00742
OG00821
Title
Denominators
Categories
Overall
ParticipantsOG0006
ParticipantsOG0014
ParticipantsOG0025
ParticipantsOG0035
ParticipantsOG0044
ParticipantsOG0056
ParticipantsOG00615
ParticipantsOG00715
ParticipantsOG00810
Title
Measurements
OG0001.71(0.92 to 3.17)
OG0011.39(0.70 to 2.78)
OG0021.29(0.58 to 2.87)
OG003
Oral
ParticipantsOG0002
ParticipantsOG0014
ParticipantsOG0023
ParticipantsOG0034
Parenteral
ParticipantsOG0004
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0032
OG002
Cohort B (5 Capsules o.d.): TIP
Cohort B (5 capsules o.d.): Tobramycin inhalation powder (TIP)
OG003
Cohort B (5 Capsules o.d.): TIP/PBO
Cohort B (5 capsules o.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
OG004
Cohort C (4 Capsules b.i.d.): TIP
Cohort C (4 capsules b.i.d.): Tobramycin inhalation powder (TIP)
OG005
Cohort C (4 Capsules b.i.d.): TIP/PBO
Cohort C (4 capsules b.i.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
OG006
Pooled TIP
Pooled Tobramycin inhalation powder (TIP): For efficacy analysis, subjects assigned to TIP groups were pooled across the 3 cohorts.
OG007
Pooled TIP/PBO
Pooled Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical: For efficacy analysis, subjects assigned to TIP/PBO groups were pooled across the 3 cohorts.
OG008
Pooled PBO
Pooled inhaled placebo (PBO): For efficacy analysis, subjects assigned to Placebo groups were pooled across the 3 cohorts, as the number of placebo capsules was not expected to impact the efficacy assessments.
Units
Counts
Participants
OG00014
OG00113
OG00215
OG00314
OG00415
OG00515
OG00644
OG00742
OG00821
Title
Denominators
Categories
Overall
Title
Measurements
No of participants with no events
OG0008
OG0019
OG00210
OG0039
OG00411
OG0059
OG00629
OG00727
OG00811
No. of participants with 1 event
OG0003
OG0011
OG0024
OG0033
OG004
No. of participants with 2 events
OG0002
OG0012
OG0021
OG0032
OG004
No. of participants with 3 events
OG0001
OG0011
OG0020
OG0030
OG004
Oral
Title
Measurements
No of participants with no events
OG00012
OG0019
OG00212
OG003
Parenteral
Title
Measurements
No of participants with no events
OG00010
OG00113
OG00213
OG003
OG004
Cohort C (4 Capsules b.i.d.): TIP
Cohort C (4 capsules b.i.d.): Tobramycin inhalation powder (TIP)
OG005
Cohort C (4 Capsules b.i.d.): TIP/PBO
Cohort C (4 capsules b.i.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
OG006
Pooled TIP
Pooled Tobramycin inhalation powder (TIP): For efficacy analysis, subjects assigned to TIP groups were pooled across the 3 cohorts.
OG007
Pooled TIP/PBO
Pooled Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical: For efficacy analysis, subjects assigned to TIP/PBO groups were pooled across the 3 cohorts.
OG008
Pooled PBO
Pooled inhaled placebo (PBO): For efficacy analysis, subjects assigned to Placebo groups were pooled across the 3 cohorts, as the number of placebo capsules was not expected to impact the efficacy assessments.
Units
Counts
Participants
OG00014
OG00113
OG00215
OG00314
OG00415
OG00515
OG00644
OG00742
OG00821
Title
Denominators
Categories
Title
Measurements
OG0002
OG0010
OG0021
OG0030
OG0040
OG0052
OG00641
OG00740
OG0080
OG004
Cohort C (4 Capsules b.i.d.): TIP
Cohort C (4 capsules b.i.d.): Tobramycin inhalation powder (TIP)
OG005
Cohort C (4 Capsules b.i.d.): TIP/PBO
Cohort C (4 capsules b.i.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
OG006
Pooled TIP
Pooled Tobramycin inhalation powder (TIP): For efficacy analysis, subjects assigned to TIP groups were pooled across the 3 cohorts.
OG007
Pooled TIP/PBO
Pooled Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical: For efficacy analysis, subjects assigned to TIP/PBO groups were pooled across the 3 cohorts.
OG008
Pooled PBO
Pooled inhaled placebo (PBO): For efficacy analysis, subjects assigned to Placebo groups were pooled across the 3 cohorts, as the number of placebo capsules was not expected to impact the efficacy assessments.
Units
Counts
Participants
OG00014
OG00113
OG00215
OG00314
OG00415
OG00515
OG00644
OG00742
OG00821
Title
Denominators
Categories
Title
Measurements
OG000NA(94.00 to NA)NA: Not estimable due to insufficient number of participants with events
OG001NA(NA to NA)NA: Not estimable due to insufficient number of participants with events
OG002NA(NA to NA)NA: Not estimable due to insufficient number of participants with events
OG003NA(NA to NA)NA: Not estimable due to insufficient number of participants with events
OG004NA(NA to NA)NA: Not estimable due to insufficient number of participants with events
OG005NA(84.00 to NA)NA: Not estimable due to insufficient number of participants with events
OG006NA(NA to NA)NA: Not estimable due to insufficient number of participants with events
OG007NA(NA to NA)NA: Not estimable due to insufficient number of participants with events
OG008NA(NA to NA)NA: Not estimable due to insufficient number of participants with events
OG004
Cohort C (4 Capsules b.i.d.): TIP
Cohort C (4 capsules b.i.d.): Tobramycin inhalation powder (TIP)
OG005
Cohort C (4 Capsules b.i.d.): TIP/PBO
Cohort C (4 capsules b.i.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
OG006
Pooled TIP
Pooled Tobramycin inhalation powder (TIP): For efficacy analysis, subjects assigned to TIP groups were pooled across the 3 cohorts.
OG007
Pooled TIP/PBO
Pooled Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical: For efficacy analysis, subjects assigned to TIP/PBO groups were pooled across the 3 cohorts.
OG008
Pooled PBO
Pooled inhaled placebo (PBO): For efficacy analysis, subjects assigned to Placebo groups were pooled across the 3 cohorts, as the number of placebo capsules was not expected to impact the efficacy assessments.
Units
Counts
Participants
OG00014
OG00113
OG00215
OG00314
OG00415
OG00515
OG00644
OG00742
OG00821
Title
Denominators
Categories
Overall
ParticipantsOG0008
ParticipantsOG0014
ParticipantsOG0026
ParticipantsOG0037
ParticipantsOG0043
ParticipantsOG0057
ParticipantsOG00617
ParticipantsOG00718
ParticipantsOG00812
Title
Measurements
OG000122.00(29.00 to NA)NA: Not estimable due to insufficient number of participants with events
OG001NA(50.00 to NA)NA: Not estimable due to insufficient number of participants with events
OG002116.00(17.00 to NA)NA: Not estimable due to insufficient number of participants with events
OG003
Oral
ParticipantsOG0005
ParticipantsOG0014
ParticipantsOG0025
ParticipantsOG0036
Parenteral
ParticipantsOG0005
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0034
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
OG008
Overall Cohort A: TIP, Pooled PBO
Hazard Ratio (HR)
1.26
2-Sided
95
0.51
3.13
Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.
Other
OG001
OG008
Overall Cohort A: TIP/PBO, Pooled PBO
Hazard Ratio (HR)
0.47
2-Sided
95
0.15
1.46
Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.
Other
OG002
OG008
Overall Cohort B: TIP, Pooled PBO
Hazard Ratio (HR)
1.18
2-Sided
95
0.44
3.21
Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.
Other
OG003
OG008
Overall Cohort B: TIP/PBO, Pooled PBO
Hazard Ratio (HR)
0.83
2-Sided
95
0.32
2.18
Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.
Other
OG004
OG008
Overall Cohort C: TIP, Pooled PBO
Hazard Ratio (HR)
0.35
2-Sided
95
0.10
1.27
Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.
Other
OG005
OG008
Overall Cohort C: TIP/PBO, Pooled PBO
Hazard Ratio (HR)
1.13
2-Sided
95
0.43
2.99
Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.
Other
OG006
OG008
Overall Pooled TIP, Pooled PBO
Hazard Ratio (HR)
0.81
2-Sided
95
0.37
1.76
Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.
Other
OG007
OG008
Overall Pooled TIP/PBO, Pooled PBO
Hazard Ratio (HR)
0.76
2-Sided
95
0.36
1.61
Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.
Other
OG000
OG008
Oral Cohort A: TIP, Pooled PBO
Hazard Ratio (HR)
0.87
2-Sided
95
0.30
2.55
Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.
Other
OG001
OG008
Oral Cohort A: TIP/PBO, Pooled PBO
Hazard Ratio (HR)
0.63
2-Sided
95
0.20
2.03
Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.
Other
OG002
OG008
Oral Cohort B: TIP, Pooled PBO
Hazard Ratio (HR)
1.20
2-Sided
95
0.40
3.60
Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.
Other
OG003
OG008
Oral Cohort B: TIP/PBO, Pooled PBO
Hazard Ratio (HR)
0.89
2-Sided
95
0.31
2.55
Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.
Other
OG004
OG008
Oral Cohort C: TIP, Pooled PBO
Hazard Ratio (HR)
0.28
2-Sided
95
0.06
1.27
Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.
Other
OG005
OG008
Oral Cohort C: TIP/PBO, Pooled PBO
Hazard Ratio (HR)
1.30
2-Sided
95
0.45
3.73
Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.
Other
OG006
OG008
Oral Pooled TIP, Pooled PBO
Hazard Ratio (HR)
0.66
2-Sided
95
0.27
1.60
Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.
Other
OG007
OG008
Oral Pooled TIP/PBO, Pooled PBO
Hazard Ratio (HR)
0.90
2-Sided
95
0.40
2.02
Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.
Other
OG000
OG008
Parenteral Cohort A: TIP, Pooled PBO
Hazard Ratio (HR)
3.72
2-Sided
95
0.84
16.52
Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.
Other
OG002
OG008
Parenteral Cohort B: TIP, Pooled PBO
Hazard Ratio (HR)
1.34
2-Sided
95
0.22
8.16
Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.
Other
OG003
OG008
Parenteral Cohort B: TIP/PBO, Pooled PBO
Hazard Ratio (HR)
2.15
2-Sided
95
0.46
10.05
Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.
Other
OG004
OG008
Parenteral Cohort C: TIP, Pooled PBO
Hazard Ratio (HR)
0.50
2-Sided
95
0.05
4.87
Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.
Other
OG005
OG008
Parenteral Cohort C: TIP/PBO, Pooled PBO
Hazard Ratio (HR)
2.56
2-Sided
95
0.53
12.49
Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.
Other
OG006
OG008
Paremteral Pooled TIP, Pooled PBO
Hazard Ratio (HR)
1.36
2-Sided
95
0.33
5.68
Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.
Other
Cohort C (4 Capsules b.i.d.): TIP
Cohort C (4 capsules b.i.d.): Tobramycin inhalation powder (TIP)
OG005
Cohort C (4 Capsules b.i.d.): TIP/PBO
Cohort C (4 capsules b.i.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
OG006
Pooled TIP
Pooled Tobramycin inhalation powder (TIP): For efficacy analysis, subjects assigned to TIP groups were pooled across the 3 cohorts.
OG007
Pooled TIP/PBO
Pooled Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical: For efficacy analysis, subjects assigned to TIP/PBO groups were pooled across the 3 cohorts.
OG008
Pooled PBO
Pooled inhaled placebo (PBO): For efficacy analysis, subjects assigned to Placebo groups were pooled across the 3 cohorts, as the number of placebo capsules was not expected to impact the efficacy assessments.
Units
Counts
Participants
OG00014
OG00113
OG00215
OG00314
OG00415
OG00515
OG00644
OG00742
OG00821
Title
Denominators
Categories
Overall
Title
Measurements
Any anti-pseudomonal antibiotic use?=Yes
OG0008
OG0014
OG0026
OG0037
OG0043
OG0057
OG00617
OG00718
OG00812
Any anti-pseudomonal antibiotic use?=No
OG0006
OG0019
OG0029
OG0037
OG004
Oral
Title
Measurements
Any anti-pseudomonal antibiotic use?=Yes
OG0005
OG0014
OG0025
OG003
Parenteral
Title
Measurements
Any anti-pseudomonal antibiotic use?=Yes
OG0005
OG0010
OG0022
OG003
Cohort C (4 Capsules b.i.d.): TIP
Cohort C (4 capsules b.i.d.): Tobramycin inhalation powder (TIP)
OG005
Cohort C (4 Capsules b.i.d.): TIP/PBO
Cohort C (4 capsules b.i.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
OG006
Pooled TIP
Pooled Tobramycin inhalation powder (TIP): For efficacy analysis, subjects assigned to TIP groups were pooled across the 3 cohorts.
OG007
Pooled TIP/PBO
Pooled Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical: For efficacy analysis, subjects assigned to TIP/PBO groups were pooled across the 3 cohorts.
OG008
Pooled PBO
Pooled inhaled placebo (PBO): For efficacy analysis, subjects assigned to Placebo groups were pooled across the 3 cohorts, as the number of placebo capsules was not expected to impact the efficacy assessments.
Units
Counts
Participants
OG00014
OG00113
OG00215
OG00314
OG00415
OG00515
OG00644
OG00742
OG00821
Title
Denominators
Categories
Overall
ParticipantsOG0008
ParticipantsOG0014
ParticipantsOG0026
ParticipantsOG0037
ParticipantsOG0043
ParticipantsOG0057
ParticipantsOG00617
ParticipantsOG00718
ParticipantsOG00812
Title
Measurements
OG00018.4± 10.39
OG00120.0± 12.03
OG00219.2± 14.84
OG003
Oral
ParticipantsOG0005
ParticipantsOG0014
ParticipantsOG0025
ParticipantsOG0036
Parenteral
ParticipantsOG0005
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0034
Cohort B (5 capsules o.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
OG004
Cohort C (4 Capsules b.i.d.): TIP
Cohort C (4 capsules b.i.d.): Tobramycin inhalation powder (TIP)
OG005
Cohort C (4 Capsules b.i.d.): TIP/PBO
Cohort C (4 capsules b.i.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
OG006
Pooled TIP
Pooled Tobramycin inhalation powder (TIP): For efficacy analysis, subjects assigned to TIP groups were pooled across the 3 cohorts.
OG007
Pooled TIP/PBO
Pooled Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical: For efficacy analysis, subjects assigned to TIP/PBO groups were pooled across the 3 cohorts.
OG008
Pooled PBO
Pooled inhaled placebo (PBO): For efficacy analysis, subjects assigned to Placebo groups were pooled across the 3 cohorts, as the number of placebo capsules was not expected to impact the efficacy assessments.
Units
Counts
Participants
OG00014
OG00113
OG00215
OG00314
OG00415
OG00515
OG00644
OG00742
OG00821
Title
Denominators
Categories
Title
Measurements
No of participants with 0 event
OG00010
OG00113
OG00213
OG00312
OG00414
OG00511
OG00637
OG00736
OG00819
No. of participants with 1 event
OG0003
OG0010
OG0022
OG0031
OG004
No. of participants with 2 events
OG0000
OG0010
OG0020
OG0030
OG004
No. of participants with > 2 events
OG0001
OG0010
OG0020
OG0031
OG004
Cohort B (5 capsules o.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
OG004
Cohort C (4 Capsules b.i.d.): TIP
Cohort C (4 capsules b.i.d.): Tobramycin inhalation powder (TIP)
OG005
Cohort C (4 Capsules b.i.d.): TIP/PBO
Cohort C (4 capsules b.i.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
OG006
Pooled TIP
Pooled Tobramycin inhalation powder (TIP): For efficacy analysis, subjects assigned to TIP groups were pooled across the 3 cohorts.
OG007
Pooled TIP/PBO
Pooled Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical: For efficacy analysis, subjects assigned to TIP/PBO groups were pooled across the 3 cohorts.
OG008
Pooled PBO
Pooled inhaled placebo (PBO): For efficacy analysis, subjects assigned to Placebo groups were pooled across the 3 cohorts, as the number of placebo capsules was not expected to impact the efficacy assessments.
Units
Counts
Participants
OG0004
OG0010
OG0022
OG0032
OG0041
OG0054
OG0067
OG0076
OG0082
Title
Denominators
Categories
Title
Measurements
OG00015.2± 5.19
OG00222.0± 12.73
OG00312.2± 6.06
OG00411.0± NANA: Not estimable due to insufficient number of participants with events
OG00519.0± 5.23
OG00616.2± 7.05
OG00715.2± 6.44
OG00810.5± 0.71
OG004
Cohort C (4 Capsules b.i.d.): TIP
Cohort C (4 capsules b.i.d.): Tobramycin inhalation powder (TIP)
OG005
Cohort C (4 Capsules b.i.d.): TIP/PBO
Cohort C (4 capsules b.i.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
OG006
Pooled TIP
Pooled Tobramycin inhalation powder (TIP): For efficacy analysis, subjects assigned to TIP groups were pooled across the 3 cohorts.
OG007
Pooled TIP/PBO
Pooled Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical: For efficacy analysis, subjects assigned to TIP/PBO groups were pooled across the 3 cohorts.
OG008
Pooled PBO
Pooled inhaled placebo (PBO): For efficacy analysis, subjects assigned to Placebo groups were pooled across the 3 cohorts, as the number of placebo capsules was not expected to impact the efficacy assessments.
Units
Counts
Participants
OG00014
OG00113
OG00215
OG00314
OG00415
OG00515
OG00644
OG00742
OG00821
Title
Denominators
Categories
Title
Measurements
OG0006
OG0010
OG0022
OG0035
OG0042
OG0054
OG00610
OG0079
OG0082
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
OG008
Cohort A (3 capsules o.d.): TIP, Pooled PBO
Odds Ratio, log
5.62
2-Sided
95
0.83
38.18
Generalized linear model assuming the negative binomial distribution including treatment and baseline macrolide use as class-effect factors. The log exposure to study in years is included as an offset variable in the model.
Other
OG002
OG008
Cohort B (5 capsules o.d.): TIP, Pooled PBO
Odds Ratio, log
2.00
2-Sided
95
0.21
19.16
Generalized linear model assuming the negative binomial distribution including treatment and baseline macrolide use as class-effect factors. The log exposure to study in years is included as an offset variable in the model.
Other
OG003
OG008
Cohort B (5 capsules o.d.): TIP/PBO, Pooled PBO
Odds Ratio, log
3.05
2-Sided
95
0.43
21.80
Generalized linear model assuming the negative binomial distribution including treatment and baseline macrolide use as class-effect factors. The log exposure to study in years is included as an offset variable in the model.
Other
OG004
OG008
Cohort C (4 capsules b.i.d.): TIP, Pooled PBO
Odds Ratio, log
1.84
2-Sided
95
0.19
17.42
Generalized linear model assuming the negative binomial distribution including treatment and baseline macrolide use as class-effect factors. The log exposure to study in years is included as an offset variable in the model.
Other
OG005
OG008
Cohort C (4 capsules b.i.d.): TIP/PBO, Pooled PBO
Odds Ratio, log
3.41
2-Sided
95
0.47
25.03
Generalized linear model assuming the negative binomial distribution including treatment and baseline macrolide use as class-effect factors. The log exposure to study in years is included as an offset variable in the model.
Other
OG006
OG008
Odds Ratio, log
2.74
2-Sided
95
0.47
16.07
Generalized linear model assuming the negative binomial distribution including treatment and baseline macrolide use as class-effect factors. The log exposure to study in years is included as an offset variable in the model.
Other
OG004
Cohort C (4 Capsules b.i.d.): TIP
Cohort C (4 capsules b.i.d.): Tobramycin inhalation powder (TIP)
OG005
Cohort C (4 Capsules b.i.d.): TIP/PBO
Cohort C (4 capsules b.i.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
OG006
Pooled TIP
Pooled Tobramycin inhalation powder (TIP): For efficacy analysis, subjects assigned to TIP groups were pooled across the 3 cohorts.
OG007
Pooled TIP/PBO
Pooled Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical: For efficacy analysis, subjects assigned to TIP/PBO groups were pooled across the 3 cohorts.
OG008
Pooled PBO
Pooled inhaled placebo (PBO): For efficacy analysis, subjects assigned to Placebo groups were pooled across the 3 cohorts, as the number of placebo capsules was not expected to impact the efficacy assessments.
Units
Counts
Participants
OG00014
OG00113
OG00215
OG00314
OG00415
OG00515
OG00644
OG00742
OG00821
Title
Denominators
Categories
Title
Measurements
OG000NA(93.00 to NA)NA: Not estimable due to insufficient number of participants with events
OG001NA(NA to NA)NA: Not estimable due to insufficient number of participants with events
OG002NA(60.00 to NA)NA: Not estimable due to insufficient number of participants with events
OG003NA(NA to NA)NA: Not estimable due to insufficient number of participants with events
OG004NA(NA to NA)NA: Not estimable due to insufficient number of participants with events
OG005NA(65.00 to NA)NA: Not estimable due to insufficient number of participants with events
OG006NA(NA to NA)NA: Not estimable due to insufficient number of participants with events
OG007NA(NA to NA)NA: Not estimable due to insufficient number of participants with events
OG008NA(NA to NA)NA: Not estimable due to insufficient number of participants with events
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
OG008
Cohort A (3 capsules o.d.): TIP, Pooled PBO
Hazard Ratio (HR)
4.50
2-Sided
95
0.77
26.42
Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.
Other
OG002
OG008
Cohort B (5 capsules o.d.): TIP, Pooled PBO
Hazard Ratio (HR)
2.00
2-Sided
95
0.28
14.47
Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.
Other
OG003
OG008
Cohort B (5 capsules o.d.): TIP/PBO, Pooled PBO
Hazard Ratio (HR)
1.54
2-Sided
95
0.20
11.60
Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.
Other
OG004
OG008
Cohort C (4 capsules b.i.d.): TIP, Pooled PBO
Hazard Ratio (HR)
0.67
2-Sided
95
0.06
7.49
Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.
Other
OG005
OG008
Cohort C (4 capsules b.i.d.): TIP/PBO, Pooled PBO
Hazard Ratio (HR)
3.81
2-Sided
95
0.62
23.29
Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.
Other
OG006
OG008
Pooled TIP, Pooled PBO
Hazard Ratio (HR)
1.82
2-Sided
95
0.35
9.45
Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.
Other
Cohort B (5 capsules o.d.): Tobramycin inhalation powder (TIP)
OG003
Cohort B (5 Capsules o.d.): TIP/PBO
Cohort B (5 capsules o.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
OG004
Cohort C (4 Capsules b.i.d.): TIP
Cohort C (4 capsules b.i.d.): Tobramycin inhalation powder (TIP)
OG005
Cohort C (4 Capsules b.i.d.): TIP/PBO
Cohort C (4 capsules b.i.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
Units
Counts
Participants
OG00014
OG00113
OG00215
OG00314
OG00415
OG00515
Title
Denominators
Categories
Visit 101 (Day 1)/0-1 hr post dose
ParticipantsOG00012
ParticipantsOG00111
ParticipantsOG00211
ParticipantsOG00311
ParticipantsOG00414
ParticipantsOG00511
Title
Measurements
OG0000.256± 0.144
OG0010.479± 0.47
OG0020.4± 0.259
OG003
Visit 101 (Day 1)/1-2 hr post dose
ParticipantsOG00011
ParticipantsOG00111
ParticipantsOG00211
ParticipantsOG00311
Visit 102 (Day 8)/0-1 hr post dose
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG0031
Visit 102 (Day 8)/1-2 hr post dose
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG0031
Visit 103 (Day 29)/0-1 hr post dose
ParticipantsOG0009
ParticipantsOG00111
ParticipantsOG0028
ParticipantsOG0039
Visit 103 (Day 29)/1-2 hr post dose
ParticipantsOG0009
ParticipantsOG0019
ParticipantsOG0028
ParticipantsOG0038
OG003
Cohort B (5 Capsules o.d.): TIP/PBO
Cohort B (5 capsules o.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
OG004
Cohort C (4 Capsules b.i.d.): TIP
Cohort C (4 capsules b.i.d.): Tobramycin inhalation powder (TIP)
OG005
Cohort C (4 Capsules b.i.d.): TIP/PBO
Cohort C (4 capsules b.i.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
Units
Counts
Participants
OG00014
OG00113
OG00215
OG00314
OG00415
OG00515
Title
Denominators
Categories
Visit 101 (Day 1)/0-1 hr post dose
ParticipantsOG00013
ParticipantsOG00111
ParticipantsOG00210
ParticipantsOG00312
ParticipantsOG00413
ParticipantsOG00511
Title
Measurements
OG0001750± 2160
OG001637± 608
OG0022640± 2680
OG003
Visit 101 (Day 1)/1-2 hr post dose
ParticipantsOG00014
ParticipantsOG00111
ParticipantsOG0028
ParticipantsOG00311
Visit 102 (Day 8)/0-2 hr post dose
ParticipantsOG00014
ParticipantsOG0019
ParticipantsOG0027
ParticipantsOG00311
Visit 102 (Day 8)/5-6 hr post dose
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0031
Visit 103 (Day 29)/5-6 hr post dose
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG0026
ParticipantsOG0037
Visit 104 (Day 57)/3-4 hr post dose
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG0031
Visit 105 (Day 85)/3-4 hr post dose
ParticipantsOG0006
ParticipantsOG0014
ParticipantsOG0022
ParticipantsOG0037
OG003
Cohort B (5 Capsules o.d.): TIP/PBO
Cohort B (5 capsules o.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
OG004
Cohort C (4 Capsules b.i.d.): TIP
Cohort C (4 capsules b.i.d.): Tobramycin inhalation powder (TIP)
OG005
Cohort C (4 Capsules b.i.d.): TIP/PBO
Cohort C (4 capsules b.i.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
OG006
Pooled TIP
Pooled Tobramycin inhalation powder (TIP): For efficacy analysis, subjects assigned to TIP groups were pooled across the 3 cohorts.
OG007
Pooled TIP/PBO
Pooled Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical: For efficacy analysis, subjects assigned to TIP/PBO groups were pooled across the 3 cohorts.
OG008
Pooled PBO
Pooled inhaled placebo (PBO): For efficacy analysis, subjects assigned to Placebo groups were pooled across the 3 cohorts, as the number of placebo capsules was not expected to impact the efficacy assessments.
Units
Counts
Participants
OG00014
OG00113
OG00215
OG00314
OG00415
OG00515
OG00643
OG00742
OG00821
Title
Denominators
Categories
Baseline (BL)
ParticipantsOG00013
ParticipantsOG00113
ParticipantsOG00215
ParticipantsOG00314
ParticipantsOG00415
ParticipantsOG00515
ParticipantsOG00643
ParticipantsOG00742
ParticipantsOG00819
Title
Measurements
OG00051.33± 38.33
OG00160.5± 28.60
OG00245.8± 19.98
OG003
Change from BL at Day 8
ParticipantsOG00013
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00314
Change from BL at Day 29
ParticipantsOG00013
ParticipantsOG00112
ParticipantsOG00210
ParticipantsOG00313
Change from BL at EoT
ParticipantsOG00013
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00314
Change from BL at Day 169
ParticipantsOG00011
ParticipantsOG00112
ParticipantsOG00210
ParticipantsOG00310
OG003
Cohort B (5 Capsules o.d.): TIP/PBO
Cohort B (5 capsules o.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
OG004
Cohort C (4 Capsules b.i.d.): TIP
Cohort C (4 capsules b.i.d.): Tobramycin inhalation powder (TIP)
OG005
Cohort C (4 Capsules b.i.d.): TIP/PBO
Cohort C (4 capsules b.i.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
OG006
Pooled TIP
Pooled Tobramycin inhalation powder (TIP): For efficacy analysis, subjects assigned to TIP groups were pooled across the 3 cohorts.
OG007
Pooled TIP/PBO
Pooled Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical: For efficacy analysis, subjects assigned to TIP/PBO groups were pooled across the 3 cohorts.
OG008
Pooled PBO
Pooled inhaled placebo (PBO): For efficacy analysis, subjects assigned to Placebo groups were pooled across the 3 cohorts, as the number of placebo capsules was not expected to impact the efficacy assessments.
Units
Counts
Participants
OG00014
OG00113
OG00215
OG00314
OG00415
OG00515
OG00643
OG00742
OG00821
Title
Denominators
Categories
Baseline (BL)
ParticipantsOG00013
ParticipantsOG00113
ParticipantsOG00215
ParticipantsOG00314
ParticipantsOG00415
ParticipantsOG00515
ParticipantsOG00643
ParticipantsOG00742
ParticipantsOG00819
Title
Measurements
OG00063.1± 24.28
OG00167.2± 14.26
OG00253.3± 21.68
OG003
Change from BL at Day 8
ParticipantsOG00013
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00314
Change from BL at Day 29
ParticipantsOG00013
ParticipantsOG00112
ParticipantsOG00210
ParticipantsOG00313
Change from BL at EoT
ParticipantsOG00013
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00314
Change from BL at Day 169
ParticipantsOG00011
ParticipantsOG00112
ParticipantsOG00210
ParticipantsOG00310
OG003
Cohort B (5 Capsules o.d.): TIP/PBO
Cohort B (5 capsules o.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
OG004
Cohort C (4 Capsules b.i.d.): TIP
Cohort C (4 capsules b.i.d.): Tobramycin inhalation powder (TIP)
OG005
Cohort C (4 Capsules b.i.d.): TIP/PBO
Cohort C (4 capsules b.i.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
OG006
Pooled TIP
Pooled Tobramycin inhalation powder (TIP): For efficacy analysis, subjects assigned to TIP groups were pooled across the 3 cohorts.
OG007
Pooled TIP/PBO
Pooled Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical: For efficacy analysis, subjects assigned to TIP/PBO groups were pooled across the 3 cohorts.
OG008
Pooled PBO
Pooled inhaled placebo (PBO): For efficacy analysis, subjects assigned to Placebo groups were pooled across the 3 cohorts, as the number of placebo capsules was not expected to impact the efficacy assessments.
Units
Counts
Participants
OG00014
OG00113
OG00215
OG00314
OG00415
OG00515
OG00642
OG00742
OG00821
Title
Denominators
Categories
Baseline (BL)
ParticipantsOG00013
ParticipantsOG00113
ParticipantsOG00214
ParticipantsOG00314
ParticipantsOG00415
ParticipantsOG00515
ParticipantsOG00642
ParticipantsOG00742
ParticipantsOG00819
Title
Measurements
OG00056.4± 22.89
OG00147.9± 17.21
OG00252.4± 21.54
OG003
Change from BL at Day 8
ParticipantsOG00013
ParticipantsOG00112
ParticipantsOG00211
ParticipantsOG00314
Change from BL at Day 29
ParticipantsOG00013
ParticipantsOG00112
ParticipantsOG0029
ParticipantsOG00313
Change from BL at EoT
ParticipantsOG00013
ParticipantsOG00112
ParticipantsOG00211
ParticipantsOG00314
Change from BL at Day 169
ParticipantsOG00011
ParticipantsOG00112
ParticipantsOG0029
ParticipantsOG00310
OG003
Cohort B (5 Capsules o.d.): TIP/PBO
Cohort B (5 capsules o.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
OG004
Cohort C (4 Capsules b.i.d.): TIP
Cohort C (4 capsules b.i.d.): Tobramycin inhalation powder (TIP)
OG005
Cohort C (4 Capsules b.i.d.): TIP/PBO
Cohort C (4 capsules b.i.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
OG006
Pooled TIP
Pooled Tobramycin inhalation powder (TIP): For efficacy analysis, subjects assigned to TIP groups were pooled across the 3 cohorts.
OG007
Pooled TIP/PBO
Pooled Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical: For efficacy analysis, subjects assigned to TIP/PBO groups were pooled across the 3 cohorts.
OG008
Pooled PBO
Pooled inhaled placebo (PBO): For efficacy analysis, subjects assigned to Placebo groups were pooled across the 3 cohorts, as the number of placebo capsules was not expected to impact the efficacy assessments.
Units
Counts
Participants
OG00014
OG00113
OG00215
OG00314
OG00415
OG00515
OG00642
OG00742
OG00821
Title
Denominators
Categories
Baseline (BL)
ParticipantsOG00013
ParticipantsOG00113
ParticipantsOG00214
ParticipantsOG00314
ParticipantsOG00415
ParticipantsOG00515
ParticipantsOG00642
ParticipantsOG00742
ParticipantsOG00818
Title
Measurements
OG00079.5± 14.28
OG00171.2± 18.51
OG00277.4± 17.73
OG003
Change from BL at Day 8
ParticipantsOG00013
ParticipantsOG00112
ParticipantsOG00211
ParticipantsOG00314
Change from BL at Day 29
ParticipantsOG00013
ParticipantsOG00112
ParticipantsOG0029
ParticipantsOG00313
Change from BL at EoT
ParticipantsOG00013
ParticipantsOG00112
ParticipantsOG00211
ParticipantsOG00314
Change from BL at Day 169
ParticipantsOG00011
ParticipantsOG00112
ParticipantsOG0029
ParticipantsOG00310
OG003
Cohort B (5 Capsules o.d.): TIP/PBO
Cohort B (5 capsules o.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
OG004
Cohort C (4 Capsules b.i.d.): TIP
Cohort C (4 capsules b.i.d.): Tobramycin inhalation powder (TIP)
OG005
Cohort C (4 Capsules b.i.d.): TIP/PBO
Cohort C (4 capsules b.i.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
OG006
Pooled TIP
Pooled Tobramycin inhalation powder (TIP): For efficacy analysis, subjects assigned to TIP groups were pooled across the 3 cohorts.
OG007
Pooled TIP/PBO
Pooled Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical: For efficacy analysis, subjects assigned to TIP/PBO groups were pooled across the 3 cohorts.
OG008
Pooled PBO
Pooled inhaled placebo (PBO): For efficacy analysis, subjects assigned to Placebo groups were pooled across the 3 cohorts, as the number of placebo capsules was not expected to impact the efficacy assessments.
Units
Counts
Participants
OG00014
OG00113
OG00215
OG00314
OG00415
OG00515
OG00643
OG00742
OG00821
Title
Denominators
Categories
Baseline (BL)
ParticipantsOG00013
ParticipantsOG00113
ParticipantsOG00215
ParticipantsOG00314
ParticipantsOG00415
ParticipantsOG00515
ParticipantsOG00643
ParticipantsOG00742
ParticipantsOG00819
Title
Measurements
OG00066.2± 19.21
OG00151.3± 22.53
OG00236.5± 21.18
OG003
Change from BL at Day 8
ParticipantsOG00013
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00314
Change from BL at Day 29
ParticipantsOG00013
ParticipantsOG00112
ParticipantsOG00210
ParticipantsOG00313
Change from BL at EoT
ParticipantsOG00013
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00314
Change from BL at Day 169
ParticipantsOG00011
ParticipantsOG00112
ParticipantsOG00210
ParticipantsOG00310
OG003
Cohort B (5 Capsules o.d.): TIP/PBO
Cohort B (5 capsules o.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
OG004
Cohort C (4 Capsules b.i.d.): TIP
Cohort C (4 capsules b.i.d.): Tobramycin inhalation powder (TIP)
OG005
Cohort C (4 Capsules b.i.d.): TIP/PBO
Cohort C (4 capsules b.i.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
OG006
Pooled TIP
Pooled Tobramycin inhalation powder (TIP): For efficacy analysis, subjects assigned to TIP groups were pooled across the 3 cohorts.
OG007
Pooled TIP/PBO
Pooled Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical: For efficacy analysis, subjects assigned to TIP/PBO groups were pooled across the 3 cohorts.
OG008
Pooled PBO
Pooled inhaled placebo (PBO): For efficacy analysis, subjects assigned to Placebo groups were pooled across the 3 cohorts, as the number of placebo capsules was not expected to impact the efficacy assessments.
Units
Counts
Participants
OG00014
OG00113
OG00215
OG00314
OG00415
OG00515
OG00638
OG00733
OG00821
Title
Denominators
Categories
Baseline (BL)
ParticipantsOG00011
ParticipantsOG00110
ParticipantsOG00214
ParticipantsOG00312
ParticipantsOG00413
ParticipantsOG00511
ParticipantsOG00638
ParticipantsOG00733
ParticipantsOG00816
Title
Measurements
OG00067.7± 25.56
OG00168.9± 26.09
OG00264.3± 29.29
OG003
Change from BL at Day 8
ParticipantsOG00010
ParticipantsOG0019
ParticipantsOG00211
ParticipantsOG00312
Change from BL at Day 29
ParticipantsOG00011
ParticipantsOG0018
ParticipantsOG0028
ParticipantsOG00310
Change from BL at EoT
ParticipantsOG00011
ParticipantsOG0019
ParticipantsOG00211
ParticipantsOG00312
Change from BL at Day 169
ParticipantsOG0008
ParticipantsOG0019
ParticipantsOG0028
ParticipantsOG0038
OG003
Cohort B (5 Capsules o.d.): TIP/PBO
Cohort B (5 capsules o.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
OG004
Cohort C (4 Capsules b.i.d.): TIP
Cohort C (4 capsules b.i.d.): Tobramycin inhalation powder (TIP)
OG005
Cohort C (4 Capsules b.i.d.): TIP/PBO
Cohort C (4 capsules b.i.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
OG006
Pooled TIP
Pooled Tobramycin inhalation powder (TIP): For efficacy analysis, subjects assigned to TIP groups were pooled across the 3 cohorts.
OG007
Pooled TIP/PBO
Pooled Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical: For efficacy analysis, subjects assigned to TIP/PBO groups were pooled across the 3 cohorts.
OG008
Pooled PBO
Pooled inhaled placebo (PBO): For efficacy analysis, subjects assigned to Placebo groups were pooled across the 3 cohorts, as the number of placebo capsules was not expected to impact the efficacy assessments.
Units
Counts
Participants
OG00014
OG00113
OG00215
OG00314
OG00415
OG00515
OG00643
OG00742
OG00821
Title
Denominators
Categories
Baseline (BL)
ParticipantsOG00013
ParticipantsOG00113
ParticipantsOG00215
ParticipantsOG00314
ParticipantsOG00415
ParticipantsOG00515
ParticipantsOG00643
ParticipantsOG00742
ParticipantsOG00819
Title
Measurements
OG00041.0± 17.83
OG00135.3± 19.29
OG00233.1± 20.26
OG003
Change from BL at Day 8
ParticipantsOG00013
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00314
Change from BL at Day 29
ParticipantsOG00013
ParticipantsOG00112
ParticipantsOG00210
ParticipantsOG00313
Change from BL at EoT
ParticipantsOG00013
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00314
Change from BL at Day 169
ParticipantsOG00011
ParticipantsOG00112
ParticipantsOG00210
ParticipantsOG00310
OG003
Cohort B (5 Capsules o.d.): TIP/PBO
Cohort B (5 capsules o.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
OG004
Cohort C (4 Capsules b.i.d.): TIP
Cohort C (4 capsules b.i.d.): Tobramycin inhalation powder (TIP)
OG005
Cohort C (4 Capsules b.i.d.): TIP/PBO
Cohort C (4 capsules b.i.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
OG006
Pooled TIP
Pooled Tobramycin inhalation powder (TIP): For efficacy analysis, subjects assigned to TIP groups were pooled across the 3 cohorts.
OG007
Pooled TIP/PBO
Pooled Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical: For efficacy analysis, subjects assigned to TIP/PBO groups were pooled across the 3 cohorts.
OG008
Pooled PBO
Pooled inhaled placebo (PBO): For efficacy analysis, subjects assigned to Placebo groups were pooled across the 3 cohorts, as the number of placebo capsules was not expected to impact the efficacy assessments.
Units
Counts
Participants
OG00014
OG00113
OG00215
OG00314
OG00415
OG00515
OG00643
OG00742
OG00821
Title
Denominators
Categories
Baseline (BL)
ParticipantsOG00013
ParticipantsOG00113
ParticipantsOG00215
ParticipantsOG00314
ParticipantsOG00415
ParticipantsOG00515
ParticipantsOG00643
ParticipantsOG00742
ParticipantsOG00819
Title
Measurements
OG00056.0± 13.05
OG00153.8± 18.12
OG00256.8± 17.63
OG003
Change from BL at Day 8
ParticipantsOG00013
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00314
Change from BL at Day 29
ParticipantsOG00013
ParticipantsOG00112
ParticipantsOG00210
ParticipantsOG00313
Change from BL at EoT
ParticipantsOG00013
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00314
Change from BL at Day 169
ParticipantsOG00011
ParticipantsOG00112
ParticipantsOG00210
ParticipantsOG00310
1 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0051 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0061 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
1 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0061 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
2 affected
15 at risk
EG0041 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0073 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0081 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0061 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0061 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0061 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0041 affected14 at risk
EG0050 affected7 at risk
EG0061 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0041 affected14 at risk
EG0051 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0041 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0071 affected15 at risk
EG0080 affected7 at risk
1 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0071 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0081 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0061 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0061 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0081 affected7 at risk
1 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0051 affected7 at risk
EG0061 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
1 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
1 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0041 affected14 at risk
EG0051 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0081 affected7 at risk
1 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0071 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0071 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
1 affected
15 at risk
EG0041 affected14 at risk
EG0050 affected7 at risk
EG0062 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0042 affected14 at risk
EG0051 affected7 at risk
EG0061 affected15 at risk
EG0070 affected15 at risk
EG0081 affected7 at risk
1 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
1 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0041 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0051 affected7 at risk
EG0061 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0071 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0041 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0041 affected14 at risk
EG0051 affected7 at risk
EG0062 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0072 affected15 at risk
EG0080 affected7 at risk
2 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0061 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
1 affected
15 at risk
EG0043 affected14 at risk
EG0052 affected7 at risk
EG0062 affected15 at risk
EG0070 affected15 at risk
EG0081 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0061 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0051 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0041 affected14 at risk
EG0050 affected7 at risk
EG0062 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0061 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0041 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
1 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0071 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0061 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0081 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
1 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
3 affected
15 at risk
EG0045 affected14 at risk
EG0052 affected7 at risk
EG0064 affected15 at risk
EG0075 affected15 at risk
EG0082 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0061 affected15 at risk
EG0070 affected15 at risk
EG0081 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0071 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0071 affected15 at risk
EG0080 affected7 at risk
1 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
1 affected
15 at risk
EG0042 affected14 at risk
EG0051 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0041 affected14 at risk
EG0051 affected7 at risk
EG0060 affected15 at risk
EG0071 affected15 at risk
EG0081 affected7 at risk
0 affected
15 at risk
EG0041 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0061 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0061 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0071 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0041 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0071 affected15 at risk
EG0080 affected7 at risk
1 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0071 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0072 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0061 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0051 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0071 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0071 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0071 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0041 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
1 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0061 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
1 affected
15 at risk
EG0041 affected14 at risk
EG0050 affected7 at risk
EG0066 affected15 at risk
EG0071 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
1 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
2 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0062 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0041 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0041 affected14 at risk
EG0050 affected7 at risk
EG0061 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0061 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
1 affected
15 at risk
EG0041 affected14 at risk
EG0050 affected7 at risk
EG0061 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0061 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0051 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
1 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
1 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0061 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0071 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0061 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0062 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0081 affected7 at risk
1 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0041 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0041 affected14 at risk
EG0051 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
1 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0071 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0041 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0081 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0061 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0061 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0051 affected7 at risk
EG0061 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0062 affected15 at risk
EG0070 affected15 at risk
EG0081 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0041 affected14 at risk
EG0050 affected7 at risk
EG0061 affected15 at risk
EG0071 affected15 at risk
EG0081 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0081 affected7 at risk
0 affected
15 at risk
EG0041 affected14 at risk
EG0052 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
1 affected
15 at risk
EG0042 affected14 at risk
EG0051 affected7 at risk
EG0062 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
1 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0051 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0051 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0081 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0081 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0081 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0081 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0071 affected15 at risk
EG0080 affected7 at risk
1 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0071 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0081 affected7 at risk
0 affected
15 at risk
EG0041 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0071 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0071 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0061 affected15 at risk
EG0073 affected15 at risk
EG0080 affected7 at risk
4 affected
15 at risk
EG0042 affected14 at risk
EG0051 affected7 at risk
EG0062 affected15 at risk
EG0072 affected15 at risk
EG0083 affected7 at risk
0 affected
15 at risk
EG0041 affected14 at risk
EG0050 affected7 at risk
EG0063 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
1 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0061 affected15 at risk
EG0072 affected15 at risk
EG0080 affected7 at risk
3 affected
15 at risk
EG0042 affected14 at risk
EG0052 affected7 at risk
EG0064 affected15 at risk
EG0072 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0041 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0081 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0071 affected15 at risk
EG0080 affected7 at risk
1 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0061 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0042 affected14 at risk
EG0053 affected7 at risk
EG0060 affected15 at risk
EG0072 affected15 at risk
EG0081 affected7 at risk
1 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0061 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0051 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0061 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0042 affected14 at risk
EG0051 affected7 at risk
EG0062 affected15 at risk
EG0070 affected15 at risk
EG0081 affected7 at risk
0 affected
15 at risk
EG0041 affected14 at risk
EG0051 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0061 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0041 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0051 affected7 at risk
EG0061 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0041 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0073 affected15 at risk
EG0081 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0071 affected15 at risk
EG0080 affected7 at risk
1 affected
15 at risk
EG0040 affected14 at risk
EG0051 affected7 at risk
EG0061 affected15 at risk
EG0072 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0041 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
1 affected
15 at risk
EG0040 affected14 at risk
EG0051 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0041 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0061 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0071 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0071 affected15 at risk
EG0080 affected7 at risk
0 affected
15 at risk
EG0040 affected14 at risk
EG0050 affected7 at risk
EG0060 affected15 at risk
EG0071 affected15 at risk
EG0080 affected7 at risk
1 affected
15 at risk
EG0040 affected14 at risk
EG0051 affected7 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected7 at risk
-3.98
± 1.865
OG004-4.54± 1.283
OG005-3.47± 1.583
OG006-3.30± 1.937
OG007-3.58± 1.878
OG008-0.72± 1.765
-3.57
± 2.218
OG004-4.36± 1.101
OG005-2.58± 2.871
OG006-2.98± 2.474
OG007-2.96± 2.618
OG0080.05± 1.518
6.98
± 1.804
OG0046.79± 0.908
OG0055.73± 1.885
OG0066.57± 1.625
OG0076.74± 1.892
OG0087.09± 2.012
ParticipantsOG00413
ParticipantsOG00510
ParticipantsOG00632
ParticipantsOG00732
ParticipantsOG00817
Title
Measurements
OG000-1.72± 3.066
OG001-0.72± 2.677
OG002-0.90± 1.894
OG003-1.62± 2.804
OG004-3.53± 2.220
OG005-0.49± 2.305
OG006-2.25± 2.646
OG007-0.96± 2.576
OG0080.20± 1.408
ParticipantsOG0049
ParticipantsOG0058
ParticipantsOG00626
ParticipantsOG00727
ParticipantsOG00817
Title
Measurements
OG000-2.47± 2.446
OG001-2.94± 2.492
OG002-2.81± 3.653
OG003-3.88± 2.470
OG004-3.08± 1.624
OG005-2.00± 2.951
OG006-2.76± 2.446
OG007-3.01± 2.641
OG008-0.36± 2.238
ParticipantsOG0047
ParticipantsOG0056
ParticipantsOG00619
ParticipantsOG00725
ParticipantsOG00816
Title
Measurements
OG000-2.94± 1.977
OG001-1.03± 2.002
OG002-1.82± 2.331
OG003-1.99± 3.020
OG004-3.17± 2.378
OG005-1.54± 3.534
OG006-2.79± 2.141
OG007-1.50± 2.707
OG008-0.20± 1.513
ParticipantsOG00412
ParticipantsOG00513
ParticipantsOG00635
ParticipantsOG00736
ParticipantsOG00821
Title
Measurements
OG000-2.49± 1.896
OG001-1.08± 1.907
OG002-0.84± 1.766
OG003-1.86± 2.607
OG004-2.60± 2.531
OG005-1.29± 3.300
OG006-2.01± 2.192
OG007-1.42± 2.650
OG008-0.34± 1.445
ParticipantsOG0049
ParticipantsOG0057
ParticipantsOG00626
ParticipantsOG00729
ParticipantsOG00817
Title
Measurements
OG000-0.90± 2.113
OG001-0.82± 2.117
OG0020.10± 1.551
OG003-2.17± 2.863
OG004-0.92± 2.385
OG005-0.87± 3.640
OG006-0.68± 2.067
OG007-1.34± 2.793
OG008-0.06± 2.191
ParticipantsOG0046
ParticipantsOG0057
ParticipantsOG00623
ParticipantsOG00725
ParticipantsOG00818
Title
Measurements
OG000-0.62± 2.324
OG001-1.19± 1.885
OG0020.46± 1.651
OG003-1.27± 2.684
OG0040.62± 1.038
OG0051.33± 4.219
OG0060.03± 1.882
OG007-0.51± 3.036
OG0080.62± 2.694
NA
(85.00 to NA)
NA: Not estimable due to insufficient number of participants with events
OG004NA(127.00 to NA)NA: Not estimable due to insufficient number of participants with events
OG005NA(24.00 to NA)NA: Not estimable due to insufficient number of participants with events
OG006NA(127.00 to NA)NA: Not estimable due to insufficient number of participants with events
OG007NA(85.00 to NA)NA: Not estimable due to insufficient number of participants with events
OG008173.00(77.00 to NA)NA: Not estimable due to insufficient number of participants with events
Participants
OG004
1
ParticipantsOG0053
ParticipantsOG0066
ParticipantsOG00711
ParticipantsOG0088
Title
Measurements
OG000NA(NA to NA)NA: Not estimable due to insufficient number of participants with events
OG001NA(48.00 to NA)NA: Not estimable due to insufficient number of participants with events
OG002NA(22.00 to NA)NA: Not estimable due to insufficient number of participants with events
OG003NA(85.00 to NA)NA: Not estimable due to insufficient number of participants with events
OG004NA(NA to NA)NA: Not estimable due to insufficient number of participants with events
OG005NA(84.00 to NA)NA: Not estimable due to insufficient number of participants with events
OG006NA(NA to NA)NA: Not estimable due to insufficient number of participants with events
OG007NA(NA to NA)NA: Not estimable due to insufficient number of participants with events
OG008173.00(106.00 to NA)NA: Not estimable due to insufficient number of participants with events
Participants
OG004
1
ParticipantsOG0054
ParticipantsOG0067
ParticipantsOG0076
ParticipantsOG0081
Title
Measurements
OG000NA(110.00 to NA)NA: Not estimable due to insufficient number of participants with events
OG002NA(60.00 to NA)NA: Not estimable due to insufficient number of participants with events
OG003NA(154.00 to NA)NA: Not estimable due to insufficient number of participants with events
OG004NA(NA to NA)NA: Not estimable due to insufficient number of participants with events
OG005NA(33.00 to NA)NA: Not estimable due to insufficient number of participants with events
OG006NA(NA to NA)NA: Not estimable due to insufficient number of participants with events
OG007NA(NA to NA)NA: Not estimable due to insufficient number of participants with events
OG008NA(NA to NA)NA: Not estimable due to insufficient number of participants with events
10.3
± 5.12
OG00425.5± 27.09
OG00514.8± 6.73
OG00619.0± 12.64
OG00715.2± 7.39
OG00814.5± 5.61
Participants
OG004
1
ParticipantsOG0053
ParticipantsOG0067
ParticipantsOG00715
ParticipantsOG00811
Title
Measurements
OG00019.5± 12.02
OG00115.4± 4.24
OG00219.3± 3.20
OG0038.3± 4.16
OG00414.0± NANA: Not estimable due to insufficient number of participants with events
OG00516.3± 5.51
OG00618.6± 5.77
OG00714.0± 5.24
OG00815.6± 5.75
Participants
OG004
1
ParticipantsOG0054
ParticipantsOG0068
ParticipantsOG0076
ParticipantsOG0081
Title
Measurements
OG00015.0± 5.52
OG00222.0± 12.73
OG00316.0± NANA: Not estimable due to insufficient number of participants with events
OG00466.0± NANA: Not estimable due to insufficient number of participants with events
OG00516.8± 4.86
OG00623.1± 18.73
OG00716.6± 4.22
OG00810.0± NANA: Not estimable due to insufficient number of participants with events
1.20
(0.57 to 2.51)
OG0040.66(0.25 to 1.76)
OG0051.46(0.73 to 2.93)
OG0061.21(0.78 to 1.87)
OG0071.35(0.90 to 2.03)
OG0081.41(0.82 to 2.42)
Participants
OG004
1
ParticipantsOG0053
ParticipantsOG0066
ParticipantsOG00711
ParticipantsOG0088
Title
Measurements
OG0000.34(0.09 to 1.37)
OG0011.22(0.58 to 2.56)
OG0020.86(0.32 to 2.29)
OG0030.85(0.36 to 2.05)
OG0040.16(0.02 to 1.17)
OG0050.55(0.18 to 1.70)
OG0060.42(0.20 to 0.89)
OG0070.88(0.53 to 1.46)
OG0081.19(0.66 to 2.15)
Participants
OG004
1
ParticipantsOG0054
ParticipantsOG0067
ParticipantsOG0076
ParticipantsOG0081
Title
Measurements
OG0000.85(0.36 to 2.05)
OG0020.43(0.11 to 1.72)
OG0030.34(0.09 to 1.37)
OG0040.16(0.02 to 1.17)
OG0050.73(0.27 to 1.95)
OG0060.48(0.24 to 0.96)
OG0070.35(0.16 to 0.78)
OG0080.11(0.02 to 0.77)
4
OG0054
OG00611
OG0078
OG0087
0
OG0052
OG0063
OG0076
OG0083
0
OG0050
OG0061
OG0071
OG0080
10
OG00414
OG00512
OG00638
OG00731
OG00813
No. of participants with 1 event
OG0002
OG0012
OG0022
OG0033
OG0041
OG0053
OG0065
OG0078
OG0085
No. of participants with 2 events
OG0000
OG0011
OG0021
OG0031
OG0040
OG0050
OG0061
OG0072
OG0083
No. of participants with 3 events
OG0000
OG0011
OG0020
OG0030
OG0040
OG0050
OG0060
OG0071
OG0080
12
OG00414
OG00511
OG00637
OG00736
OG00820
No. of participants with 1 event
OG0003
OG0010
OG0022
OG0032
OG0041
OG0054
OG0066
OG0076
OG0081
No. of participants with 2 events
OG0001
OG0010
OG0020
OG0030
OG0040
OG0050
OG0061
OG0070
OG0080
No. of participants with 3 events
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
161.00
(58.00 to NA)
NA: Not estimable due to insufficient number of participants with events
OG004NA(127.00 to NA)NA: Not estimable due to insufficient number of participants with events
OG005NA(11.00 to NA)NA: Not estimable due to insufficient number of participants with events
OG006NA(110.00 to NA)NA: Not estimable due to insufficient number of participants with events
OG007NA(84.00 to NA)NA: Not estimable due to insufficient number of participants with events
OG008141.00(57.00 to NA)NA: Not estimable due to insufficient number of participants with events
Participants
OG004
2
ParticipantsOG0056
ParticipantsOG00612
ParticipantsOG00716
ParticipantsOG00810
Title
Measurements
OG000NA(43.00 to NA)NA: Not estimable due to insufficient number of participants with events
OG001NA(50.00 to NA)NA: Not estimable due to insufficient number of participants with events
OG002NA(17.00 to NA)NA: Not estimable due to insufficient number of participants with events
OG003NA(85.00 to NA)NA: Not estimable due to insufficient number of participants with events
OG004NA(NA to NA)NA: Not estimable due to insufficient number of participants with events
OG005NA(11.00 to NA)NA: Not estimable due to insufficient number of participants with events
OG006NA(NA to NA)NA: Not estimable due to insufficient number of participants with events
OG007NA(85.00 to NA)NA: Not estimable due to insufficient number of participants with events
OG008173.00(106.00 to NA)NA: Not estimable due to insufficient number of participants with events
Participants
OG004
1
ParticipantsOG0054
ParticipantsOG0068
ParticipantsOG0078
ParticipantsOG0083
Title
Measurements
OG000NA(105.0 to NA)NA: Not estimable due to insufficient number of participants with events
OG002NA(63.00 to NA)NA: Not estimable due to insufficient number of participants with events
OG003NA(95.00 to NA)NA: Not estimable due to insufficient number of participants with events
OG004NA(NA to NA)NA: Not estimable due to insufficient number of participants with events
OG005NA(37.00 to NA)NA: Not estimable due to insufficient number of participants with events
OG006NA(NA to NA)NA: Not estimable due to insufficient number of participants with events
OG007NA(NA to NA)NA: Not estimable due to insufficient number of participants with events
OG008NA(NA to NA)NA: Not estimable due to insufficient number of participants with events
12
OG0058
OG00627
OG00724
OG0089
6
OG0042
OG0056
OG00612
OG00716
OG00810
Any anti-pseudomonal antibiotic use?=No
OG0009
OG0019
OG00210
OG0038
OG00413
OG0059
OG00632
OG00726
OG00811
4
OG0041
OG0054
OG0068
OG0078
OG0083
Any anti-pseudomonal antibiotic use?=No
OG0009
OG00113
OG00213
OG00310
OG00414
OG00511
OG00636
OG00734
OG00818
25.7
± 13.21
OG00415.3± 10.07
OG00515.7± 10.90
OG00618.1± 11.43
OG00720.6± 12.24
OG00814.6± 8.27
Participants
OG004
2
ParticipantsOG0056
ParticipantsOG00612
ParticipantsOG00716
ParticipantsOG00810
Title
Measurements
OG00014.2± 7.79
OG00119.8± 12.34
OG00215.0± 7.42
OG00314.0± 10.92
OG00420.0± 8.49
OG00510.8± 6.24
OG00615.5± 7.29
OG00714.3± 9.79
OG00813.7± 7.41
Participants
OG004
1
ParticipantsOG0054
ParticipantsOG0068
ParticipantsOG0078
ParticipantsOG0083
Title
Measurements
OG00015.0± 10.02
OG00220.0± 14.14
OG00323.8± 15.20
OG0046.0± NANA: Not estimable due to insufficient number of participants with events
OG00511.3± 2.75
OG00615.1± 10.23
OG00717.5± 12.12
OG00812.7± 7.64
0
OG0054
OG0065
OG0075
OG0082
1
OG0050
OG0061
OG0070
OG0080
0
OG0050
OG0061
OG0071
OG0080
0.441
± 0.273
OG0040.59± 0.37
OG0050.321± 0.21
ParticipantsOG00413
ParticipantsOG00510
Title
Measurements
OG0000.481± 0.287
OG0010.571± 0.349
OG0020.517± 0.392
OG0030.624± 0.322
OG0040.64± 0.338
OG0050.476± 0.295
ParticipantsOG0041
ParticipantsOG0052
Title
Measurements
OG0010± NANA: Not estimable due to insufficient number of participants with events
OG0021.81± NANA: Not estimable due to insufficient number of participants with events
OG0030.258± NANA: Not estimable due to insufficient number of participants with events
OG0041.4± NANA: Not estimable due to insufficient number of participants with events
OG0050.489± 0.257
ParticipantsOG0041
ParticipantsOG0051
Title
Measurements
OG0010.18± NANA: Not estimable due to insufficient number of participants with events
OG0021.67± NANA: Not estimable due to insufficient number of participants with events
OG0030.588± NANA: Not estimable due to insufficient number of participants with events
OG0041.48± NANA: Not estimable due to insufficient number of participants with events
OG0050.447± NANA: Not estimable due to insufficient number of participants with events
ParticipantsOG0049
ParticipantsOG0057
Title
Measurements
OG0000.607± 0.455
OG0010.0718± 0.0498
OG0021.23± 1.08
OG0030.103± 0.0983
OG0041.05± 0.603
OG0050.339± 0.274
ParticipantsOG00410
ParticipantsOG0057
Title
Measurements
OG0000.768± 0.477
OG0010.0818± 0.0972
OG0021.37± 0.647
OG0030.104± 0.096
OG0041.05± 0.622
OG0050.307± 0.24
2020
± 2360
OG0042820± 2250
OG0052060± 1840
ParticipantsOG00410
ParticipantsOG0057
Title
Measurements
OG0001100± 2480
OG001204± 445
OG0021650± 2340
OG0031100± 2310
OG004631± 441
OG005610± 463
ParticipantsOG00411
ParticipantsOG0059
Title
Measurements
OG0001440± 1470
OG0012390± 2730
OG0022460± 761
OG0034290± 3730
OG0041980± 2060
OG0052290± 1560
ParticipantsOG0040
ParticipantsOG0052
Title
Measurements
OG00132.4± NANA: Not estimable due to insufficient number of participants with events
OG0034460± NANA: Not estimable due to insufficient number of participants with events
OG0051200± 51.6
ParticipantsOG0044
ParticipantsOG0057
Title
Measurements
OG000389± 554
OG001136± 258
OG002915± 1450
OG00316.3± 28.6
OG004620± 513
OG005134± 175
ParticipantsOG0040
ParticipantsOG0052
Title
Measurements
OG000198± 138
OG0010± NANA: Not estimable due to insufficient number of participants with events
OG00296.4± NANA: Not estimable due to insufficient number of participants with events
OG0034540± NANA: Not estimable due to insufficient number of participants with events