Trial Outcomes & Findings for Safety and Tolerability Study of 2 Dose Level of Arikayce™ in Patients With Bronchiectasis and Chronic Infection Due to Pseudomonas Aeruginosa. (NCT NCT00775138)
NCT ID: NCT00775138
Last Updated: 2019-07-10
Results Overview
Number of Subjects reporting TEAE in the Arikayce™ groups and the placebo groups during the study. The table shows the events incidents, not the number of participants.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
64 participants
Primary outcome timeframe
Day 1 through 56.
Results posted on
2019-07-10
Participant Flow
Participant milestones
| Measure |
Arikayce™ at 280 mg
Study subjects will receive Arikayce™ 280 mg on Days 1-28.
|
Matching Placebo (280 mg)
Study subjects will receive matching placebo on Days 1-28.
|
Arikayce™ at 560 mg
Study subjects will receive Arikayce™ 560 mg on Days 1-28.
|
Matching Placebo (560 mg)
Study subjects will receive matching placebo on Days 1-28.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
24
|
10
|
20
|
10
|
|
Overall Study
COMPLETED
|
24
|
10
|
17
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
3
|
2
|
Reasons for withdrawal
| Measure |
Arikayce™ at 280 mg
Study subjects will receive Arikayce™ 280 mg on Days 1-28.
|
Matching Placebo (280 mg)
Study subjects will receive matching placebo on Days 1-28.
|
Arikayce™ at 560 mg
Study subjects will receive Arikayce™ 560 mg on Days 1-28.
|
Matching Placebo (560 mg)
Study subjects will receive matching placebo on Days 1-28.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
2
|
2
|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Safety and Tolerability Study of 2 Dose Level of Arikayce™ in Patients With Bronchiectasis and Chronic Infection Due to Pseudomonas Aeruginosa.
Baseline characteristics by cohort
| Measure |
Arikayce™ at 280 mg
n=24 Participants
Study subjects will receive Arikayce™ 280 mg on Days 1-28.
|
Matching Placebo (280 mg)
n=10 Participants
Study subjects will receive matching placebo on Days 1-28.
|
Arikayce™ at 560 mg
n=19 Participants
Study subjects will receive Arikayce™ 560 mg on Days 1-28.
|
Matching Placebo (560 mg)
n=9 Participants
Study subjects will receive matching placebo on Days 1-28.
|
Total
n=62 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
49.9 years
STANDARD_DEVIATION 21.1 • n=5 Participants
|
46.8 years
STANDARD_DEVIATION 15.0 • n=7 Participants
|
58.5 years
STANDARD_DEVIATION 16.0 • n=5 Participants
|
52.3 years
STANDARD_DEVIATION 11.1 • n=4 Participants
|
52.4 years
STANDARD_DEVIATION 17.7 • n=21 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Day 1 through 56.Population: Safety population, the same as the mITT population, defined as all randomized patients who received at least 1 dose of study drug.
Number of Subjects reporting TEAE in the Arikayce™ groups and the placebo groups during the study. The table shows the events incidents, not the number of participants.
Outcome measures
| Measure |
Arikace™ 280 mg
n=24 Participants
Study subjects will receive Arikace™ 280 mg on Days 1-28.
|
Matching Placebo (280 mg)
n=10 Participants
Study subjects will receive matching placebo on Days 1-28.
|
Arikace™ 560 mg
n=19 Participants
Study subjects will receive Arikace™ 560 mg on Days 1-28.
|
Matching Placebo (560 mg)
n=9 Participants
Study subjects will receive matching placebo on Days 1-28.
|
|---|---|---|---|---|
|
Number of Participants Reporting Treatment-emergent AEs (TEAEs) up to End of Treatment
Productive Cough
|
2 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants Reporting Treatment-emergent AEs (TEAEs) up to End of Treatment
Bronchial disorder
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Treatment-emergent AEs (TEAEs) up to End of Treatment
Cough
|
1 Participants
|
2 Participants
|
5 Participants
|
0 Participants
|
|
Number of Participants Reporting Treatment-emergent AEs (TEAEs) up to End of Treatment
Haemoptysis
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Treatment-emergent AEs (TEAEs) up to End of Treatment
Pyrexia
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants Reporting Treatment-emergent AEs (TEAEs) up to End of Treatment
Wheezing
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Treatment-emergent AEs (TEAEs) up to End of Treatment
Dyspnoea
|
0 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants Reporting Treatment-emergent AEs (TEAEs) up to End of Treatment
Headache
|
1 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
|
Number of Participants Reporting Treatment-emergent AEs (TEAEs) up to End of Treatment
Nasopharyngitis
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Treatment-emergent AEs (TEAEs) up to End of Treatment
Sneezing
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Treatment-emergent AEs (TEAEs) up to End of Treatment
Agitation
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Treatment-emergent AEs (TEAEs) up to End of Treatment
Aphthous stomatitis
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Treatment-emergent AEs (TEAEs) up to End of Treatment
Arthralgia
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Treatment-emergent AEs (TEAEs) up to End of Treatment
Cervicobrachial syndrome
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Treatment-emergent AEs (TEAEs) up to End of Treatment
Chronic obstructive pulmonary disease
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Treatment-emergent AEs (TEAEs) up to End of Treatment
Dizziness
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Treatment-emergent AEs (TEAEs) up to End of Treatment
Dysgeusia
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Treatment-emergent AEs (TEAEs) up to End of Treatment
Dysphonia
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants Reporting Treatment-emergent AEs (TEAEs) up to End of Treatment
Forced expiratory volume decreased
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Treatment-emergent AEs (TEAEs) up to End of Treatment
Pharyngolaryngeal pain
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Treatment-emergent AEs (TEAEs) up to End of Treatment
Pruritus
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Treatment-emergent AEs (TEAEs) up to End of Treatment
Rash
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Treatment-emergent AEs (TEAEs) up to End of Treatment
Rhinorrhoea
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Treatment-emergent AEs (TEAEs) up to End of Treatment
Sinus bradycardia
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Treatment-emergent AEs (TEAEs) up to End of Treatment
Tinnitus
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Treatment-emergent AEs (TEAEs) up to End of Treatment
Toothache
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Treatment-emergent AEs (TEAEs) up to End of Treatment
Upper respiratory tract infection
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Treatment-emergent AEs (TEAEs) up to End of Treatment
Anorexia
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting Treatment-emergent AEs (TEAEs) up to End of Treatment
Bronchiectasis
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting Treatment-emergent AEs (TEAEs) up to End of Treatment
Fatigue
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting Treatment-emergent AEs (TEAEs) up to End of Treatment
Insomnia
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting Treatment-emergent AEs (TEAEs) up to End of Treatment
Abortion incomplete
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Treatment-emergent AEs (TEAEs) up to End of Treatment
Blood creatinine increased
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Treatment-emergent AEs (TEAEs) up to End of Treatment
Constipation
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Treatment-emergent AEs (TEAEs) up to End of Treatment
Laryngitis
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Treatment-emergent AEs (TEAEs) up to End of Treatment
Lung abscess
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Treatment-emergent AEs (TEAEs) up to End of Treatment
Nausea
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Treatment-emergent AEs (TEAEs) up to End of Treatment
Palpitations
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 through 56.Population: The safety population is the mITT population.
Number of subjects reporting Incidence of clinically significant abnormalities in clinical values (Common Terminology Criteria for Adverse Events \[CTCAE\] grade \>= 3) in Arikayce™ and placebo groups.
Outcome measures
| Measure |
Arikace™ 280 mg
n=24 Participants
Study subjects will receive Arikace™ 280 mg on Days 1-28.
|
Matching Placebo (280 mg)
n=10 Participants
Study subjects will receive matching placebo on Days 1-28.
|
Arikace™ 560 mg
n=19 Participants
Study subjects will receive Arikace™ 560 mg on Days 1-28.
|
Matching Placebo (560 mg)
n=9 Participants
Study subjects will receive matching placebo on Days 1-28.
|
|---|---|---|---|---|
|
Treatment-emergent Marked Laboratory Abnormalities up to 28 Days After Study Medication Discontinuation
Leukocytes
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Marked Laboratory Abnormalities up to 28 Days After Study Medication Discontinuation
Neutrophils Abs
|
4 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Treatment-emergent Marked Laboratory Abnormalities up to 28 Days After Study Medication Discontinuation
Sodium
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Marked Laboratory Abnormalities up to 28 Days After Study Medication Discontinuation
Uric acid
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Pre-dose, 0-1 hour post-dose and 2-4 hours post-dose on day 1, 0-1 hour post-dose and 2-4 hours post-dose on day 14, and 0-1 hour post-dose and 2-4 hours post-dose on day 28Population: The analysis population is the safety population, the same as the mITT population, defined as all randomized patients who received at least 1 dose of study drug.
Changes in PFT from pre-dose during the study were measured on Days 1, 14, and 28. Acute tolerability of the study treatment was assessed by examining the relative (rel.) changes in FEV1 from pre-dose assessments to 0-1 hour post-dose and 2-4 hours post-dose for each time point at which post-dose spirometry was conducted.
Outcome measures
| Measure |
Arikace™ 280 mg
n=24 Participants
Study subjects will receive Arikace™ 280 mg on Days 1-28.
|
Matching Placebo (280 mg)
n=10 Participants
Study subjects will receive matching placebo on Days 1-28.
|
Arikace™ 560 mg
n=19 Participants
Study subjects will receive Arikace™ 560 mg on Days 1-28.
|
Matching Placebo (560 mg)
n=9 Participants
Study subjects will receive matching placebo on Days 1-28.
|
|---|---|---|---|---|
|
Treatment-emergent Pulmonary Function Test (PFT) for Acute Tolerability Assessment
Day 1: Pre-Dose
|
1.917 L
Standard Deviation 0.793
|
1.841 L
Standard Deviation 0.536
|
1.939 L
Standard Deviation 0.515
|
1.758 L
Standard Deviation 0.654
|
|
Treatment-emergent Pulmonary Function Test (PFT) for Acute Tolerability Assessment
Day 1: 0 - 1 Hr Post-Dose
|
1.922 L
Standard Deviation 0.780
|
1.820 L
Standard Deviation 0.546
|
1.907 L
Standard Deviation 0.475
|
1.807 L
Standard Deviation 0.666
|
|
Treatment-emergent Pulmonary Function Test (PFT) for Acute Tolerability Assessment
Day 1: 2 - 4 Hrs Post-Dose
|
1.955 L
Standard Deviation 0.766
|
1.864 L
Standard Deviation 0.520
|
1.912 L
Standard Deviation 0.477
|
1.812 L
Standard Deviation 0.675
|
|
Treatment-emergent Pulmonary Function Test (PFT) for Acute Tolerability Assessment
Day1:0-1 Hr Post-Dose Rel. Change from Pre-dose
|
0.816 L
Standard Deviation 9.317
|
-1.186 L
Standard Deviation 3.028
|
-0.873 L
Standard Deviation 9.640
|
3.128 L
Standard Deviation 12.088
|
|
Treatment-emergent Pulmonary Function Test (PFT) for Acute Tolerability Assessment
Day1:2-4 Hrs Post-Dose Rel. Change from Pre-dose
|
3.323 L
Standard Deviation 11.181
|
1.484 L
Standard Deviation 3.507
|
-0.661 L
Standard Deviation 8.374
|
3.082 L
Standard Deviation 11.671
|
|
Treatment-emergent Pulmonary Function Test (PFT) for Acute Tolerability Assessment
Day 14: Pre-Dose
|
1.892 L
Standard Deviation 0.759
|
1.761 L
Standard Deviation 0.550
|
1.864 L
Standard Deviation 0.607
|
1.895 L
Standard Deviation 0.592
|
|
Treatment-emergent Pulmonary Function Test (PFT) for Acute Tolerability Assessment
Day 14: 0 - 1 Hr Post-Dose
|
1.907 L
Standard Deviation 0.776
|
1.794 L
Standard Deviation 0.556
|
1.856 L
Standard Deviation 0.555
|
1.908 L
Standard Deviation 0.611
|
|
Treatment-emergent Pulmonary Function Test (PFT) for Acute Tolerability Assessment
Day 14: 2 - 4 Hr Post-Dose
|
1.931 L
Standard Deviation 0.771
|
1.797 L
Standard Deviation 0.520
|
1.843 L
Standard Deviation 0.567
|
1.901 L
Standard Deviation 0.542
|
|
Treatment-emergent Pulmonary Function Test (PFT) for Acute Tolerability Assessment
Day14:0-1 Hr Post-Dose Rel. Change from Pre-dose
|
0.800 L
Standard Deviation 8.818
|
2.061 L
Standard Deviation 4.509
|
-1.629 L
Standard Deviation 9.961
|
0.589 L
Standard Deviation 4.558
|
|
Treatment-emergent Pulmonary Function Test (PFT) for Acute Tolerability Assessment
Day14:2-4 Hr Post-Dose Rel. Change from Pre-dose
|
2.388 L
Standard Deviation 9.020
|
2.711 L
Standard Deviation 6.620
|
-3.114 L
Standard Deviation 8.506
|
1.228 L
Standard Deviation 9.617
|
|
Treatment-emergent Pulmonary Function Test (PFT) for Acute Tolerability Assessment
Day 28: Pre-Dose
|
1.919 L
Standard Deviation 0.761
|
1.794 L
Standard Deviation 0.507
|
1.846 L
Standard Deviation 0.532
|
1.934 L
Standard Deviation 0.560
|
|
Treatment-emergent Pulmonary Function Test (PFT) for Acute Tolerability Assessment
Day 28: 0 - 1 Hr Post-Dose
|
1.928 L
Standard Deviation 0.751
|
1.803 L
Standard Deviation 0.502
|
1.797 L
Standard Deviation 0.541
|
1.901 L
Standard Deviation 0.550
|
|
Treatment-emergent Pulmonary Function Test (PFT) for Acute Tolerability Assessment
Day 28: 2 - 4 Hrs Post-Dose
|
1.908 L
Standard Deviation 0.754
|
1.809 L
Standard Deviation 0.527
|
1.799 L
Standard Deviation 0.578
|
1.940 L
Standard Deviation 0.641
|
|
Treatment-emergent Pulmonary Function Test (PFT) for Acute Tolerability Assessment
Day 28:0-1 Hr Post-Dose Rel. Change from Pre-dose
|
0.635 L
Standard Deviation 7.647
|
0.654 L
Standard Deviation 3.675
|
0.607 L
Standard Deviation 4.185
|
-1.437 L
Standard Deviation 6.454
|
|
Treatment-emergent Pulmonary Function Test (PFT) for Acute Tolerability Assessment
Day 28:2-4 Hrs Post-Dose Rel. Change from Pre-dose
|
-0.356 L
Standard Deviation 8.858
|
0.601 L
Standard Deviation 3.184
|
-0.006 L
Standard Deviation 6.156
|
-0.542 L
Standard Deviation 7.690
|
PRIMARY outcome
Timeframe: Day 1, Day 14 and Day 28Population: The analysis population is the safety population, the same as the mITT population, defined as all randomized patients who received at least 1 dose of study drug.
Number of Subjects with Decrease of \>= 15% in FEV1 (L) from Pre- to Post-dose by Study Day
Outcome measures
| Measure |
Arikace™ 280 mg
n=24 Participants
Study subjects will receive Arikace™ 280 mg on Days 1-28.
|
Matching Placebo (280 mg)
n=10 Participants
Study subjects will receive matching placebo on Days 1-28.
|
Arikace™ 560 mg
n=19 Participants
Study subjects will receive Arikace™ 560 mg on Days 1-28.
|
Matching Placebo (560 mg)
n=9 Participants
Study subjects will receive matching placebo on Days 1-28.
|
|---|---|---|---|---|
|
Treatment-emergent PFT Abnormalities up to the End of Study
Day 1 · No
|
22 Participants
|
10 Participants
|
17 Participants
|
9 Participants
|
|
Treatment-emergent PFT Abnormalities up to the End of Study
Day 1 · Yes
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Treatment-emergent PFT Abnormalities up to the End of Study
Day 14 · No
|
23 Participants
|
10 Participants
|
18 Participants
|
9 Participants
|
|
Treatment-emergent PFT Abnormalities up to the End of Study
Day 14 · Yes
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Treatment-emergent PFT Abnormalities up to the End of Study
Day 28 · No
|
23 Participants
|
10 Participants
|
19 Participants
|
9 Participants
|
|
Treatment-emergent PFT Abnormalities up to the End of Study
Day 28 · Yes
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Screening to Day 56Population: The analysis population is the safety population, the same as the mITT population, defined as all randomized patients who received at least 1 dose of study drug.
Outcome measures
| Measure |
Arikace™ 280 mg
n=24 Participants
Study subjects will receive Arikace™ 280 mg on Days 1-28.
|
Matching Placebo (280 mg)
n=10 Participants
Study subjects will receive matching placebo on Days 1-28.
|
Arikace™ 560 mg
n=19 Participants
Study subjects will receive Arikace™ 560 mg on Days 1-28.
|
Matching Placebo (560 mg)
n=9 Participants
Study subjects will receive matching placebo on Days 1-28.
|
|---|---|---|---|---|
|
Number of Subjects With an Adverse Event Leading to Permanent Discontinuation of Study Medication
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Screening to Day 56Population: The safety population is the modified intent-to-treat (mITT) population, defined as all randomized patients who received at least 1 dose of study drug.
Number of subjects with a SAE in the Arikace™ groups and the placebo group up to 28 days after study medication discontinuation. See SAE table in the safety section for details.
Outcome measures
| Measure |
Arikace™ 280 mg
n=24 Participants
Study subjects will receive Arikace™ 280 mg on Days 1-28.
|
Matching Placebo (280 mg)
n=10 Participants
Study subjects will receive matching placebo on Days 1-28.
|
Arikace™ 560 mg
n=19 Participants
Study subjects will receive Arikace™ 560 mg on Days 1-28.
|
Matching Placebo (560 mg)
n=9 Participants
Study subjects will receive matching placebo on Days 1-28.
|
|---|---|---|---|---|
|
Serious Adverse Events up to 28 Days After Study Medication Discontinuation
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline to Day 14, Day 28 and Day 42.Population: Per source, this is the Pa population, which includes patients who grew Pa on day 1, analyzed as treated.
The change in Pseudomonas aeruginosa density from from baseline to Day 14, 28, and 42 were evaluated.Treatment differences with respect to the changes from baseline to each measured study day, defined as the log10 of the sum of all morphotypes (colony-forming units \[CFU\]) per gram of sputum in (log10CFU/gram \[g\]), was estimated for each treatment group; standard deviations accompanied the treatment differences.
Outcome measures
| Measure |
Arikace™ 280 mg
n=17 Participants
Study subjects will receive Arikace™ 280 mg on Days 1-28.
|
Matching Placebo (280 mg)
n=9 Participants
Study subjects will receive matching placebo on Days 1-28.
|
Arikace™ 560 mg
n=15 Participants
Study subjects will receive Arikace™ 560 mg on Days 1-28.
|
Matching Placebo (560 mg)
n=8 Participants
Study subjects will receive matching placebo on Days 1-28.
|
|---|---|---|---|---|
|
Change From Baseline in Log10CFU Per Gram (Density) of Pseudomonas Aeruginosa in Sputum.
Day 14 Change from Baseline
|
-0.227 log10CFU per gram
Standard Deviation 0.805
|
-0.333 log10CFU per gram
Standard Deviation 0.515
|
-2.016 log10CFU per gram
Standard Deviation 1.942
|
-0.474 log10CFU per gram
Standard Deviation 1.942
|
|
Change From Baseline in Log10CFU Per Gram (Density) of Pseudomonas Aeruginosa in Sputum.
Day 28 Change from Baseline
|
-0.094 log10CFU per gram
Standard Deviation 0.975
|
0.315 log10CFU per gram
Standard Deviation 0.732
|
-1.013 log10CFU per gram
Standard Deviation 1.099
|
-0.302 log10CFU per gram
Standard Deviation 0.443
|
|
Change From Baseline in Log10CFU Per Gram (Density) of Pseudomonas Aeruginosa in Sputum.
Day 42 Change from Baseline
|
0.101 log10CFU per gram
Standard Deviation 0.788
|
-0.057 log10CFU per gram
Standard Deviation 0.627
|
0.046 log10CFU per gram
Standard Deviation 0.705
|
-0.641 log10CFU per gram
Standard Deviation 1.095
|
SECONDARY outcome
Timeframe: Baseline to Day 14, Day 28, Day 42 and Day 56.Population: The safety population is used for this analysis. It is the same as the mITT population, defined as all randomized patients who received at least one dose of study medication.
Changes in the severity and intensity (frequency x severity) of individual symptoms and change in composite PSSS from baseline to Days 14, 28, 42 and 56. The Pulmonary Symptom Severity Score (PSSS) was assessed on patient's responses to the Patients Symptoms Questionnaire, which employs symptom frequency and severity scales described for the validated Memorial Symptoms Assessment Scale. Symptom severity was scored on a scale of 0 (not applicable or symptom not present) to 4 (very severe) for each of the 5 symptoms (cough, shortness of breath, sputum production \[frequency and severity\], fatigue, and wheezing), and a composite score (range, 0 to 20 \[low score represents better outcome\]) was obtained as the sum of the severity scores for each symptom.
Outcome measures
| Measure |
Arikace™ 280 mg
n=24 Participants
Study subjects will receive Arikace™ 280 mg on Days 1-28.
|
Matching Placebo (280 mg)
n=10 Participants
Study subjects will receive matching placebo on Days 1-28.
|
Arikace™ 560 mg
n=19 Participants
Study subjects will receive Arikace™ 560 mg on Days 1-28.
|
Matching Placebo (560 mg)
n=9 Participants
Study subjects will receive matching placebo on Days 1-28.
|
|---|---|---|---|---|
|
Total Pulmonary Symptom Severity Score (PSSS)
Day 14 change from Day 1
|
-1.125 score on a scale
Standard Deviation 2.213
|
-0.200 score on a scale
Standard Deviation 0.789
|
-0.471 score on a scale
Standard Deviation 2.035
|
-0.250 score on a scale
Standard Deviation 2.053
|
|
Total Pulmonary Symptom Severity Score (PSSS)
Day 28 change from Day 1
|
-2.167 score on a scale
Standard Deviation 2.988
|
0.000 score on a scale
Standard Deviation 2.357
|
-1.000 score on a scale
Standard Deviation 4.087
|
-0.125 score on a scale
Standard Deviation 4.257
|
|
Total Pulmonary Symptom Severity Score (PSSS)
Day 42 change from Day 1
|
-2.458 score on a scale
Standard Deviation 3.476
|
-1.000 score on a scale
Standard Deviation 1.491
|
-1.882 score on a scale
Standard Deviation 4.285
|
1.125 score on a scale
Standard Deviation 3.137
|
|
Total Pulmonary Symptom Severity Score (PSSS)
Day 56 change from Day 1
|
-2.458 score on a scale
Standard Deviation 2.874
|
-1.500 score on a scale
Standard Deviation 2.121
|
-2.167 score on a scale
Standard Deviation 3.053
|
-2.000 score on a scale
Standard Deviation 1.690
|
SECONDARY outcome
Timeframe: Day 1 to Day 14, Day 28, Day 42 and Day 56.Population: The analysis population is the mITT population, defined as all randomized patients who received at least one dose of study medication.
A composite total score is derived as the sum of domain scores for symptoms, activity, and impact, with 0 as the best possible score and 100 as the worst possible score. A reduction in score of 4 points is generally recognized as a clinically meaningful improvement in quality of life. This analysis compared the changes from Day 1 (prior to first dosing) to Days 14, 28, 42, and 56.
Outcome measures
| Measure |
Arikace™ 280 mg
n=24 Participants
Study subjects will receive Arikace™ 280 mg on Days 1-28.
|
Matching Placebo (280 mg)
n=10 Participants
Study subjects will receive matching placebo on Days 1-28.
|
Arikace™ 560 mg
n=19 Participants
Study subjects will receive Arikace™ 560 mg on Days 1-28.
|
Matching Placebo (560 mg)
n=9 Participants
Study subjects will receive matching placebo on Days 1-28.
|
|---|---|---|---|---|
|
To Evaluate Change in St. George's Respiratory Questionnaire Measurements
Day 14 change from Day 1
|
-4.024 score on a scale
Standard Deviation 8.558
|
-6.350 score on a scale
Standard Deviation 8.756
|
-6.101 score on a scale
Standard Deviation 12.164
|
-2.807 score on a scale
Standard Deviation 7.256
|
|
To Evaluate Change in St. George's Respiratory Questionnaire Measurements
Day 28 change from Day 1
|
-6.205 score on a scale
Standard Deviation 13.661
|
-5.812 score on a scale
Standard Deviation 12.039
|
-6.200 score on a scale
Standard Deviation 11.855
|
-8.304 score on a scale
Standard Deviation 12.993
|
|
To Evaluate Change in St. George's Respiratory Questionnaire Measurements
Day 42 change from Day 1
|
-7.611 score on a scale
Standard Deviation 13.274
|
-6.130 score on a scale
Standard Deviation 14.271
|
-8.196 score on a scale
Standard Deviation 12.332
|
0.242 score on a scale
Standard Deviation 5.818
|
|
To Evaluate Change in St. George's Respiratory Questionnaire Measurements
Day 56 change from Day 1
|
-7.937 score on a scale
Standard Deviation 16.281
|
-7.371 score on a scale
Standard Deviation 11.270
|
-9.282 score on a scale
Standard Deviation 10.302
|
-1.637 score on a scale
Standard Deviation 15.161
|
SECONDARY outcome
Timeframe: Screening to Day 56.Population: The analysis population is the mITT population, defined as all randomized patients who received at least one dose of study medication
Outcome measures
| Measure |
Arikace™ 280 mg
n=24 Participants
Study subjects will receive Arikace™ 280 mg on Days 1-28.
|
Matching Placebo (280 mg)
n=10 Participants
Study subjects will receive matching placebo on Days 1-28.
|
Arikace™ 560 mg
n=19 Participants
Study subjects will receive Arikace™ 560 mg on Days 1-28.
|
Matching Placebo (560 mg)
n=9 Participants
Study subjects will receive matching placebo on Days 1-28.
|
|---|---|---|---|---|
|
To Evaluate the Use of Systemic Antipseudomonal Rescue Therapy
Rescue Medication Initiation by Day 28
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
To Evaluate the Use of Systemic Antipseudomonal Rescue Therapy
Rescue Medication Initiation by Day 56
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
To Evaluate the Use of Systemic Antipseudomonal Rescue Therapy
No Rescue Medication Initiation
|
24 Participants
|
10 Participants
|
19 Participants
|
7 Participants
|
Adverse Events
Arikace at 280 mg
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Matching Placebo (280 mg)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Arikace at 560 mg
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Matching Placebo (560 mg)
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arikace at 280 mg
n=24 participants at risk
Study subjects will receive Arikace™ 280 mg on Days 1-28.
|
Matching Placebo (280 mg)
n=10 participants at risk
Study subjects will receive matching placebo on Days 1-28.
|
Arikace at 560 mg
n=19 participants at risk
Study subjects will receive Arikace™ 560 mg on Days 1-28.
|
Matching Placebo (560 mg)
n=9 participants at risk
Study subjects will receive matching placebo on Days 1-28.
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
4.2%
1/24 • Number of events 1 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
0.00%
0/10 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
0.00%
0/19 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
0.00%
0/9 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
|
Pregnancy, puerperium and perinatal conditions
Abortion Incomplete
|
0.00%
0/24 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
0.00%
0/10 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
5.3%
1/19 • Number of events 1 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
0.00%
0/9 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
|
Respiratory, thoracic and mediastinal disorders
Lung Abscess
|
0.00%
0/24 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
0.00%
0/10 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
0.00%
0/19 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
11.1%
1/9 • Number of events 1 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
Other adverse events
| Measure |
Arikace at 280 mg
n=24 participants at risk
Study subjects will receive Arikace™ 280 mg on Days 1-28.
|
Matching Placebo (280 mg)
n=10 participants at risk
Study subjects will receive matching placebo on Days 1-28.
|
Arikace at 560 mg
n=19 participants at risk
Study subjects will receive Arikace™ 560 mg on Days 1-28.
|
Matching Placebo (560 mg)
n=9 participants at risk
Study subjects will receive matching placebo on Days 1-28.
|
|---|---|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/24 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
0.00%
0/10 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
5.3%
1/19 • Number of events 1 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
0.00%
0/9 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
|
Cardiac disorders
Sinus Bradycardia
|
0.00%
0/24 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
10.0%
1/10 • Number of events 1 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
0.00%
0/19 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
0.00%
0/9 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
|
Gastrointestinal disorders
Aphthous Stomatitis
|
0.00%
0/24 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
10.0%
1/10 • Number of events 1 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
0.00%
0/19 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
0.00%
0/9 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/24 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
0.00%
0/10 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
0.00%
0/19 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
11.1%
1/9 • Number of events 1 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/24 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
0.00%
0/10 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
5.3%
1/19 • Number of events 1 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
0.00%
0/9 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
|
General disorders
Pyrexia
|
8.3%
2/24 • Number of events 2 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
10.0%
1/10 • Number of events 1 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
5.3%
1/19 • Number of events 1 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
22.2%
2/9 • Number of events 3 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
|
General disorders
Fatigue
|
0.00%
0/24 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
0.00%
0/10 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
5.3%
1/19 • Number of events 1 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
11.1%
1/9 • Number of events 1 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
|
Infections and infestations
Nasopharyngitis
|
4.2%
1/24 • Number of events 1 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
10.0%
1/10 • Number of events 1 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
0.00%
0/19 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
11.1%
1/9 • Number of events 1 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
|
Infections and infestations
Bronchiectasis
|
0.00%
0/24 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
0.00%
0/10 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
5.3%
1/19 • Number of events 1 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
11.1%
1/9 • Number of events 1 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
|
Infections and infestations
Laryngitis
|
0.00%
0/24 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
0.00%
0/10 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
5.3%
1/19 • Number of events 1 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
0.00%
0/9 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
|
Infections and infestations
Respiratory Tract Infection
|
0.00%
0/24 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
0.00%
0/10 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
5.3%
1/19 • Number of events 1 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
0.00%
0/9 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
|
Investigations
Blood Creatinine Increased
|
0.00%
0/24 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
0.00%
0/10 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
5.3%
1/19 • Number of events 1 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
0.00%
0/9 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
|
Investigations
Heart Rate Increased
|
0.00%
0/24 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
0.00%
0/10 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
0.00%
0/19 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
11.1%
1/9 • Number of events 1 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/24 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
0.00%
0/10 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
5.3%
1/19 • Number of events 1 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
11.1%
1/9 • Number of events 1 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
|
Nervous system disorders
Headache
|
4.2%
1/24 • Number of events 1 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
10.0%
1/10 • Number of events 3 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
21.1%
4/19 • Number of events 4 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
11.1%
1/9 • Number of events 2 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
|
Nervous system disorders
Dizziness
|
0.00%
0/24 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
10.0%
1/10 • Number of events 21 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
5.3%
1/19 • Number of events 1 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
0.00%
0/9 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
|
Nervous system disorders
Cervicobrachial Syndrome
|
0.00%
0/24 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
10.0%
1/10 • Number of events 1 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
0.00%
0/19 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
0.00%
0/9 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/24 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
0.00%
0/10 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
5.3%
1/19 • Number of events 1 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
11.1%
1/9 • Number of events 1 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
8.3%
2/24 • Number of events 2 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
30.0%
3/10 • Number of events 4 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
10.5%
2/19 • Number of events 3 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
33.3%
3/9 • Number of events 3 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.2%
1/24 • Number of events 1 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
20.0%
2/10 • Number of events 4 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
26.3%
5/19 • Number of events 11 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
0.00%
0/9 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/24 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
20.0%
2/10 • Number of events 3 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
15.8%
3/19 • Number of events 3 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
11.1%
1/9 • Number of events 1 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial Disorder
|
12.5%
3/24 • Number of events 4 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
0.00%
0/10 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
5.3%
1/19 • Number of events 1 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
0.00%
0/9 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
8.3%
2/24 • Number of events 2 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
10.0%
1/10 • Number of events 1 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
5.3%
1/19 • Number of events 1 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
0.00%
0/9 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
4.2%
1/24 • Number of events 1 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
20.0%
2/10 • Number of events 3 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
5.3%
1/19 • Number of events 1 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
0.00%
0/9 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
4.2%
1/24 • Number of events 1 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
0.00%
0/10 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
10.5%
2/19 • Number of events 2 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
0.00%
0/9 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/24 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
10.0%
1/10 • Number of events 1 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
0.00%
0/19 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
11.1%
1/9 • Number of events 1 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/24 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
20.0%
2/10 • Number of events 3 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
0.00%
0/19 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
11.1%
1/9 • Number of events 1 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/24 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
10.0%
1/10 • Number of events 5 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
0.00%
0/19 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
0.00%
0/9 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/24 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
10.0%
1/10 • Number of events 1 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
0.00%
0/19 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
0.00%
0/9 • TEAEs were assessed at Baseline and all subsequent study visits up to day 56
|
Additional Information
Dr. Kevin Mange, Sr. Vice President, Clinical Development
Insmed
Phone: 908-947-2651
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place