Trial Outcomes & Findings for A Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib in Participants With Non-Cystic Fibrosis Bronchiectasis (NCT NCT04594369)
NCT ID: NCT04594369
Last Updated: 2025-12-16
Results Overview
PE was defined as having 3 or more of these symptoms for at least 48 hours resulting in a physician's decision to prescribe antibiotics: 1. Increased cough 2. Increased sputum volume or change in sputum consistency 3. Increased sputum purulence 4. Increased breathlessness and/or decreased exercise tolerance 5. Fatigue and/or malaise 6. Hemoptysis. A severe pulmonary exacerbation was that required intravenous (IV) antibacterial drug treatment and/or hospitalization. A minimum of 14 days must have occurred between one exacerbation onset and the next. Any exacerbation that occurred less than 14 days from the prior exacerbation was not considered a new exacerbation. Independent adjudication committee with pulmonary physicians adjudicated reported PE events to see if they fulfil the protocol definition. The rate of PE was analyzed using the negative binomial model.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1767 participants
Primary outcome timeframe
Up to Week 52
Results posted on
2025-12-16
Participant Flow
Participants took part in the study at 373 sites in 36 countries from 01 Dec 2020 to 28 Oct 2024.
A total of 2296 participants were screened, 1767 participants with non-cystic fibrosis bronchiectasis were enrolled in the study. Due to the war in Ukraine, 44 participants from Ukraine were discontinued and excluded from all analyses. There were 2 additional participants who were excluded from all analyses due to serious Good Clinical Practice (GCP) non-compliance. A total of 1721 participants were randomized and analyzed.
Participant milestones
| Measure |
Brensocatib 10 Milligrams (mg)
Participants received brensocatib 10 mg tablets, orally, once daily, for 52 weeks.
|
Brensocatib 25 mg
Participants received brensocatib 25 mg tablets, orally, once daily, for 52 weeks.
|
Placebo
Participants received a brensocatib matching placebo, tablets orally, once daily, for 52 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
583
|
575
|
563
|
|
Overall Study
COMPLETED
|
458
|
466
|
457
|
|
Overall Study
NOT COMPLETED
|
125
|
109
|
106
|
Reasons for withdrawal
| Measure |
Brensocatib 10 Milligrams (mg)
Participants received brensocatib 10 mg tablets, orally, once daily, for 52 weeks.
|
Brensocatib 25 mg
Participants received brensocatib 25 mg tablets, orally, once daily, for 52 weeks.
|
Placebo
Participants received a brensocatib matching placebo, tablets orally, once daily, for 52 weeks.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
10
|
10
|
9
|
|
Overall Study
Death
|
2
|
4
|
8
|
|
Overall Study
Lost to Follow-up
|
10
|
2
|
4
|
|
Overall Study
Physician Decision
|
2
|
2
|
3
|
|
Overall Study
Protocol deviation
|
1
|
3
|
2
|
|
Overall Study
Withdrawal by Subject
|
40
|
32
|
37
|
|
Overall Study
Reason not specified
|
60
|
56
|
43
|
Baseline Characteristics
A Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib in Participants With Non-Cystic Fibrosis Bronchiectasis
Baseline characteristics by cohort
| Measure |
Brensocatib 10 mg
n=583 Participants
Participants received brensocatib 10 mg tablets, orally, once daily, for 52 weeks.
|
Brensocatib 25 mg
n=575 Participants
Participants received brensocatib 25 mg tablets orally, once daily, for 52 weeks.
|
Placebo
n=563 Participants
Participants received a brensocatib matching placebo tablets orally, once daily, for 52 weeks.
|
Total
n=1721 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
59.8 Years
STANDARD_DEVIATION 15.92 • n=6 Participants
|
60.6 Years
STANDARD_DEVIATION 15.78 • n=5 Participants
|
60.0 Years
STANDARD_DEVIATION 15.44 • n=5 Participants
|
60.2 Years
STANDARD_DEVIATION 15.72 • n=387 Participants
|
|
Sex: Female, Male
Female
|
385 Participants
n=6 Participants
|
360 Participants
n=5 Participants
|
362 Participants
n=5 Participants
|
1107 Participants
n=387 Participants
|
|
Sex: Female, Male
Male
|
198 Participants
n=6 Participants
|
215 Participants
n=5 Participants
|
201 Participants
n=5 Participants
|
614 Participants
n=387 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
177 Participants
n=6 Participants
|
164 Participants
n=5 Participants
|
170 Participants
n=5 Participants
|
511 Participants
n=387 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
391 Participants
n=6 Participants
|
397 Participants
n=5 Participants
|
373 Participants
n=5 Participants
|
1161 Participants
n=387 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
15 Participants
n=6 Participants
|
14 Participants
n=5 Participants
|
20 Participants
n=5 Participants
|
49 Participants
n=387 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
8 Participants
n=6 Participants
|
6 Participants
n=5 Participants
|
9 Participants
n=5 Participants
|
23 Participants
n=387 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
63 Participants
n=6 Participants
|
64 Participants
n=5 Participants
|
64 Participants
n=5 Participants
|
191 Participants
n=387 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
2 Participants
n=6 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=5 Participants
|
10 Participants
n=387 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Other Pacific Islander
|
1 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=387 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
431 Participants
n=6 Participants
|
430 Participants
n=5 Participants
|
405 Participants
n=5 Participants
|
1266 Participants
n=387 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
15 Participants
n=6 Participants
|
13 Participants
n=5 Participants
|
11 Participants
n=5 Participants
|
39 Participants
n=387 Participants
|
|
Race/Ethnicity, Customized
Race · Unknown or Not Reported
|
48 Participants
n=6 Participants
|
46 Participants
n=5 Participants
|
59 Participants
n=5 Participants
|
153 Participants
n=387 Participants
|
|
Race/Ethnicity, Customized
Race · More than one race
|
15 Participants
n=6 Participants
|
11 Participants
n=5 Participants
|
11 Participants
n=5 Participants
|
37 Participants
n=387 Participants
|
PRIMARY outcome
Timeframe: Up to Week 52Population: The ITT analysis set included all participants who were randomized.
PE was defined as having 3 or more of these symptoms for at least 48 hours resulting in a physician's decision to prescribe antibiotics: 1. Increased cough 2. Increased sputum volume or change in sputum consistency 3. Increased sputum purulence 4. Increased breathlessness and/or decreased exercise tolerance 5. Fatigue and/or malaise 6. Hemoptysis. A severe pulmonary exacerbation was that required intravenous (IV) antibacterial drug treatment and/or hospitalization. A minimum of 14 days must have occurred between one exacerbation onset and the next. Any exacerbation that occurred less than 14 days from the prior exacerbation was not considered a new exacerbation. Independent adjudication committee with pulmonary physicians adjudicated reported PE events to see if they fulfil the protocol definition. The rate of PE was analyzed using the negative binomial model.
Outcome measures
| Measure |
Brensocatib 10 mg
n=583 Participants
Participants received brensocatib 10 mg, tablets orally, once daily, for 52 weeks.
|
Brensocatib 25 mg
n=575 Participants
Participants received brensocatib 25 mg, tablets orally, once daily, for 52 weeks.
|
Placebo
n=563 Participants
Participants received a brensocatib matching placebo, tablets orally, once daily, for 52 weeks.
|
|---|---|---|---|
|
Annualized Rate of Pulmonary Exacerbations (PEs)
|
1.015 exacerbation per participant-year
Interval 0.91 to 1.132
|
1.036 exacerbation per participant-year
Interval 0.927 to 1.157
|
1.286 exacerbation per participant-year
Interval 1.158 to 1.428
|
SECONDARY outcome
Timeframe: Up to Week 52Population: The ITT analysis set included all participants who were randomized.
PE was defined as having 3 or more of following symptoms for at least 48 hours resulting in physician's decision to prescribe antibiotics:1.Increased cough2.Increased sputum volume or change in sputum consistency3.Increased sputum purulence4.Increased breathlessness \&/or decreased exercise tolerance5.Fatigue \&/or malaise6.Hemoptysis.Severe PE were those requiring IV antibacterial drug treatment \&/or hospitalization. Minimum of 14 days must have occurred between one exacerbation onset and next. Any exacerbation that occurred within 14 days of prior exacerbation was not considered a new exacerbation. Time to first PE was calculated from randomization date to onset date of the first exacerbation. Participants who did not have exacerbation at end of 52-week treatment period were considered as censored at date of Week 52 in Cox proportional hazard model. Independent adjudication committee with pulmonary physicians adjudicated reported PE events to see if they fulfil protocol definition.
Outcome measures
| Measure |
Brensocatib 10 mg
n=583 Participants
Participants received brensocatib 10 mg, tablets orally, once daily, for 52 weeks.
|
Brensocatib 25 mg
n=575 Participants
Participants received brensocatib 25 mg, tablets orally, once daily, for 52 weeks.
|
Placebo
n=563 Participants
Participants received a brensocatib matching placebo, tablets orally, once daily, for 52 weeks.
|
|---|---|---|---|
|
Time to First PE
|
49.000 weeks
Interval 40.0 to
NA indicates that upper limit of confidence interval (CI) was not estimable due to insufficient number of participants with events during the 52 weeks treatment period.
|
50.714 weeks
Interval 37.571 to
NA indicates that upper limit of confidence interval (CI) was not estimable due to insufficient number of participants with events during the 52 weeks treatment period.
|
36.714 weeks
Interval 31.143 to 41.429
|
SECONDARY outcome
Timeframe: Up to Week 52Population: The ITT analysis set included all participants who were randomized.
Responder status was based on percentage of participants who were exacerbation free over 52-weeks of treatment period. Pulmonary exacerbation was defined as having 3 or more of the following symptoms for at least 48 hours resulting in a physician's decision to prescribe antibiotics: 1. Increased cough 2. Increased sputum volume or change in sputum consistency 3. Increased sputum purulence 4. Increased breathlessness and/or decreased exercise tolerance 5. Fatigue and/or malaise 6. Hemoptysis. A minimum of 14 days must have occurred between one exacerbation onset and the next. Any exacerbation that occurred less than 14 days from the prior exacerbation was not considered a new exacerbation. Independent adjudication committee of pulmonary physicians adjudicated reported PE events to see if they fulfill protocol definition. For discontinuation prior to Week 52 without having experienced a confirmed PE, responder status was imputed by multiple imputation.
Outcome measures
| Measure |
Brensocatib 10 mg
n=583 Participants
Participants received brensocatib 10 mg, tablets orally, once daily, for 52 weeks.
|
Brensocatib 25 mg
n=575 Participants
Participants received brensocatib 25 mg, tablets orally, once daily, for 52 weeks.
|
Placebo
n=563 Participants
Participants received a brensocatib matching placebo, tablets orally, once daily, for 52 weeks.
|
|---|---|---|---|
|
Responder Status for Exacerbation-Free Over the 52-Week Treatment Period
|
48.5 percentage of participants
|
48.5 percentage of participants
|
40.3 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: The ITT analysis set included all participants who were randomized. 'Overall number of participants analyzed' indicates the number of participants with data available for analyses.
FEV1 was used to assess lung function and is the maximum amount of air that can be forced out in one second after first second after taking a forced expiration as measured by spirometer. Postbronchodilator FEV1 tests included spirometry tests performed referred to the spirometry performed within 30 minutes after administration of bronchodilator (4 puffs of salbutamol/albuterol, terbutaline or ipratropium). A positive change from baseline indicates an improvement in lung function. Baseline was the most recent non-missing assessment determined as best effort prior to the first dose of the investigational product.
Outcome measures
| Measure |
Brensocatib 10 mg
n=564 Participants
Participants received brensocatib 10 mg, tablets orally, once daily, for 52 weeks.
|
Brensocatib 25 mg
n=551 Participants
Participants received brensocatib 25 mg, tablets orally, once daily, for 52 weeks.
|
Placebo
n=539 Participants
Participants received a brensocatib matching placebo, tablets orally, once daily, for 52 weeks.
|
|---|---|---|---|
|
Change From Baseline at Week 52 in Postbronchodilator Forced Expiratory Volume in 1 Second (FEV1)
|
-0.050 liter (L)
Standard Error 0.0093
|
-0.024 liter (L)
Standard Error 0.0099
|
-0.062 liter (L)
Standard Error 0.0094
|
SECONDARY outcome
Timeframe: Up to Week 52Population: The ITT analysis set included all participants who were randomized.
Pulmonary exacerbation was defined as having 3 or more of the following symptoms for at least 48 hours resulting in a physician's decision to prescribe antibiotics: 1. Increased cough 2. Increased sputum volume or change in sputum consistency 3. Increased sputum purulence 4. Increased breathlessness and/or decreased exercise tolerance 5. Fatigue and/or malaise 6. Hemoptysis. A severe PE was defined as those requiring IV antibacterial drug treatment and/or hospitalization. A minimum of 14 days must have occurred between one exacerbation onset and the next. Any exacerbation that occurred less than 14 days from the prior exacerbation was not considered a new exacerbation. Independent adjudication committee with pulmonary physicians adjucated reported PE events to see if they fulfil the protocol definition. The rate of PE was analyzed using the negative binomial model.
Outcome measures
| Measure |
Brensocatib 10 mg
n=583 Participants
Participants received brensocatib 10 mg, tablets orally, once daily, for 52 weeks.
|
Brensocatib 25 mg
n=575 Participants
Participants received brensocatib 25 mg, tablets orally, once daily, for 52 weeks.
|
Placebo
n=563 Participants
Participants received a brensocatib matching placebo, tablets orally, once daily, for 52 weeks.
|
|---|---|---|---|
|
Annualized Rate of Severe PEs
|
0.137 exacerbation per participant-year
Interval 0.103 to 0.182
|
0.137 exacerbation per participant-year
Interval 0.105 to 0.179
|
0.185 exacerbation per participant-year
Interval 0.142 to 0.242
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: The ITT analysis set included all participants who were randomised. Overall number of participants analyzed indicates the number of participants with data available for analyses.
The QOL-B is a validated, self-administered patient-reported outcome (PRO) that assesses symptoms, functioning, and health-related quality of life for participants with non-cystic fibrosis bronchiectasis (NCFBE). It contains 37 items in 8 domains (Respiratory Symptoms, Physical Functioning, Role Functioning, Emotional Functioning, Social Functioning, Vitality, Health Perceptions and Treatment Burden). Each of the 37 items is scored from 1 to 4, and each of the 8 domains scale scores is standardized on a 0-100 point scale, with higher scores representing fewer symptoms or better functioning. A positive change from Baseline indicates improvement in symptoms. For this outcome measure, change in the respiratory symptoms domain score from Baseline was reported. Baseline refers to most recent assessment on or before study Day 1.
Outcome measures
| Measure |
Brensocatib 10 mg
n=487 Participants
Participants received brensocatib 10 mg, tablets orally, once daily, for 52 weeks.
|
Brensocatib 25 mg
n=495 Participants
Participants received brensocatib 25 mg, tablets orally, once daily, for 52 weeks.
|
Placebo
n=486 Participants
Participants received a brensocatib matching placebo, tablets orally, once daily, for 52 weeks.
|
|---|---|---|---|
|
Change From Baseline at Week 52 in Quality of Life Questionnaire - Bronchiectasis (QOL-B) Respiratory Symptoms Domain Score in Adult Participants
|
6.841 score on scale
Standard Error 0.7706
|
8.575 score on scale
Standard Error 0.7556
|
4.809 score on scale
Standard Error 0.7500
|
SECONDARY outcome
Timeframe: Up to Week 56Population: The Safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAEs are AEs that occurred on or after the date of first dose of study drugs and within 28 days after the end of treatment.
Outcome measures
| Measure |
Brensocatib 10 mg
n=582 Participants
Participants received brensocatib 10 mg, tablets orally, once daily, for 52 weeks.
|
Brensocatib 25 mg
n=574 Participants
Participants received brensocatib 25 mg, tablets orally, once daily, for 52 weeks.
|
Placebo
n=563 Participants
Participants received a brensocatib matching placebo, tablets orally, once daily, for 52 weeks.
|
|---|---|---|---|
|
Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Events (TEAEs)
|
452 Participants
|
440 Participants
|
448 Participants
|
SECONDARY outcome
Timeframe: 2 hours (h) post-dose on Day 1; Pre-dose and 2 h post-dose at Weeks 4, 28 and 40; Pre-dose at Weeks 16 and 52Population: The Pharmacokinetics (PK) concentration analysis set included adult participants who consented to participate in the main study in adult's cohort, received at least 1 dose of brensocatib, and had at least 1 postdose plasma concentration of brensocatib. 'Overall number of participants analyzed' indicates the number of participants with data available for analysis. 'Number analyzed' signifies number of adult participants with data available for analysis at specified time point.
Outcome measures
| Measure |
Brensocatib 10 mg
n=194 Participants
Participants received brensocatib 10 mg, tablets orally, once daily, for 52 weeks.
|
Brensocatib 25 mg
n=208 Participants
Participants received brensocatib 25 mg, tablets orally, once daily, for 52 weeks.
|
Placebo
Participants received a brensocatib matching placebo, tablets orally, once daily, for 52 weeks.
|
|---|---|---|---|
|
Plasma Concentration of Brensocatib in Adults (Main Study)
Week 40: Pre-dose
|
45.71 nanograms per milliliter (ng/ml)
Geometric Coefficient of Variation 54.2
|
136.8 nanograms per milliliter (ng/ml)
Geometric Coefficient of Variation 63.4
|
—
|
|
Plasma Concentration of Brensocatib in Adults (Main Study)
Week 40: 2 h post-dose
|
107.3 nanograms per milliliter (ng/ml)
Geometric Coefficient of Variation 45.0
|
302.6 nanograms per milliliter (ng/ml)
Geometric Coefficient of Variation 40.7
|
—
|
|
Plasma Concentration of Brensocatib in Adults (Main Study)
Week 52: Pre-dose
|
45.78 nanograms per milliliter (ng/ml)
Geometric Coefficient of Variation 61.7
|
135.4 nanograms per milliliter (ng/ml)
Geometric Coefficient of Variation 60.3
|
—
|
|
Plasma Concentration of Brensocatib in Adults (Main Study)
Week 28: 2 h post-dose
|
91.79 nanograms per milliliter (ng/ml)
Geometric Coefficient of Variation 45.3
|
323.7 nanograms per milliliter (ng/ml)
Geometric Coefficient of Variation 40.1
|
—
|
|
Plasma Concentration of Brensocatib in Adults (Main Study)
Week 4: 2 h post-dose
|
100.5 nanograms per milliliter (ng/ml)
Geometric Coefficient of Variation 32.8
|
293.6 nanograms per milliliter (ng/ml)
Geometric Coefficient of Variation 35.1
|
—
|
|
Plasma Concentration of Brensocatib in Adults (Main Study)
Week 16: Pre-dose
|
45.19 nanograms per milliliter (ng/ml)
Geometric Coefficient of Variation 55.0
|
131.6 nanograms per milliliter (ng/ml)
Geometric Coefficient of Variation 69.0
|
—
|
|
Plasma Concentration of Brensocatib in Adults (Main Study)
Pre-dose at Week 28
|
49.30 nanograms per milliliter (ng/ml)
Geometric Coefficient of Variation 63.9
|
143.0 nanograms per milliliter (ng/ml)
Geometric Coefficient of Variation 64.6
|
—
|
|
Plasma Concentration of Brensocatib in Adults (Main Study)
Day 1: 2 h post-dose
|
40.52 nanograms per milliliter (ng/ml)
Geometric Coefficient of Variation 69.1
|
134.9 nanograms per milliliter (ng/ml)
Geometric Coefficient of Variation 51.4
|
—
|
|
Plasma Concentration of Brensocatib in Adults (Main Study)
Week 4: Pre-dose
|
52.60 nanograms per milliliter (ng/ml)
Geometric Coefficient of Variation 68.7
|
157.4 nanograms per milliliter (ng/ml)
Geometric Coefficient of Variation 70.8
|
—
|
SECONDARY outcome
Timeframe: 0.5 h, 2 h, and 4 to 8 h post-dose on Day 1and at Week 28; Pre-dose and 2 h post-dose at Weeks 4 and 48; Pre-dose at Weeks 16 and 52Population: The PK concentration analysis set included adult participants who consented to participate in the PK substudy and received at least 1 dose of brensocatib, and had at least 1 postdose plasma concentration of brensocatib. 'Overall number of participants analyzed' indicates the number of participants with data available for analysis. 'Number analyzed' signifies number of adult participants with data available for analysis at specified time point.
Outcome measures
| Measure |
Brensocatib 10 mg
n=62 Participants
Participants received brensocatib 10 mg, tablets orally, once daily, for 52 weeks.
|
Brensocatib 25 mg
n=64 Participants
Participants received brensocatib 25 mg, tablets orally, once daily, for 52 weeks.
|
Placebo
Participants received a brensocatib matching placebo, tablets orally, once daily, for 52 weeks.
|
|---|---|---|---|
|
Plasma Concentration of Brensocatib in Adults (PK Substudy)
Day 1: 0.5 h post-dose
|
34.51 ng/ml
Geometric Coefficient of Variation 97.9
|
85.13 ng/ml
Geometric Coefficient of Variation 103.5
|
—
|
|
Plasma Concentration of Brensocatib in Adults (PK Substudy)
Day 1: 2 h post-dose
|
44.52 ng/ml
Geometric Coefficient of Variation 55.0
|
120.0 ng/ml
Geometric Coefficient of Variation 56.2
|
—
|
|
Plasma Concentration of Brensocatib in Adults (PK Substudy)
Day 1: 4-8 h post-dose
|
38.13 ng/ml
Geometric Coefficient of Variation 52.9
|
108.5 ng/ml
Geometric Coefficient of Variation 46.9
|
—
|
|
Plasma Concentration of Brensocatib in Adults (PK Substudy)
Week 4: Pre-dose
|
57.53 ng/ml
Geometric Coefficient of Variation 53.4
|
131.3 ng/ml
Geometric Coefficient of Variation 60.2
|
—
|
|
Plasma Concentration of Brensocatib in Adults (PK Substudy)
Week 4: 2 h post-dose
|
100.3 ng/ml
Geometric Coefficient of Variation 44.1
|
286.7 ng/ml
Geometric Coefficient of Variation 38.4
|
—
|
|
Plasma Concentration of Brensocatib in Adults (PK Substudy)
Week 16: Pre-dose
|
50.24 ng/ml
Geometric Coefficient of Variation 58.1
|
138.0 ng/ml
Geometric Coefficient of Variation 64.5
|
—
|
|
Plasma Concentration of Brensocatib in Adults (PK Substudy)
Week 28: Pre-dose
|
50.33 ng/ml
Geometric Coefficient of Variation 54.7
|
124.6 ng/ml
Geometric Coefficient of Variation 59.8
|
—
|
|
Plasma Concentration of Brensocatib in Adults (PK Substudy)
Week 28: 0.5 h post-dose
|
89.75 ng/ml
Geometric Coefficient of Variation 46.0
|
235.5 ng/ml
Geometric Coefficient of Variation 53.3
|
—
|
|
Plasma Concentration of Brensocatib in Adults (PK Substudy)
Week 28: 2 h post-dose
|
95.33 ng/ml
Geometric Coefficient of Variation 35.3
|
271.9 ng/ml
Geometric Coefficient of Variation 46.0
|
—
|
|
Plasma Concentration of Brensocatib in Adults (PK Substudy)
Week 28: 4-8 h post-dose
|
86.27 ng/ml
Geometric Coefficient of Variation 40.7
|
246.4 ng/ml
Geometric Coefficient of Variation 43.7
|
—
|
|
Plasma Concentration of Brensocatib in Adults (PK Substudy)
Week 40: Pre-dose
|
51.80 ng/ml
Geometric Coefficient of Variation 54.4
|
119.3 ng/ml
Geometric Coefficient of Variation 51.3
|
—
|
|
Plasma Concentration of Brensocatib in Adults (PK Substudy)
Week 40: 2 h post-dose
|
93.74 ng/ml
Geometric Coefficient of Variation 32.1
|
271.2 ng/ml
Geometric Coefficient of Variation 45.0
|
—
|
|
Plasma Concentration of Brensocatib in Adults (PK Substudy)
Week 52: Pre-dose
|
49.93 ng/ml
Geometric Coefficient of Variation 72.2
|
131.6 ng/ml
Geometric Coefficient of Variation 56.5
|
—
|
SECONDARY outcome
Timeframe: 0.5 h, 2 h, and 4 to 8 h post-dose on Day 1 and at Week 28; Pre-dose and 2 h post-dose at Weeks 4 and 48; Pre-dose at Weeks 16 and 52Population: The PK concentration analysis set included adolescent participants who consented to participate in the main study and received at least 1 dose of brensocatib, and had at least 1 postdose plasma concentration of brensocatib. 'Overall number of participants analyzed' indicates the number of participants with data available for analysis. 'Number analyzed' signifies number of adolescent participants with data available for analysis at specified time point.
Outcome measures
| Measure |
Brensocatib 10 mg
n=14 Participants
Participants received brensocatib 10 mg, tablets orally, once daily, for 52 weeks.
|
Brensocatib 25 mg
n=16 Participants
Participants received brensocatib 25 mg, tablets orally, once daily, for 52 weeks.
|
Placebo
Participants received a brensocatib matching placebo, tablets orally, once daily, for 52 weeks.
|
|---|---|---|---|
|
Plasma Concentration of Brensocatib in Adolescents (Main Study)
Day 1: 0.5 h post-dose
|
63.20 ng/ml
Geometric Coefficient of Variation 51.7
|
109.3 ng/ml
Geometric Coefficient of Variation 139.1
|
—
|
|
Plasma Concentration of Brensocatib in Adolescents (Main Study)
Day 1: 2 h post-dose
|
68.33 ng/ml
Geometric Coefficient of Variation 32.5
|
202.5 ng/ml
Geometric Coefficient of Variation 50.7
|
—
|
|
Plasma Concentration of Brensocatib in Adolescents (Main Study)
Day 1: 4-8 h post-dose
|
56.07 ng/ml
Geometric Coefficient of Variation 24.1
|
196.1 ng/ml
Geometric Coefficient of Variation 52.4
|
—
|
|
Plasma Concentration of Brensocatib in Adolescents (Main Study)
Week 4: Pre-dose
|
44.10 ng/ml
Geometric Coefficient of Variation 64.2
|
126.6 ng/ml
Geometric Coefficient of Variation 90.4
|
—
|
|
Plasma Concentration of Brensocatib in Adolescents (Main Study)
Week 4: 2 h post-dose
|
134.9 ng/ml
Geometric Coefficient of Variation 52.8
|
432.9 ng/ml
Geometric Coefficient of Variation 44.3
|
—
|
|
Plasma Concentration of Brensocatib in Adolescents (Main Study)
Week 16: Pre-dose
|
40.62 ng/ml
Geometric Coefficient of Variation 51.6
|
158.1 ng/ml
Geometric Coefficient of Variation 95.7
|
—
|
|
Plasma Concentration of Brensocatib in Adolescents (Main Study)
Week 28: Pre-dose
|
43.74 ng/ml
Geometric Coefficient of Variation 57.2
|
132.9 ng/ml
Geometric Coefficient of Variation 96.3
|
—
|
|
Plasma Concentration of Brensocatib in Adolescents (Main Study)
Week 28: 0.5 h post-dose
|
123.4 ng/ml
Geometric Coefficient of Variation 49.1
|
321.6 ng/ml
Geometric Coefficient of Variation 93.8
|
—
|
|
Plasma Concentration of Brensocatib in Adolescents (Main Study)
Week 28: 2 h post-dose
|
118.5 ng/ml
Geometric Coefficient of Variation 30.5
|
336.9 ng/ml
Geometric Coefficient of Variation 77.7
|
—
|
|
Plasma Concentration of Brensocatib in Adolescents (Main Study)
Week 28: 4-8 h post-dose
|
115.4 ng/ml
Geometric Coefficient of Variation 27.7
|
309.9 ng/ml
Geometric Coefficient of Variation 48.0
|
—
|
|
Plasma Concentration of Brensocatib in Adolescents (Main Study)
Week 40: Pre-dose
|
37.30 ng/ml
Geometric Coefficient of Variation 52.5
|
84.39 ng/ml
Geometric Coefficient of Variation 102.3
|
—
|
|
Plasma Concentration of Brensocatib in Adolescents (Main Study)
Week 40: 2 h post-dose
|
110.4 ng/ml
Geometric Coefficient of Variation 43.9
|
262.8 ng/ml
Geometric Coefficient of Variation 77.6
|
—
|
|
Plasma Concentration of Brensocatib in Adolescents (Main Study)
Week 52: Pre-dose
|
43.02 ng/ml
Geometric Coefficient of Variation 64.8
|
104.0 ng/ml
Geometric Coefficient of Variation 57.8
|
—
|
Adverse Events
Brensocatib 10 mg
Serious events: 101 serious events
Other events: 197 other events
Deaths: 2 deaths
Brensocatib 25 mg
Serious events: 97 serious events
Other events: 213 other events
Deaths: 4 deaths
Placebo
Serious events: 108 serious events
Other events: 203 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Brensocatib 10 mg
n=582 participants at risk
Participants received brensocatib 10 mg tablets, orally, once daily, for 52 weeks.
|
Brensocatib 25 mg
n=574 participants at risk
Participants received brensocatib 25 mg tablets, orally, once daily, for 52 weeks.
|
Placebo
n=563 participants at risk
Participants received a brensocatib matching placebo tablets orally, once daily, for 52 weeks.
|
|---|---|---|---|
|
Investigations
Urinary sediment abnormal
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.18%
1/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.18%
1/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.17%
1/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.17%
1/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Cardiac disorders
Atrial fibrillation
|
0.34%
2/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.17%
1/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.71%
4/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.17%
1/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.18%
1/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.18%
1/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.17%
1/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Cardiac disorders
Cardiac failure acute
|
0.17%
1/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.17%
1/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.18%
1/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.18%
1/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Cardiac disorders
Cardiomyopathy
|
0.17%
1/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.18%
1/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Cardiac disorders
Diastolic dysfunction
|
0.17%
1/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.18%
1/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Cardiac disorders
Myocardial infarction
|
0.17%
1/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.17%
1/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Cardiac disorders
Pericardial effusion
|
0.17%
1/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Eye disorders
Blindness transient
|
0.17%
1/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Eye disorders
Cataract
|
0.17%
1/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.53%
3/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Eye disorders
Cataract nuclear
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.18%
1/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Eye disorders
Glaucoma
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.17%
1/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Eye disorders
Macular hole
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.18%
1/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.18%
1/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Eye disorders
Vitreoretinal traction syndrome
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.18%
1/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.17%
1/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.18%
1/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Gastrointestinal disorders
Enteritis
|
0.17%
1/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Gastrointestinal disorders
Femoral hernia incarcerated
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.18%
1/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.17%
1/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.17%
1/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Gastrointestinal disorders
Malabsorption
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.18%
1/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.18%
1/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.17%
1/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.36%
2/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.17%
1/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.17%
1/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
General disorders
General physical health deterioration
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.17%
1/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Investigations
Weight decreased
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.17%
1/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
General disorders
Generalised oedema
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.17%
1/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
General disorders
Pyrexia
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.17%
1/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Hepatobiliary disorders
Biliary cyst
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.17%
1/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.17%
1/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.17%
1/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.17%
1/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.17%
1/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Immune system disorders
Drug hypersensitivity
|
0.17%
1/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Infections and infestations
Abscess neck
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.17%
1/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Infections and infestations
Appendicitis
|
0.34%
2/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.18%
1/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Infections and infestations
Aspergillus infection
|
0.17%
1/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Infections and infestations
Bacterial infection
|
0.17%
1/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Infections and infestations
Bronchitis fungal
|
0.17%
1/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Infections and infestations
Burkholderia gladioli infection
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.17%
1/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Infections and infestations
COVID-19
|
0.69%
4/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
1.6%
9/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
1.1%
6/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.17%
1/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.18%
1/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Infections and infestations
Cellulitis
|
0.17%
1/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Infections and infestations
Coronavirus infection
|
0.17%
1/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.18%
1/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.17%
1/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Infections and infestations
Empyema
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.18%
1/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Infections and infestations
Endophthalmitis
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.17%
1/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Infections and infestations
Gastroenteritis cryptosporidial
|
0.17%
1/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.35%
2/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.18%
1/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Infections and infestations
Influenza
|
0.34%
2/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.17%
1/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.18%
1/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Infections and infestations
Klebsiella infection
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.17%
1/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Infections and infestations
Large intestine infection
|
0.17%
1/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.17%
1/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.17%
1/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Infections and infestations
Lung abscess
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.35%
2/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.18%
1/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Infections and infestations
Mastitis
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.17%
1/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Infections and infestations
Periorbital cellulitis
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.18%
1/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Infections and infestations
Pneumonia
|
1.9%
11/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
2.3%
13/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
2.8%
16/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.36%
2/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.17%
1/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.18%
1/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Infections and infestations
Pneumonia influenzal
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.18%
1/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Infections and infestations
Pneumonia necrotising
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.17%
1/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.18%
1/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Infections and infestations
Pneumonia pseudomonal
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.17%
1/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Infections and infestations
Postoperative wound infection
|
0.17%
1/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Infections and infestations
Pseudomonas infection
|
0.34%
2/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.35%
2/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.36%
2/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Infections and infestations
Pyelonephritis chronic
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.18%
1/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Infections and infestations
Scrub typhus
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.18%
1/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Infections and infestations
Sepsis
|
0.17%
1/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.18%
1/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Infections and infestations
Sinusitis
|
0.34%
2/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.18%
1/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Infections and infestations
Urinary tract infection
|
0.17%
1/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.35%
2/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.18%
1/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Infections and infestations
Viral infection
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.17%
1/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Infections and infestations
Viral pharyngitis
|
0.17%
1/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.17%
1/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.18%
1/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.17%
1/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.18%
1/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.18%
1/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Injury, poisoning and procedural complications
Fall
|
0.17%
1/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.18%
1/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.17%
1/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Injury, poisoning and procedural complications
Foreign body in throat
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.17%
1/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.17%
1/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.34%
2/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.17%
1/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Injury, poisoning and procedural complications
Limb traumatic amputation
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.18%
1/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.18%
1/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.34%
2/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.17%
1/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.18%
1/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.17%
1/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.18%
1/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.17%
1/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.17%
1/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.17%
1/573 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.18%
1/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.17%
1/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.17%
1/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.18%
1/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.17%
1/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.18%
1/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.17%
1/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.17%
1/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.18%
1/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
0.17%
1/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.17%
1/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.17%
1/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.18%
1/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.17%
1/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.17%
1/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.17%
1/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal squamous cell carcinoma
|
0.17%
1/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign salivary gland neoplasm
|
0.17%
1/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.18%
1/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.17%
1/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.17%
1/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.18%
1/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.17%
1/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.17%
1/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mantle cell lymphoma
|
0.17%
1/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.17%
1/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.17%
1/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.17%
1/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/562 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.17%
1/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.18%
1/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.18%
1/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Nervous system disorders
Loss of consciousness
|
0.17%
1/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Nervous system disorders
Presyncope
|
0.17%
1/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Nervous system disorders
Sciatica
|
0.17%
1/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.17%
1/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Product Issues
Device dislocation
|
0.17%
1/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Product Issues
Device malfunction
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.18%
1/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.18%
1/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.17%
1/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.17%
1/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.17%
1/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.18%
1/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.17%
1/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.17%
1/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.17%
1/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Reproductive system and breast disorders
Pelvic organ prolapse
|
0.17%
1/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Reproductive system and breast disorders
Uterovaginal prolapse
|
0.17%
1/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.34%
2/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.17%
1/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.36%
2/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
8.1%
47/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
8.4%
48/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
11.9%
67/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.18%
1/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Eosinophilic pneumonia
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.17%
1/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.52%
3/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.17%
1/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
1.1%
6/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.17%
1/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Lung opacity
|
0.17%
1/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.17%
1/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.17%
1/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary arterial hypertension
|
0.17%
1/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.34%
2/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.17%
1/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.36%
2/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.18%
1/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.18%
1/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.17%
1/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.18%
1/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.17%
1/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Vascular disorders
Hypertension
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.17%
1/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.18%
1/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.18%
1/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Vascular disorders
Hypotension
|
0.00%
0/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.00%
0/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
0.18%
1/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
Other adverse events
| Measure |
Brensocatib 10 mg
n=582 participants at risk
Participants received brensocatib 10 mg tablets, orally, once daily, for 52 weeks.
|
Brensocatib 25 mg
n=574 participants at risk
Participants received brensocatib 25 mg tablets, orally, once daily, for 52 weeks.
|
Placebo
n=563 participants at risk
Participants received a brensocatib matching placebo tablets orally, once daily, for 52 weeks.
|
|---|---|---|---|
|
Infections and infestations
COVID-19
|
15.3%
89/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
19.7%
113/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
14.7%
83/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Infections and infestations
Nasopharyngitis
|
7.7%
45/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
6.3%
36/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
7.6%
43/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Infections and infestations
Urinary tract infection
|
4.6%
27/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
5.2%
30/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
5.9%
33/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.2%
13/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
3.0%
17/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
6.2%
35/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Nervous system disorders
Headache
|
6.7%
39/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
8.5%
49/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
6.9%
39/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.0%
41/582 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
6.1%
35/574 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
6.4%
36/563 • Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER