Trial Outcomes & Findings for Efficacy and Safety Trial of 12 Weeks of Treatment With Nebulized SUN-101 in Patients With COPD (NCT NCT02347761)
NCT ID: NCT02347761
Last Updated: 2018-03-22
Results Overview
ALL COLLECTED-Spirometry was performed according to internationally accepted standards.Trough FEV1 at Week 12 was defined as the mean of the values collected at two time points 30 minutes apart at approximately 24 hours (± 1 hour) after the previous morning dose.Change from baseline in trough FEV1 was calculated as the trough FEV1 value at Week 12 minus the morning trough FEV1 at baseline (mean of the two pre-dose values at 45 and 15 minutes prior to the first dose). All collected values were used in this analyses, regardless if the subject remained on randomized treatment or not, and regardless if the values might potentially be affected by other therapies or not Values not collected remained as missing values and were assumed to be missing at random (MAR) "ALL COLLECTED" and "ON TREATMENT" data are the same. The only difference is in the number of visits included for those participants who may have discontinued randomized treatment but remained in the study." for all endpoints
COMPLETED
PHASE3
653 participants
Baseline and Week 12
2018-03-22
Participant Flow
Participant milestones
| Measure |
SUN-101 50 mcg BID eFlow (CS) Nebulizer
SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer
SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow Closed System (CS) nebulizer
|
SUN-101 25 mcg BID eFlow (CS) Nebulizer
SUN-101 25 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer
SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg twice daily (BID) eFlow Closed System (CS) nebulizer
|
Placebo BID eFlow (CS) Nebulizer
Placebo twice daily (BID) eFlow (R) Closed System (CR) nebulizer
Placebo BID eFlow Closed System (CS) nebulizer: Placebo twice daily (BID) eFlow Closed System (CS) nebulizer
|
|---|---|---|---|
|
All Collected
STARTED
|
218
|
217
|
218
|
|
All Collected
COMPLETED
|
201
|
203
|
191
|
|
All Collected
NOT COMPLETED
|
17
|
14
|
27
|
|
On Study Treatment
STARTED
|
218
|
217
|
218
|
|
On Study Treatment
COMPLETED
|
191
|
194
|
176
|
|
On Study Treatment
NOT COMPLETED
|
27
|
23
|
42
|
Reasons for withdrawal
| Measure |
SUN-101 50 mcg BID eFlow (CS) Nebulizer
SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer
SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow Closed System (CS) nebulizer
|
SUN-101 25 mcg BID eFlow (CS) Nebulizer
SUN-101 25 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer
SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg twice daily (BID) eFlow Closed System (CS) nebulizer
|
Placebo BID eFlow (CS) Nebulizer
Placebo twice daily (BID) eFlow (R) Closed System (CR) nebulizer
Placebo BID eFlow Closed System (CS) nebulizer: Placebo twice daily (BID) eFlow Closed System (CS) nebulizer
|
|---|---|---|---|
|
All Collected
Death
|
1
|
0
|
0
|
|
All Collected
Lost to Follow-up
|
3
|
2
|
3
|
|
All Collected
Withdrawal by Subject
|
11
|
11
|
22
|
|
All Collected
invetigator disretion
|
2
|
0
|
0
|
|
All Collected
instillation site pain
|
0
|
0
|
1
|
|
All Collected
exacerbation of COPD
|
0
|
0
|
1
|
|
All Collected
moved/travel
|
0
|
1
|
0
|
|
On Study Treatment
Lack of Efficacy
|
2
|
3
|
4
|
|
On Study Treatment
non-compliance with study medication
|
0
|
0
|
2
|
|
On Study Treatment
Withdrawal by Subject
|
7
|
3
|
5
|
|
On Study Treatment
move/travel
|
2
|
6
|
5
|
|
On Study Treatment
dissastisfaction with device
|
2
|
1
|
4
|
|
On Study Treatment
Lost to Follow-up
|
2
|
1
|
1
|
|
On Study Treatment
investigator discretion
|
2
|
0
|
0
|
|
On Study Treatment
durg not working
|
0
|
1
|
1
|
|
On Study Treatment
Adverse Event
|
10
|
8
|
20
|
Baseline Characteristics
Efficacy and Safety Trial of 12 Weeks of Treatment With Nebulized SUN-101 in Patients With COPD
Baseline characteristics by cohort
| Measure |
SUN-101 50 mcg BID eFlow (CS) Nebulizer
n=218 Participants
SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer
SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow Closed System (CS) nebulizer
|
SUN-101 25 mcg BID eFlow (CS) Nebulizer
n=217 Participants
SUN-101 25 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer
SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg twice daily (BID) eFlow Closed System (CS) nebulizer
|
Placebo BID eFlow (CS) Nebulizer
n=218 Participants
Placebo twice daily (BID) eFlow (R) Closed System (CR) nebulizer
Placebo BID eFlow Closed System (CS) nebulizer: Placebo twice daily (BID) eFlow Closed System (CS) nebulizer
|
Total
n=653 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
135 Participants
n=5 Participants
|
122 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
366 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
83 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
287 Participants
n=4 Participants
|
|
Age, Continuous
|
62.5 years
STANDARD_DEVIATION 8.09 • n=5 Participants
|
63.1 years
STANDARD_DEVIATION 8.78 • n=7 Participants
|
63.7 years
STANDARD_DEVIATION 8.37 • n=5 Participants
|
63.1 years
STANDARD_DEVIATION 8.42 • n=4 Participants
|
|
Sex: Female, Male
Female
|
98 Participants
n=5 Participants
|
99 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
304 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
120 Participants
n=5 Participants
|
118 Participants
n=7 Participants
|
111 Participants
n=5 Participants
|
349 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
212 Participants
n=5 Participants
|
210 Participants
n=7 Participants
|
212 Participants
n=5 Participants
|
634 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
18 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
198 Participants
n=5 Participants
|
200 Participants
n=7 Participants
|
196 Participants
n=5 Participants
|
594 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
218 Participants
n=5 Participants
|
217 Participants
n=7 Participants
|
218 Participants
n=5 Participants
|
653 Participants
n=4 Participants
|
|
cardiovascular risk (low/high) and categories for high caridovascular risk
low cardiovascular risk
|
77 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
231 Participants
n=4 Participants
|
|
cardiovascular risk (low/high) and categories for high caridovascular risk
high cardiovascular risk
|
141 Participants
n=5 Participants
|
139 Participants
n=7 Participants
|
142 Participants
n=5 Participants
|
422 Participants
n=4 Participants
|
|
cardiovascular risk (low/high) and categories for high caridovascular risk
cerebrovascular disease
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
|
cardiovascular risk (low/high) and categories for high caridovascular risk
peripheral arterial disease
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
|
cardiovascular risk (low/high) and categories for high caridovascular risk
clinically significant arrhythmia
|
7 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
cardiovascular risk (low/high) and categories for high caridovascular risk
heart failure
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
cardiovascular risk (low/high) and categories for high caridovascular risk
hyertension
|
127 Participants
n=5 Participants
|
128 Participants
n=7 Participants
|
138 Participants
n=5 Participants
|
393 Participants
n=4 Participants
|
|
background long-acting beta(2) agonist (LABA) use
background LABA use =yes
|
68 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
197 Participants
n=4 Participants
|
|
background long-acting beta(2) agonist (LABA) use
background LABA use =no
|
150 Participants
n=5 Participants
|
151 Participants
n=7 Participants
|
155 Participants
n=5 Participants
|
456 Participants
n=4 Participants
|
|
Forced expiratory volume in one second (FEV1)
|
1.3745 liters
STANDARD_DEVIATION 0.52957 • n=5 Participants
|
1.3108 liters
STANDARD_DEVIATION 0.50243 • n=7 Participants
|
1.3122 liters
STANDARD_DEVIATION 0.47511 • n=5 Participants
|
1.3325 liters
STANDARD_DEVIATION 0.50297 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Intent to Treat (ITT) Population: all subjects who were randomized to treatment and received at least one dose of study medication. Subjects were analyzed based on the treatment they were randomized to.
ALL COLLECTED-Spirometry was performed according to internationally accepted standards.Trough FEV1 at Week 12 was defined as the mean of the values collected at two time points 30 minutes apart at approximately 24 hours (± 1 hour) after the previous morning dose.Change from baseline in trough FEV1 was calculated as the trough FEV1 value at Week 12 minus the morning trough FEV1 at baseline (mean of the two pre-dose values at 45 and 15 minutes prior to the first dose). All collected values were used in this analyses, regardless if the subject remained on randomized treatment or not, and regardless if the values might potentially be affected by other therapies or not Values not collected remained as missing values and were assumed to be missing at random (MAR) "ALL COLLECTED" and "ON TREATMENT" data are the same. The only difference is in the number of visits included for those participants who may have discontinued randomized treatment but remained in the study." for all endpoints
Outcome measures
| Measure |
SUN-101 50 mcg BID eFlow (CS) Nebulizer
n=218 Participants
SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer
SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow Closed System (CS) nebulizer
|
SUN-101 25 mcg BID eFlow (CS) Nebulizer
n=217 Participants
SUN-101 25 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer
SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg twice daily (BID) eFlow Closed System (CS) nebulizer
|
Placebo BID eFlow (CS) Nebulizer
n=218 Participants
Placebo twice daily (BID) eFlow (R) Closed System (CR) nebulizer
Placebo BID eFlow Closed System (CS) nebulizer: Placebo twice daily (BID) eFlow Closed System (CS) nebulizer
|
|---|---|---|---|
|
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12
|
0.0961 liters
Standard Error 0.01371
|
0.0886 liters
Standard Error 0.01369
|
-0.0075 liters
Standard Error 0.01397
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Intent to Treat (ITT) Population: all subjects who were randomized to treatment and received at least one dose of study medication. Subjects were analyzed based on the treatment they were randomized to.
ON TEATMENT-Spirometry was performed according to internationally accepted standards.Trough FEV1 at Week 12 was defined as the mean of the values collected at two time points 30 minutes apart at approximately 24 hours (± 1 hour) after the previous morning dose.Change from baseline in trough FEV1 was calculated as the trough FEV1 value at Week 12 minus the morning trough FEV1 at baseline (mean of the two pre-dose values at 45 and 15 minutes prior to the first dose).Only on-treatment values (which included only data collected while subjects were taking study drug) are used for this analysis. Values affected by other medication use were set to missing. Non-collected or missing data were not imputed for this analysis. Values not collected remained as missing values and were assumed to be missing at random (MAR).
Outcome measures
| Measure |
SUN-101 50 mcg BID eFlow (CS) Nebulizer
n=218 Participants
SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer
SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow Closed System (CS) nebulizer
|
SUN-101 25 mcg BID eFlow (CS) Nebulizer
n=217 Participants
SUN-101 25 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer
SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg twice daily (BID) eFlow Closed System (CS) nebulizer
|
Placebo BID eFlow (CS) Nebulizer
n=218 Participants
Placebo twice daily (BID) eFlow (R) Closed System (CR) nebulizer
Placebo BID eFlow Closed System (CS) nebulizer: Placebo twice daily (BID) eFlow Closed System (CS) nebulizer
|
|---|---|---|---|
|
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) Week 12
|
0.1025 liters
Standard Error 0.01497
|
0.0814 liters
Standard Error 0.01475
|
-0.0238 liters
Standard Error 0.01534
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: The Substudy Population consisted of all ITT subjects who participated in post-dose serial measurements
ALL COLLECTED The standardized FEV1 AUC(0-12) was calculated at weeks 0 and 12 for the Substudy Population with extended spirometry measurements. The trapezoidal rule was used to calculate FEV1 AUC and then normalized to the length of time. Intermittent missing spirometry measurements were ignored and the trapezoidal rule would simply span the missing time point(s). If the Hour 12 time point was missing, then the AUC(0-12) calculation was based on the time interval up to the last non-missing time point prior to Hour 12. If a subject has a missing baseline FEV1, then that subject had a missing AUC. All collected values were used in the analyses, regardless if the subject remained on randomized treatment or not, and regardless if the values might potentially be affected by other therapies or not Values not collected remained as missing values and were assumed to be missing at random (MAR).
Outcome measures
| Measure |
SUN-101 50 mcg BID eFlow (CS) Nebulizer
n=62 Participants
SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer
SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow Closed System (CS) nebulizer
|
SUN-101 25 mcg BID eFlow (CS) Nebulizer
n=49 Participants
SUN-101 25 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer
SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg twice daily (BID) eFlow Closed System (CS) nebulizer
|
Placebo BID eFlow (CS) Nebulizer
n=42 Participants
Placebo twice daily (BID) eFlow (R) Closed System (CR) nebulizer
Placebo BID eFlow Closed System (CS) nebulizer: Placebo twice daily (BID) eFlow Closed System (CS) nebulizer
|
|---|---|---|---|
|
Standardized Change From Baseline at Week 12 in FEV1 Area Under the Curve (AUC) (0-12) in the Substudy Population
|
0.0749 liters
Standard Error 0.02638
|
0.0579 liters
Standard Error 0.3011
|
-0.0474 liters
Standard Error 0.03229
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: The Substudy Population consisted of all ITT subjects who participated in post-dose serial measurements, including serial spirometry, serial ECGs, serial vital sign measurements, as well as Holter monitoring at Visit 6.
ON TREATMENT The standardized FEV1 AUC(0-12) was calculated at weeks 0 and 12 for the Substudy Population with extended spirometry measurements. The trapezoidal rule was used to calculate FEV1 AUC and then normalized to the length of time. Intermittent missing spirometry measurements were ignored and the trapezoidal rule would simply span the missing time points. If the Hour 12 time point was missing, then the AUC(0-12) calculation was based on the time interval up to the last non-missing time point prior to Hour 12. If a subject has a missing baseline FEV1, then that subject had a missing AUC.Only on-treatment values (which included only data collected while subjects were taking study drug) are used for this analysis. Values affected by other medication use were set to missing. Non-collected or missing data were not imputed for this analysis. Values not collected remained as missing values and were assumed to be missing at random (MAR).
Outcome measures
| Measure |
SUN-101 50 mcg BID eFlow (CS) Nebulizer
n=62 Participants
SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer
SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow Closed System (CS) nebulizer
|
SUN-101 25 mcg BID eFlow (CS) Nebulizer
n=49 Participants
SUN-101 25 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer
SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg twice daily (BID) eFlow Closed System (CS) nebulizer
|
Placebo BID eFlow (CS) Nebulizer
n=42 Participants
Placebo twice daily (BID) eFlow (R) Closed System (CR) nebulizer
Placebo BID eFlow Closed System (CS) nebulizer: Placebo twice daily (BID) eFlow Closed System (CS) nebulizer
|
|---|---|---|---|
|
Standardized Change From Baseline at Week 12 in FEV1 Area Under the Curve (AUC) (0-12) in Substudy Population
|
0.0708 liters
Standard Error 0.02792
|
0.0496 liters
Standard Error 0.03280
|
-0.0527 liters
Standard Error 0.03450
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Intent to Treat (ITT) Population: all subjects who were randomized to treatment and received at least one dose of study medication. Subjects were analyzed based on the treatment they were randomized to.
ALL COLLECTED Spirometry was performed according to internationally accepted standards. Trough FVC at Week 12 was defined as the mean of the values collected at two time points 30 minutes apart at approximately 24 hours (± 1 hour) after the previous morning dose. All collected values were used in the analyses, regardless if the subject remained on randomized treatment or not, and regardless if the values might potentially be affected by other therapies or not Values not collected remained as missing values and were assumed to be missing at random
Outcome measures
| Measure |
SUN-101 50 mcg BID eFlow (CS) Nebulizer
n=218 Participants
SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer
SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow Closed System (CS) nebulizer
|
SUN-101 25 mcg BID eFlow (CS) Nebulizer
n=217 Participants
SUN-101 25 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer
SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg twice daily (BID) eFlow Closed System (CS) nebulizer
|
Placebo BID eFlow (CS) Nebulizer
n=218 Participants
Placebo twice daily (BID) eFlow (R) Closed System (CR) nebulizer
Placebo BID eFlow Closed System (CS) nebulizer: Placebo twice daily (BID) eFlow Closed System (CS) nebulizer
|
|---|---|---|---|
|
Change From Baseline in Trough Forced Vital Capacity (FVC) at Week 12
|
0.1476 liters
Standard Error 0.02226
|
0.1515 liters
Standard Error 0.02220
|
0.0147 liters
Standard Error 0.2266
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Intent to Treat (ITT) Population: all subjects who were randomized to treatment and received at least one dose of study medication. Subjects were analyzed based on the treatment they were randomized to.
ON TREATMENT Spirometry was performed according to internationally accepted standards. Trough FVC at Week 12 was defined as the mean of the values collected at two time points 30 minutes apart at approximately 24 hours (± 1 hour) after the previous morning dose. Change from baseline in trough FVC was calculated as the trough FVC value at Week 12 minus the morning trough FVC at baseline (mean of the two pre-dose values at 45 and 15 minutes prior to the first dose).Only on-treatment values (which included only data collected while subjects were taking study drug) are used for this analysis. Values affected by other medication use were set to missing. Non-collected or missing data were not imputed for this analysis. Values not collected remained as missing values and were assumed to be missing at random (MAR).
Outcome measures
| Measure |
SUN-101 50 mcg BID eFlow (CS) Nebulizer
n=218 Participants
SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer
SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow Closed System (CS) nebulizer
|
SUN-101 25 mcg BID eFlow (CS) Nebulizer
n=217 Participants
SUN-101 25 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer
SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg twice daily (BID) eFlow Closed System (CS) nebulizer
|
Placebo BID eFlow (CS) Nebulizer
n=218 Participants
Placebo twice daily (BID) eFlow (R) Closed System (CR) nebulizer
Placebo BID eFlow Closed System (CS) nebulizer: Placebo twice daily (BID) eFlow Closed System (CS) nebulizer
|
|---|---|---|---|
|
Change From Baseline in Trough Forced Vital Capacity (FVC) Week 12
|
0.1566 liters
Standard Error 0.02392
|
0.1393 liters
Standard Error 0.02353
|
-0.0101 liters
Standard Error 0.2450
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Intent to Treat (ITT) Population: all subjects who were randomized to treatment and received at least one dose of study medication. Subjects were analyzed based on the treatment they were randomized to.
ALL COLLECTED Participants reported change in health status by using the SGRQ. The SGRQ contains 50 items divided into 2 parts covering 3 aspects of health related to COPD: symptoms, activity, and impacts. A score was calculated for each of these 3 subscales and a "Total" score was calculated. In each case the lowest possible value is 0 and the highest 100. Higher values correspond to greater impairment of health status. All collected values were used in the analyses, regardless if the subject remained on randomized treatment or not. Values not collected remained as missing values and were assumed to be missing at random (MAR).
Outcome measures
| Measure |
SUN-101 50 mcg BID eFlow (CS) Nebulizer
n=218 Participants
SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer
SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow Closed System (CS) nebulizer
|
SUN-101 25 mcg BID eFlow (CS) Nebulizer
n=217 Participants
SUN-101 25 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer
SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg twice daily (BID) eFlow Closed System (CS) nebulizer
|
Placebo BID eFlow (CS) Nebulizer
n=218 Participants
Placebo twice daily (BID) eFlow (R) Closed System (CR) nebulizer
Placebo BID eFlow Closed System (CS) nebulizer: Placebo twice daily (BID) eFlow Closed System (CS) nebulizer
|
|---|---|---|---|
|
Change From Baseline in Health Status Measured by St. George's Respiratory Questionnaire (SGRQ) at Week 12/End of Study
|
-2.363 scores on a scale
Standard Error 0.8344
|
-4.250 scores on a scale
Standard Error 0.8211
|
-0.844 scores on a scale
Standard Error 0.8396
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Intent to Treat (ITT) Population: all subjects who were randomized to treatment and received at least one dose of study medication. Subjects were analyzed based on the treatment they were randomized to.
ON TREATMENT Participants reported change in health status by using the SGRQ. The SGRQ contains 50 items divided into 2 parts covering 3 aspects of health related to COPD: symptoms, activity, and impacts. A score was calculated for each of these 3 subscales and a "Total" score was calculated. In each case the lowest possible value is 0 and the highest 100. Higher values correspond to greater impairment of health status. Only on-treatment values (which included only data collected while subjects were taking study drug) are used for this analysis. Values affected by other medication use were set to missing. Non-collected or missing data were not imputed for this analysis. Values not collected remained as missing values and were assumed to be missing at random (MAR).
Outcome measures
| Measure |
SUN-101 50 mcg BID eFlow (CS) Nebulizer
n=218 Participants
SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer
SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow Closed System (CS) nebulizer
|
SUN-101 25 mcg BID eFlow (CS) Nebulizer
n=217 Participants
SUN-101 25 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer
SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg twice daily (BID) eFlow Closed System (CS) nebulizer
|
Placebo BID eFlow (CS) Nebulizer
n=218 Participants
Placebo twice daily (BID) eFlow (R) Closed System (CR) nebulizer
Placebo BID eFlow Closed System (CS) nebulizer: Placebo twice daily (BID) eFlow Closed System (CS) nebulizer
|
|---|---|---|---|
|
Change From Baseline in Health Status Measured by St. George's Respiratory Questionnaire (SGRQ) Week 12/End of Study
|
-2.538 scores on a scale
Standard Error 0.8391
|
-3.762 scores on a scale
Standard Error 0.8187
|
-0.690 scores on a scale
Standard Error 0.8535
|
SECONDARY outcome
Timeframe: Week 0-12Population: Intent to Treat (ITT) Population: all subjects who were randomized to treatment and received at least one dose of study medication. Subjects were analyzed based on the treatment they were randomized to.
ALL COLLECTED Participants completed an electronic diary (eDiary) daily (night time) to record the number of puffs of rescue medication inhaled in the previous 24 hours. A negative change from baseline indicates improvement. All collected values were used in the analyses, regardless if the subject remained on randomized treatment or not. Values not collected remained as missing values and were assumed to be missing at random (MAR).
Outcome measures
| Measure |
SUN-101 50 mcg BID eFlow (CS) Nebulizer
n=218 Participants
SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer
SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow Closed System (CS) nebulizer
|
SUN-101 25 mcg BID eFlow (CS) Nebulizer
n=217 Participants
SUN-101 25 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer
SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg twice daily (BID) eFlow Closed System (CS) nebulizer
|
Placebo BID eFlow (CS) Nebulizer
n=218 Participants
Placebo twice daily (BID) eFlow (R) Closed System (CR) nebulizer
Placebo BID eFlow Closed System (CS) nebulizer: Placebo twice daily (BID) eFlow Closed System (CS) nebulizer
|
|---|---|---|---|
|
Change in Number of Rescue Medication Puffs Per Day Over the 12-week Double-blind Treatment Period
|
-0.815 puffs (medication used)
Standard Error 0.1234
|
-0.609 puffs (medication used)
Standard Error 0.1259
|
-0.632 puffs (medication used)
Standard Error 0.1257
|
SECONDARY outcome
Timeframe: Week 0-12Population: Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication.
ALL COLLECTED All deaths and any other findings suggestive of a potential MACE (including clinically relevant information and SAEs, and all PTs form the SMQs "myocardial infarction", "other ischemic heart disease", "central nervous system hemorrhages and cerebrovascular conditions") were sent to an adjudication committee for review and categorized as CV death, nonfatal MI, and nonfatal stroke. The MACE score was defined as the total number of subjects with CV deaths, nonfatal MIs, and nonfatal strokes. These events were collected for the double-blind period (from the first date of study medication until the date of last contact)
Outcome measures
| Measure |
SUN-101 50 mcg BID eFlow (CS) Nebulizer
n=218 Participants
SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer
SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow Closed System (CS) nebulizer
|
SUN-101 25 mcg BID eFlow (CS) Nebulizer
n=217 Participants
SUN-101 25 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer
SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg twice daily (BID) eFlow Closed System (CS) nebulizer
|
Placebo BID eFlow (CS) Nebulizer
n=218 Participants
Placebo twice daily (BID) eFlow (R) Closed System (CR) nebulizer
Placebo BID eFlow Closed System (CS) nebulizer: Placebo twice daily (BID) eFlow Closed System (CS) nebulizer
|
|---|---|---|---|
|
Number of Subjects With Major Adverse Cardiac Events (MACE)
MACE score
|
3 participants
|
0 participants
|
0 participants
|
|
Number of Subjects With Major Adverse Cardiac Events (MACE)
Cardiovascular Death
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Subjects With Major Adverse Cardiac Events (MACE)
non-fatal myocardial infraction
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Subjects With Major Adverse Cardiac Events (MACE)
non-fatal stroke
|
1 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Week 0-12Population: Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication.
ALL COLLECTED All deaths and any other findings suggestive of a potential MACE (including clinically relevant information and SAEs, and all PTs form the SMQs "myocardial infarction", "other ischemic heart disease", "central nervous system hemorrhages and cerebrovascular conditions") were sent to an adjudication committee for review and categorized as CV death, nonfatal MI, and nonfatal stroke. The MACE score was defined as the total number of subjects with CV deaths, nonfatal MIs, and nonfatal strokes. These events were collected for the double-blind period (from the first date of study medication until the date of last contact)
Outcome measures
| Measure |
SUN-101 50 mcg BID eFlow (CS) Nebulizer
n=218 Participants
SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer
SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow Closed System (CS) nebulizer
|
SUN-101 25 mcg BID eFlow (CS) Nebulizer
n=217 Participants
SUN-101 25 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer
SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg twice daily (BID) eFlow Closed System (CS) nebulizer
|
Placebo BID eFlow (CS) Nebulizer
n=218 Participants
Placebo twice daily (BID) eFlow (R) Closed System (CR) nebulizer
Placebo BID eFlow Closed System (CS) nebulizer: Placebo twice daily (BID) eFlow Closed System (CS) nebulizer
|
|---|---|---|---|
|
Percentage of Subjects With Major Cardiac Events (MACE)
MACE score
|
1.4 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Subjects With Major Cardiac Events (MACE)
Cardiovascular Death
|
0.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Subjects With Major Cardiac Events (MACE)
non-fatal myocardial infraction
|
0.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Subjects With Major Cardiac Events (MACE)
non-fatal stroke
|
0.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 0-12Population: Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication.
ON TREATMENT A TEAE is defined as any non-serious AE that occurred on or after the first dose of study medication and within 7 days after the last dose of study medication, or any serious AE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent AE is an on-treatment AE.
Outcome measures
| Measure |
SUN-101 50 mcg BID eFlow (CS) Nebulizer
n=218 Participants
SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer
SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow Closed System (CS) nebulizer
|
SUN-101 25 mcg BID eFlow (CS) Nebulizer
n=217 Participants
SUN-101 25 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer
SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg twice daily (BID) eFlow Closed System (CS) nebulizer
|
Placebo BID eFlow (CS) Nebulizer
n=218 Participants
Placebo twice daily (BID) eFlow (R) Closed System (CR) nebulizer
Placebo BID eFlow Closed System (CS) nebulizer: Placebo twice daily (BID) eFlow Closed System (CS) nebulizer
|
|---|---|---|---|
|
Number of Subjects With Treatment Emergent Adverse Events (TEAE)
|
105 participants
|
86 participants
|
114 participants
|
SECONDARY outcome
Timeframe: Week 0-12Population: Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication.
ON TREATMENT A TEAE is defined as any non-serious AE that occurred on or after the first dose of study medication and within 7 days after the last dose of study medication, or any serious AE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent AE is an on-treatment AE.
Outcome measures
| Measure |
SUN-101 50 mcg BID eFlow (CS) Nebulizer
n=218 Participants
SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer
SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow Closed System (CS) nebulizer
|
SUN-101 25 mcg BID eFlow (CS) Nebulizer
n=217 Participants
SUN-101 25 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer
SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg twice daily (BID) eFlow Closed System (CS) nebulizer
|
Placebo BID eFlow (CS) Nebulizer
n=218 Participants
Placebo twice daily (BID) eFlow (R) Closed System (CR) nebulizer
Placebo BID eFlow Closed System (CS) nebulizer: Placebo twice daily (BID) eFlow Closed System (CS) nebulizer
|
|---|---|---|---|
|
Percent of Subjects With Treatment Emergent Adverse Events (TEAE)
|
48.2 percentage of participants
|
39.6 percentage of participants
|
52.3 percentage of participants
|
SECONDARY outcome
Timeframe: Week 0-12Population: Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication
ON TREATMENT A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE
Outcome measures
| Measure |
SUN-101 50 mcg BID eFlow (CS) Nebulizer
n=218 Participants
SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer
SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow Closed System (CS) nebulizer
|
SUN-101 25 mcg BID eFlow (CS) Nebulizer
n=217 Participants
SUN-101 25 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer
SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg twice daily (BID) eFlow Closed System (CS) nebulizer
|
Placebo BID eFlow (CS) Nebulizer
n=218 Participants
Placebo twice daily (BID) eFlow (R) Closed System (CR) nebulizer
Placebo BID eFlow Closed System (CS) nebulizer: Placebo twice daily (BID) eFlow Closed System (CS) nebulizer
|
|---|---|---|---|
|
Number of Subjects With Treatment Emergent Serious Adverse Events (SAE)
|
10 participants
|
8 participants
|
11 participants
|
SECONDARY outcome
Timeframe: Week 0-12Population: Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication
ON TREATMENT A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE
Outcome measures
| Measure |
SUN-101 50 mcg BID eFlow (CS) Nebulizer
n=218 Participants
SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer
SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow Closed System (CS) nebulizer
|
SUN-101 25 mcg BID eFlow (CS) Nebulizer
n=217 Participants
SUN-101 25 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer
SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg twice daily (BID) eFlow Closed System (CS) nebulizer
|
Placebo BID eFlow (CS) Nebulizer
n=218 Participants
Placebo twice daily (BID) eFlow (R) Closed System (CR) nebulizer
Placebo BID eFlow Closed System (CS) nebulizer: Placebo twice daily (BID) eFlow Closed System (CS) nebulizer
|
|---|---|---|---|
|
Percent of Subjects With Treatment Emergent Serious Adverse Events (SAE)
|
4.6 percentage of participants
|
3.7 percentage of participants
|
5.0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 0-12Population: Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study meidcation
ON TREATMENT A TEAE is defined as any AE that occurred on or after the first dose of study medication and within 7 days after the last dose of study medication, or any serious AE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent AE is an on-treatment AE.
Outcome measures
| Measure |
SUN-101 50 mcg BID eFlow (CS) Nebulizer
n=218 Participants
SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer
SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow Closed System (CS) nebulizer
|
SUN-101 25 mcg BID eFlow (CS) Nebulizer
n=217 Participants
SUN-101 25 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer
SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg twice daily (BID) eFlow Closed System (CS) nebulizer
|
Placebo BID eFlow (CS) Nebulizer
n=218 Participants
Placebo twice daily (BID) eFlow (R) Closed System (CR) nebulizer
Placebo BID eFlow Closed System (CS) nebulizer: Placebo twice daily (BID) eFlow Closed System (CS) nebulizer
|
|---|---|---|---|
|
Number of Subjects Who Discontinue Treatment Due to TEAE
|
8 participants
|
7 participants
|
21 participants
|
SECONDARY outcome
Timeframe: Week 0-12Population: Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study meidcation
ON TREATMENT A TEAE is defined as any AE that occurred on or after the first dose of study medication and within 7 days after the last dose of study medication, or any serious AE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent AE is an on-treatment AE.
Outcome measures
| Measure |
SUN-101 50 mcg BID eFlow (CS) Nebulizer
n=218 Participants
SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer
SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow Closed System (CS) nebulizer
|
SUN-101 25 mcg BID eFlow (CS) Nebulizer
n=217 Participants
SUN-101 25 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer
SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg twice daily (BID) eFlow Closed System (CS) nebulizer
|
Placebo BID eFlow (CS) Nebulizer
n=218 Participants
Placebo twice daily (BID) eFlow (R) Closed System (CR) nebulizer
Placebo BID eFlow Closed System (CS) nebulizer: Placebo twice daily (BID) eFlow Closed System (CS) nebulizer
|
|---|---|---|---|
|
Percent of Subjects Who Discontinue Treatment Due to TEAE
|
3.7 percentage of participants
|
3.2 percentage of participants
|
9.6 percentage of participants
|
SECONDARY outcome
Timeframe: Week 0-12Population: Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication.
ALL COLLECTED All deaths and any other findings suggestive of a potential MACE (including clinically relevant information and SAEs, and all PTs form the SMQs "myocardial infarction", "other ischemic heart disease", "central nervous system hemorrhages and cerebrovascular conditions") were sent to an adjudication committee for review and categorized as CV death, nonfatal MI, and nonfatal stroke. The MACE score was defined as the total number of subjects with CV deaths, nonfatal MIs, and nonfatal strokes. These events were collected for the double-blind period (from the first date of study medication until the date of last contact)I ncidence rate: TT= Total Time in years. Total Time (TT) is defined as the time from the first date of study drug until the latter of the date of last contact or 30 days after the date of last dose. Incidence Rate (per 1000 person-years) = n/TT x 1000.
Outcome measures
| Measure |
SUN-101 50 mcg BID eFlow (CS) Nebulizer
n=218 Participants
SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer
SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow Closed System (CS) nebulizer
|
SUN-101 25 mcg BID eFlow (CS) Nebulizer
n=217 Participants
SUN-101 25 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer
SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg twice daily (BID) eFlow Closed System (CS) nebulizer
|
Placebo BID eFlow (CS) Nebulizer
n=218 Participants
Placebo twice daily (BID) eFlow (R) Closed System (CR) nebulizer
Placebo BID eFlow Closed System (CS) nebulizer: Placebo twice daily (BID) eFlow Closed System (CS) nebulizer
|
|---|---|---|---|
|
Incidence Rate Per 100 Person-years of Subjects With Treatment Emergent Adverse Events (TEAE)
MACE score
|
45.5 events per 100 person-years
|
0 events per 100 person-years
|
0 events per 100 person-years
|
|
Incidence Rate Per 100 Person-years of Subjects With Treatment Emergent Adverse Events (TEAE)
Cardiovascular Death
|
15.2 events per 100 person-years
|
0 events per 100 person-years
|
0 events per 100 person-years
|
|
Incidence Rate Per 100 Person-years of Subjects With Treatment Emergent Adverse Events (TEAE)
non-fatal myocardial infraction
|
15.2 events per 100 person-years
|
0 events per 100 person-years
|
0 events per 100 person-years
|
|
Incidence Rate Per 100 Person-years of Subjects With Treatment Emergent Adverse Events (TEAE)
non-fatal stroke
|
15.2 events per 100 person-years
|
0 events per 100 person-years
|
0 events per 100 person-years
|
Adverse Events
SUN-101 50 mcg BID eFlow (CS) Nebulizer
SUN-101 25 mcg BID eFlow (CS) Nebulizer
Placebo BID eFlow (CS) Nebulizer
Serious adverse events
| Measure |
SUN-101 50 mcg BID eFlow (CS) Nebulizer
n=218 participants at risk
SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer
SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow Closed System (CS) nebulizer
|
SUN-101 25 mcg BID eFlow (CS) Nebulizer
n=217 participants at risk
SUN-101 25 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer
SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg twice daily (BID) eFlow Closed System (CS) nebulizer
|
Placebo BID eFlow (CS) Nebulizer
n=218 participants at risk
Placebo twice daily (BID) eFlow (R) Closed System (CR) nebulizer
Placebo BID eFlow Closed System (CS) nebulizer: Placebo twice daily (BID) eFlow Closed System (CS) nebulizer
|
|---|---|---|---|
|
Cardiac disorders
angina pectoris
|
0.00%
0/218 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
0.46%
1/217 • Number of events 1 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
0.00%
0/218 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
|
Cardiac disorders
angina unstable
|
0.46%
1/218 • Number of events 1 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
0.00%
0/217 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
0.46%
1/218 • Number of events 1 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
|
Cardiac disorders
coronary artery stenosis
|
0.00%
0/218 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
0.46%
1/217 • Number of events 1 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
0.00%
0/218 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
|
Cardiac disorders
diastolic dysfunction
|
0.46%
1/218 • Number of events 1 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
0.00%
0/217 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
0.00%
0/218 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
|
Gastrointestinal disorders
small intestinal obstruction
|
0.00%
0/218 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
0.46%
1/217 • Number of events 1 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
0.00%
0/218 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
|
General disorders
chest pain
|
0.46%
1/218 • Number of events 1 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
0.00%
0/217 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
0.00%
0/218 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
|
Hepatobiliary disorders
gallbladder necrosis
|
0.46%
1/218 • Number of events 1 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
0.00%
0/217 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
0.00%
0/218 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
|
Infections and infestations
bronchitis
|
0.00%
0/218 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
0.00%
0/217 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
0.46%
1/218 • Number of events 1 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
|
Infections and infestations
emphysematous cholecystitis
|
0.46%
1/218 • Number of events 1 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
0.00%
0/217 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
0.00%
0/218 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
|
Infections and infestations
lobar pheumonia
|
0.00%
0/218 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
0.00%
0/217 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
0.46%
1/218 • Number of events 1 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
|
Immune system disorders
pneumonia
|
0.92%
2/218 • Number of events 2 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
0.00%
0/217 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
0.00%
0/218 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
|
Infections and infestations
pyelonephritis
|
0.00%
0/218 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
0.46%
1/217 • Number of events 1 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
0.00%
0/218 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
|
Infections and infestations
septic shock
|
0.46%
1/218 • Number of events 1 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
0.00%
0/217 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
0.00%
0/218 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
|
Injury, poisoning and procedural complications
intentional overdose
|
0.46%
1/218 • Number of events 1 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
0.00%
0/217 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
0.00%
0/218 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
|
Injury, poisoning and procedural complications
subdural haematoma
|
0.00%
0/218 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
0.00%
0/217 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
0.46%
1/218 • Number of events 1 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
|
Investigations
antiphospholiid antibodies
|
0.00%
0/218 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
0.00%
0/217 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
0.46%
1/218 • Number of events 1 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
|
Metabolism and nutrition disorders
dehydration
|
0.46%
1/218 • Number of events 1 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
0.00%
0/217 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
0.00%
0/218 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
|
Metabolism and nutrition disorders
diabetes mellitus inadequate control
|
0.00%
0/218 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
0.00%
0/217 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
0.46%
1/218 • Number of events 1 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
0.00%
0/218 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
0.00%
0/217 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
0.46%
1/218 • Number of events 1 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
lung adenocarcinoma stage IV
|
0.00%
0/218 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
0.46%
1/217 • Number of events 1 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
0.00%
0/218 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
malignant neoplasm of pleura metastatic
|
0.00%
0/218 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
0.00%
0/217 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
0.46%
1/218 • Number of events 1 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
|
Nervous system disorders
carotid artery stenosis
|
0.00%
0/218 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
0.46%
1/217 • Number of events 1 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
0.00%
0/218 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
|
Nervous system disorders
lacunar infarction
|
0.46%
1/218 • Number of events 1 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
0.00%
0/217 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
0.00%
0/218 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
|
Nervous system disorders
transient ischaemic attack
|
0.46%
1/218 • Number of events 1 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
0.00%
0/217 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
0.00%
0/218 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
|
Renal and urinary disorders
nephrolithiasis
|
0.00%
0/218 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
0.00%
0/217 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
0.46%
1/218 • Number of events 1 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
|
Renal and urinary disorders
obstructive uropathy
|
0.00%
0/218 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
0.46%
1/217 • Number of events 1 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
0.00%
0/218 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
|
Renal and urinary disorders
renal failure acute
|
0.00%
0/218 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
0.00%
0/217 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
0.46%
1/218 • Number of events 1 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
|
Respiratory, thoracic and mediastinal disorders
acute respiratory failure
|
0.00%
0/218 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
0.00%
0/217 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
0.46%
1/218 • Number of events 1 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
|
Respiratory, thoracic and mediastinal disorders
chronic obstructive pulmonary disease
|
1.8%
4/218 • Number of events 4 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
0.92%
2/217 • Number of events 2 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
0.92%
2/218 • Number of events 2 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
|
Respiratory, thoracic and mediastinal disorders
pleural effusion
|
0.46%
1/218 • Number of events 2 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
0.00%
0/217 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
0.00%
0/218 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary hypertension
|
0.46%
1/218 • Number of events 1 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
0.00%
0/217 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
0.00%
0/218 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
|
Respiratory, thoracic and mediastinal disorders
respiratory failure
|
0.46%
1/218 • Number of events 1 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
0.00%
0/217 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
0.00%
0/218 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
Other adverse events
| Measure |
SUN-101 50 mcg BID eFlow (CS) Nebulizer
n=218 participants at risk
SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer
SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow Closed System (CS) nebulizer
|
SUN-101 25 mcg BID eFlow (CS) Nebulizer
n=217 participants at risk
SUN-101 25 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer
SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg twice daily (BID) eFlow Closed System (CS) nebulizer
|
Placebo BID eFlow (CS) Nebulizer
n=218 participants at risk
Placebo twice daily (BID) eFlow (R) Closed System (CR) nebulizer
Placebo BID eFlow Closed System (CS) nebulizer: Placebo twice daily (BID) eFlow Closed System (CS) nebulizer
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
chronic obstructive ulmonary disease
|
8.7%
19/218 • Number of events 19 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
4.1%
9/217 • Number of events 9 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
7.8%
17/218 • Number of events 19 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
9.6%
21/218 • Number of events 22 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
7.4%
16/217 • Number of events 20 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
10.1%
22/218 • Number of events 23 • Week 0-12
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
|
Additional Information
Respiratory Medical Director
Sunovion Pharmaceuticals Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee In the event the Study is part of a multi-center study, the first publication of the results of the Study shall be made in conjunction with the results of other participating study sites as a multi-center publication; provided however, if a multi-center publication is not forthcoming within twenty-four (24) months following completion of the Study at all sites, Institution and Investigator shall be free to publish.
- Publication restrictions are in place
Restriction type: OTHER