Trial Outcomes & Findings for Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Refractory Chronic Cough (NCT NCT03282591)
NCT ID: NCT03282591
Last Updated: 2021-05-20
Results Overview
Change in 24-hour objective cough frequency is total number of cough events during the monitoring period (24-hour interval)/24 (Total duration (in hours) for the monitoring period) which is captured through sound recordings by a custom-built digital recording device (VitaloJAK, Vitalograph, Ltd).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
185 participants
Primary outcome timeframe
from Baseline to Day 84
Results posted on
2021-05-20
Participant Flow
Participant milestones
| Measure |
Serlopitant 5 mg
Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by a tablet taken once daily for 84 days.
|
Placebo
Subjects received a 3-tablet Placebo loading dose on the first day of the treatment period followed by a tablet taken once daily for 84 days.
|
|---|---|---|
|
Overall Study
STARTED
|
92
|
93
|
|
Overall Study
COMPLETED
|
88
|
89
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Refractory Chronic Cough
Baseline characteristics by cohort
| Measure |
Serlopitant 5 mg
n=88 Participants
Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by a tablet taken once daily for 84 days.
|
Placebo
n=88 Participants
Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by a tablet taken once daily for 84 days.
|
Total
n=176 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.5 years
n=5 Participants
|
64.5 years
n=7 Participants
|
65 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
68 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
135 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
83 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
170 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
83 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
166 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
NA Participants
n=5 Participants
|
NA Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
69 participants
n=5 Participants
|
68 participants
n=7 Participants
|
137 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
19 participants
n=5 Participants
|
20 participants
n=7 Participants
|
39 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: from Baseline to Day 84Change in 24-hour objective cough frequency is total number of cough events during the monitoring period (24-hour interval)/24 (Total duration (in hours) for the monitoring period) which is captured through sound recordings by a custom-built digital recording device (VitaloJAK, Vitalograph, Ltd).
Outcome measures
| Measure |
Serlopitant 5 mg
n=88 Participants
Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by a tablet taken once daily for 84 days.
|
Placebo
n=88 Participants
Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by a tablet taken once daily for 84 days.
|
|---|---|---|
|
Change in 24-hour Objective Cough Frequency (Log Normalized Percent Change Relative to Placebo)
|
-0.18 coughs/hr
Standard Error 0.09
|
-0.45 coughs/hr
Standard Error 0.08
|
SECONDARY outcome
Timeframe: from Baseline to Day 84Awake cough frequency = (total number of cough events during the monitoring period (24-hour interval) the subject is awake)/(Total duration (in hours) for the monitoring period the subject is awake) which is captured by a custom-built digital recording device (VitaloJAK, Vitalograph, Ltd).
Outcome measures
| Measure |
Serlopitant 5 mg
n=88 Participants
Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by a tablet taken once daily for 84 days.
|
Placebo
n=88 Participants
Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by a tablet taken once daily for 84 days.
|
|---|---|---|
|
Change in Awake Objective Cough Frequency
Day 84 (Week 12)
|
-0.19 coughs/hr
Interval -0.34 to -0.04
|
-0.46 coughs/hr
Interval -0.6 to -0.31
|
|
Change in Awake Objective Cough Frequency
Day 28 (Week 4)
|
-0.12 coughs/hr
Interval -0.26 to 0.01
|
-0.30 coughs/hr
Interval -0.43 to -0.17
|
|
Change in Awake Objective Cough Frequency
Day 56 (Week 8)
|
-0.25 coughs/hr
Interval -0.39 to -0.1
|
-0.32 coughs/hr
Interval -0.47 to -0.18
|
SECONDARY outcome
Timeframe: from Baseline to Day 84The percentage of participants with ≥ 30% of reduction from baseline in 24-hour cough frequency is the number of participants with ≤-30% change in 24-hour cough frequency divided by the total number of participants with available data. This data is captured by a custom-built digital recording device (VitaloJAK, Vitalograph, Ltd).
Outcome measures
| Measure |
Serlopitant 5 mg
n=88 Participants
Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by a tablet taken once daily for 84 days.
|
Placebo
n=88 Participants
Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by a tablet taken once daily for 84 days.
|
|---|---|---|
|
Percentage of Participants With ≥ 30% Reduction in 24-hour Objective Cough Frequency
|
71.4 Percentage of participants
|
90.2 Percentage of participants
|
SECONDARY outcome
Timeframe: from Baseline to Day 84The percentage of participants with ≥ 30% of reduction from baseline in the awake cough frequency is the number of participants with ≤30% change in awake cough frequency divided by the total number of participants with available data. This data is captured by a custom-built digital recording device (VitaloJAK, Vitalograph, Ltd).
Outcome measures
| Measure |
Serlopitant 5 mg
n=88 Participants
Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by a tablet taken once daily for 84 days.
|
Placebo
n=88 Participants
Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by a tablet taken once daily for 84 days.
|
|---|---|---|
|
Percentage of Participants With ≥30% Reduction in Awake Objective Cough Frequency
|
32.6 percentage of participants
|
37.0 percentage of participants
|
SECONDARY outcome
Timeframe: from Baseline to Day 84Visual Analog Scale (VAS) 101-point scale ranging from 0 (no cough) to 100 (worst cough). A higher score corresponds to higher cough severity.
Outcome measures
| Measure |
Serlopitant 5 mg
n=88 Participants
Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by a tablet taken once daily for 84 days.
|
Placebo
n=88 Participants
Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by a tablet taken once daily for 84 days.
|
|---|---|---|
|
Change From Baseline in Cough Severity Visual Analog Scale (VAS)
Day 56 (Week 8)
|
-14.6 units on a scale
Interval -19.4 to -9.8
|
-7.4 units on a scale
Interval -12.3 to -2.5
|
|
Change From Baseline in Cough Severity Visual Analog Scale (VAS)
Day 28 (Week 4)
|
-10.2 units on a scale
Interval -14.6 to -5.8
|
-9.9 units on a scale
Interval -14.4 to -5.5
|
|
Change From Baseline in Cough Severity Visual Analog Scale (VAS)
Day 84 (Week 12)
|
-14.2 units on a scale
Interval -19.2 to -9.3
|
-9.9 units on a scale
Interval -15.0 to -4.9
|
Adverse Events
Serlopitant 5 mg
Serious events: 3 serious events
Other events: 43 other events
Deaths: 1 deaths
Placebo
Serious events: 3 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Serlopitant 5 mg
n=92 participants at risk
Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by a tablet taken once daily for 84 days.
|
Placebo
n=92 participants at risk
Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by a tablet taken once daily for 84 days.
|
|---|---|---|
|
Infections and infestations
Urosepsis
|
0.00%
0/92 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at approximately Day 112 (± 3 days). After the Follow-Up visit, only SAEs that are believed to be drug related will be reported, without a specific end time.
The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.
|
1.1%
1/92 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at approximately Day 112 (± 3 days). After the Follow-Up visit, only SAEs that are believed to be drug related will be reported, without a specific end time.
The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/92 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at approximately Day 112 (± 3 days). After the Follow-Up visit, only SAEs that are believed to be drug related will be reported, without a specific end time.
The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.
|
1.1%
1/92 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at approximately Day 112 (± 3 days). After the Follow-Up visit, only SAEs that are believed to be drug related will be reported, without a specific end time.
The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/92 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at approximately Day 112 (± 3 days). After the Follow-Up visit, only SAEs that are believed to be drug related will be reported, without a specific end time.
The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.
|
1.1%
1/92 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at approximately Day 112 (± 3 days). After the Follow-Up visit, only SAEs that are believed to be drug related will be reported, without a specific end time.
The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/92 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at approximately Day 112 (± 3 days). After the Follow-Up visit, only SAEs that are believed to be drug related will be reported, without a specific end time.
The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.
|
1.1%
1/92 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at approximately Day 112 (± 3 days). After the Follow-Up visit, only SAEs that are believed to be drug related will be reported, without a specific end time.
The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic malignant melanoma
|
0.00%
0/92 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at approximately Day 112 (± 3 days). After the Follow-Up visit, only SAEs that are believed to be drug related will be reported, without a specific end time.
The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.
|
1.1%
1/92 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at approximately Day 112 (± 3 days). After the Follow-Up visit, only SAEs that are believed to be drug related will be reported, without a specific end time.
The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.
|
|
Reproductive system and breast disorders
Pelvic pain
|
1.1%
1/92 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at approximately Day 112 (± 3 days). After the Follow-Up visit, only SAEs that are believed to be drug related will be reported, without a specific end time.
The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.
|
0.00%
0/92 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at approximately Day 112 (± 3 days). After the Follow-Up visit, only SAEs that are believed to be drug related will be reported, without a specific end time.
The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.
|
|
Gastrointestinal disorders
Constipation
|
1.1%
1/92 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at approximately Day 112 (± 3 days). After the Follow-Up visit, only SAEs that are believed to be drug related will be reported, without a specific end time.
The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.
|
0.00%
0/92 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at approximately Day 112 (± 3 days). After the Follow-Up visit, only SAEs that are believed to be drug related will be reported, without a specific end time.
The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.
|
|
Infections and infestations
Sepsis
|
1.1%
1/92 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at approximately Day 112 (± 3 days). After the Follow-Up visit, only SAEs that are believed to be drug related will be reported, without a specific end time.
The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.
|
0.00%
0/92 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at approximately Day 112 (± 3 days). After the Follow-Up visit, only SAEs that are believed to be drug related will be reported, without a specific end time.
The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.1%
1/92 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at approximately Day 112 (± 3 days). After the Follow-Up visit, only SAEs that are believed to be drug related will be reported, without a specific end time.
The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.
|
0.00%
0/92 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at approximately Day 112 (± 3 days). After the Follow-Up visit, only SAEs that are believed to be drug related will be reported, without a specific end time.
The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.
|
Other adverse events
| Measure |
Serlopitant 5 mg
n=92 participants at risk
Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by a tablet taken once daily for 84 days.
|
Placebo
n=92 participants at risk
Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by a tablet taken once daily for 84 days.
|
|---|---|---|
|
Infections and infestations
Upper Respiratory Tract Infection
|
7.6%
7/92 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at approximately Day 112 (± 3 days). After the Follow-Up visit, only SAEs that are believed to be drug related will be reported, without a specific end time.
The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.
|
6.5%
6/92 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at approximately Day 112 (± 3 days). After the Follow-Up visit, only SAEs that are believed to be drug related will be reported, without a specific end time.
The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.
|
|
Nervous system disorders
Headache
|
6.5%
6/92 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at approximately Day 112 (± 3 days). After the Follow-Up visit, only SAEs that are believed to be drug related will be reported, without a specific end time.
The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.
|
8.7%
8/92 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at approximately Day 112 (± 3 days). After the Follow-Up visit, only SAEs that are believed to be drug related will be reported, without a specific end time.
The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.
|
|
Infections and infestations
Urinary tract infection
|
6.5%
6/92 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at approximately Day 112 (± 3 days). After the Follow-Up visit, only SAEs that are believed to be drug related will be reported, without a specific end time.
The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.
|
3.3%
3/92 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at approximately Day 112 (± 3 days). After the Follow-Up visit, only SAEs that are believed to be drug related will be reported, without a specific end time.
The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.
|
|
Infections and infestations
Bronchitis
|
5.4%
5/92 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at approximately Day 112 (± 3 days). After the Follow-Up visit, only SAEs that are believed to be drug related will be reported, without a specific end time.
The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.
|
1.1%
1/92 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at approximately Day 112 (± 3 days). After the Follow-Up visit, only SAEs that are believed to be drug related will be reported, without a specific end time.
The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.4%
5/92 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at approximately Day 112 (± 3 days). After the Follow-Up visit, only SAEs that are believed to be drug related will be reported, without a specific end time.
The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.
|
3.3%
3/92 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at approximately Day 112 (± 3 days). After the Follow-Up visit, only SAEs that are believed to be drug related will be reported, without a specific end time.
The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.
|
|
General disorders
Fatigue
|
5.4%
5/92 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at approximately Day 112 (± 3 days). After the Follow-Up visit, only SAEs that are believed to be drug related will be reported, without a specific end time.
The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.
|
6.5%
6/92 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at approximately Day 112 (± 3 days). After the Follow-Up visit, only SAEs that are believed to be drug related will be reported, without a specific end time.
The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.
|
|
Nervous system disorders
Dizziness
|
4.3%
4/92 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at approximately Day 112 (± 3 days). After the Follow-Up visit, only SAEs that are believed to be drug related will be reported, without a specific end time.
The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.
|
1.1%
1/92 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at approximately Day 112 (± 3 days). After the Follow-Up visit, only SAEs that are believed to be drug related will be reported, without a specific end time.
The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.3%
4/92 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at approximately Day 112 (± 3 days). After the Follow-Up visit, only SAEs that are believed to be drug related will be reported, without a specific end time.
The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.
|
0.00%
0/92 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at approximately Day 112 (± 3 days). After the Follow-Up visit, only SAEs that are believed to be drug related will be reported, without a specific end time.
The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.
|
|
Infections and infestations
Sinusitis
|
4.3%
4/92 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at approximately Day 112 (± 3 days). After the Follow-Up visit, only SAEs that are believed to be drug related will be reported, without a specific end time.
The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.
|
4.3%
4/92 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at approximately Day 112 (± 3 days). After the Follow-Up visit, only SAEs that are believed to be drug related will be reported, without a specific end time.
The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.
|
|
Infections and infestations
Acute sinusitis
|
3.3%
3/92 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at approximately Day 112 (± 3 days). After the Follow-Up visit, only SAEs that are believed to be drug related will be reported, without a specific end time.
The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.
|
0.00%
0/92 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at approximately Day 112 (± 3 days). After the Follow-Up visit, only SAEs that are believed to be drug related will be reported, without a specific end time.
The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.3%
3/92 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at approximately Day 112 (± 3 days). After the Follow-Up visit, only SAEs that are believed to be drug related will be reported, without a specific end time.
The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.
|
3.3%
3/92 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at approximately Day 112 (± 3 days). After the Follow-Up visit, only SAEs that are believed to be drug related will be reported, without a specific end time.
The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.3%
3/92 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at approximately Day 112 (± 3 days). After the Follow-Up visit, only SAEs that are believed to be drug related will be reported, without a specific end time.
The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.
|
6.5%
6/92 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at approximately Day 112 (± 3 days). After the Follow-Up visit, only SAEs that are believed to be drug related will be reported, without a specific end time.
The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.
|
|
Gastrointestinal disorders
Dry mouth
|
3.3%
3/92 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at approximately Day 112 (± 3 days). After the Follow-Up visit, only SAEs that are believed to be drug related will be reported, without a specific end time.
The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.
|
2.2%
2/92 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at approximately Day 112 (± 3 days). After the Follow-Up visit, only SAEs that are believed to be drug related will be reported, without a specific end time.
The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.
|
|
Vascular disorders
Hypertension
|
3.3%
3/92 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at approximately Day 112 (± 3 days). After the Follow-Up visit, only SAEs that are believed to be drug related will be reported, without a specific end time.
The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.
|
0.00%
0/92 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at approximately Day 112 (± 3 days). After the Follow-Up visit, only SAEs that are believed to be drug related will be reported, without a specific end time.
The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.
|
|
Infections and infestations
Viral Upper respiratory tract infection
|
2.2%
2/92 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at approximately Day 112 (± 3 days). After the Follow-Up visit, only SAEs that are believed to be drug related will be reported, without a specific end time.
The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.
|
3.3%
3/92 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at approximately Day 112 (± 3 days). After the Follow-Up visit, only SAEs that are believed to be drug related will be reported, without a specific end time.
The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place