Trial Outcomes & Findings for Nebivolol Effect on Nitric Oxide Levels, Blood Pressure, and Renal Function in Kidney Transplant Patients (NCT NCT01157234)
NCT ID: NCT01157234
Last Updated: 2024-11-06
Results Overview
Percent change in Nitric Oxide (NO) blood level (nmol/L)=\[Month-12 NO blood level minus baseline NO blood level\] divided by \[baseline NO blood level\] multiplied by 100, where all levels are in nmol/L.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
32 participants
Primary outcome timeframe
Change in Baseline, Month-12
Results posted on
2024-11-06
Participant Flow
The trial was conducted at the University of Florida and Shands Renal Transplant Clinic. The first patient was randomized on July 8, 2010 and the follow up of the last patient ended on July 21, 2014.
32 participants were screened, 2 failed screening and 30 met the eligibility criteria and randomized to either the arm with nebivolol or the arm with metoprolol.
Participant milestones
| Measure |
Nebivolol
Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of \<140/90 and continued until month-12 of the study.
|
Metoprolol
Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of \<140/90 and continued until month-12 of the study.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
14
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Nebivolol
Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of \<140/90 and continued until month-12 of the study.
|
Metoprolol
Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of \<140/90 and continued until month-12 of the study.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Nebivolol Effect on Nitric Oxide Levels, Blood Pressure, and Renal Function in Kidney Transplant Patients
Baseline characteristics by cohort
| Measure |
Nebivolol
n=15 Participants
Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of \<140/90 and continued until month-12 of the study.
|
Metoprolol
n=15 Participants
Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of \<140/90 and continued until month-12 of the study.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53 years
STANDARD_DEVIATION 15.9 • n=5 Participants
|
46.4 years
STANDARD_DEVIATION 13.8 • n=7 Participants
|
49.7 years
STANDARD_DEVIATION 14.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Plasma Nitric Oxide
|
52.93 nmol/l
STANDARD_DEVIATION 21.09 • n=5 Participants
|
48.23 nmol/l
STANDARD_DEVIATION 15.37 • n=7 Participants
|
50.53 nmol/l
STANDARD_DEVIATION 17.99 • n=5 Participants
|
|
Estimated Glomerular Filtration Rate
|
53.13 milliliter/minute
STANDARD_DEVIATION 14.15 • n=5 Participants
|
54.47 milliliter/minute
STANDARD_DEVIATION 14.65 • n=7 Participants
|
53.80 milliliter/minute
STANDARD_DEVIATION 13.67 • n=5 Participants
|
|
Systolic Blood Pressure
|
132.93 millimeter, mercury
STANDARD_DEVIATION 15.79 • n=5 Participants
|
131.33 millimeter, mercury
STANDARD_DEVIATION 18.14 • n=7 Participants
|
132.13 millimeter, mercury
STANDARD_DEVIATION 16.73 • n=5 Participants
|
|
Diastolic Blood Pressure
|
84.07 millimeter, mercury
STANDARD_DEVIATION 8.59 • n=5 Participants
|
86.33 millimeter, mercury
STANDARD_DEVIATION 8.62 • n=7 Participants
|
85.20 millimeter, mercury
STANDARD_DEVIATION 8.53 • n=5 Participants
|
|
Mean Arterial Blood Pressure
|
100.20 millimeter, mercury
STANDARD_DEVIATION 8.06 • n=5 Participants
|
101.47 millimeter, mercury
STANDARD_DEVIATION 10.76 • n=7 Participants
|
100.83 millimeter, mercury
STANDARD_DEVIATION 9.36 • n=5 Participants
|
|
Number of Antihypertensive Drug Classes Being Used
|
2.00 Antihypertensive Drug Classes
STANDARD_DEVIATION 0.84 • n=5 Participants
|
1.80 Antihypertensive Drug Classes
STANDARD_DEVIATION 0.68 • n=7 Participants
|
1.90 Antihypertensive Drug Classes
STANDARD_DEVIATION 0.89 • n=5 Participants
|
PRIMARY outcome
Timeframe: Change in Baseline, Month-12Population: Full analysis set included all participants who signed informed consent and received at least one dose of study drug.
Percent change in Nitric Oxide (NO) blood level (nmol/L)=\[Month-12 NO blood level minus baseline NO blood level\] divided by \[baseline NO blood level\] multiplied by 100, where all levels are in nmol/L.
Outcome measures
| Measure |
Nebivolol
n=15 Participants
Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of \<140/90 and continued until month-12 of the study.
|
Metoprolol
n=15 Participants
Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of \<140/90 and continued until month-12 of the study.
|
|---|---|---|
|
Plasma Nitric Oxide Level Change From Baseline to Month 12 Between the Groups.
|
11.47 percent change
Standard Error 9.20
|
-17.27 percent change
Standard Error 9.20
|
SECONDARY outcome
Timeframe: Change in Baseline, Month-12Population: Full analysis set included all participants who signed inform consent and received at least one dose of study drug.
The changed percentage in Estimated Glomerular Filtration Rate (eGFR), (based on the Modification of Diet in Renal Disease Equation)=\[Month-12 GFR level minus baseline eGFR level\] divided by \[baseline eGFR level\] multiplied by 100, where all levels are in ml/min.
Outcome measures
| Measure |
Nebivolol
n=15 Participants
Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of \<140/90 and continued until month-12 of the study.
|
Metoprolol
n=15 Participants
Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of \<140/90 and continued until month-12 of the study.
|
|---|---|---|
|
Estimated Glomerular Filtration Rate (ml/Minute) Change From Baseline to Month-12 Between the Groups
|
2.16 percent change
Standard Error 7.16
|
10.43 percent change
Standard Error 7.16
|
SECONDARY outcome
Timeframe: Change in Baseline, Month-12Population: Full analysis set included all participants who signed inform consent and received at least one dose of study drug.
Absolute change in Systolic Blood Pressure (SBP), (millimeter, Mercury)=Month-12 sitting trough SBP level minus baseline sitting trough SBP level
Outcome measures
| Measure |
Nebivolol
n=15 Participants
Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of \<140/90 and continued until month-12 of the study.
|
Metoprolol
n=15 Participants
Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of \<140/90 and continued until month-12 of the study.
|
|---|---|---|
|
Systolic Blood Pressure (Millimeter, Mercury) Change From Baseline to Month-12 of Treatment Between the Groups
|
-2.65 millimeter, Mercury
Standard Error 2.73
|
-3.88 millimeter, Mercury
Standard Error 2.73
|
SECONDARY outcome
Timeframe: Change in Baseline, Month-12Population: Full analysis set included all participants who signed inform consent and received at least one dose of study drug.
Absolute Change in Diastolic Blood Pressure (DBP), (millimeter, Mercury)= Month-12 sitting trough Diastolic Blood Pressure (millimeter, Mercury) level minus baseline sitting trough Diastolic Blood Pressure (millimeter, Mercury).
Outcome measures
| Measure |
Nebivolol
n=15 Participants
Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of \<140/90 and continued until month-12 of the study.
|
Metoprolol
n=15 Participants
Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of \<140/90 and continued until month-12 of the study.
|
|---|---|---|
|
Diastolic Blood Pressure (Millimeter, Mercury) Change From Baseline to Month-12 Between the Groups
|
-0.66 millimeter, mercury
Standard Error 1.91
|
-2.35 millimeter, mercury
Standard Error 1.91
|
SECONDARY outcome
Timeframe: Change in Baseline, Month-12Population: Full analysis set included all participants who signed inform consent and received at least one dose of study drug.
Absolute change in Mean Arterial Blood Pressure, (MAP), (millimeter, Mercury= Month-12 sitting trough MAP minus baseline sitting trough MAP. Mean Arterial Pressure= 2/3 trough diastolic blood pressure + 1/3 trough systolic blood pressure
Outcome measures
| Measure |
Nebivolol
n=15 Participants
Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of \<140/90 and continued until month-12 of the study.
|
Metoprolol
n=15 Participants
Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of \<140/90 and continued until month-12 of the study.
|
|---|---|---|
|
Mean Arterial Blood Pressure (Millimeter, Mercury) Change From Baseline to Month-12 Between the Groups
|
-1.07 millimeter, Mercury
Standard Error 2.11
|
-3.19 millimeter, Mercury
Standard Error 2.11
|
SECONDARY outcome
Timeframe: Change in Baseline, Month-12Population: Percent change
Percent change in quantity of Anti-Hypertensive Drug Classes (AHDC)=\[Month-12 absolute number of AHDC minus baseline absolute number of AHDC\] divided by \[baseline absolute number of AHDC\] multiplied by 100.
Outcome measures
| Measure |
Nebivolol
n=15 Participants
Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of \<140/90 and continued until month-12 of the study.
|
Metoprolol
n=15 Participants
Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of \<140/90 and continued until month-12 of the study.
|
|---|---|---|
|
Number of Antihypertensive Drug Classes Change From Baseline to Month-12 Between the Groups.
|
-8.14 percent change
Standard Error 11.58
|
8.70 percent change
Standard Error 11.58
|
SECONDARY outcome
Timeframe: Baseline, Month-12Population: Technical limitations constrained measurements of Asymmetric Dimethylarginine (ADMA), resulting in no analysis for this outcome.
Percent change in plasma ADMA (umol/L)=\[month-12 plasma ADMA level minus baseline plasma ADMA level\] divided by \[baseline plasma ADMA level\] multiplied by 100, where all levels are in umol/L.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Month-12Population: Technical limitations constrained measurements of plasma Arginine, resulting in no analysis for this outcome.
Percent change in plasma Arginine (umol/L)=\[month-12 plasma Arginine level minus baseline plasma Arginine level\] divided by \[baseline plasma Arginine level\] multiplied by 100, where all levels are in umol/L
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 MonthsPopulation: Full analysis set included all participants who signed inform consent and received at least one dose of study drug
Outcome measures
| Measure |
Nebivolol
n=15 Participants
Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of \<140/90 and continued until month-12 of the study.
|
Metoprolol
n=15 Participants
Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of \<140/90 and continued until month-12 of the study.
|
|---|---|---|
|
Plasma Nitric Oxide Level (Nmol/L) at Month-12 Between the Groups.
|
50.07 nmol/L
Standard Error 3.93
|
38.13 nmol/L
Standard Error 3.93
|
POST_HOC outcome
Timeframe: Baseline and Month-12Population: Nebivolol and metoprolol groups were subdivided into \<50 years old and \>50 years old subgroups and differences between subgroups were analyzed.
Outcome measures
| Measure |
Nebivolol
n=6 Participants
Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of \<140/90 and continued until month-12 of the study.
|
Metoprolol
n=7 Participants
Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of \<140/90 and continued until month-12 of the study.
|
|---|---|---|
|
Percent Change in Plasma Nitric Oxide Level From Baseline to Month-12 of Treatment With Nebivolol in Transplant Recipients <50 Years Old Compared With Metoprolol in Transplant Recipients >/= 50 Years Old.
|
51.55 percent change
Standard Error 14.55
|
-17.99 percent change
Standard Error 13.47
|
POST_HOC outcome
Timeframe: Change in Baseline, Month-12Population: Nebivolol and metoprolol groups were subdivided into \<50 years old and \>50 years old subgroups and differences between subgroups were analyzed.
Outcome measures
| Measure |
Nebivolol
n=6 Participants
Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of \<140/90 and continued until month-12 of the study.
|
Metoprolol
n=8 Participants
Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of \<140/90 and continued until month-12 of the study.
|
|---|---|---|
|
Percent Change in Plasma Nitric Oxide Level From Baseline to Month-12 of Treatment With Nebivolol in Transplant Recipients < 50 Years Old Compared With Metoprolol in Transplant Recipients < 50 Years Old
|
51.55 percent change
Standard Error 14.55
|
-16.64 percent change
Standard Error 12.60
|
POST_HOC outcome
Timeframe: Change in Baseline, Month-12Population: Nebivolol and metoprolol groups were subdivided into \<50 years old and \>50 years old subgroups and differences between subgroups were analyzed.
Outcome measures
| Measure |
Nebivolol
n=9 Participants
Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of \<140/90 and continued until month-12 of the study.
|
Metoprolol
n=8 Participants
Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of \<140/90 and continued until month-12 of the study.
|
|---|---|---|
|
Percent Change in Plasma Nitric Oxide Level From Baseline to Month-twelve of Treatment With Nebivolol in Transplant Recipients >/= 50 Years Old Compared With Nebivolol in Transplant Recipients < 50 Years Old.
|
-15.25 percent change
Standard Error 11.88
|
-16.64 percent change
Standard Error 12.60
|
POST_HOC outcome
Timeframe: Change in Baseline, Month-12Outcome measures
| Measure |
Nebivolol
n=9 Participants
Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of \<140/90 and continued until month-12 of the study.
|
Metoprolol
n=7 Participants
Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of \<140/90 and continued until month-12 of the study.
|
|---|---|---|
|
Percent Change in Plasma Nitric Oxide Level From Baseline to Month-12 of Treatment With Nebivolol in Transplant Recipients >/= 50 Years Old Compared With Metoprolol in Transplant Recipients Age >/= 50 Years Old.
|
-15.25 percent change
Standard Error 11.88
|
-17.99 percent change
Standard Error 13.47
|
Adverse Events
Nebivolol
Serious events: 4 serious events
Other events: 9 other events
Deaths: 0 deaths
Metoprolol
Serious events: 5 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nebivolol
n=15 participants at risk
Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of \<140/90 and continued until month-12 of the study.
Nebivolol: Nebivolol 5 mg once daily, titrated to a maximum total daily dose of 40 mg to achieve a blood pressure of \< 140/ 90.
|
Metoprolol
n=15 participants at risk
Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of \<140/90 and continued until month-12 of the study.
Metoprolol: Metoprolol 25 mg twice daily, titrated to a maximum total daily dose of 400 mg to achieve a blood pressure \< 140/90.
|
|---|---|---|
|
Infections and infestations
Urinary Tract Infection
|
6.7%
1/15 • 4 years
|
0.00%
0/15 • 4 years
|
|
Injury, poisoning and procedural complications
Abdominal Hematoma
|
6.7%
1/15 • 4 years
|
0.00%
0/15 • 4 years
|
|
Renal and urinary disorders
Renal Insufficiency
|
13.3%
2/15 • 4 years
|
6.7%
1/15 • 4 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.00%
0/15 • 4 years
|
6.7%
1/15 • 4 years
|
|
Surgical and medical procedures
Herniorraphy
|
0.00%
0/15 • 4 years
|
6.7%
1/15 • 4 years
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/15 • 4 years
|
6.7%
1/15 • 4 years
|
|
Infections and infestations
Cytomegalovirus Infection
|
0.00%
0/15 • 4 years
|
6.7%
1/15 • 4 years
|
Other adverse events
| Measure |
Nebivolol
n=15 participants at risk
Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of \<140/90 and continued until month-12 of the study.
Nebivolol: Nebivolol 5 mg once daily, titrated to a maximum total daily dose of 40 mg to achieve a blood pressure of \< 140/ 90.
|
Metoprolol
n=15 participants at risk
Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of \<140/90 and continued until month-12 of the study.
Metoprolol: Metoprolol 25 mg twice daily, titrated to a maximum total daily dose of 400 mg to achieve a blood pressure \< 140/90.
|
|---|---|---|
|
Blood and lymphatic system disorders
leukopenia
|
0.00%
0/15 • 4 years
|
6.7%
1/15 • 4 years
|
|
Endocrine disorders
hyperglycemia
|
13.3%
2/15 • 4 years
|
20.0%
3/15 • 4 years
|
|
Ear and labyrinth disorders
Earache
|
6.7%
1/15 • 4 years
|
0.00%
0/15 • 4 years
|
|
Eye disorders
Eye Irritation
|
6.7%
1/15 • 4 years
|
0.00%
0/15 • 4 years
|
|
Gastrointestinal disorders
Abdominal Pain
|
6.7%
1/15 • 4 years
|
6.7%
1/15 • 4 years
|
|
Gastrointestinal disorders
Constipation
|
6.7%
1/15 • 4 years
|
0.00%
0/15 • 4 years
|
|
Gastrointestinal disorders
Diarrhea
|
26.7%
4/15 • 4 years
|
13.3%
2/15 • 4 years
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/15 • 4 years
|
6.7%
1/15 • 4 years
|
|
Gastrointestinal disorders
Nausea
|
13.3%
2/15 • 4 years
|
6.7%
1/15 • 4 years
|
|
Gastrointestinal disorders
Vomiting
|
13.3%
2/15 • 4 years
|
0.00%
0/15 • 4 years
|
|
General disorders
Chest Pain
|
6.7%
1/15 • 4 years
|
6.7%
1/15 • 4 years
|
|
General disorders
Edema
|
6.7%
1/15 • 4 years
|
6.7%
1/15 • 4 years
|
|
General disorders
Fatigue
|
6.7%
1/15 • 4 years
|
0.00%
0/15 • 4 years
|
|
General disorders
Influenza-like Illness
|
6.7%
1/15 • 4 years
|
0.00%
0/15 • 4 years
|
|
Infections and infestations
Cytomegalovirus Infection
|
6.7%
1/15 • 4 years
|
0.00%
0/15 • 4 years
|
|
Infections and infestations
Urinary Tract Infection
|
13.3%
2/15 • 4 years
|
20.0%
3/15 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Arm Pain
|
6.7%
1/15 • 4 years
|
0.00%
0/15 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Low Back Pain
|
6.7%
1/15 • 4 years
|
0.00%
0/15 • 4 years
|
|
Nervous system disorders
Dizziness
|
0.00%
0/15 • 4 years
|
6.7%
1/15 • 4 years
|
|
Nervous system disorders
Headache
|
13.3%
2/15 • 4 years
|
13.3%
2/15 • 4 years
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/15 • 4 years
|
6.7%
1/15 • 4 years
|
|
Reproductive system and breast disorders
Hydrocele
|
0.00%
0/15 • 4 years
|
6.7%
1/15 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
26.7%
4/15 • 4 years
|
13.3%
2/15 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.7%
1/15 • 4 years
|
0.00%
0/15 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
20.0%
3/15 • 4 years
|
20.0%
3/15 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/15 • 4 years
|
6.7%
1/15 • 4 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER