Trial Outcomes & Findings for Vardenafil Inhaled for Pulmonary Arterial Hypertension PRN Phase 2B Study (NCT NCT04266197)
NCT ID: NCT04266197
Last Updated: 2026-07-13
Results Overview
The primary efficacy endpoint was the change from Baseline in peak V̇ O2 measured during CPET after RT234 dosing.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
42 participants
Primary outcome timeframe
Comparison of measure between baseline and treatment CPETs, typically ~14 days apart
Results posted on
2026-07-13
Participant Flow
Participant milestones
| Measure |
RT234 0.5 mg Dose Cohort
Subjects received a single 0.5 mg dose of RT234 (vardenafil inhalation powder) \~ 30 minutes prior to performing a cardiopulmonary exercise test (CPET). At at subsequent visit, subjects received a single 0.5 mg dose of RT234 \~30 minutes prior to performing a 6-minute walk test.
|
RT234 1.0 mg Dose Cohort
Subjects received a single 1.0 mg dose of RT234 (vardenafil inhalation powder) \~ 30 minutes prior to performing a cardiopulmonary exercise test (CPET). At at subsequent visit, subjects received a single 1.0 mg dose of RT234 \~30 minutes prior to performing a 6-minute walk test.
|
RT234 2.0 mg Dose Cohort
Subjects received a single 2.0 mg dose of RT234 (vardenafil inhalation powder) \~ 30 minutes prior to performing a cardiopulmonary exercise test (CPET). At at subsequent visit, subjects received a single 2.0 mg dose of RT234 \~30 minutes prior to performing a 6-minute walk test.
|
|---|---|---|---|
|
Overall Study
STARTED
|
7
|
21
|
14
|
|
Overall Study
COMPLETED
|
7
|
21
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vardenafil Inhaled for Pulmonary Arterial Hypertension PRN Phase 2B Study
Baseline characteristics by cohort
| Measure |
RT234 0.5 mg Dose Cohort
n=5 Participants
RT234 at a capsule dose strength of 0.5 mg.
At visit 1 (screening), subjects performed a baseline six-minute walk test (6MWT). At visit 2, subjects meeting eligibility criteria performed a baseline cardiopulmonary exercise test (CPET). At visit 3 (typically \~14 days after visit 2), subjects received a single 0.5 mg dose of RT234 (vardenafil inhalation powder administered via the Axial Oscillating Sphere dry powder inhaler, or AOS DPI) \~ 30 minutes prior to performing a treatment CPET. At visit 4, subjects received a single 0.5 mg dose of RT234 \~30 minutes prior to performing the treatment 6MWT.
The acute effects of a single 0.5 mg dose of RT234 were evaluated by comparing differences in outcome measures between baseline and treatment CPETs and 6MWTs.
|
RT234 1.0 mg Dose Cohort
n=20 Participants
RT234 at a capsule dose strength of 1.0 mg.
At visit 1 (screening), subjects performed a baseline six-minute walk test (6MWT). At visit 2, subjects meeting eligibility criteria performed a baseline cardiopulmonary exercise test (CPET). At visit 3 (typically \~14 days after visit 2), subjects received a single 1.0 mg dose of RT234 (vardenafil inhalation powder administered via the Axial Oscillating Sphere dry powder inhaler, or AOS DPI) \~ 30 minutes prior to performing a treatment CPET. At visit 4, subjects received a single 1.0 mg dose of RT234 \~30 minutes prior to performing the treatment 6MWT.
The acute effects of a single 1.0 mg dose of RT234 were evaluated by comparing differences in outcome measures between baseline and treatment CPETs and 6MWTs.
|
RT234 2.0 mg Dose Cohort
n=14 Participants
RT234 at a capsule dose strength of 2.0 mg.
At visit 1 (screening), subjects performed a baseline six-minute walk test (6MWT). At visit 2, subjects meeting eligibility criteria performed a baseline cardiopulmonary exercise test (CPET). At visit 3 (typically \~14 days after visit 2), subjects received a single 2.0 mg dose of RT234 (vardenafil inhalation powder administered via the Axial Oscillating Sphere dry powder inhaler, or AOS DPI) \~ 30 minutes prior to performing a treatment CPET. At visit 4, subjects received a single 2.0 mg dose of RT234 \~30 minutes prior to performing the treatment 6MWT.
The acute effects of a single 2.0 mg dose of RT234 were evaluated by comparing differences in outcome measures between baseline and treatment CPETs and 6MWTs.
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
47.9 years
STANDARD_DEVIATION 19.70 • n=20 Participants
|
52.8 years
STANDARD_DEVIATION 9.83 • n=20 Participants
|
56.4 years
STANDARD_DEVIATION 15.11 • n=40 Participants
|
53.1 years
STANDARD_DEVIATION 13.51 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=20 Participants
|
16 Participants
n=20 Participants
|
11 Participants
n=40 Participants
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=20 Participants
|
16 Participants
n=20 Participants
|
10 Participants
n=40 Participants
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=20 Participants
|
17 Participants
n=20 Participants
|
12 Participants
n=40 Participants
|
34 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=20 Participants
|
20 participants
n=20 Participants
|
14 participants
n=40 Participants
|
37 participants
n=5 Participants
|
|
Region of Enrollment
Serbia
|
2 participants
n=20 Participants
|
0 participants
n=20 Participants
|
0 participants
n=40 Participants
|
2 participants
n=5 Participants
|
|
Peak VO2 relative to actual weight
|
16.24 mL/min/kg
STANDARD_DEVIATION 1.679 • n=20 Participants
|
14.63 mL/min/kg
STANDARD_DEVIATION 5.131 • n=20 Participants
|
14.00 mL/min/kg
STANDARD_DEVIATION 2.459 • n=40 Participants
|
14.61 mL/min/kg
STANDARD_DEVIATION 4.002 • n=5 Participants
|
PRIMARY outcome
Timeframe: Comparison of measure between baseline and treatment CPETs, typically ~14 days apartPopulation: Per-Protocol CPET Analysis Set
The primary efficacy endpoint was the change from Baseline in peak V̇ O2 measured during CPET after RT234 dosing.
Outcome measures
| Measure |
RT234 0.5 mg Dose Cohort
n=5 Participants
RT234 at a capsule dose strength of 0.5 mg.
Subjects received a single 0.5 mg dose of RT234 (vardenafil inhalation powder administered via the Axial Oscillating Sphere dry powder inhaler, or AOS DPI) \~ 30 minutes prior to performing a cardiopulmonary exercise test (CPET). At at subsequent visit, subjects received a single 0.5 mg dose of RT234 \~30 minutes prior to performing a 6-minute walk test.
|
RT234 1.0 mg Dose Cohort
n=20 Participants
RT234 at a capsule dose strength of 1.0 mg.
Subjects received a single 1.0 mg dose of RT234 (vardenafil inhalation powder administered via the Axial Oscillating Sphere dry powder inhaler, or AOS DPI) \~ 30 minutes prior to performing a cardiopulmonary exercise test (CPET). At at subsequent visit, subjects received a single 1.0 mg dose of RT234 \~30 minutes prior to performing a 6-minute walk test.
|
RT234 2.0 mg Dose Cohort
n=14 Participants
RT234 at a capsule dose strength of 2.0 mg.
Subjects received a single 2.0 mg dose of RT234 (vardenafil inhalation powder administered via the Axial Oscillating Sphere dry powder inhaler, or AOS DPI) \~ 30 minutes prior to performing a cardiopulmonary exercise test (CPET). At at subsequent visit, subjects received a single 2.0 mg dose of RT234 \~30 minutes prior to performing a 6-minute walk test.
|
Overall
n=39 Participants
Pooled results from all dose groups
|
|---|---|---|---|---|
|
Mean Change in Peak Oxygen Uptake at Peak Exercise During CPET (Peak VO2)
|
0.22 mL/min/kg
Standard Deviation 1.753
|
0.26 mL/min/kg
Standard Deviation 1.580
|
0.55 mL/min/kg
Standard Deviation 0.779
|
0.36 mL/min/kg
Standard Deviation 1.342
|
PRIMARY outcome
Timeframe: Comparison of measure between baseline and treatment CPETs, typically ~14 days apartPopulation: Per-Protocol CPET Analysis Set
The primary efficacy endpoint was the change from Baseline in peak V̇ O2 measured during CPET after RT234 dosing.
Outcome measures
| Measure |
RT234 0.5 mg Dose Cohort
n=5 Participants
RT234 at a capsule dose strength of 0.5 mg.
Subjects received a single 0.5 mg dose of RT234 (vardenafil inhalation powder administered via the Axial Oscillating Sphere dry powder inhaler, or AOS DPI) \~ 30 minutes prior to performing a cardiopulmonary exercise test (CPET). At at subsequent visit, subjects received a single 0.5 mg dose of RT234 \~30 minutes prior to performing a 6-minute walk test.
|
RT234 1.0 mg Dose Cohort
n=20 Participants
RT234 at a capsule dose strength of 1.0 mg.
Subjects received a single 1.0 mg dose of RT234 (vardenafil inhalation powder administered via the Axial Oscillating Sphere dry powder inhaler, or AOS DPI) \~ 30 minutes prior to performing a cardiopulmonary exercise test (CPET). At at subsequent visit, subjects received a single 1.0 mg dose of RT234 \~30 minutes prior to performing a 6-minute walk test.
|
RT234 2.0 mg Dose Cohort
n=14 Participants
RT234 at a capsule dose strength of 2.0 mg.
Subjects received a single 2.0 mg dose of RT234 (vardenafil inhalation powder administered via the Axial Oscillating Sphere dry powder inhaler, or AOS DPI) \~ 30 minutes prior to performing a cardiopulmonary exercise test (CPET). At at subsequent visit, subjects received a single 2.0 mg dose of RT234 \~30 minutes prior to performing a 6-minute walk test.
|
Overall
n=39 Participants
Pooled results from all dose groups
|
|---|---|---|---|---|
|
Median Change in Peak Oxygen Uptake at Peak Exercise During CPET (Peak VO2)
|
-0.80 mL/min/kg
Interval -0.8 to 0.9
|
0.55 mL/min/kg
Interval -0.6 to 1.5
|
0.45 mL/min/kg
Interval -0.1 to 1.2
|
0.40 mL/min/kg
Interval -0.4 to 1.4
|
SECONDARY outcome
Timeframe: Comparison of measure between baseline and treatment CPETs, typically ~14 days apartPopulation: Per-Protocol Population
Change from Baseline to postdose in the V̇E/V̇CO2 slope, a recognized measure of ventilatory efficiency, measured up to peak during CPET. VE/VCO2 tracks the ratio between total air breathed in per minute (VE) and the amount of carbon dioxide exhaled (VCO2) during a cardiopulmonary exercise test (CPET). A reduction in the ratio is favorable, as it indicates that less breathed air is required to clear out the same amount of CO2.
Outcome measures
| Measure |
RT234 0.5 mg Dose Cohort
n=5 Participants
RT234 at a capsule dose strength of 0.5 mg.
Subjects received a single 0.5 mg dose of RT234 (vardenafil inhalation powder administered via the Axial Oscillating Sphere dry powder inhaler, or AOS DPI) \~ 30 minutes prior to performing a cardiopulmonary exercise test (CPET). At at subsequent visit, subjects received a single 0.5 mg dose of RT234 \~30 minutes prior to performing a 6-minute walk test.
|
RT234 1.0 mg Dose Cohort
n=19 Participants
RT234 at a capsule dose strength of 1.0 mg.
Subjects received a single 1.0 mg dose of RT234 (vardenafil inhalation powder administered via the Axial Oscillating Sphere dry powder inhaler, or AOS DPI) \~ 30 minutes prior to performing a cardiopulmonary exercise test (CPET). At at subsequent visit, subjects received a single 1.0 mg dose of RT234 \~30 minutes prior to performing a 6-minute walk test.
|
RT234 2.0 mg Dose Cohort
n=14 Participants
RT234 at a capsule dose strength of 2.0 mg.
Subjects received a single 2.0 mg dose of RT234 (vardenafil inhalation powder administered via the Axial Oscillating Sphere dry powder inhaler, or AOS DPI) \~ 30 minutes prior to performing a cardiopulmonary exercise test (CPET). At at subsequent visit, subjects received a single 2.0 mg dose of RT234 \~30 minutes prior to performing a 6-minute walk test.
|
Overall
n=38 Participants
Pooled results from all dose groups
|
|---|---|---|---|---|
|
Mean Change in Ventilatory Efficiency up to Peak Exercise During CPET
|
0.38 Unitless
Standard Deviation 8.033
|
-1.30 Unitless
Standard Deviation 6.326
|
-3.38 Unitless
Standard Deviation 4.233
|
-1.85 Unitless
Standard Deviation 5.869
|
SECONDARY outcome
Timeframe: Comparison of measure between baseline and treatment CPETs, typically ~14 days apartPopulation: Per-Protocol Population
Change from Baseline to postdose in the V̇E/V̇CO2 slope, a recognized measure of ventilatory efficiency, measured up to peak during CPET. VE/VCO2 tracks the ratio between total air breathed in per minute (VE) and the amount of carbon dioxide exhaled (VCO2) during a cardiopulmonary exercise test (CPET). A reduction in the ratio is favorable, as it indicates that less breathed air is required to clear out the same amount of CO2.
Outcome measures
| Measure |
RT234 0.5 mg Dose Cohort
n=5 Participants
RT234 at a capsule dose strength of 0.5 mg.
Subjects received a single 0.5 mg dose of RT234 (vardenafil inhalation powder administered via the Axial Oscillating Sphere dry powder inhaler, or AOS DPI) \~ 30 minutes prior to performing a cardiopulmonary exercise test (CPET). At at subsequent visit, subjects received a single 0.5 mg dose of RT234 \~30 minutes prior to performing a 6-minute walk test.
|
RT234 1.0 mg Dose Cohort
n=19 Participants
RT234 at a capsule dose strength of 1.0 mg.
Subjects received a single 1.0 mg dose of RT234 (vardenafil inhalation powder administered via the Axial Oscillating Sphere dry powder inhaler, or AOS DPI) \~ 30 minutes prior to performing a cardiopulmonary exercise test (CPET). At at subsequent visit, subjects received a single 1.0 mg dose of RT234 \~30 minutes prior to performing a 6-minute walk test.
|
RT234 2.0 mg Dose Cohort
n=14 Participants
RT234 at a capsule dose strength of 2.0 mg.
Subjects received a single 2.0 mg dose of RT234 (vardenafil inhalation powder administered via the Axial Oscillating Sphere dry powder inhaler, or AOS DPI) \~ 30 minutes prior to performing a cardiopulmonary exercise test (CPET). At at subsequent visit, subjects received a single 2.0 mg dose of RT234 \~30 minutes prior to performing a 6-minute walk test.
|
Overall
n=38 Participants
Pooled results from all dose groups
|
|---|---|---|---|---|
|
Median Change in Ventilatory Efficiency up to Peak Exercise During CPET
|
4.10 Unitless
Interval -0.9 to 5.9
|
-0.90 Unitless
Interval -5.8 to 3.9
|
-3.05 Unitless
Interval -4.5 to -0.4
|
-1.34 Unitless
Interval -4.5 to 3.7
|
SECONDARY outcome
Timeframe: Comparison of measure between baseline and treatment CPETs, typically ~14 days apartPopulation: Per-protocol population
Self-reported by subjects. Change in perceived dyspnea at peak exercise during CPET as assessed by the Modified Borg Dyspnea Scale Score. (Minimum score: 0 representing no dyspnea; maximum score: 10 representing maximal dyspnea; a reduction in score represents a favorable outcome.)
Outcome measures
| Measure |
RT234 0.5 mg Dose Cohort
n=5 Participants
RT234 at a capsule dose strength of 0.5 mg.
Subjects received a single 0.5 mg dose of RT234 (vardenafil inhalation powder administered via the Axial Oscillating Sphere dry powder inhaler, or AOS DPI) \~ 30 minutes prior to performing a cardiopulmonary exercise test (CPET). At at subsequent visit, subjects received a single 0.5 mg dose of RT234 \~30 minutes prior to performing a 6-minute walk test.
|
RT234 1.0 mg Dose Cohort
n=20 Participants
RT234 at a capsule dose strength of 1.0 mg.
Subjects received a single 1.0 mg dose of RT234 (vardenafil inhalation powder administered via the Axial Oscillating Sphere dry powder inhaler, or AOS DPI) \~ 30 minutes prior to performing a cardiopulmonary exercise test (CPET). At at subsequent visit, subjects received a single 1.0 mg dose of RT234 \~30 minutes prior to performing a 6-minute walk test.
|
RT234 2.0 mg Dose Cohort
n=14 Participants
RT234 at a capsule dose strength of 2.0 mg.
Subjects received a single 2.0 mg dose of RT234 (vardenafil inhalation powder administered via the Axial Oscillating Sphere dry powder inhaler, or AOS DPI) \~ 30 minutes prior to performing a cardiopulmonary exercise test (CPET). At at subsequent visit, subjects received a single 2.0 mg dose of RT234 \~30 minutes prior to performing a 6-minute walk test.
|
Overall
n=39 Participants
Pooled results from all dose groups
|
|---|---|---|---|---|
|
Change in Perceived Dyspnea at Peak Exercise During CPET
|
-2.3 Change in score on a scale
Standard Deviation 2.22
|
-1.4 Change in score on a scale
Standard Deviation 2.17
|
-0.9 Change in score on a scale
Standard Deviation 1.93
|
-1.3 Change in score on a scale
Standard Deviation 2.07
|
SECONDARY outcome
Timeframe: Comparison of measure between baseline and treatment CPETs, typically ~14 days apartPopulation: Per-protocol population
Self-reported by subjects. Change in perceived exertion at peak exercise during CPET as assessed by the Borg Rating of Perceived Exertion (RPE) Scale score, which rates exertion from a scale of 6 (no exertion) to 20 (maximum effort). A decrease in score is favorable.
Outcome measures
| Measure |
RT234 0.5 mg Dose Cohort
n=4 Participants
RT234 at a capsule dose strength of 0.5 mg.
Subjects received a single 0.5 mg dose of RT234 (vardenafil inhalation powder administered via the Axial Oscillating Sphere dry powder inhaler, or AOS DPI) \~ 30 minutes prior to performing a cardiopulmonary exercise test (CPET). At at subsequent visit, subjects received a single 0.5 mg dose of RT234 \~30 minutes prior to performing a 6-minute walk test.
|
RT234 1.0 mg Dose Cohort
n=19 Participants
RT234 at a capsule dose strength of 1.0 mg.
Subjects received a single 1.0 mg dose of RT234 (vardenafil inhalation powder administered via the Axial Oscillating Sphere dry powder inhaler, or AOS DPI) \~ 30 minutes prior to performing a cardiopulmonary exercise test (CPET). At at subsequent visit, subjects received a single 1.0 mg dose of RT234 \~30 minutes prior to performing a 6-minute walk test.
|
RT234 2.0 mg Dose Cohort
n=11 Participants
RT234 at a capsule dose strength of 2.0 mg.
Subjects received a single 2.0 mg dose of RT234 (vardenafil inhalation powder administered via the Axial Oscillating Sphere dry powder inhaler, or AOS DPI) \~ 30 minutes prior to performing a cardiopulmonary exercise test (CPET). At at subsequent visit, subjects received a single 2.0 mg dose of RT234 \~30 minutes prior to performing a 6-minute walk test.
|
Overall
n=34 Participants
Pooled results from all dose groups
|
|---|---|---|---|---|
|
Change in Perceived Exertion at Peak Exercise During CPET
|
-2.0 Change in score on a scale
Standard Deviation 0.82
|
-1.4 Change in score on a scale
Standard Deviation 2.41
|
0 Change in score on a scale
Standard Deviation 2.37
|
-1.0 Change in score on a scale
Standard Deviation 2.34
|
SECONDARY outcome
Timeframe: Comparison of measure between baseline and treatment CPETs, typically ~14 days apartPopulation: Per-protocol population
Change in partial pressure of end-tidal CO2 (PETCO2) apex response to exercise, i.e., highest level during CPET
Outcome measures
| Measure |
RT234 0.5 mg Dose Cohort
n=5 Participants
RT234 at a capsule dose strength of 0.5 mg.
Subjects received a single 0.5 mg dose of RT234 (vardenafil inhalation powder administered via the Axial Oscillating Sphere dry powder inhaler, or AOS DPI) \~ 30 minutes prior to performing a cardiopulmonary exercise test (CPET). At at subsequent visit, subjects received a single 0.5 mg dose of RT234 \~30 minutes prior to performing a 6-minute walk test.
|
RT234 1.0 mg Dose Cohort
n=20 Participants
RT234 at a capsule dose strength of 1.0 mg.
Subjects received a single 1.0 mg dose of RT234 (vardenafil inhalation powder administered via the Axial Oscillating Sphere dry powder inhaler, or AOS DPI) \~ 30 minutes prior to performing a cardiopulmonary exercise test (CPET). At at subsequent visit, subjects received a single 1.0 mg dose of RT234 \~30 minutes prior to performing a 6-minute walk test.
|
RT234 2.0 mg Dose Cohort
n=14 Participants
RT234 at a capsule dose strength of 2.0 mg.
Subjects received a single 2.0 mg dose of RT234 (vardenafil inhalation powder administered via the Axial Oscillating Sphere dry powder inhaler, or AOS DPI) \~ 30 minutes prior to performing a cardiopulmonary exercise test (CPET). At at subsequent visit, subjects received a single 2.0 mg dose of RT234 \~30 minutes prior to performing a 6-minute walk test.
|
Overall
n=39 Participants
Pooled results from all dose groups
|
|---|---|---|---|---|
|
Change in Partial Pressure of End-tidal CO2 (PETCO2)
|
0.6 mm Hg
Standard Deviation 1.34
|
0.0 mm Hg
Standard Deviation 2.65
|
1.1 mm Hg
Standard Deviation 1.31
|
0.5 mm Hg
Standard Deviation 2.14
|
SECONDARY outcome
Timeframe: Comparison of measure between baseline and treatment CPETs, typically ~14 days apartPopulation: Per-protocol population
Outcome measures
| Measure |
RT234 0.5 mg Dose Cohort
n=5 Participants
RT234 at a capsule dose strength of 0.5 mg.
Subjects received a single 0.5 mg dose of RT234 (vardenafil inhalation powder administered via the Axial Oscillating Sphere dry powder inhaler, or AOS DPI) \~ 30 minutes prior to performing a cardiopulmonary exercise test (CPET). At at subsequent visit, subjects received a single 0.5 mg dose of RT234 \~30 minutes prior to performing a 6-minute walk test.
|
RT234 1.0 mg Dose Cohort
n=19 Participants
RT234 at a capsule dose strength of 1.0 mg.
Subjects received a single 1.0 mg dose of RT234 (vardenafil inhalation powder administered via the Axial Oscillating Sphere dry powder inhaler, or AOS DPI) \~ 30 minutes prior to performing a cardiopulmonary exercise test (CPET). At at subsequent visit, subjects received a single 1.0 mg dose of RT234 \~30 minutes prior to performing a 6-minute walk test.
|
RT234 2.0 mg Dose Cohort
n=14 Participants
RT234 at a capsule dose strength of 2.0 mg.
Subjects received a single 2.0 mg dose of RT234 (vardenafil inhalation powder administered via the Axial Oscillating Sphere dry powder inhaler, or AOS DPI) \~ 30 minutes prior to performing a cardiopulmonary exercise test (CPET). At at subsequent visit, subjects received a single 2.0 mg dose of RT234 \~30 minutes prior to performing a 6-minute walk test.
|
Overall
n=38 Participants
Pooled results from all dose groups
|
|---|---|---|---|---|
|
Change in Ramp-incremental Duration of CPET
|
1.2 minutes
Standard Deviation 2.06
|
0.0 minutes
Standard Deviation 0.98
|
0.2 minutes
Standard Deviation 0.7
|
0.2 minutes
Standard Deviation 1.12
|
SECONDARY outcome
Timeframe: Baseline 6MWD at baseline (during screening visit) and 6MWD measured ~ 30 minutes following RT234 dosing at visit 4, which typically occurred 4-6 weeks following the screening visitPopulation: Per-protocol population
Change from 6MWD at baseline (during screening visit) to 6MWD following RT234 dosing
Outcome measures
| Measure |
RT234 0.5 mg Dose Cohort
n=7 Participants
RT234 at a capsule dose strength of 0.5 mg.
Subjects received a single 0.5 mg dose of RT234 (vardenafil inhalation powder administered via the Axial Oscillating Sphere dry powder inhaler, or AOS DPI) \~ 30 minutes prior to performing a cardiopulmonary exercise test (CPET). At at subsequent visit, subjects received a single 0.5 mg dose of RT234 \~30 minutes prior to performing a 6-minute walk test.
|
RT234 1.0 mg Dose Cohort
n=20 Participants
RT234 at a capsule dose strength of 1.0 mg.
Subjects received a single 1.0 mg dose of RT234 (vardenafil inhalation powder administered via the Axial Oscillating Sphere dry powder inhaler, or AOS DPI) \~ 30 minutes prior to performing a cardiopulmonary exercise test (CPET). At at subsequent visit, subjects received a single 1.0 mg dose of RT234 \~30 minutes prior to performing a 6-minute walk test.
|
RT234 2.0 mg Dose Cohort
n=14 Participants
RT234 at a capsule dose strength of 2.0 mg.
Subjects received a single 2.0 mg dose of RT234 (vardenafil inhalation powder administered via the Axial Oscillating Sphere dry powder inhaler, or AOS DPI) \~ 30 minutes prior to performing a cardiopulmonary exercise test (CPET). At at subsequent visit, subjects received a single 2.0 mg dose of RT234 \~30 minutes prior to performing a 6-minute walk test.
|
Overall
n=41 Participants
Pooled results from all dose groups
|
|---|---|---|---|---|
|
Change in 6-minute Walk Distance (6MWD)
|
29.1 Meters
Standard Deviation 30.89
|
-0.6 Meters
Standard Deviation 20.33
|
12.6 Meters
Standard Deviation 40.20
|
9.2 Meters
Standard Deviation 31.60
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Comparison of measure between baseline and treatment CPETs, typically ~14 days apartPopulation: Per-protocol populaton
A responder for peak VO2 is defined as any subject who exhibited any increase in peak V̇O2 during the treatment CPET versus the baseline CPET (i.e. change \>0).
Outcome measures
| Measure |
RT234 0.5 mg Dose Cohort
n=5 Participants
RT234 at a capsule dose strength of 0.5 mg.
Subjects received a single 0.5 mg dose of RT234 (vardenafil inhalation powder administered via the Axial Oscillating Sphere dry powder inhaler, or AOS DPI) \~ 30 minutes prior to performing a cardiopulmonary exercise test (CPET). At at subsequent visit, subjects received a single 0.5 mg dose of RT234 \~30 minutes prior to performing a 6-minute walk test.
|
RT234 1.0 mg Dose Cohort
n=20 Participants
RT234 at a capsule dose strength of 1.0 mg.
Subjects received a single 1.0 mg dose of RT234 (vardenafil inhalation powder administered via the Axial Oscillating Sphere dry powder inhaler, or AOS DPI) \~ 30 minutes prior to performing a cardiopulmonary exercise test (CPET). At at subsequent visit, subjects received a single 1.0 mg dose of RT234 \~30 minutes prior to performing a 6-minute walk test.
|
RT234 2.0 mg Dose Cohort
n=14 Participants
RT234 at a capsule dose strength of 2.0 mg.
Subjects received a single 2.0 mg dose of RT234 (vardenafil inhalation powder administered via the Axial Oscillating Sphere dry powder inhaler, or AOS DPI) \~ 30 minutes prior to performing a cardiopulmonary exercise test (CPET). At at subsequent visit, subjects received a single 2.0 mg dose of RT234 \~30 minutes prior to performing a 6-minute walk test.
|
Overall
n=39 Participants
Pooled results from all dose groups
|
|---|---|---|---|---|
|
Responders for Peak VO2
|
2 Participants
|
11 Participants
|
9 Participants
|
22 Participants
|
Adverse Events
RT234 0.5 mg Dose Cohort (Safety Analysis Population; N=7)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
RT234 1.0 mg Dose Cohort (Safety Analysis Population; N=21)
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
RT234 2.0 mg Dose Cohort Safety Analysis Population (N=14)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Overall Safety Analysis Population (N=42)
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
RT234 0.5 mg Dose Cohort (Safety Analysis Population; N=7)
n=7 participants at risk
RT234 at a capsule dose strength of 0.5 mg.
Subjects received a single 0.5 mg dose of RT234 (vardenafil inhalation powder administered via the Axial Oscillating Sphere dry powder inhaler, or AOS DPI) \~ 30 minutes prior to performing a cardiopulmonary exercise test (CPET). At at subsequent visit, subjects received a single 0.5 mg dose of RT234 \~30 minutes prior to performing a 6-minute walk test.
|
RT234 1.0 mg Dose Cohort (Safety Analysis Population; N=21)
n=21 participants at risk
RT234 at a capsule dose strength of 1.0 mg.
Subjects received a single 1.0 mg dose of RT234 (vardenafil inhalation powder administered via the Axial Oscillating Sphere dry powder inhaler, or AOS DPI) \~ 30 minutes prior to performing a cardiopulmonary exercise test (CPET). At at subsequent visit, subjects received a single 1.0 mg dose of RT234 \~30 minutes prior to performing a 6-minute walk test.
|
RT234 2.0 mg Dose Cohort Safety Analysis Population (N=14)
n=14 participants at risk
RT234 at a capsule dose strength of 2.0 mg.
Subjects received a single 2.0 mg dose of RT234 (vardenafil inhalation powder administered via the Axial Oscillating Sphere dry powder inhaler, or AOS DPI) \~ 30 minutes prior to performing a cardiopulmonary exercise test (CPET). At at subsequent visit, subjects received a single 2.0 mg dose of RT234 \~30 minutes prior to performing a 6-minute walk test.
|
Overall Safety Analysis Population (N=42)
n=42 participants at risk
Pooled results from all dose groups
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
14.3%
1/7 • Number of events 1 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
9.5%
2/21 • Number of events 2 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
0.00%
0/14 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
7.1%
3/42 • Number of events 3 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
|
Gastrointestinal disorders
Dry mouth
|
14.3%
1/7 • Number of events 1 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
0.00%
0/21 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
4.8%
2/42 • Number of events 2 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/7 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
0.00%
0/14 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
2.4%
1/42 • Number of events 1 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/7 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
0.00%
0/14 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
2.4%
1/42 • Number of events 1 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/7 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
0.00%
0/14 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
2.4%
1/42 • Number of events 1 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/7 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
0.00%
0/14 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
2.4%
1/42 • Number of events 1 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
|
Gastrointestinal disorders
Salivary duct obstruction
|
0.00%
0/7 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
0.00%
0/21 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
2.4%
1/42 • Number of events 1 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/7 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
21.4%
3/14 • Number of events 3 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
9.5%
4/42 • Number of events 4 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
0.00%
0/7 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
4.8%
2/42 • Number of events 2 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/7 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
0.00%
0/14 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
2.4%
1/42 • Number of events 1 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/7 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
0.00%
0/14 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
2.4%
1/42 • Number of events 1 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/7 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
0.00%
0/21 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
2.4%
1/42 • Number of events 1 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/7 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
4.8%
2/42 • Number of events 2 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/7 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
0.00%
0/21 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
2.4%
1/42 • Number of events 1 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/7 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
0.00%
0/14 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
2.4%
1/42 • Number of events 1 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/7 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
0.00%
0/21 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
2.4%
1/42 • Number of events 1 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
|
Musculoskeletal and connective tissue disorders
Tempomandibular joint syndrome
|
0.00%
0/7 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
0.00%
0/21 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
2.4%
1/42 • Number of events 1 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
|
Infections and infestations
COVID-19
|
0.00%
0/7 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
0.00%
0/21 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
2.4%
1/42 • Number of events 1 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/7 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
0.00%
0/14 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
2.4%
1/42 • Number of events 1 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/7 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
0.00%
0/14 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
2.4%
1/42 • Number of events 1 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/7 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
0.00%
0/14 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
2.4%
1/42 • Number of events 1 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
|
General disorders
Chest discomfort
|
0.00%
0/7 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
4.8%
2/42 • Number of events 2 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
|
General disorders
Sensation of foreign body
|
0.00%
0/7 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
0.00%
0/14 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
2.4%
1/42 • Number of events 1 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
|
General disorders
Vessel puncture site hematoma
|
0.00%
0/7 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
0.00%
0/21 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
2.4%
1/42 • Number of events 1 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
|
Nervous system disorders
Headache
|
0.00%
0/7 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
9.5%
2/21 • Number of events 2 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
0.00%
0/14 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
4.8%
2/42 • Number of events 2 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
|
Nervous system disorders
Dysguesia
|
0.00%
0/7 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
0.00%
0/14 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
2.4%
1/42 • Number of events 1 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/7 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
0.00%
0/14 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
2.4%
1/42 • Number of events 1 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/7 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
0.00%
0/14 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
2.4%
1/42 • Number of events 1 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
|
Injury, poisoning and procedural complications
Post procedural constipation
|
0.00%
0/7 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
0.00%
0/21 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
2.4%
1/42 • Number of events 1 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/7 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
0.00%
0/21 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
2.4%
1/42 • Number of events 1 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
|
Investigations
Human metapneumovirus test
|
0.00%
0/7 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
0.00%
0/14 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
2.4%
1/42 • Number of events 1 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
|
Psychiatric disorders
Bruxism
|
0.00%
0/7 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
0.00%
0/21 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
2.4%
1/42 • Number of events 1 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/7 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
0.00%
0/21 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
2.4%
1/42 • Number of events 1 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
|
Vascular disorders
Flushing
|
0.00%
0/7 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
0.00%
0/14 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
2.4%
1/42 • Number of events 1 • Adverse event data were collected for each subject from their screening visit through visit 5, which occurred 30 days following the 6MWT dosing visit. The overall time-frame over which adverse event data were collected for each subject was typically ~8-10 weeks. Treatment emergent adverse events (TEAEs) are not necessarily related to treatment and are defined as adverse events that start or increase in severity after the first RT234 dose and within 30 days of the last RT234 dose.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place