Trial Outcomes & Findings for Beraprost-314d Added-on to Tyvaso® (BEAT) (NCT NCT01908699)
NCT ID: NCT01908699
Last Updated: 2020-08-03
Results Overview
The number of participants that experienced a Clinical Worsening event confirmed by Endpoint Adjudication Committee at First Maximum Severity. Clinical Worsening was defined as any of these events following the Baseline visit: Death (all causes); Hospitalization due to worsening PAH; Initiation of a parenteral (infusion or sub-cutaneous) prostacyclin, directly related to worsening PAH; Disease progression; Unsatisfactory long-term clinical response. The number of participants that experienced clinical worsening is presented; time to clinical worsening data was not measured. Given the rate of clinical worsening overall and the large number of censored observations at the end of the study, the mean survival time estimates were not available for this endpoint.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
273 participants
Primary outcome timeframe
up to 144 weeks
Results posted on
2020-08-03
Participant Flow
273 participants randomized, 271 received treatment: 136 participants in the esuberaprost group and 135 in the placebo group. Two participants were excluded after randomization and never received treatment: 1 participant in the esuberaprost group was randomized by mistake and 1 participant in the placebo group was terminated per physician decision.
Participant milestones
| Measure |
Esuberaprost
Participants received 1 tablet of esuberaprost (BPS-314d-MR) 14.2 micrograms (mcg) orally 4 times daily (QID) (total daily dose: 56.8 mcg) in conjunction with inhaled treprostinil for 2 weeks. After 2 weeks, esuberaprost dose was increased to 2 tablets (14.2 mcg each) QID (total daily dose: 113.6 mcg). Participants who were unable to tolerate the 2 tablets QID dosing regimen were permitted to continue on 1 tablet QID during the study treatment.
|
Placebo
Participants received 1 or 2 tablets of placebo matched to esuberaprost orally QID in conjunction with inhaled treprostinil.
|
|---|---|---|
|
Overall Study
STARTED
|
137
|
136
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
136
|
135
|
|
Overall Study
COMPLETED
|
62
|
58
|
|
Overall Study
NOT COMPLETED
|
75
|
78
|
Reasons for withdrawal
| Measure |
Esuberaprost
Participants received 1 tablet of esuberaprost (BPS-314d-MR) 14.2 micrograms (mcg) orally 4 times daily (QID) (total daily dose: 56.8 mcg) in conjunction with inhaled treprostinil for 2 weeks. After 2 weeks, esuberaprost dose was increased to 2 tablets (14.2 mcg each) QID (total daily dose: 113.6 mcg). Participants who were unable to tolerate the 2 tablets QID dosing regimen were permitted to continue on 1 tablet QID during the study treatment.
|
Placebo
Participants received 1 or 2 tablets of placebo matched to esuberaprost orally QID in conjunction with inhaled treprostinil.
|
|---|---|---|
|
Overall Study
Adverse Event
|
8
|
12
|
|
Overall Study
Lack of Efficacy
|
2
|
2
|
|
Overall Study
Lost to Follow-up
|
2
|
4
|
|
Overall Study
Physician Decision
|
8
|
8
|
|
Overall Study
Withdrawal by Subject
|
15
|
10
|
|
Overall Study
Pregnancy
|
0
|
1
|
|
Overall Study
Randomized in Error
|
1
|
0
|
|
Overall Study
Death
|
9
|
12
|
|
Overall Study
Progressive Disease
|
30
|
29
|
Baseline Characteristics
all randomized participants that received at least one dose of study drug and were analyzed for this baseline measure
Baseline characteristics by cohort
| Measure |
Esuberaprost
n=136 Participants
Participants received 1 tablet of esuberaprost (BPS-314d-MR) 14.2 micrograms (mcg) orally 4 times daily (QID) (total daily dose: 56.8 mcg) in conjunction with inhaled treprostinil for 2 weeks. After 2 weeks, esuberaprost dose was increased to 2 tablets (14.2 mcg each) QID (total daily dose: 113.6 mcg). Participants who were unable to tolerate the 2 tablets QID dosing regimen were permitted to continue on 1 tablet QID during the study treatment.
|
Placebo
n=135 Participants
Participants received 1 or 2 tablets of placebo matched to esuberaprost orally QID in conjunction with inhaled treprostinil.
|
Total
n=271 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.9 Years
STANDARD_DEVIATION 13.61 • n=136 Participants
|
56.1 Years
STANDARD_DEVIATION 13.32 • n=135 Participants
|
55.5 Years
STANDARD_DEVIATION 13.45 • n=271 Participants
|
|
Sex: Female, Male
Female
|
99 Participants
n=136 Participants
|
98 Participants
n=135 Participants
|
197 Participants
n=271 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=136 Participants
|
37 Participants
n=135 Participants
|
74 Participants
n=271 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15 Participants
n=136 Participants
|
12 Participants
n=135 Participants
|
27 Participants
n=271 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
121 Participants
n=136 Participants
|
123 Participants
n=135 Participants
|
244 Participants
n=271 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=136 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=271 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=136 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=271 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=136 Participants
|
3 Participants
n=135 Participants
|
7 Participants
n=271 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=136 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=271 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=136 Participants
|
19 Participants
n=135 Participants
|
33 Participants
n=271 Participants
|
|
Race (NIH/OMB)
White
|
115 Participants
n=136 Participants
|
112 Participants
n=135 Participants
|
227 Participants
n=271 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=136 Participants
|
0 Participants
n=135 Participants
|
1 Participants
n=271 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=136 Participants
|
1 Participants
n=135 Participants
|
3 Participants
n=271 Participants
|
|
N-Terminal ProB-type Natriuretic Peptide (BNP) Levels
|
99.65 picograms per milliliter (pg/mL)
STANDARD_DEVIATION 137.95 • n=113 Participants • all randomized participants that received at least one dose of study drug and were analyzed for this baseline measure
|
102.31 picograms per milliliter (pg/mL)
STANDARD_DEVIATION 240.51 • n=105 Participants • all randomized participants that received at least one dose of study drug and were analyzed for this baseline measure
|
100.93 picograms per milliliter (pg/mL)
STANDARD_DEVIATION 193.77 • n=218 Participants • all randomized participants that received at least one dose of study drug and were analyzed for this baseline measure
|
|
Participant's Clinical Status Per World Health Organization (WHO) Functional Class
WHO Class I
|
0 Participants
n=136 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=271 Participants
|
|
Participant's Clinical Status Per World Health Organization (WHO) Functional Class
WHO Class II
|
0 Participants
n=136 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=271 Participants
|
|
Participant's Clinical Status Per World Health Organization (WHO) Functional Class
WHO Class III
|
130 Participants
n=136 Participants
|
128 Participants
n=135 Participants
|
258 Participants
n=271 Participants
|
|
Participant's Clinical Status Per World Health Organization (WHO) Functional Class
WHO Class IV
|
6 Participants
n=136 Participants
|
7 Participants
n=135 Participants
|
13 Participants
n=271 Participants
|
|
Borg Dyspnea Score
|
3.57 score on a scale
STANDARD_DEVIATION 1.91 • n=136 Participants • all randomized participants that received at least one dose of study drug and were analyzed for this baseline measure. 2. \*In the case of a single, missing Baseline Day 1 or Day 2 Borg Dyspnea Score, the single value is used as Baseline Average value.
|
3.84 score on a scale
STANDARD_DEVIATION 2.10 • n=135 Participants • all randomized participants that received at least one dose of study drug and were analyzed for this baseline measure. 2. \*In the case of a single, missing Baseline Day 1 or Day 2 Borg Dyspnea Score, the single value is used as Baseline Average value.
|
3.70 score on a scale
STANDARD_DEVIATION 2.01 • n=271 Participants • all randomized participants that received at least one dose of study drug and were analyzed for this baseline measure. 2. \*In the case of a single, missing Baseline Day 1 or Day 2 Borg Dyspnea Score, the single value is used as Baseline Average value.
|
|
Six-Minute Walk Distance
|
356.75 meters
STANDARD_DEVIATION 109.32 • n=136 Participants • all randomized participants that received at least one dose of study drug and were analyzed for this baseline measure
|
365.37 meters
STANDARD_DEVIATION 102.22 • n=135 Participants • all randomized participants that received at least one dose of study drug and were analyzed for this baseline measure
|
361.12 meters
STANDARD_DEVIATION 105.62 • n=271 Participants • all randomized participants that received at least one dose of study drug and were analyzed for this baseline measure
|
PRIMARY outcome
Timeframe: up to 144 weeksThe number of participants that experienced a Clinical Worsening event confirmed by Endpoint Adjudication Committee at First Maximum Severity. Clinical Worsening was defined as any of these events following the Baseline visit: Death (all causes); Hospitalization due to worsening PAH; Initiation of a parenteral (infusion or sub-cutaneous) prostacyclin, directly related to worsening PAH; Disease progression; Unsatisfactory long-term clinical response. The number of participants that experienced clinical worsening is presented; time to clinical worsening data was not measured. Given the rate of clinical worsening overall and the large number of censored observations at the end of the study, the mean survival time estimates were not available for this endpoint.
Outcome measures
| Measure |
Esuberaprost
n=136 Participants
Participants received 1 tablet of esuberaprost (BPS-314d-MR) 14.2 micrograms (mcg) orally 4 times daily (QID) (total daily dose: 56.8 mcg) in conjunction with inhaled treprostinil for 2 weeks. After 2 weeks, esuberaprost dose was increased to 2 tablets (14.2 mcg each) QID (total daily dose: 113.6 mcg). Participants who were unable to tolerate the 2 tablets QID dosing regimen were permitted to continue on 1 tablet QID during the study treatment.
|
Placebo
n=135 Participants
Participants received 1 or 2 tablets of placebo matched to esuberaprost orally QID in conjunction with inhaled treprostinil.
|
|---|---|---|
|
Number of Participants That Experienced Clinical Worsening
Death (all causes)
|
8 Participants
|
13 Participants
|
|
Number of Participants That Experienced Clinical Worsening
Hospitalization due to worsening PAH
|
23 Participants
|
14 Participants
|
|
Number of Participants That Experienced Clinical Worsening
Initiation of a parenteral prostacyclin
|
7 Participants
|
13 Participants
|
|
Number of Participants That Experienced Clinical Worsening
Disease progression
|
6 Participants
|
4 Participants
|
|
Number of Participants That Experienced Clinical Worsening
Unsatisfactory long-term clinical response
|
5 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: Only participants with both a measurement at baseline and at the given visit are presented.
The Borg dyspnea score was assessed prior to and following the completion of the 6MWT at Week 24. The Borg dyspnea score is a 10-point scale rating the maximum level of dyspnea experienced during the 6MWT. Scores range from 0 (for the best condition) to 10 (for the worst condition).
Outcome measures
| Measure |
Esuberaprost
n=136 Participants
Participants received 1 tablet of esuberaprost (BPS-314d-MR) 14.2 micrograms (mcg) orally 4 times daily (QID) (total daily dose: 56.8 mcg) in conjunction with inhaled treprostinil for 2 weeks. After 2 weeks, esuberaprost dose was increased to 2 tablets (14.2 mcg each) QID (total daily dose: 113.6 mcg). Participants who were unable to tolerate the 2 tablets QID dosing regimen were permitted to continue on 1 tablet QID during the study treatment.
|
Placebo
n=135 Participants
Participants received 1 or 2 tablets of placebo matched to esuberaprost orally QID in conjunction with inhaled treprostinil.
|
|---|---|---|
|
Mean Change From Baseline in Borg Dyspnea Score at Week 24
|
-0.10 scores on a scale
Standard Deviation 1.68
|
-0.26 scores on a scale
Standard Deviation 1.66
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: Only participants with both a measurement at baseline and at the given visit are presented.
Plasma NT-proBNP concentration is a useful biomarker for PAH as it is associated with changes in right heart morphology and function.
Outcome measures
| Measure |
Esuberaprost
n=136 Participants
Participants received 1 tablet of esuberaprost (BPS-314d-MR) 14.2 micrograms (mcg) orally 4 times daily (QID) (total daily dose: 56.8 mcg) in conjunction with inhaled treprostinil for 2 weeks. After 2 weeks, esuberaprost dose was increased to 2 tablets (14.2 mcg each) QID (total daily dose: 113.6 mcg). Participants who were unable to tolerate the 2 tablets QID dosing regimen were permitted to continue on 1 tablet QID during the study treatment.
|
Placebo
n=135 Participants
Participants received 1 or 2 tablets of placebo matched to esuberaprost orally QID in conjunction with inhaled treprostinil.
|
|---|---|---|
|
Mean Change From Baseline in NT-pro-BNP Levels at Week 24
|
12.38 picomole per liter (pmol/L)
Standard Deviation 131.46
|
20.48 picomole per liter (pmol/L)
Standard Deviation 300.57
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: Only participants with both a measurement at baseline and at the given visit are presented.
Change from Baseline in participant clinical status was recorded according to the World Health Organization (WHO) Functional Class. A change from lower to higher functional class (i.e. 'III to IV' or 'II to III') was considered as a deterioration. A change from higher to lower functional class (i.e. 'III to II' or 'II to I') was considered as an improvement. All efficacy results are descriptive; no statistical analysis was conducted.
Outcome measures
| Measure |
Esuberaprost
n=136 Participants
Participants received 1 tablet of esuberaprost (BPS-314d-MR) 14.2 micrograms (mcg) orally 4 times daily (QID) (total daily dose: 56.8 mcg) in conjunction with inhaled treprostinil for 2 weeks. After 2 weeks, esuberaprost dose was increased to 2 tablets (14.2 mcg each) QID (total daily dose: 113.6 mcg). Participants who were unable to tolerate the 2 tablets QID dosing regimen were permitted to continue on 1 tablet QID during the study treatment.
|
Placebo
n=135 Participants
Participants received 1 or 2 tablets of placebo matched to esuberaprost orally QID in conjunction with inhaled treprostinil.
|
|---|---|---|
|
Change in WHO Functional Class From Baseline to Week 24
Improved
|
42 Participants
|
46 Participants
|
|
Change in WHO Functional Class From Baseline to Week 24
No Change
|
71 Participants
|
60 Participants
|
|
Change in WHO Functional Class From Baseline to Week 24
Worsened
|
0 Participants
|
2 Participants
|
|
Change in WHO Functional Class From Baseline to Week 24
Not Reported
|
23 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: Only participants with both a measurement at baseline and at the given visit are presented.
Area used for the Six Minute Walk Test (6MWT) was pre-measured at 30 meters in length. Rest periods were allowed if patient could no longer continue. If patient needed to rest, he/she could stand or sit and then begin again when rested but the clock continued to run. At the end of 6 minutes, the tester called "stop" while stopping the watch and then measured the distance walked. For purposes of the 6MWT, if patient was assessed at Baseline using oxygen therapy, all future 6MWT were conducted in the same manner.
Outcome measures
| Measure |
Esuberaprost
n=109 Participants
Participants received 1 tablet of esuberaprost (BPS-314d-MR) 14.2 micrograms (mcg) orally 4 times daily (QID) (total daily dose: 56.8 mcg) in conjunction with inhaled treprostinil for 2 weeks. After 2 weeks, esuberaprost dose was increased to 2 tablets (14.2 mcg each) QID (total daily dose: 113.6 mcg). Participants who were unable to tolerate the 2 tablets QID dosing regimen were permitted to continue on 1 tablet QID during the study treatment.
|
Placebo
n=106 Participants
Participants received 1 or 2 tablets of placebo matched to esuberaprost orally QID in conjunction with inhaled treprostinil.
|
|---|---|---|
|
Mean Change From Baseline in Six Minutes Walk Distance (6MWD) at Week 24
|
13.47 meters
Standard Deviation 44.83
|
19.32 meters
Standard Deviation 53.23
|
SECONDARY outcome
Timeframe: up to 144 weeksPopulation: Safety analysis population included all randomized participants who received at least 1 dose of study drug and analyzed as per the actual treatment received. Participants who received both esuberaprost and placebo were assigned to the esuberaprost group.
The number of participants experiencing overall Treatment-Emergent Adverse Adverse Events (TEAEs), serious TEAEs, Investigations SOC TEAEs, and serious Investigations SOC TEAEs were reported.Investigations SOC TEAEs were any event categorized within the Investigations System Order Class (SOC) and include adverse events due to physical examinations, vital signs, clinical laboratory parameters, and electrocardiogram findings.
Outcome measures
| Measure |
Esuberaprost
n=137 Participants
Participants received 1 tablet of esuberaprost (BPS-314d-MR) 14.2 micrograms (mcg) orally 4 times daily (QID) (total daily dose: 56.8 mcg) in conjunction with inhaled treprostinil for 2 weeks. After 2 weeks, esuberaprost dose was increased to 2 tablets (14.2 mcg each) QID (total daily dose: 113.6 mcg). Participants who were unable to tolerate the 2 tablets QID dosing regimen were permitted to continue on 1 tablet QID during the study treatment.
|
Placebo
n=134 Participants
Participants received 1 or 2 tablets of placebo matched to esuberaprost orally QID in conjunction with inhaled treprostinil.
|
|---|---|---|
|
Number of Participants With TEAEs, Serious TEAEs, Investigations SOC TEAEs, and Serious Investigations SOC TEAEs
at least 1 TEAE
|
135 Participants
|
132 Participants
|
|
Number of Participants With TEAEs, Serious TEAEs, Investigations SOC TEAEs, and Serious Investigations SOC TEAEs
at least 1 Serious TEAEs
|
75 Participants
|
78 Participants
|
|
Number of Participants With TEAEs, Serious TEAEs, Investigations SOC TEAEs, and Serious Investigations SOC TEAEs
at least 1 Investigations SOC TEAEs
|
61 Participants
|
49 Participants
|
|
Number of Participants With TEAEs, Serious TEAEs, Investigations SOC TEAEs, and Serious Investigations SOC TEAEs
at least 1 Investigations SOC Serious TEAEs
|
2 Participants
|
1 Participants
|
Adverse Events
Esuberaprost
Serious events: 75 serious events
Other events: 135 other events
Deaths: 26 deaths
Placebo
Serious events: 78 serious events
Other events: 132 other events
Deaths: 22 deaths
Serious adverse events
| Measure |
Esuberaprost
n=137 participants at risk
Participants received 1 tablet of esuberaprost (BPS-314d-MR) 14.2 micrograms (mcg) orally 4 times daily (QID) (total daily dose: 56.8 mcg) in conjunction with inhaled treprostinil for 2 weeks. After 2 weeks, esuberaprost dose was increased to 2 tablets (14.2 mcg each) QID (total daily dose: 113.6 mcg). Participants who were unable to tolerate the 2 tablets QID dosing regimen were permitted to continue on 1 tablet QID during the study treatment.
|
Placebo
n=136 participants at risk
Participants received 1 or 2 tablets of placebo matched to esuberaprost orally QID in conjunction with inhaled treprostinil.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.73%
1/137 • Up to 144 weeks
|
2.2%
3/136 • Up to 144 weeks
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/137 • Up to 144 weeks
|
1.5%
2/136 • Up to 144 weeks
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.73%
1/137 • Up to 144 weeks
|
0.00%
0/136 • Up to 144 weeks
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
1.5%
2/137 • Up to 144 weeks
|
0.00%
0/136 • Up to 144 weeks
|
|
Cardiac disorders
Acute myocardial infarction
|
0.73%
1/137 • Up to 144 weeks
|
0.74%
1/136 • Up to 144 weeks
|
|
Cardiac disorders
Angina pectoris
|
1.5%
2/137 • Up to 144 weeks
|
0.00%
0/136 • Up to 144 weeks
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/137 • Up to 144 weeks
|
0.74%
1/136 • Up to 144 weeks
|
|
Cardiac disorders
Atrial fibrillation
|
1.5%
2/137 • Up to 144 weeks
|
4.4%
6/136 • Up to 144 weeks
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/137 • Up to 144 weeks
|
0.74%
1/136 • Up to 144 weeks
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/137 • Up to 144 weeks
|
0.74%
1/136 • Up to 144 weeks
|
|
Cardiac disorders
Cardiac arrest
|
1.5%
2/137 • Up to 144 weeks
|
0.74%
1/136 • Up to 144 weeks
|
|
Cardiac disorders
Cardiac failure
|
0.73%
1/137 • Up to 144 weeks
|
1.5%
2/136 • Up to 144 weeks
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/137 • Up to 144 weeks
|
2.2%
3/136 • Up to 144 weeks
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.73%
1/137 • Up to 144 weeks
|
0.00%
0/136 • Up to 144 weeks
|
|
Cardiac disorders
Paroxysmal atrioventricular block
|
0.00%
0/137 • Up to 144 weeks
|
0.74%
1/136 • Up to 144 weeks
|
|
Cardiac disorders
Pericardial effusion
|
0.73%
1/137 • Up to 144 weeks
|
0.00%
0/136 • Up to 144 weeks
|
|
Cardiac disorders
Pericarditis
|
0.73%
1/137 • Up to 144 weeks
|
0.74%
1/136 • Up to 144 weeks
|
|
Cardiac disorders
Pulseless electrical activity
|
0.00%
0/137 • Up to 144 weeks
|
0.74%
1/136 • Up to 144 weeks
|
|
Cardiac disorders
Right ventricular failure
|
5.1%
7/137 • Up to 144 weeks
|
3.7%
5/136 • Up to 144 weeks
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.73%
1/137 • Up to 144 weeks
|
0.74%
1/136 • Up to 144 weeks
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/137 • Up to 144 weeks
|
0.74%
1/136 • Up to 144 weeks
|
|
Endocrine disorders
Adrenal insufficiency
|
0.73%
1/137 • Up to 144 weeks
|
0.00%
0/136 • Up to 144 weeks
|
|
Gastrointestinal disorders
Abdominal incarcerated hernia
|
0.73%
1/137 • Up to 144 weeks
|
0.00%
0/136 • Up to 144 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
0.73%
1/137 • Up to 144 weeks
|
1.5%
2/136 • Up to 144 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
0.73%
1/137 • Up to 144 weeks
|
0.00%
0/136 • Up to 144 weeks
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/137 • Up to 144 weeks
|
0.74%
1/136 • Up to 144 weeks
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/137 • Up to 144 weeks
|
0.74%
1/136 • Up to 144 weeks
|
|
Gastrointestinal disorders
Ileus
|
0.73%
1/137 • Up to 144 weeks
|
0.00%
0/136 • Up to 144 weeks
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.73%
1/137 • Up to 144 weeks
|
0.74%
1/136 • Up to 144 weeks
|
|
Gastrointestinal disorders
Intussusception
|
0.73%
1/137 • Up to 144 weeks
|
0.00%
0/136 • Up to 144 weeks
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.73%
1/137 • Up to 144 weeks
|
0.00%
0/136 • Up to 144 weeks
|
|
Gastrointestinal disorders
Pancreatitis
|
0.73%
1/137 • Up to 144 weeks
|
0.00%
0/136 • Up to 144 weeks
|
|
Gastrointestinal disorders
Rectal fissure
|
0.00%
0/137 • Up to 144 weeks
|
0.74%
1/136 • Up to 144 weeks
|
|
General disorders
Adverse drug reaction
|
0.00%
0/137 • Up to 144 weeks
|
0.74%
1/136 • Up to 144 weeks
|
|
General disorders
Asthenia
|
0.00%
0/137 • Up to 144 weeks
|
1.5%
2/136 • Up to 144 weeks
|
|
General disorders
Chest pain
|
1.5%
2/137 • Up to 144 weeks
|
1.5%
2/136 • Up to 144 weeks
|
|
General disorders
Death
|
0.73%
1/137 • Up to 144 weeks
|
0.74%
1/136 • Up to 144 weeks
|
|
General disorders
General physical health deterioration
|
1.5%
2/137 • Up to 144 weeks
|
0.00%
0/136 • Up to 144 weeks
|
|
General disorders
Impaired healing
|
0.73%
1/137 • Up to 144 weeks
|
0.00%
0/136 • Up to 144 weeks
|
|
General disorders
Infusion site reaction
|
0.73%
1/137 • Up to 144 weeks
|
0.00%
0/136 • Up to 144 weeks
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/137 • Up to 144 weeks
|
0.74%
1/136 • Up to 144 weeks
|
|
General disorders
Non-cardiac chest pain
|
2.2%
3/137 • Up to 144 weeks
|
0.74%
1/136 • Up to 144 weeks
|
|
General disorders
Oedema peripheral
|
0.73%
1/137 • Up to 144 weeks
|
0.74%
1/136 • Up to 144 weeks
|
|
General disorders
Pyrexia
|
1.5%
2/137 • Up to 144 weeks
|
0.00%
0/136 • Up to 144 weeks
|
|
General disorders
Sudden cardiac death
|
0.00%
0/137 • Up to 144 weeks
|
0.74%
1/136 • Up to 144 weeks
|
|
General disorders
Sudden death
|
0.00%
0/137 • Up to 144 weeks
|
0.74%
1/136 • Up to 144 weeks
|
|
General disorders
Systemic inflammatory response syndrome
|
0.73%
1/137 • Up to 144 weeks
|
0.74%
1/136 • Up to 144 weeks
|
|
Infections and infestations
Breast abscess
|
0.73%
1/137 • Up to 144 weeks
|
0.00%
0/136 • Up to 144 weeks
|
|
Infections and infestations
Bronchitis
|
0.73%
1/137 • Up to 144 weeks
|
2.2%
3/136 • Up to 144 weeks
|
|
Infections and infestations
Cellulitis
|
2.2%
3/137 • Up to 144 weeks
|
0.00%
0/136 • Up to 144 weeks
|
|
Infections and infestations
Clostridium difficile colitis
|
0.73%
1/137 • Up to 144 weeks
|
0.00%
0/136 • Up to 144 weeks
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/137 • Up to 144 weeks
|
0.74%
1/136 • Up to 144 weeks
|
|
Infections and infestations
Diverticulitis
|
0.73%
1/137 • Up to 144 weeks
|
0.00%
0/136 • Up to 144 weeks
|
|
Infections and infestations
Endocarditis
|
0.00%
0/137 • Up to 144 weeks
|
0.74%
1/136 • Up to 144 weeks
|
|
Infections and infestations
Extradural abscess
|
0.00%
0/137 • Up to 144 weeks
|
0.74%
1/136 • Up to 144 weeks
|
|
Infections and infestations
Gangrene
|
0.73%
1/137 • Up to 144 weeks
|
0.00%
0/136 • Up to 144 weeks
|
|
Infections and infestations
Gastroenteritis
|
0.73%
1/137 • Up to 144 weeks
|
0.74%
1/136 • Up to 144 weeks
|
|
Infections and infestations
Influenza
|
0.00%
0/137 • Up to 144 weeks
|
3.7%
5/136 • Up to 144 weeks
|
|
Infections and infestations
Osteomyelitis
|
0.73%
1/137 • Up to 144 weeks
|
0.00%
0/136 • Up to 144 weeks
|
|
Infections and infestations
Osteomyelitis acute
|
0.73%
1/137 • Up to 144 weeks
|
0.00%
0/136 • Up to 144 weeks
|
|
Infections and infestations
Parotid abscess
|
0.73%
1/137 • Up to 144 weeks
|
0.00%
0/136 • Up to 144 weeks
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.73%
1/137 • Up to 144 weeks
|
0.00%
0/136 • Up to 144 weeks
|
|
Infections and infestations
Pneumonia
|
5.8%
8/137 • Up to 144 weeks
|
8.8%
12/136 • Up to 144 weeks
|
|
Infections and infestations
Pneumonia influenzal
|
0.73%
1/137 • Up to 144 weeks
|
0.74%
1/136 • Up to 144 weeks
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/137 • Up to 144 weeks
|
0.74%
1/136 • Up to 144 weeks
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/137 • Up to 144 weeks
|
1.5%
2/136 • Up to 144 weeks
|
|
Infections and infestations
Sepsis
|
0.73%
1/137 • Up to 144 weeks
|
0.74%
1/136 • Up to 144 weeks
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/137 • Up to 144 weeks
|
0.74%
1/136 • Up to 144 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
0.73%
1/137 • Up to 144 weeks
|
0.00%
0/136 • Up to 144 weeks
|
|
Infections and infestations
Urinary tract infection
|
1.5%
2/137 • Up to 144 weeks
|
1.5%
2/136 • Up to 144 weeks
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.73%
1/137 • Up to 144 weeks
|
0.00%
0/136 • Up to 144 weeks
|
|
Infections and infestations
Urosepsis
|
0.00%
0/137 • Up to 144 weeks
|
0.74%
1/136 • Up to 144 weeks
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.73%
1/137 • Up to 144 weeks
|
0.74%
1/136 • Up to 144 weeks
|
|
Injury, poisoning and procedural complications
Adjacent segment degeneration
|
0.73%
1/137 • Up to 144 weeks
|
0.00%
0/136 • Up to 144 weeks
|
|
Injury, poisoning and procedural complications
Endotracheal intubation complication
|
0.73%
1/137 • Up to 144 weeks
|
0.00%
0/136 • Up to 144 weeks
|
|
Injury, poisoning and procedural complications
Head injury
|
0.73%
1/137 • Up to 144 weeks
|
0.00%
0/136 • Up to 144 weeks
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.73%
1/137 • Up to 144 weeks
|
0.00%
0/136 • Up to 144 weeks
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/137 • Up to 144 weeks
|
0.74%
1/136 • Up to 144 weeks
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.73%
1/137 • Up to 144 weeks
|
0.00%
0/136 • Up to 144 weeks
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/137 • Up to 144 weeks
|
0.74%
1/136 • Up to 144 weeks
|
|
Injury, poisoning and procedural complications
Pubis fracture
|
0.73%
1/137 • Up to 144 weeks
|
0.00%
0/136 • Up to 144 weeks
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.73%
1/137 • Up to 144 weeks
|
0.00%
0/136 • Up to 144 weeks
|
|
Injury, poisoning and procedural complications
Shunt malfunction
|
0.00%
0/137 • Up to 144 weeks
|
0.74%
1/136 • Up to 144 weeks
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.73%
1/137 • Up to 144 weeks
|
0.00%
0/136 • Up to 144 weeks
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.73%
1/137 • Up to 144 weeks
|
0.00%
0/136 • Up to 144 weeks
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.73%
1/137 • Up to 144 weeks
|
0.00%
0/136 • Up to 144 weeks
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/137 • Up to 144 weeks
|
0.74%
1/136 • Up to 144 weeks
|
|
Investigations
Anticoagulation drug level above therapeutic
|
0.73%
1/137 • Up to 144 weeks
|
0.00%
0/136 • Up to 144 weeks
|
|
Investigations
Electrocardiogram change
|
0.00%
0/137 • Up to 144 weeks
|
0.74%
1/136 • Up to 144 weeks
|
|
Investigations
Pulmonary arterial pressure increased
|
0.73%
1/137 • Up to 144 weeks
|
0.00%
0/136 • Up to 144 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
0.73%
1/137 • Up to 144 weeks
|
0.00%
0/136 • Up to 144 weeks
|
|
Metabolism and nutrition disorders
Fluid overload
|
2.2%
3/137 • Up to 144 weeks
|
1.5%
2/136 • Up to 144 weeks
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.73%
1/137 • Up to 144 weeks
|
0.00%
0/136 • Up to 144 weeks
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.73%
1/137 • Up to 144 weeks
|
0.00%
0/136 • Up to 144 weeks
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/137 • Up to 144 weeks
|
0.74%
1/136 • Up to 144 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/137 • Up to 144 weeks
|
0.74%
1/136 • Up to 144 weeks
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.73%
1/137 • Up to 144 weeks
|
0.00%
0/136 • Up to 144 weeks
|
|
Musculoskeletal and connective tissue disorders
Immunoglobulin G4 related disease
|
0.73%
1/137 • Up to 144 weeks
|
0.00%
0/136 • Up to 144 weeks
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/137 • Up to 144 weeks
|
0.74%
1/136 • Up to 144 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/137 • Up to 144 weeks
|
0.74%
1/136 • Up to 144 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.73%
1/137 • Up to 144 weeks
|
0.00%
0/136 • Up to 144 weeks
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.73%
1/137 • Up to 144 weeks
|
0.00%
0/136 • Up to 144 weeks
|
|
Musculoskeletal and connective tissue disorders
Still's disease
|
0.00%
0/137 • Up to 144 weeks
|
0.74%
1/136 • Up to 144 weeks
|
|
Musculoskeletal and connective tissue disorders
Systemic scleroderma
|
0.00%
0/137 • Up to 144 weeks
|
0.74%
1/136 • Up to 144 weeks
|
|
Musculoskeletal and connective tissue disorders
Vertebral foraminal stenosis
|
0.73%
1/137 • Up to 144 weeks
|
0.00%
0/136 • Up to 144 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.73%
1/137 • Up to 144 weeks
|
0.00%
0/136 • Up to 144 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/137 • Up to 144 weeks
|
0.74%
1/136 • Up to 144 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.73%
1/137 • Up to 144 weeks
|
0.00%
0/136 • Up to 144 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma stage IV
|
0.73%
1/137 • Up to 144 weeks
|
0.00%
0/136 • Up to 144 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer stage IV
|
0.00%
0/137 • Up to 144 weeks
|
0.74%
1/136 • Up to 144 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/137 • Up to 144 weeks
|
0.74%
1/136 • Up to 144 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/137 • Up to 144 weeks
|
0.74%
1/136 • Up to 144 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vulval cancer stage 0
|
0.00%
0/137 • Up to 144 weeks
|
0.74%
1/136 • Up to 144 weeks
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/137 • Up to 144 weeks
|
0.74%
1/136 • Up to 144 weeks
|
|
Nervous system disorders
Cerebrovascular accident
|
1.5%
2/137 • Up to 144 weeks
|
2.9%
4/136 • Up to 144 weeks
|
|
Nervous system disorders
Embolic cerebral infarction
|
0.00%
0/137 • Up to 144 weeks
|
0.74%
1/136 • Up to 144 weeks
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/137 • Up to 144 weeks
|
0.74%
1/136 • Up to 144 weeks
|
|
Nervous system disorders
Post-traumatic epilepsy
|
0.73%
1/137 • Up to 144 weeks
|
0.00%
0/136 • Up to 144 weeks
|
|
Nervous system disorders
Syncope
|
2.9%
4/137 • Up to 144 weeks
|
2.2%
3/136 • Up to 144 weeks
|
|
Nervous system disorders
Transient ischaemic attack
|
0.73%
1/137 • Up to 144 weeks
|
0.00%
0/136 • Up to 144 weeks
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/137 • Up to 144 weeks
|
1.5%
2/136 • Up to 144 weeks
|
|
Psychiatric disorders
Depression
|
0.00%
0/137 • Up to 144 weeks
|
0.74%
1/136 • Up to 144 weeks
|
|
Psychiatric disorders
Generalised anxiety disorder
|
0.00%
0/137 • Up to 144 weeks
|
0.74%
1/136 • Up to 144 weeks
|
|
Psychiatric disorders
Major depression
|
0.00%
0/137 • Up to 144 weeks
|
0.74%
1/136 • Up to 144 weeks
|
|
Psychiatric disorders
Mental status changes
|
0.73%
1/137 • Up to 144 weeks
|
1.5%
2/136 • Up to 144 weeks
|
|
Renal and urinary disorders
Acute kidney injury
|
1.5%
2/137 • Up to 144 weeks
|
2.2%
3/136 • Up to 144 weeks
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.73%
1/137 • Up to 144 weeks
|
0.00%
0/136 • Up to 144 weeks
|
|
Renal and urinary disorders
End stage renal disease
|
0.73%
1/137 • Up to 144 weeks
|
0.00%
0/136 • Up to 144 weeks
|
|
Reproductive system and breast disorders
Adenomyosis
|
0.73%
1/137 • Up to 144 weeks
|
0.00%
0/136 • Up to 144 weeks
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.73%
1/137 • Up to 144 weeks
|
0.00%
0/136 • Up to 144 weeks
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/137 • Up to 144 weeks
|
0.74%
1/136 • Up to 144 weeks
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.00%
0/137 • Up to 144 weeks
|
0.74%
1/136 • Up to 144 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/137 • Up to 144 weeks
|
0.74%
1/136 • Up to 144 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
3.6%
5/137 • Up to 144 weeks
|
3.7%
5/136 • Up to 144 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.73%
1/137 • Up to 144 weeks
|
0.00%
0/136 • Up to 144 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/137 • Up to 144 weeks
|
2.2%
3/136 • Up to 144 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.5%
2/137 • Up to 144 weeks
|
2.2%
3/136 • Up to 144 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.73%
1/137 • Up to 144 weeks
|
0.74%
1/136 • Up to 144 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.73%
1/137 • Up to 144 weeks
|
0.74%
1/136 • Up to 144 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.73%
1/137 • Up to 144 weeks
|
0.00%
0/136 • Up to 144 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/137 • Up to 144 weeks
|
0.74%
1/136 • Up to 144 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/137 • Up to 144 weeks
|
0.74%
1/136 • Up to 144 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary arterial hypertension
|
16.8%
23/137 • Up to 144 weeks
|
22.1%
30/136 • Up to 144 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/137 • Up to 144 weeks
|
0.74%
1/136 • Up to 144 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/137 • Up to 144 weeks
|
0.74%
1/136 • Up to 144 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/137 • Up to 144 weeks
|
0.74%
1/136 • Up to 144 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/137 • Up to 144 weeks
|
0.74%
1/136 • Up to 144 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.2%
3/137 • Up to 144 weeks
|
4.4%
6/136 • Up to 144 weeks
|
|
Vascular disorders
Aortic stenosis
|
0.73%
1/137 • Up to 144 weeks
|
1.5%
2/136 • Up to 144 weeks
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/137 • Up to 144 weeks
|
0.74%
1/136 • Up to 144 weeks
|
|
Vascular disorders
Haematoma
|
0.00%
0/137 • Up to 144 weeks
|
0.74%
1/136 • Up to 144 weeks
|
|
Vascular disorders
Hypertension
|
0.00%
0/137 • Up to 144 weeks
|
0.74%
1/136 • Up to 144 weeks
|
|
Vascular disorders
Hypotension
|
0.73%
1/137 • Up to 144 weeks
|
0.74%
1/136 • Up to 144 weeks
|
|
Vascular disorders
Orthostatic hypotension
|
0.73%
1/137 • Up to 144 weeks
|
0.00%
0/136 • Up to 144 weeks
|
|
Vascular disorders
Venous thrombosis limb
|
0.73%
1/137 • Up to 144 weeks
|
0.00%
0/136 • Up to 144 weeks
|
Other adverse events
| Measure |
Esuberaprost
n=137 participants at risk
Participants received 1 tablet of esuberaprost (BPS-314d-MR) 14.2 micrograms (mcg) orally 4 times daily (QID) (total daily dose: 56.8 mcg) in conjunction with inhaled treprostinil for 2 weeks. After 2 weeks, esuberaprost dose was increased to 2 tablets (14.2 mcg each) QID (total daily dose: 113.6 mcg). Participants who were unable to tolerate the 2 tablets QID dosing regimen were permitted to continue on 1 tablet QID during the study treatment.
|
Placebo
n=136 participants at risk
Participants received 1 or 2 tablets of placebo matched to esuberaprost orally QID in conjunction with inhaled treprostinil.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
7.3%
10/137 • Up to 144 weeks
|
5.1%
7/136 • Up to 144 weeks
|
|
Renal and urinary disorders
Acute kidney injury
|
3.6%
5/137 • Up to 144 weeks
|
5.1%
7/136 • Up to 144 weeks
|
|
Blood and lymphatic system disorders
Anaemia
|
8.8%
12/137 • Up to 144 weeks
|
5.9%
8/136 • Up to 144 weeks
|
|
Psychiatric disorders
Anxiety
|
2.2%
3/137 • Up to 144 weeks
|
7.4%
10/136 • Up to 144 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.2%
14/137 • Up to 144 weeks
|
12.5%
17/136 • Up to 144 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.7%
16/137 • Up to 144 weeks
|
8.8%
12/136 • Up to 144 weeks
|
|
Infections and infestations
Bronchitis
|
9.5%
13/137 • Up to 144 weeks
|
8.8%
12/136 • Up to 144 weeks
|
|
Infections and infestations
Cellulitis
|
7.3%
10/137 • Up to 144 weeks
|
2.2%
3/136 • Up to 144 weeks
|
|
General disorders
Chest discomfort
|
5.8%
8/137 • Up to 144 weeks
|
6.6%
9/136 • Up to 144 weeks
|
|
General disorders
Chest pain
|
3.6%
5/137 • Up to 144 weeks
|
5.1%
7/136 • Up to 144 weeks
|
|
Gastrointestinal disorders
Constipation
|
8.0%
11/137 • Up to 144 weeks
|
6.6%
9/136 • Up to 144 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
19.7%
27/137 • Up to 144 weeks
|
18.4%
25/136 • Up to 144 weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.1%
7/137 • Up to 144 weeks
|
2.9%
4/136 • Up to 144 weeks
|
|
Psychiatric disorders
Depression
|
5.1%
7/137 • Up to 144 weeks
|
3.7%
5/136 • Up to 144 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
22.6%
31/137 • Up to 144 weeks
|
17.6%
24/136 • Up to 144 weeks
|
|
Nervous system disorders
Dizziness
|
17.5%
24/137 • Up to 144 weeks
|
26.5%
36/136 • Up to 144 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
4.4%
6/137 • Up to 144 weeks
|
6.6%
9/136 • Up to 144 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
25.5%
35/137 • Up to 144 weeks
|
30.9%
42/136 • Up to 144 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
6.6%
9/137 • Up to 144 weeks
|
4.4%
6/136 • Up to 144 weeks
|
|
Investigations
Electrocardiogram QT prolonged
|
5.1%
7/137 • Up to 144 weeks
|
0.74%
1/136 • Up to 144 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.4%
6/137 • Up to 144 weeks
|
5.9%
8/136 • Up to 144 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
8.8%
12/137 • Up to 144 weeks
|
8.8%
12/136 • Up to 144 weeks
|
|
General disorders
Fatigue
|
16.1%
22/137 • Up to 144 weeks
|
20.6%
28/136 • Up to 144 weeks
|
|
Metabolism and nutrition disorders
Fluid overload
|
2.2%
3/137 • Up to 144 weeks
|
5.1%
7/136 • Up to 144 weeks
|
|
Vascular disorders
Flushing
|
12.4%
17/137 • Up to 144 weeks
|
12.5%
17/136 • Up to 144 weeks
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
7.3%
10/137 • Up to 144 weeks
|
2.2%
3/136 • Up to 144 weeks
|
|
Nervous system disorders
Headache
|
45.3%
62/137 • Up to 144 weeks
|
28.7%
39/136 • Up to 144 weeks
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
10.2%
14/137 • Up to 144 weeks
|
5.1%
7/136 • Up to 144 weeks
|
|
Vascular disorders
Hypotension
|
2.9%
4/137 • Up to 144 weeks
|
6.6%
9/136 • Up to 144 weeks
|
|
Infections and infestations
Influenza
|
7.3%
10/137 • Up to 144 weeks
|
7.4%
10/136 • Up to 144 weeks
|
|
Psychiatric disorders
Insomnia
|
5.1%
7/137 • Up to 144 weeks
|
6.6%
9/136 • Up to 144 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.8%
8/137 • Up to 144 weeks
|
8.1%
11/136 • Up to 144 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
5.1%
7/137 • Up to 144 weeks
|
3.7%
5/136 • Up to 144 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.1%
7/137 • Up to 144 weeks
|
2.9%
4/136 • Up to 144 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
10.2%
14/137 • Up to 144 weeks
|
8.8%
12/136 • Up to 144 weeks
|
|
Infections and infestations
Nasopharyngitis
|
14.6%
20/137 • Up to 144 weeks
|
14.0%
19/136 • Up to 144 weeks
|
|
Gastrointestinal disorders
Nausea
|
29.9%
41/137 • Up to 144 weeks
|
24.3%
33/136 • Up to 144 weeks
|
|
General disorders
Non-cardiac chest pain
|
5.8%
8/137 • Up to 144 weeks
|
5.9%
8/136 • Up to 144 weeks
|
|
Investigations
N-terminal prohormone brain natriuretic peptide increased
|
13.1%
18/137 • Up to 144 weeks
|
7.4%
10/136 • Up to 144 weeks
|
|
General disorders
Oedema
|
4.4%
6/137 • Up to 144 weeks
|
6.6%
9/136 • Up to 144 weeks
|
|
General disorders
Oedema peripheral
|
16.1%
22/137 • Up to 144 weeks
|
12.5%
17/136 • Up to 144 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
8.8%
12/137 • Up to 144 weeks
|
5.1%
7/136 • Up to 144 weeks
|
|
General disorders
Pain
|
3.6%
5/137 • Up to 144 weeks
|
5.1%
7/136 • Up to 144 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
14.6%
20/137 • Up to 144 weeks
|
10.3%
14/136 • Up to 144 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
11.7%
16/137 • Up to 144 weeks
|
6.6%
9/136 • Up to 144 weeks
|
|
Cardiac disorders
Palpitations
|
10.2%
14/137 • Up to 144 weeks
|
10.3%
14/136 • Up to 144 weeks
|
|
Nervous system disorders
Paraesthesia
|
5.1%
7/137 • Up to 144 weeks
|
2.2%
3/136 • Up to 144 weeks
|
|
Infections and infestations
Pneumonia
|
8.0%
11/137 • Up to 144 weeks
|
4.4%
6/136 • Up to 144 weeks
|
|
Nervous system disorders
Presyncope
|
3.6%
5/137 • Up to 144 weeks
|
5.9%
8/136 • Up to 144 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary arterial hypertension
|
8.0%
11/137 • Up to 144 weeks
|
5.9%
8/136 • Up to 144 weeks
|
|
General disorders
Pyrexia
|
7.3%
10/137 • Up to 144 weeks
|
10.3%
14/136 • Up to 144 weeks
|
|
Infections and infestations
Respiratory tract infection
|
2.2%
3/137 • Up to 144 weeks
|
5.1%
7/136 • Up to 144 weeks
|
|
Infections and infestations
Sinusitis
|
15.3%
21/137 • Up to 144 weeks
|
14.0%
19/136 • Up to 144 weeks
|
|
Nervous system disorders
Syncope
|
6.6%
9/137 • Up to 144 weeks
|
5.9%
8/136 • Up to 144 weeks
|
|
Infections and infestations
Tooth infection
|
6.6%
9/137 • Up to 144 weeks
|
0.00%
0/136 • Up to 144 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
18.2%
25/137 • Up to 144 weeks
|
31.6%
43/136 • Up to 144 weeks
|
|
Infections and infestations
Urinary tract infection
|
18.2%
25/137 • Up to 144 weeks
|
14.7%
20/136 • Up to 144 weeks
|
|
Gastrointestinal disorders
Vomiting
|
10.9%
15/137 • Up to 144 weeks
|
11.8%
16/136 • Up to 144 weeks
|
|
Investigations
Weight increased
|
5.8%
8/137 • Up to 144 weeks
|
2.9%
4/136 • Up to 144 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
5.1%
7/137 • Up to 144 weeks
|
5.9%
8/136 • Up to 144 weeks
|
Additional Information
Lung Biotechnology PBC Study Director
Lung Biotechnology PBC
Phone: 301-608-9292
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60