The number of subjects that achieved an oral treprostinil dose of ≥4 mg TID (or a total daily dose [TDD] of 12 mg) at Week 16 (or a dose of ≥0.057 mg/kg TID [TDD of 0.171 mg/kg] for subjects <70 kg).

Per-protocol Population

The 6-Minute Walk Test (6MWT) is used to measure exercise ability in patients with chronic respiratory diseases. The distance walked on a predetermined course over 6 minutes was recorded.

Per-protocol Population. Only Subjects with Baseline and Week 16 are included.

The Borg dyspnea score is a 10-point scale rating the maximum level of dyspnea experienced during the 6MWT. Scores range from 0 (no shortness of breath) to 10 (worst shortness of breath you have ever had).

Per-protocol Population. Only Subjects with Baseline and Week 16 are included.

WHO FC ranges from I (subjects with PH but without resulting limitation of physical activity) to IV (subjects with PH with inability to carry out any physical activities without symptoms). A lower WHO FC was considered "improved"; a higher WHO FC was considered "worsened."

Per-protocol Population. Only Subjects with Baseline and Week 16 are included.

NT-proBNP is a hormone produced by the heart. NT-proBNP concentration is associated with changes in right heart morphology and function. The main purpose of NT-proBNP testing is to see if the blood levels of this protein are within the expected range for a healthy person. Normal levels of NT-proBNP are less than 125 pg/mL for people under 75 years old and less than 450 pg/mL for people over age 75. NT-proBNP levels over 900 pg/mL may be a sign of heart failure. The higher the level, the more serious the condition.

Per-protocol Population. Only Subjects with Baseline and Week 16 are included.

ECHOs provide information regarding cardiac structure and function. Cardiac output was summarized at each time point listed.

Per-protocol Population. Only Subjects with Baseline and Week 16 are included.

ECHOs provide information regarding cardiac structure and function. Heart rate was summarized at each time point listed.

Per-protocol Population. Only Subjects with Baseline and Week 16 are included.

ECHOs provide information regarding cardiac structure and function. Left ventricular outflow track (LVOT) dimension was summarized at each time point listed.

Per-protocol Population. Only Subjects with Baseline and Week 16 are included.

ECHOs provide information regarding cardiac structure and function. LVOT velocity time integral was summarized at each time point listed.

Per-protocol Population. Only Subjects with Baseline and Week 16 are included.

ECHOs provide information regarding cardiac structure and function. LV diameter was summarized at each time point listed.

Per-protocol Population. Only Subjects with Baseline and Week 16 are included.

ECHOs provide information regarding cardiac structure and function. LV Eccentricity Index (Diastole) was summarized at each time point listed. Diastole LV Eccentricity Index is measured during ECHOs to assess how much the shape of the LV deviates from normal while the heart is relaxing (full of blood prior to contraction). A lower Diastole LV Eccentricity Index indicates that the LV is closer to a normal shape during diastole. A higher Diastole LV Eccentricity Index indicates that the LV is more elongated/stretched during diastole, indicating potential heart problems. There is no theoretical minimum or maximum value for the index range.

Per-protocol Population. Only Subjects with Baseline and Week 16 are included.

ECHOs provide information regarding cardiac structure and function. LV Eccentricity Index (Systole) was summarized at each time point listed. Systole LV Eccentricity Index is measured during ECHOs to assess how much the shape of the LV deviates from normal while the heart is contracting (pumping blood to the body). A lower Systole LV Eccentricity Index indicates that the LV is closer to a normal shape during systole. A higher Systole LV Eccentricity Index indicates that the LV is more elongated/stretched during systole, indicating potential heart problems. There is no theoretical minimum or maximum value for the index range.

Per-protocol Population. Only Subjects with Baseline and Week 16 are included.

ECHOs provide information regarding cardiac structure and function. Pulmonary valve acceleration time was summarized at each time point listed.=.

Per-protocol Population. Only Subjects with Baseline and Week 16 are included.

ECHOs provide information regarding cardiac structure and function. RV/LV (diastole) ratio was summarized at each time point listed. RV/LV Ratio is the ratio of right ventricular to left ventricular diameter. A normal RV/LV Ratio is 0.6 to 1.0. When the ratio exceeds 1.0 it is indicative of high pulmonary artery pressure or right ventricular hypertrophy.

Per-protocol Population. Only Subjects with Baseline and Week 16 are included.

ECHOs provide information regarding cardiac structure and function. Right atrial area was summarized at each time point listed.

Per-protocol Population. Only Subjects with Baseline and Week 16 are included.

ECHOs provide information regarding cardiac structure and function. RV diameter was summarized at each time point.

Per-protocol Population. Only Subjects with Baseline and Week 16 are included.

ECHOs provide information regarding cardiac structure and function. RV free wall strain was summarized at each time point listed .

Per-protocol Population. Only Subjects with Baseline and Week 16 are included.

ECHOs provide information regarding cardiac structure and function. RV myocardial performance index (MPI) was summarized at each time point listed. RV MPI is a measurement used to assess RV systolic function in patients with PH. MPI correlates with pulmonary arterial pressure. Normal MPI is approximately 0.35. Higher MPI values indicate higher pulmonary arterial pressure.

Per-protocol Population. Only Subjects with Baseline and Week 16 are included.

ECHOs provide information regarding cardiac structure and function. Tricuspid annular plane systolic excursion was summarized at each time point listed.

Per-protocol Population. Only Subjects with Baseline and Week 16 are included.

PAH symptoms included fatigue, dyspnea, lower extremity edema, dizziness, syncope, chest pain, and orthopnea. Symptoms were scored (Grades 0 [none], 1 [mild], 2 [moderate], to 3 [severe]) except for syncope (0 [No], 1 [Infrequent; 1 episode], 2 [Somewhat frequent; 2 to 3 episodes], and 3 [Often; >4 episodes). A lower score was considered "improved"; a higher score was considered "worsened."](streamdown:incomplete-link)

Per-protocol Population. The Count of Participants analyzed in each row differs from the Overall Number of Participants since only subjects with Baseline and Week 16 values were measured and analyzed (ie, contributed data reported in the table).

The Health-related Quality of Life in Pulmonary Hypertension Questionnaire (emPHasis-10) is a 10-question questionnaire used during clinical assessments that measures quality of life by the patients participating in the study. The patients graded their response to each of the 10 health-related questions on a scale of 0 to 5 based on how they were feeling that day. The most favorable score for each question is 0, and the least favorable score for each question is 5. A total score was then summed for each subject based on their responses to the 10 questions. The lower the total score was (best possible total score was 0), the less living with PH was negatively affecting the quality of the patient's life. The higher the total score (worst possible score was 50), the more living with PH was negatively affecting the quality of the patient's life.

Per-protocol Population. Only Subjects with Baseline and Week 16 are included.

The Treatment Satisfaction Questionnaire for Medication (TSQM) is a 14-question questionnaire that measures the level of satisfaction or dissatisfaction patients have with their study medication in 4 areas: effectiveness (3 questions), side effects (5 questions), convenience (3 questions), and global satisfaction (3 questions). With the exception of the first side effects question (a yes or no question), all items have 5 or 7 responses which are scored from 1 (least satisfied) to 5 or 7 (most satisfied). A total score is then summed for each domain on the following scales: effectiveness 1-21, side effects 1-20, convenience 1-21, and global satisfaction 1-17. Lower total scores in each domain indicate dissatisfaction with the study medication and higher total scores indicate satisfaction.

Per-protocol Population. The Count of Participants analyzed in each row differs from the Overall Number of Participants since only subjects with Baseline and Week 16 values were measured and analyzed (ie, contributed data reported in the table).

6MWD low risk: >440 m, intermediate risk: 165-440 m, high risk: <165 m; NT-proBNP low risk: <300 ng/L, intermediate risk: 300-1400 ng/L, high risk: >1400 ng/L; WHO FC: low risk: I or II, intermediate risk: III, high risk: IV; and Right Atrial Area: low risk: <18 cm², intermediate risk: 18-26 cm², high risk: >26 cm². Moving from a higher risk category to a low risk category was considered "improved;" moving from a lower risk category to a higher risk category was considered "worsened."

Per-protocol Population. The Count of Participants analyzed in each row differs from the Overall Number of Participants since only subjects with Baseline and Week 16 values were measured and analyzed (ie, contributed data reported in the table).

Low risk categories for the 4 selected parameters were: 6MWD >440 m, serum NT-proBNP <300 ng/L, WHO FC I or II, and right atrial area <18cm². The rows of the table indicate the count of participants that were in the low risk category for the parameter at Week 16.

Per-protocol Population. The Count of Participants analyzed in each row differs from the Overall Number of Participants since only subjects with Baseline and Week 16 values were measured and analyzed (ie, contributed data reported in the table).

The percentage of subjects that ended the study in achievement Class 1 (either achieved an Orenitram dose of ≥4 mg TID [or TDD of 12 mg] at Week 16 or a dose of ≥0.057 mg/kg TID [or a TDD of 0.171 mg/kg] for subjects <70 kg), Class 2 (achieved a prescribed Orenitram dose ≥2 mg TID and <4 mg TID [or a TDD ≥6 mg and <12 mg] at specific visit, with at least 2 of the following 3 clinical parameters: 6MWD increase by ≥10% or ≥30 m from baseline, serum NT-proBNP reduction >30% from baseline, or WHO FC I or II), or Class 3 (were not Class 1 or Class 2, or with class undetermined).

Per-protocol Population. Only Subjects with Baseline and Week 16 are included.

The percentage of subjects that transitioned to oral treprostinil at any dose and were maintained on therapy at Week 16 (considered a "successful" result).

Per-protocol Population. Only Subjects with Baseline and Week 16 are included.