Registered outcomes15

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 15 of 15

List	Outcome	Time frame	Description
Primary	Change From Baseline in Medical Outcomes Study Short Form 36 (SF-36)	Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) and Week 4 (Visit 3)	Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health), 2 summary scores (physical component and mental component), and a self-evaluated change in health status. Subscale and summary scores range: 0-100. Higher subscale and summary scores was considered as better health status. Change from Baseline was calculated as score at observation minus score at baseline. Baseline was defined as Visit 2 i.e. Day-14 (+ or - 7 days).
Primary	Change From Baseline in Study Specific Participant Acceptance Survey	Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) and Week 4 (Visit 3).	Study-specific questionnaire comprised the pre-defined15 questions which included activities of daily living assessment. Participants rated the question on a scale of 1 to 10, where 1 was do not agree and 10 was strongly agree. Change from Baseline was calculated as score at observation minus score at Baseline. Changes from Baseline was assessed for Questions 2 to 12. Baseline was defined as Visit 2 i.e. Day-14 (+ or - 7 days).
Primary	Change From Baseline in Dose of Thermo Stable Epoprostenol Sodium at Week 4	Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) and Week 4	Dose titration requirement was assessed at the time of discharge. Change from Baseline was calculated as score at observation minus score at Baseline. Units- nanogram per kilogram per minute (ng/kg/min). Baseline was Visit 2 i.e . Day-14 (+ or - 7 days).
Secondary	Number of Participants With Any Treatment Emergent Adverse Events (AEs) and Treatment Emergent Serious Adverse Events(SAEs)	Up to visit 3 (Week 4)	An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. An SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, congenital anomaly/birth defect and medically significant and all events of possible drug-induced liver injury with hyperbilirubinaemia. Only treatment emergent AEs and SAEs were reported in this outcome measure. Specifically, this study reported 2 SAEs, but only 1 was categorized as treatment emergent.
Secondary	Number of Participants With Infusion Site Reactions During Treatment Period	Baseline visit (Visit 2) to Week 4 (Visit 3)	Infusion site reactions were reported during the treatment period. Infusion site was inspected for erythema, excoriation, induration, skin necrosis or signs of local sepsis.
Secondary	Change From Baseline in Vital Signs at Week 4 : Systolic and Diastolic Blood Pressure	Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) and Week 4(Visit 3)	Systolic blood pressure is a measure of blood pressure while the heart is beating. Diastolic blood pressure is a measure of blood pressure while the heart is relaxed. Change from Baseline was calculated as the value at the indicated time points minus the value at Baseline. Baseline was Visit 2 i.e. Day-14 (+ or - 7 days).
Secondary	Change From Baseline in Vital Signs at Week 4: Heart Rate	Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) to Week 4	Summary mean change in heart rate measured in beats per minute (beats/min or BPM). Change from Baseline was calculated as the value at the indicated time points minus the value at Baseline. Baseline was Visit 2 i.e. Day-14 (+ or - 7 days).
Secondary	Number of Participants With Abnormal Clinical Chemistry	Up to 1 week after Week 4 (Follow-up)	Abnormal clinical chemistry was analyzed as follows: serum alanine aminotransferase (ALT/SGPT) \>= 3 x upper limit of normal (ULN) , aspartate aminotransferase (AST/SGOT) \>= 3 x ULN , total bilirubin \>= 34.2, creatinine \>= 176.8.
Secondary	Number of Participants With Abnormal Hematology	Up to 1 week after Week 4 (Follow-up)	Values for hemoglobin, hematocrit, and platelet count were analyzed. Participants with abnormal values have been reported. The low and high value concern were as follows: hemoglobin (Males \< 98, \>180.0) (females \<91, \>161.0)grams per litre (g/L); hematocrit (Males \< 32.0, \>54.0) (females \<29.0, \>50.6) fraction (1); platelet count (\< 100, \> 500) gram international units per litre (gI/L).
Secondary	Number of Participants With Abnormal Urinalysis	Up to 1 week after Week 4 (Follow-up)	Dipstick method was used to measure blood, glucose and protein. Data was analyzed up to 1 week after Week 4 (Follow-up visit).
Secondary	Change From Baseline in Six Minute Walk Distance Test (6MWD) After 4-weeks of Treatment	Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) and Week 4	This assessment was a non-encouraged test that measures the distance walked for a duration of 6 minutes. Change from Baseline was calculated as value at observation minus value at Baseline. Baseline visit was Visit 2 i.e. Day-14 (+ or - 7 days).
Secondary	Breathlessness After 6MWD - Borg Dyspnoea Index (BDI)	Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) to Week 4	The BDI was calculated by using a 10-point scale (0 = None, 10 = Maximum) and indicates the degree of breathlessness after completion of the 6-minute walk test. The BDI scale was assessed by each participant. Change from Baseline = score at observation minus score at Baseline. Baseline visit was Visit 2 i.e. Day-14 (+ or - 7 days).
Secondary	World Health Organization [WHO] Functional Class at Baseline and After 4- Weeks of Treatment	Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) and Week 4	World Health Organization functional class was analyzed as class I, class II, class III and class IV. World Health Organization functional class was analyzed at Baseline (Visit 2 i.e. Day-14 \[+ or - 7 days\]) and Week 4. The classed were defined as Class I: No symptoms of pulmonary arterial hypertension with exercise or at rest, Class II: No symptoms at rest but uncomfortable and short of breath with normal activity, Class III: May not have symptoms at rest but activities greatly limited by shortness of breath, fatigue, or near fainting and Class IV: Symptoms at rest and severe symptoms with any activity. Hence the severity increased from class I (better) to Class IV (worse).
Secondary	Mean Oxygen Saturation in Blood Over Time	up to the treatment follow up (1 week after Visit 3 [Week 4])	Pulse oximetry (oxygen saturation) was analyzed. Data for Pulse oximetry (oxygen saturation) was analyzed up to the treatment follow up (1 week after Visit 3 \[Week 4\]).
Secondary	Number of Participants With Urine Pregnancy Test Positive	up to the treatment follow up (1 week after Visit 3 [Week 4])	Urine samples were collected for urine pregnancy test. Urine samples were collected at up to the treatment follow up (1 week after Visit 3 \[Week 4\]). Number of participants with urine pregnancy test positive has been reported.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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