Extension Study of Efficacy and Safety of LTP001 in Pulmo... | NCT05764265

ID	Type	Description	Link
2022-002007-38	EudraCT Number

Status Module

Description Module

Label	Type	Description	Intervention Names
LTP001	Experimental	Participants received LTP001, 6 mg, orally once daily in the morning for approximately 39 weeks	Drug: LTP001

Name	Type	Description	Arm Group Labels	Other Names
LTP001	Drug	LTP001, 6 mg, was administered orally once daily in the morning	LTP001

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	Incidence and severity of adverse events (AEs) by treatment group, including changes in the vital signs, electrocardiogram and laboratory results qualifying and reported as AEs. Due to the study termination, no patient reached Week 52. At the end of treatment visit, final safety assessments were performed.	Up to approximately 45 weeks

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in Average Cardiac Output (CO) at Week 26	Right heart catheterization (RHC) assessment was performed to assess several hemodynamic variables in pulmonary hypertension, including CO.	Baseline, Week 26
Change From Baseline in Mean Pulmonary Artery (PA) Pressure at Week 26

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Written informed consent must have been obtained before any assessment was performed.
Participant was currently completing the Novartis-sponsored study CLTP001A12201 in PAH and completed key efficacy and safety procedures up to the end of treatment of the core study, without meeting discontinuation criteria in the core study.
Willingness and ability to comply with scheduled visits, treatment plans and any other study procedures.
In the opinion of the Investigator would benefit from LTP001 treatment.

Exclusion Criteria:

History of hypersensitivity to the study treatment.
Sexually active males not committing to condom use precautions: sexually active males must have used a condom during intercourse while taking drug and for 24 hours after stopping study medication and should not father a child in this period nor donate sperm. A condom was required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid.
Required or planned transplant or heart/lung surgery.
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they were using highly effective methods of contraception while taking study treatment and until EOT visit (2 weeks post-last treatment). Highly effective contraception methods included:
Total abstinence (when this was in line with the preferred and usual lifestyle of the participant. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal were not acceptable methods of contraception.
Female sterilization (had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or bilateral tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman had been confirmed by follow up hormone level assessment.
Male sterilization (at least 6 months prior to screening). For female participants on the study, the vasectomized male partner should have been the sole partner for that participant
Use of oral, estrogen and progesterone, injected, or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal hormone contraception.

In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment.

Women were considered post-menopausal if they had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate history of vasomotor symptoms). Women were considered not of child-bearing potential if they were post-menopausal or had surgical bilateral oophorectomy (with or without hysterectomy) or total hysterectomy at least six weeks prior. In the case of oophorectomy alone, only when the reproductive status of the woman had been confirmed by follow up hormone level assessment was she considered not of child bearing potential.

Pregnant or nursing (lactating) women, where pregnancy was defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
Acute or chronic impairment (other than dyspnea), which would limit the ability to comply with study requirements, including interference with physical activity or execution of study procedures such as 6MWT (e.g., angina pectoris, claudication, musculoskeletal disorder, need for walking aids).
Permanent discontinuation of Novartis drug in the core efficacy study due to toxicity or disease progression despite active treatment, non-compliance to study procedures, withdrawal of consent or any other reason.

Facility	Status	City	State	ZIP	Country	Contacts
Pulmonary Associates PA		Mesa	Arizona	85206	United States
Novartis Investigative Site

Label	URL
A Plain Language Trial Summary is available on www.novctrd.com	View source

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	LTP001 6 mg (Actual Treatment in CLTP001A12201)	Participants had received LTP001, 6 mg, in Study CLTP001A12201, and continued to receive LTP001, 6 mg, orally once daily in the morning for approximately 39 weeks in this extension study
FG001	LTP001 6 mg (Placebo in CLTP001A12201)

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jan 30, 2023	Apr 21, 2025

ID	Title	Description
BG000	LTP001 6 mg (Actual Treatment in CLTP001A12201)	Participants had received LTP001, 6 mg, in Study CLTP001A12201, and continued to receive LTP001, 6 mg, orally once daily in the morning for approximately 39 weeks in this extension study
BG001	LTP001 6 mg (Placebo in CLTP001A12201)	Participants had received placebo in Study CLTP001A12201, followed by LTP001, 6 mg, orally once daily in the morning for approximately 39 weeks in this extension study
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00023 BG0018 BG00231

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Incidence and severity of adverse events (AEs) by treatment group, including changes in the vital signs, electrocardiogram and laboratory results qualifying and reported as AEs. Due to the study termination, no patient reached Week 52. At the end of treatment visit, final safety assessments were performed.

The safety analysis set included all participants who received any study treatment.

Posted

Number

Percentage of participants

Up to approximately 45 weeks

ID	Title	Description
OG000	LTP001 6 mg (Actual Treatment in CLTP001A12201)	Participants had received LTP001, 6 mg, in Study CLTP001A12201, and continued to receive LTP001, 6 mg, orally once daily in the morning for approximately 39 weeks in this extension study
OG001	LTP001 6 mg (Placebo in CLTP001A12201)	Participants had received placebo in Study CLTP001A12201, followed by LTP001, 6 mg, orally once daily in the morning for approximately 39 weeks in this extension study

Units	Counts
Participants	OG00023 OG0018

Title

Denominators

Categories

AEs

Title	Measurements
	OG00052.2 OG00162.5

Serious AEs

Title	Measurements
	OG000

Secondary

Change From Baseline in Average Cardiac Output (CO) at Week 26

Right heart catheterization (RHC) assessment was performed to assess several hemodynamic variables in pulmonary hypertension, including CO.

The pharmacodynamic (PD) analysis set included all participants who received study treatment and had no protocol deviations with a relevant impact on PD data.

Posted

Mean

Standard Deviation

liters per minute

Baseline, Week 26

ID	Title	Description
OG000	LTP001 6 mg (Actual Treatment in CLTP001A12201)	Participants had received LTP001, 6 mg, in Study CLTP001A12201, and continued to receive LTP001, 6 mg, orally once daily in the morning for approximately 39 weeks in this extension study
OG001	LTP001 6 mg (Placebo in CLTP001A12201)	Participants had received placebo in Study CLTP001A12201, followed by LTP001, 6 mg, orally once daily in the morning for approximately 39 weeks in this extension study

Units	Counts
Participants

Secondary

Change From Baseline in Mean Pulmonary Artery (PA) Pressure at Week 26

Right heart catheterization (RHC) assessment was performed to assess several hemodynamic variables in pulmonary hypertension, including PA pressure.

The pharmacodynamic (PD) analysis set included all participants who received study treatment and had no protocol deviations with a relevant impact on PD data.

Posted

Mean

Standard Deviation

mmHg

Baseline, Week 26

ID	Title	Description
OG000	LTP001 6 mg (Actual Treatment in CLTP001A12201)	Participants had received LTP001, 6 mg, in Study CLTP001A12201, and continued to receive LTP001, 6 mg, orally once daily in the morning for approximately 39 weeks in this extension study
OG001	LTP001 6 mg (Placebo in CLTP001A12201)	Participants had received placebo in Study CLTP001A12201, followed by LTP001, 6 mg, orally once daily in the morning for approximately 39 weeks in this extension study

Units	Counts
Participants

Secondary

Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at Week 26

Right heart catheterization (RHC) assessment was performed to assess several hemodynamic variables in pulmonary hypertension, including pulmonary capillary wedge pressure (PCWP).

The pharmacodynamic (PD) analysis set included all participants who received study treatment and had no protocol deviations with a relevant impact on PD data.

Posted

Mean

Standard Deviation

mmHg

Baseline, Week 26

ID	Title	Description
OG000	LTP001 6 mg (Actual Treatment in CLTP001A12201)	Participants had received LTP001, 6 mg, in Study CLTP001A12201, and continued to receive LTP001, 6 mg, orally once daily in the morning for approximately 39 weeks in this extension study
OG001	LTP001 6 mg (Placebo in CLTP001A12201)	Participants had received placebo in Study CLTP001A12201, followed by LTP001, 6 mg, orally once daily in the morning for approximately 39 weeks in this extension study

Units	Counts
Participants

Secondary

Change From Baseline in Right Heart Catheterization Pulmonary Vascular Resistance (PVR) at Week 26

PVR was defined as the resistance against blood flow from the pulmonary artery to the left atrium measured in dynes.sec.cm-5.

The pharmacodynamic (PD) analysis set included all participants who received study treatment and had no protocol deviations with a relevant impact on PD data.

Posted

Mean

Standard Deviation

dynes.sec.cm-5

Baseline, Week 26

ID	Title	Description
OG000	LTP001 6 mg (Actual Treatment in CLTP001A12201)	Participants had received LTP001, 6 mg, in Study CLTP001A12201, and continued to receive LTP001, 6 mg, orally once daily in the morning for approximately 39 weeks in this extension study
OG001	LTP001 6 mg (Placebo in CLTP001A12201)	Participants had received placebo in Study CLTP001A12201, followed by LTP001, 6 mg, orally once daily in the morning for approximately 39 weeks in this extension study

Units	Counts
Participants

Secondary

Change From Baseline in Right Atrium (RA) Pressures at Week 26

The Right Heart Catheterization (RHC) assessment was performed to assess several hemodynamic variables in pulmonary hypertension, including RA pressures.

The pharmacodynamic (PD) analysis set included all participants who received study treatment and had no protocol deviations with a relevant impact on PD data.

Posted

Mean

Standard Deviation

mmHg

Baseline, Week 26

ID	Title	Description
OG000	LTP001 6 mg (Actual Treatment in CLTP001A12201)	Participants had received LTP001, 6 mg, in Study CLTP001A12201, and continued to receive LTP001, 6 mg, orally once daily in the morning for approximately 39 weeks in this extension study
OG001	LTP001 6 mg (Placebo in CLTP001A12201)	Participants had received placebo in Study CLTP001A12201, followed by LTP001, 6 mg, orally once daily in the morning for approximately 39 weeks in this extension study

Units	Counts
Participants

Secondary

Change From Baseline in Systemic Vascular Resistance (SVR) at Week 26

The Right Heart Catheterization (RHC) assessment was performed to assess several hemodynamic variables in pulmonary hypertension, including SVR.

The pharmacodynamic (PD) analysis set included all participants who received study treatment and had no protocol deviations with a relevant impact on PD data.

Posted

Mean

Standard Deviation

dynes.sec.cm-5

Baseline, Week 26

ID	Title	Description
OG000	LTP001 6 mg (Actual Treatment in CLTP001A12201)	Participants had received LTP001, 6 mg, in Study CLTP001A12201, and continued to receive LTP001, 6 mg, orally once daily in the morning for approximately 39 weeks in this extension study
OG001	LTP001 6 mg (Placebo in CLTP001A12201)	Participants had received placebo in Study CLTP001A12201, followed by LTP001, 6 mg, orally once daily in the morning for approximately 39 weeks in this extension study

Units	Counts
Participants

Secondary

Change From Baseline in Six Minute Walk Distance (6MWD)

6MWD test measures the distance that a participant can walk on a flat, hard surface in a period of 6 minutes. Due to the study termination, no patient reached Week 52. At the end of treatment (EOT) visit, final safety assessments were performed based on investigator judgement and patient willingness to undergo procedures.

The pharmacodynamic (PD) analysis set included all participants who received study treatment and had no protocol deviations with a relevant impact on PD data.

Posted

Mean

Standard Deviation

meters

Baseline, Week 26, up to 39 weeks (EOT)

ID	Title	Description
OG000	LTP001 6 mg (Actual Treatment in CLTP001A12201)	Participants had received LTP001, 6 mg, in Study CLTP001A12201, and continued to receive LTP001, 6 mg, orally once daily in the morning for approximately 39 weeks in this extension study
OG001	LTP001 6 mg (Placebo in CLTP001A12201)	Participants had received placebo in Study CLTP001A12201, followed by LTP001, 6 mg, orally once daily in the morning for approximately 39 weeks in this extension study

Units	Counts
Participants

Secondary

Change From Baseline in Tricuspid Annular Plane Systolic Excursion (TAPSE)

Key right ventricular (RV) function endpoints such as tricuspid annular plane systolic excursion (TAPSE) were assessed with echocardiography. Due to the study termination, no patient reached Week 52. At the end of treatment (EOT) visit, final safety assessments were performed based on investigator judgement and patient willingness to undergo procedures. Only a minimal number of patients completed an echocardiogram (Echo).

The pharmacodynamic (PD) analysis set included all participants who received study treatment and had no protocol deviations with a relevant impact on PD data. Number analyzed is the number of participants with data available at the specified time points.

Posted

Mean

Standard Deviation

centimeters

Baseline, Week 26, up to 39 weeks (EOT)

ID	Title	Description
OG000	LTP001 6 mg (Actual Treatment in CLTP001A12201)	Participants had received LTP001, 6 mg, in Study CLTP001A12201, and continued to receive LTP001, 6 mg, orally once daily in the morning for approximately 39 weeks in this extension study
OG001	LTP001 6 mg (Placebo in CLTP001A12201)	Participants had received placebo in Study CLTP001A12201, followed by LTP001, 6 mg, orally once daily in the morning for approximately 39 weeks in this extension study

Secondary

Change From Baseline in Tricuspid Annular Plane Systolic Velocity (TASV)

Key right ventricular (RV) function endpoints such as tricuspid annular systolic velocity (TASV) were assessed with echocardiography. Due to the study termination, no patient reached Week 52. At the end of treatment (EOT) visit, final safety assessments were performed based on investigator judgement and patient willingness to undergo procedures. Only a minimal number of patients completed an echocardiogram (Echo).

Posted

Mean

Standard Deviation

centimeters per second

Baseline, Week 26, up to 39 weeks (EOT)

ID	Title	Description
OG000	LTP001 6 mg (Actual Treatment in CLTP001A12201)	Participants had received LTP001, 6 mg, in Study CLTP001A12201, and continued to receive LTP001, 6 mg, orally once daily in the morning for approximately 39 weeks in this extension study
OG001	LTP001 6 mg (Placebo in CLTP001A12201)	Participants had received placebo in Study CLTP001A12201, followed by LTP001, 6 mg, orally once daily in the morning for approximately 39 weeks in this extension study

Secondary

Change From Baseline in Peak Velocity of Excursion (RV S')

Key right ventricular (RV) function per echocardiography. The terms Tricuspid Annular Systolic Velocity (TASV) and Peak Velocity of Excursion (RV S') are synonymous in echocardiography to describe the peak systolic velocity of the lateral tricuspid annulus. Including both TASV and RV S' as separate secondary endpoints was an oversight in the protocol as the data, calculation, and analyses for both (TASV and RV S') are identical. Therefore, the TASV and RV S' data in this results disclosure are the same. Due to the study termination, no patient reached Week 52. At the end of treatment (EOT) visit, final safety assessments were performed based on investigator judgement and patient willingness to undergo procedures. Only a minimal number of patients completed an echocardiogram (Echo).

Posted

Mean

Standard Deviation

centimeters per second

Baseline, Week 26, up to 39 weeks (EOT)

ID	Title	Description
OG000	LTP001 6 mg (Actual Treatment in CLTP001A12201)	Participants had received LTP001, 6 mg, in Study CLTP001A12201, and continued to receive LTP001, 6 mg, orally once daily in the morning for approximately 39 weeks in this extension study
OG001	LTP001 6 mg (Placebo in CLTP001A12201)

Secondary

Change From Baseline in Fractional Area Change (FAC)

Key right ventricular (RV) function endpoints such as RV fractional area change (RV FAC) were assessed with echocardiography. Due to the study termination, no patient reached Week 52. At the end of treatment (EOT) visit, final safety assessments were performed based on investigator judgement and patient willingness to undergo procedures. Only a minimal number of patients completed an echocardiogram (Echo).

Posted

Mean

Standard Deviation

percent

Baseline, Week 26, up to 39 weeks (EOT)

ID	Title	Description
OG000	LTP001 6 mg (Actual Treatment in CLTP001A12201)	Participants had received LTP001, 6 mg, in Study CLTP001A12201, and continued to receive LTP001, 6 mg, orally once daily in the morning for approximately 39 weeks in this extension study
OG001	LTP001 6 mg (Placebo in CLTP001A12201)	Participants had received placebo in Study CLTP001A12201, followed by LTP001, 6 mg, orally once daily in the morning for approximately 39 weeks in this extension study

Secondary

Change From Baseline in Quality of Life Measured by the emPHasis-10 Questionnaire

emPHasis-10 is a questionnaire with 10 questions designed to determine how pulmonary hypertension affects a participant's life. Each item is scored on a scale of 0 to 5, with a total score ranging from 0 to 50. A higher score indicates worse quality of life. Due to the study termination, no patient reached Week 52. At the end of treatment (EOT) visit, final safety assessments were performed based on investigator judgement and patient willingness to undergo procedures.

The pharmacodynamic (PD) analysis set included all participants who received study treatment and had no protocol deviations with a relevant impact on PD data.

Posted

Mean

Standard Deviation

score

Baseline up to 39 weeks (EOT)

ID	Title	Description
OG000	LTP001 6 mg (Actual Treatment in CLTP001A12201)	Participants had received LTP001, 6 mg, in Study CLTP001A12201, and continued to receive LTP001, 6 mg, orally once daily in the morning for approximately 39 weeks in this extension study
OG001	LTP001 6 mg (Placebo in CLTP001A12201)	Participants had received placebo in Study CLTP001A12201, followed by LTP001, 6 mg, orally once daily in the morning for approximately 39 weeks in this extension study

Secondary

Change From Baseline in Quality of Life Measured by the PAH-SYMPACT Questionnaire

PAH-SYMPACT is a questionnaire used to assess pulmonary arterial hypertension symptoms and their impact. Individual item scores range from 0 to 4. Total score is calculated as the sum of the scores for the individual items divided by the number of items. A higher score indicates more severe symptoms/impacts. Due to the study termination, no patient reached Week 52. At the end of treatment (EOT) visit, final safety assessments were performed based on investigator judgement and patient willingness to undergo procedures.

The pharmacodynamic (PD) analysis set included all participants who received study treatment and had no protocol deviations with a relevant impact on PD data.

Posted

Mean

Standard Deviation

score

Baseline up to 39 weeks (EOT)

ID	Title	Description
OG000	LTP001 6 mg (Actual Treatment in CLTP001A12201)	Participants had received LTP001, 6 mg, in Study CLTP001A12201, and continued to receive LTP001, 6 mg, orally once daily in the morning for approximately 39 weeks in this extension study
OG001	LTP001 6 mg (Placebo in CLTP001A12201)	Participants had received placebo in Study CLTP001A12201, followed by LTP001, 6 mg, orally once daily in the morning for approximately 39 weeks in this extension study

Secondary

Time to Clinical Worsening

Time to any of the following:

Death
Hospital stay greater than 24 hours due to worsening of pulmonary arterial hypertension
Worsening of PAH resulting in need for lung transplantation or balloon atrial septostomy
Initiation of parenteral prostanoid therapy, initiation of oxygen therapy, initiation of any other pulmonary arterial hypertension-specific therapies or need for increase of diuretics for more than 4 weeks due to worsening of pulmonary arterial hypertension
Significant drop in six-minute walk distance Due to the study termination, no patient reached Week 52. At the end of treatment (EOT) visit, final safety assessments were performed based on investigator judgement and patient willingness to undergo procedures.

Posted

Median

95% Confidence Interval

days

Baseline up to 39 weeks (EOT)

ID	Title	Description
OG000	LTP001 6 mg (Actual Treatment in CLTP001A12201)	Participants had received LTP001, 6 mg, in Study CLTP001A12201, and continued to receive LTP001, 6 mg, orally once daily in the morning for approximately 39 weeks in this extension study
OG001	LTP001 6 mg (Placebo in CLTP001A12201)	Participants had received placebo in Study CLTP001A12201, followed by LTP001, 6 mg, orally once daily in the morning for approximately 39 weeks in this extension study

Secondary

Change From Baseline in N-terminal Fragment of the Prohormone B-type Natriuretic Peptide (NT-ProBNP)

NT-proBNP is a blood biomarker to assess right ventricular distress. Due to the study termination, no patient reached Week 52. At the end of treatment (EOT) visit, final safety assessments were performed based on investigator judgement and patient willingness to undergo procedures.

The pharmacodynamic (PD) analysis set included all participants who received study treatment and had no protocol deviations with a relevant impact on PD data.

Posted

Mean

Standard Deviation

picomoles per liter

Baseline up to 39 weeks (EOT)

ID	Title	Description
OG000	LTP001 6 mg (Actual Treatment in CLTP001A12201)	Participants had received LTP001, 6 mg, in Study CLTP001A12201, and continued to receive LTP001, 6 mg, orally once daily in the morning for approximately 39 weeks in this extension study
OG001	LTP001 6 mg (Placebo in CLTP001A12201)	Participants had received placebo in Study CLTP001A12201, followed by LTP001, 6 mg, orally once daily in the morning for approximately 39 weeks in this extension study

Units	Counts

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected23 at risk EG0011 affected8 at risk EG0021 affected31 at risk
Eczema eyelids	Eye disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected23 at risk EG0011 affected8 at risk EG0021 affected31 at risk
Fatigue	General disorders and administration site conditions	MedDRA (27.0)	Systematic Assessment	EG0000 affected23 at risk EG0011 affected8 at risk EG0021 affected31 at risk
Bartholinitis	Infections and infestations	MedDRA (27.0)	Systematic Assessment	EG0000 affected23 at risk EG0011 affected8 at risk EG0021 affected31 at risk
Bronchitis	Infections and infestations	MedDRA (27.0)	Systematic Assessment	EG0000 affected23 at risk EG0011 affected8 at risk EG0021 affected31 at risk
Nasopharyngitis	Infections and infestations	MedDRA (27.0)	Systematic Assessment	EG0002 affected23 at risk EG0011 affected8 at risk EG0023 affected31 at risk
Tooth abscess	Infections and infestations	MedDRA (27.0)	Systematic Assessment	EG0000 affected23 at risk EG0011 affected8 at risk EG0021 affected31 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (27.0)	Systematic Assessment	EG0002 affected23 at risk EG0010 affected8 at risk EG0022 affected31 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected23 at risk EG0011 affected8 at risk EG0021 affected31 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected23 at risk EG0011 affected8 at risk EG0021 affected31 at risk
Dizziness	Nervous system disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected23 at risk EG0011 affected8 at risk EG0021 affected31 at risk
Headache	Nervous system disorders	MedDRA (27.0)	Systematic Assessment	EG0001 affected23 at risk EG0011 affected8 at risk EG0022 affected31 at risk
Insomnia	Psychiatric disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected23 at risk EG0011 affected8 at risk EG0021 affected31 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (27.0)	Systematic Assessment	EG0000 affected23 at risk EG0011 affected8 at risk EG0021 affected31 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (27.0)	Systematic Assessment	EG0002 affected23 at risk EG0010 affected8 at risk EG0022 affected31 at risk

ID	Term
D000081029	Pulmonary Arterial Hypertension
D006976	Hypertension, Pulmonary

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D006973	Hypertension
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	LTP001 6 mg (Actual Treatment in CLTP001A12201)	Participants had received LTP001, 6 mg, in Study CLTP001A12201, and continued to receive LTP001, 6 mg, orally once daily in the morning for approximately 39 weeks in this extension study	23	4	23	5	23
EG001	LTP001 6 mg (Placebo in CLTP001A12201)	Participants had received placebo in Study CLTP001A12201, followed by LTP001, 6 mg, orally once daily in the morning for approximately 39 weeks in this extension study	8	0	8	5	8
EG002	Total	Total	31	4	31	10	31

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Medical device site haemorrhage	General disorders and administration site conditions	MedDRA (27.0)	Systematic Assessment	EG0001 affected23 at risk EG0010 affected8 at risk EG0021 affected31 at risk
Device related infection	Infections and infestations	MedDRA (27.0)	Systematic Assessment	EG0001 affected23 at risk EG0010 affected8 at risk EG0021 affected31 at risk
Disseminated gonococcal infection	Infections and infestations	MedDRA (27.0)	Systematic Assessment	EG0001 affected23 at risk EG0010 affected8 at risk EG0021 affected31 at risk
Pulmonary arterial hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA (27.0)	Systematic Assessment	EG0002 affected23 at risk EG0010 affected8 at risk EG0022 affected31 at risk