Trial Outcomes & Findings for Study of a New Thermo Stable Formulation of Epoprostenol Sodium to Treat Pulmonary Arterial Hypertension (PAH) (NCT NCT01462565)

NCT ID: NCT01462565

Last Updated: 2017-10-16

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 16 participants
• Primary outcome timeframe: Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) and Week 4 (Visit 3)
• Results posted on: 2017-10-16

Participant Flow

A total of 17 participants were recruited from 23 November 2011 to 16 May 2012, out of which 16 participants entered the treatment phase. Study was conducted across 5 centres in the United States, 1 centre in Canada and 1 centre in the Netherlands.

There was a 4-week run-in period during which 1 participant was assessed to be a screen failure at the Baseline Visit (Visit 2) due to the participant self-titrating their epoprostenol sodium. During the 4-week run-in period, participants received currently marketed epoprostenol sodium.

Participant milestones

Measure	Epoprostenol Sodium for Injection Participants received new thermo stable 100 milliliter (mL) formulation of epoprostenol sodium via intravenous infusion each day for 4-week treatment period.
Overall Study STARTED	16
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of a New Thermo Stable Formulation of Epoprostenol Sodium to Treat Pulmonary Arterial Hypertension (PAH)

Baseline characteristics by cohort

Measure	Epoprostenol Sodium for Injection n=16 Participants Participants received new thermo stable 100 mL formulation of epoprostenol sodium via intravenous infusion each day for 4-week treatment period.
Age, Continuous	50.0 Years STANDARD_DEVIATION 13.37 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) and Week 4 (Visit 3)

Population: Intent-to-Treat (ITT) population consisted of all participants who received at least one dose of epoprostenol sodium during the Run-in period (either currently marketed epoprostenol sodium or the study drug).

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).

Outcome measures

Measure	Epoprostenol Sodium for Injection n=16 Participants Participants received new thermo stable 100 mL formulation of epoprostenol sodium via intravenous infusion each day for 4-week treatment period.
Change From Baseline in Medical Outcomes Study Short Form 36 (SF-36) Vitality	0.781 Score on a scale Standard Deviation 7.1636
Change From Baseline in Medical Outcomes Study Short Form 36 (SF-36) Physical Functioning	-1.156 Score on a scale Standard Deviation 3.6593
Change From Baseline in Medical Outcomes Study Short Form 36 (SF-36) Role-Physical	-0.765 Score on a scale Standard Deviation 6.3050
Change From Baseline in Medical Outcomes Study Short Form 36 (SF-36) Role-Emotional	0.002 Score on a scale Standard Deviation 11.1773
Change From Baseline in Medical Outcomes Study Short Form 36 (SF-36) Mental Health	0.883 Score on a scale Standard Deviation 7.6063
Change From Baseline in Medical Outcomes Study Short Form 36 (SF-36) Social Functioning	1.706 Score on a scale Standard Deviation 7.1043
Change From Baseline in Medical Outcomes Study Short Form 36 (SF-36) Bodily Pain	3.065 Score on a scale Standard Deviation 5.8291
Change From Baseline in Medical Outcomes Study Short Form 36 (SF-36) General Health	-0.606 Score on a scale Standard Deviation 5.6068
Change From Baseline in Medical Outcomes Study Short Form 36 (SF-36) Physical Health Component	-0.123 Score on a scale Standard Deviation 4.2876
Change From Baseline in Medical Outcomes Study Short Form 36 (SF-36) Mental Health Component	1.141 Score on a scale Standard Deviation 6.5078

PRIMARY outcome

Timeframe: Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) and Week 4 (Visit 3).

Population: ITT population.

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).

Outcome measures

Measure	Epoprostenol Sodium for Injection n=16 Participants Participants received new thermo stable 100 mL formulation of epoprostenol sodium via intravenous infusion each day for 4-week treatment period.
Change From Baseline in Study Specific Participant Acceptance Survey Q5- ability to participate in social activities	-0.9 Score on a scale Standard Deviation 1.88
Change From Baseline in Study Specific Participant Acceptance Survey Q9- interested physical activity	-0.1 Score on a scale Standard Deviation 2.53
Change From Baseline in Study Specific Participant Acceptance Survey Q2- ability to perform physical activities	-0.9 Score on a scale Standard Deviation 2.29
Change From Baseline in Study Specific Participant Acceptance Survey Q3- ability to perform your basic daily activies	-1.5 Score on a scale Standard Deviation 1.86
Change From Baseline in Study Specific Participant Acceptance Survey Q10- feel physically restricted from participating	0.1 Score on a scale Standard Deviation 2.73
Change From Baseline in Study Specific Participant Acceptance Survey Q4- ability to perform activities with your family	-0.8 Score on a scale Standard Deviation 2.37
Change From Baseline in Study Specific Participant Acceptance Survey Q6- ability to comply with your Flolan treatment	0.3 Score on a scale Standard Deviation 3.34
Change From Baseline in Study Specific Participant Acceptance Survey Q7- ability to perform new activity(Jogging, walk)	0.4 Score on a scale Standard Deviation 2.00
Change From Baseline in Study Specific Participant Acceptance Survey Q8- overall satisfaction	0.4 Score on a scale Standard Deviation 1.09
Change From Baseline in Study Specific Participant Acceptance Survey Q11- confident in my ability to do new activity	0.6 Score on a scale Standard Deviation 2.50
Change From Baseline in Study Specific Participant Acceptance Survey Q12- treatment regimen constantly weighs on mind	-0.6 Score on a scale Standard Deviation 1.75

PRIMARY outcome

Timeframe: Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) and Week 4

Population: ITT population.

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).

Outcome measures

Measure	Epoprostenol Sodium for Injection n=16 Participants Participants received new thermo stable 100 mL formulation of epoprostenol sodium via intravenous infusion each day for 4-week treatment period.
Change From Baseline in Dose of Thermo Stable Epoprostenol Sodium at Week 4	0.22 ng/kg/min Standard Deviation 1.169

SECONDARY outcome

Timeframe: Up to visit 3 (Week 4)

Population: ITT population.

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.

Outcome measures

Measure	Epoprostenol Sodium for Injection n=16 Participants Participants received new thermo stable 100 mL formulation of epoprostenol sodium via intravenous infusion each day for 4-week treatment period.
Number of Participants With Any Treatment Emergent Adverse Events (AEs) and Treatment Emergent Serious Adverse Events(SAEs) Any AEs	9 Participants
Number of Participants With Any Treatment Emergent Adverse Events (AEs) and Treatment Emergent Serious Adverse Events(SAEs) Any SAEs	1 Participants

SECONDARY outcome

Timeframe: Baseline visit (Visit 2) to Week 4 (Visit 3)

Population: ITT population.

Infusion site reactions were reported during the treatment period. Infusion site was inspected for erythema, excoriation, induration, skin necrosis or signs of local sepsis.

Outcome measures

Measure	Epoprostenol Sodium for Injection n=16 Participants Participants received new thermo stable 100 mL formulation of epoprostenol sodium via intravenous infusion each day for 4-week treatment period.
Number of Participants With Infusion Site Reactions During Treatment Period Erythema	1 Participants
Number of Participants With Infusion Site Reactions During Treatment Period Signs of local sepsis	1 Participants
Number of Participants With Infusion Site Reactions During Treatment Period Other	1 Participants

SECONDARY outcome

Timeframe: Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) and Week 4(Visit 3)

Population: ITT population.

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).

Outcome measures

Measure	Epoprostenol Sodium for Injection n=16 Participants Participants received new thermo stable 100 mL formulation of epoprostenol sodium via intravenous infusion each day for 4-week treatment period.
Change From Baseline in Vital Signs at Week 4 : Systolic and Diastolic Blood Pressure Systolic blood pressure	-0.4 Millimeter of mercury (mmHg) Standard Deviation 11.47
Change From Baseline in Vital Signs at Week 4 : Systolic and Diastolic Blood Pressure Diastolic blood pressure	0.4 Millimeter of mercury (mmHg) Standard Deviation 10.99

SECONDARY outcome

Timeframe: Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) to Week 4

Population: ITT population.

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).

Outcome measures

Measure	Epoprostenol Sodium for Injection n=16 Participants Participants received new thermo stable 100 mL formulation of epoprostenol sodium via intravenous infusion each day for 4-week treatment period.
Change From Baseline in Vital Signs at Week 4: Heart Rate	-1.7 beats/min Standard Deviation 8.52

SECONDARY outcome

Timeframe: Up to 1 week after Week 4 (Follow-up)

Population: ITT population.

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.

Outcome measures

Measure	Epoprostenol Sodium for Injection n=16 Participants Participants received new thermo stable 100 mL formulation of epoprostenol sodium via intravenous infusion each day for 4-week treatment period.
Number of Participants With Abnormal Clinical Chemistry	0 Participants

SECONDARY outcome

Timeframe: Up to 1 week after Week 4 (Follow-up)

Population: ITT population. Only those participant available at the indicated time points were analyzed.

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).

Outcome measures

Measure	Epoprostenol Sodium for Injection n=16 Participants Participants received new thermo stable 100 mL formulation of epoprostenol sodium via intravenous infusion each day for 4-week treatment period.
Number of Participants With Abnormal Hematology Platelet count (GI/L): Screening: Low	5 Participants
Number of Participants With Abnormal Hematology Hemoglobin (G/L) : Week 4: high	1 Participants
Number of Participants With Abnormal Hematology Hematocrit (1): Screening: Low	14 Participants
Number of Participants With Abnormal Hematology Hematocrit (1): Baseline: Low	15 Participants
Number of Participants With Abnormal Hematology Hematocrit (1): Week 4: Low	15 Participants
Number of Participants With Abnormal Hematology Hematocrit (1): Follow-up: Low	1 Participants
Number of Participants With Abnormal Hematology Platelet count (GI/L): Baseline: Low	2 Participants
Number of Participants With Abnormal Hematology Platelet count (GI/L): Week 4: Low	1 Participants
Number of Participants With Abnormal Hematology Platelet count (GI/L): Follow up: Low	1 Participants

SECONDARY outcome

Timeframe: Up to 1 week after Week 4 (Follow-up)

Population: ITT population.

Dipstick method was used to measure blood, glucose and protein. Data was analyzed up to 1 week after Week 4 (Follow-up visit).

Outcome measures

Measure	Epoprostenol Sodium for Injection n=16 Participants Participants received new thermo stable 100 mL formulation of epoprostenol sodium via intravenous infusion each day for 4-week treatment period.
Number of Participants With Abnormal Urinalysis	0 Participants

SECONDARY outcome

Timeframe: Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) and Week 4

Population: ITT population.

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).

Outcome measures

Measure	Epoprostenol Sodium for Injection n=16 Participants Participants received new thermo stable 100 mL formulation of epoprostenol sodium via intravenous infusion each day for 4-week treatment period.
Change From Baseline in Six Minute Walk Distance Test (6MWD) After 4-weeks of Treatment	-3.55 meters Standard Deviation 45.321

SECONDARY outcome

Timeframe: Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) to Week 4

Population: ITT population.

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).

Outcome measures

Measure	Epoprostenol Sodium for Injection n=16 Participants Participants received new thermo stable 100 mL formulation of epoprostenol sodium via intravenous infusion each day for 4-week treatment period.
Breathlessness After 6MWD - Borg Dyspnoea Index (BDI)	0.36 Score on a scale Standard Deviation 0.535

SECONDARY outcome

Timeframe: Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) and Week 4

Population: ITT population. Only those participants with data available at the specified time point were analyzed.

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).

Outcome measures

Measure	Epoprostenol Sodium for Injection n=16 Participants Participants received new thermo stable 100 mL formulation of epoprostenol sodium via intravenous infusion each day for 4-week treatment period.
World Health Organization [WHO] Functional Class at Baseline and After 4- Weeks of Treatment Baseline WHO Class I	2 Participants
World Health Organization [WHO] Functional Class at Baseline and After 4- Weeks of Treatment Baseline WHO Class II	9 Participants
World Health Organization [WHO] Functional Class at Baseline and After 4- Weeks of Treatment Baseline WHO Class III	4 Participants
World Health Organization [WHO] Functional Class at Baseline and After 4- Weeks of Treatment Baseline WHO Class IV	0 Participants
World Health Organization [WHO] Functional Class at Baseline and After 4- Weeks of Treatment Week 4 Class I	2 Participants
World Health Organization [WHO] Functional Class at Baseline and After 4- Weeks of Treatment Week 4 Class II	10 Participants
World Health Organization [WHO] Functional Class at Baseline and After 4- Weeks of Treatment Week 4 Class III	4 Participants
World Health Organization [WHO] Functional Class at Baseline and After 4- Weeks of Treatment Week 4 Class IV	0 Participants

SECONDARY outcome

Timeframe: up to the treatment follow up (1 week after Visit 3 [Week 4])

Population: ITT population. Only those participant available at the indicated time points were analyzed.

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]).

Outcome measures

Measure	Epoprostenol Sodium for Injection n=16 Participants Participants received new thermo stable 100 mL formulation of epoprostenol sodium via intravenous infusion each day for 4-week treatment period.
Mean Oxygen Saturation in Blood Over Time Baseline	94.3 Percentage of oxygen in blood Standard Deviation 1.95
Mean Oxygen Saturation in Blood Over Time Week 4	94.5 Percentage of oxygen in blood Standard Deviation 2.58
Mean Oxygen Saturation in Blood Over Time Follow-up (1 week after Week 4)	93.0 Percentage of oxygen in blood Standard Deviation NA Data for only 1 participant was analyzed.

SECONDARY outcome

Timeframe: up to the treatment follow up (1 week after Visit 3 [Week 4])

Population: ITT population. Only those participants with data available at the indicated time point were analyzed.

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.

Outcome measures

Measure	Epoprostenol Sodium for Injection n=12 Participants Participants received new thermo stable 100 mL formulation of epoprostenol sodium via intravenous infusion each day for 4-week treatment period.
Number of Participants With Urine Pregnancy Test Positive	0 Participants

Adverse Events

Epoprostenol Sodium for Injection

Serious events: 2 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Measure	Epoprostenol Sodium for Injection n=16 participants at risk Participants received new thermo stable 100 mL formulation of epoprostenol sodium via intravenous infusion each day for 4-week treatment period.
Infections and infestations Device related infection	12.5% 2/16 • Up to 1 week after Week 4 (Follow-up) for SAEs and Up to Visit 3 (Week 4) for non-serious adverse events. ITT population was used for the analysis of AEs and SAEs.
General disorders Catheter site haemorrhage	6.2% 1/16 • Up to 1 week after Week 4 (Follow-up) for SAEs and Up to Visit 3 (Week 4) for non-serious adverse events. ITT population was used for the analysis of AEs and SAEs.

Other adverse events

Measure	Epoprostenol Sodium for Injection n=16 participants at risk Participants received new thermo stable 100 mL formulation of epoprostenol sodium via intravenous infusion each day for 4-week treatment period.
Gastrointestinal disorders Diarrhoea	12.5% 2/16 • Up to 1 week after Week 4 (Follow-up) for SAEs and Up to Visit 3 (Week 4) for non-serious adverse events. ITT population was used for the analysis of AEs and SAEs.
Gastrointestinal disorders Nausea	12.5% 2/16 • Up to 1 week after Week 4 (Follow-up) for SAEs and Up to Visit 3 (Week 4) for non-serious adverse events. ITT population was used for the analysis of AEs and SAEs.
Gastrointestinal disorders Paraesthesia oral	6.2% 1/16 • Up to 1 week after Week 4 (Follow-up) for SAEs and Up to Visit 3 (Week 4) for non-serious adverse events. ITT population was used for the analysis of AEs and SAEs.
General disorders Fatigue	12.5% 2/16 • Up to 1 week after Week 4 (Follow-up) for SAEs and Up to Visit 3 (Week 4) for non-serious adverse events. ITT population was used for the analysis of AEs and SAEs.
Gastrointestinal disorders Ascites	6.2% 1/16 • Up to 1 week after Week 4 (Follow-up) for SAEs and Up to Visit 3 (Week 4) for non-serious adverse events. ITT population was used for the analysis of AEs and SAEs.
General disorders Oedema peripheral	6.2% 1/16 • Up to 1 week after Week 4 (Follow-up) for SAEs and Up to Visit 3 (Week 4) for non-serious adverse events. ITT population was used for the analysis of AEs and SAEs.
Musculoskeletal and connective tissue disorders Back pain	6.2% 1/16 • Up to 1 week after Week 4 (Follow-up) for SAEs and Up to Visit 3 (Week 4) for non-serious adverse events. ITT population was used for the analysis of AEs and SAEs.
Musculoskeletal and connective tissue disorders Muscle tightness	6.2% 1/16 • Up to 1 week after Week 4 (Follow-up) for SAEs and Up to Visit 3 (Week 4) for non-serious adverse events. ITT population was used for the analysis of AEs and SAEs.
Musculoskeletal and connective tissue disorders Pain in extremity	6.2% 1/16 • Up to 1 week after Week 4 (Follow-up) for SAEs and Up to Visit 3 (Week 4) for non-serious adverse events. ITT population was used for the analysis of AEs and SAEs.
Infections and infestations Bronchitis	6.2% 1/16 • Up to 1 week after Week 4 (Follow-up) for SAEs and Up to Visit 3 (Week 4) for non-serious adverse events. ITT population was used for the analysis of AEs and SAEs.
Infections and infestations Catheter site infection	6.2% 1/16 • Up to 1 week after Week 4 (Follow-up) for SAEs and Up to Visit 3 (Week 4) for non-serious adverse events. ITT population was used for the analysis of AEs and SAEs.
Infections and infestations Ear infection	6.2% 1/16 • Up to 1 week after Week 4 (Follow-up) for SAEs and Up to Visit 3 (Week 4) for non-serious adverse events. ITT population was used for the analysis of AEs and SAEs.
Infections and infestations Nasopharyngitis	6.2% 1/16 • Up to 1 week after Week 4 (Follow-up) for SAEs and Up to Visit 3 (Week 4) for non-serious adverse events. ITT population was used for the analysis of AEs and SAEs.
Infections and infestations Staphylococcal infection	6.2% 1/16 • Up to 1 week after Week 4 (Follow-up) for SAEs and Up to Visit 3 (Week 4) for non-serious adverse events. ITT population was used for the analysis of AEs and SAEs.
Nervous system disorders Headache	12.5% 2/16 • Up to 1 week after Week 4 (Follow-up) for SAEs and Up to Visit 3 (Week 4) for non-serious adverse events. ITT population was used for the analysis of AEs and SAEs.
Endocrine disorders Thyroiditis	6.2% 1/16 • Up to 1 week after Week 4 (Follow-up) for SAEs and Up to Visit 3 (Week 4) for non-serious adverse events. ITT population was used for the analysis of AEs and SAEs.
Vascular disorders Haematoma	6.2% 1/16 • Up to 1 week after Week 4 (Follow-up) for SAEs and Up to Visit 3 (Week 4) for non-serious adverse events. ITT population was used for the analysis of AEs and SAEs.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

• Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
• Publication restrictions are in place

Restriction type: OTHER