Trial Outcomes & Findings for Study of Incidence of Respiratory Tract AEs in Patients Treated With Tyvaso® Compared to Other FDA Approved PAH Therapies (NCT NCT01266265)
NCT ID: NCT01266265
Last Updated: 2016-02-17
Results Overview
Percentage of patients who experienced a respiratory tract-related adverse event (grouped by category of interest) during the study.
Recruitment status
COMPLETED
Target enrollment
1333 participants
Primary outcome timeframe
Follow-up every 3 months
Results posted on
2016-02-17
Participant Flow
The recruitment period for this study was February 2010 to December 2014. All sites were located in the United States.
Participant milestones
| Measure |
Tyvaso
The Tyvaso group will consist of patients receiving Tyvaso and may be receiving another FDA approved PAH therapy as part of routine care.
inhaled prostacyclin: Tyvaso
|
Control
The control group will consist of patients with no previous Tyvaso exposure and not taking Tyvaso at the time of Baseline visit, but treated with any other FDA approved PAH therapy as part of routine care.
inhaled prostacyclin: As prescribed by the physician prostacyclin: As prescribed by the physician subcutaneous and intravenous prostacyclin: As prescribed by physician oral ERA: As prescribed by physician oral PDE5 inhibitors: As prescribed by physician
|
|---|---|---|
|
Overall Study
STARTED
|
666
|
667
|
|
Overall Study
COMPLETED
|
461
|
477
|
|
Overall Study
NOT COMPLETED
|
205
|
190
|
Reasons for withdrawal
| Measure |
Tyvaso
The Tyvaso group will consist of patients receiving Tyvaso and may be receiving another FDA approved PAH therapy as part of routine care.
inhaled prostacyclin: Tyvaso
|
Control
The control group will consist of patients with no previous Tyvaso exposure and not taking Tyvaso at the time of Baseline visit, but treated with any other FDA approved PAH therapy as part of routine care.
inhaled prostacyclin: As prescribed by the physician prostacyclin: As prescribed by the physician subcutaneous and intravenous prostacyclin: As prescribed by physician oral ERA: As prescribed by physician oral PDE5 inhibitors: As prescribed by physician
|
|---|---|---|
|
Overall Study
Death
|
95
|
73
|
|
Overall Study
Lost to Follow-up
|
23
|
28
|
|
Overall Study
Withdrawal by Subject
|
13
|
11
|
|
Overall Study
Respiratory-related adverse event
|
2
|
1
|
|
Overall Study
Transferred care to another provider
|
22
|
28
|
|
Overall Study
Stopped/changed PAH medication(s)
|
16
|
9
|
|
Overall Study
Enrolled in another clinical study
|
15
|
26
|
|
Overall Study
Non-compliance
|
8
|
5
|
|
Overall Study
Lung transplant
|
6
|
5
|
|
Overall Study
Site closed early
|
4
|
3
|
|
Overall Study
Clinical worsening
|
1
|
1
|
Baseline Characteristics
Study of Incidence of Respiratory Tract AEs in Patients Treated With Tyvaso® Compared to Other FDA Approved PAH Therapies
Baseline characteristics by cohort
| Measure |
Tyvaso
n=666 Participants
The Tyvaso group will consist of patients receiving Tyvaso and may be receiving another FDA approved PAH therapy as part of routine care.
inhaled prostacyclin: Tyvaso
|
Control
n=667 Participants
The control group will consist of patients with no previous Tyvaso exposure and not taking Tyvaso at the time of the Baseline visit, but receiving any other FDA approved PAH therapy as part of routine care.
|
Total
n=1333 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.5 years
n=99 Participants
|
57.0 years
n=107 Participants
|
57.25 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
519 Participants
n=99 Participants
|
532 Participants
n=107 Participants
|
1051 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
147 Participants
n=99 Participants
|
135 Participants
n=107 Participants
|
282 Participants
n=206 Participants
|
|
Disease etiology
Idiopathic/heritable/drug- or toxin-induced
|
341 participants
n=99 Participants
|
389 participants
n=107 Participants
|
730 participants
n=206 Participants
|
|
Disease etiology
Connective tissue disease
|
223 participants
n=99 Participants
|
195 participants
n=107 Participants
|
418 participants
n=206 Participants
|
|
Disease etiology
Congential heart disease
|
55 participants
n=99 Participants
|
37 participants
n=107 Participants
|
92 participants
n=206 Participants
|
|
Disease etiology
HIV infection/porto-pulmonary
|
53 participants
n=99 Participants
|
55 participants
n=107 Participants
|
108 participants
n=206 Participants
|
|
Disease etiology
Other
|
9 participants
n=99 Participants
|
4 participants
n=107 Participants
|
13 participants
n=206 Participants
|
|
Race
White
|
483 participants
n=99 Participants
|
510 participants
n=107 Participants
|
993 participants
n=206 Participants
|
|
Race
Black/African American
|
116 participants
n=99 Participants
|
107 participants
n=107 Participants
|
223 participants
n=206 Participants
|
|
Race
Other/race not disclosed
|
42 participants
n=99 Participants
|
33 participants
n=107 Participants
|
75 participants
n=206 Participants
|
|
Race
Asian
|
21 participants
n=99 Participants
|
15 participants
n=107 Participants
|
36 participants
n=206 Participants
|
|
Race
Native Hawaiian/Pacific Islander
|
3 participants
n=99 Participants
|
1 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Race
American Indian/Alaska Native
|
2 participants
n=99 Participants
|
1 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Years Since PAH Diagnosis
|
2.9 years
n=99 Participants
|
2.9 years
n=107 Participants
|
2.9 years
n=206 Participants
|
|
Baseline PAH Medication
Tyvaso (treprostinil) inhalation
|
666 participants
n=99 Participants
|
0 participants
n=107 Participants
|
666 participants
n=206 Participants
|
|
Baseline PAH Medication
Remodulin (treprostinil)
|
2 participants
n=99 Participants
|
150 participants
n=107 Participants
|
152 participants
n=206 Participants
|
|
Baseline PAH Medication
Flolan (epoprostenol)
|
2 participants
n=99 Participants
|
44 participants
n=107 Participants
|
46 participants
n=206 Participants
|
|
Baseline PAH Medication
Veletri (epoprostinol)
|
0 participants
n=99 Participants
|
36 participants
n=107 Participants
|
36 participants
n=206 Participants
|
|
Baseline PAH Medication
Ventavis (iloprost) inhalation
|
0 participants
n=99 Participants
|
33 participants
n=107 Participants
|
33 participants
n=206 Participants
|
|
Baseline PAH Medication
Revatio (sildenafil citrate)
|
294 participants
n=99 Participants
|
236 participants
n=107 Participants
|
530 participants
n=206 Participants
|
|
Baseline PAH Medication
Adcirca (tadalafil)
|
239 participants
n=99 Participants
|
224 participants
n=107 Participants
|
463 participants
n=206 Participants
|
|
Baseline PAH Medication
Letairis (ambrisentan)
|
250 participants
n=99 Participants
|
200 participants
n=107 Participants
|
450 participants
n=206 Participants
|
|
Baseline PAH Medication
Tracleer (bosentan)
|
164 participants
n=99 Participants
|
203 participants
n=107 Participants
|
367 participants
n=206 Participants
|
|
Baseline PAH Medication
Opsumit (macitentan)
|
4 participants
n=99 Participants
|
2 participants
n=107 Participants
|
6 participants
n=206 Participants
|
|
Baseline PAH Medication
Adempas (riociguat)
|
2 participants
n=99 Participants
|
2 participants
n=107 Participants
|
4 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Follow-up every 3 monthsPercentage of patients who experienced a respiratory tract-related adverse event (grouped by category of interest) during the study.
Outcome measures
| Measure |
Tyvaso
n=666 Participants
The Tyvaso group will consist of patients receiving Tyvaso and may be receiving another FDA approved PAH therapy as part of routine care.
inhaled prostacyclin: Tyvaso
|
Control
n=667 Participants
The control group will consist of patients with no previous Tyvaso exposure and not taking Tyvaso at the time of the Baseline visit, but receiving any other FDA approved PAH therapy as part of routine care.
|
|---|---|---|
|
Prevalence of Respiratory Tract-Related Adverse Events of Interest
Any Event
|
52 percentage of participants
|
51 percentage of participants
|
|
Prevalence of Respiratory Tract-Related Adverse Events of Interest
Bleeding from the upper or lower respiratory tract
|
16 percentage of participants
|
14 percentage of participants
|
|
Prevalence of Respiratory Tract-Related Adverse Events of Interest
Irritation/pain of nose, mouth, larynx, pharynx
|
17 percentage of participants
|
10 percentage of participants
|
|
Prevalence of Respiratory Tract-Related Adverse Events of Interest
Upper or lower respiratory tract infection
|
37 percentage of participants
|
40 percentage of participants
|
|
Prevalence of Respiratory Tract-Related Adverse Events of Interest
Wheezing, bronchospasm, or asthma/COPD exacerbate
|
12 percentage of participants
|
13 percentage of participants
|
Adverse Events
Tyvaso
Serious events: 96 serious events
Other events: 403 other events
Deaths: 0 deaths
Control
Serious events: 94 serious events
Other events: 388 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tyvaso
n=666 participants at risk
The Tyvaso group will consist of patients receiving Tyvaso and may be receiving another FDA approved PAH therapy as part of routine care.
inhaled prostacyclin: Tyvaso
|
Control
n=667 participants at risk
The control group will consist of patients with no previous Tyvaso exposure and not taking Tyvaso at the time of the Baseline visit, but receiving any other FDA approved PAH therapy as part of routine care.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
6.3%
42/666 • Number of events 45 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
5.5%
37/667 • Number of events 45 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
2.0%
13/666 • Number of events 18 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
1.0%
7/667 • Number of events 9 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.8%
12/666 • Number of events 13 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
1.5%
10/667 • Number of events 10 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.4%
9/666 • Number of events 12 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
1.0%
7/667 • Number of events 10 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.2%
8/666 • Number of events 10 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
1.2%
8/667 • Number of events 12 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
1.2%
8/666 • Number of events 8 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
0.45%
3/667 • Number of events 3 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
0.90%
6/666 • Number of events 6 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
0.90%
6/667 • Number of events 6 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.75%
5/666 • Number of events 5 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
0.75%
5/667 • Number of events 5 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.75%
5/666 • Number of events 5 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
0.30%
2/667 • Number of events 2 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.60%
4/666 • Number of events 4 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
0.75%
5/667 • Number of events 5 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.45%
3/666 • Number of events 3 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
0.30%
2/667 • Number of events 2 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.45%
3/666 • Number of events 3 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
1.3%
9/667 • Number of events 16 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
|
Respiratory, thoracic and mediastinal disorders
Lobar pneumonia
|
0.45%
3/666 • Number of events 3 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
0.60%
4/667 • Number of events 4 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia viral
|
0.30%
2/666 • Number of events 2 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
0.45%
3/667 • Number of events 3 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.30%
2/666 • Number of events 2 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
0.30%
2/667 • Number of events 2 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.30%
2/666 • Number of events 2 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
0.15%
1/667 • Number of events 1 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis viral
|
0.30%
2/666 • Number of events 2 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
0.00%
0/667 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
|
Respiratory, thoracic and mediastinal disorders
Parainfluenza virus infection
|
0.30%
2/666 • Number of events 2 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
0.00%
0/667 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
|
Respiratory, thoracic and mediastinal disorders
Influenza
|
0.15%
1/666 • Number of events 1 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
0.45%
3/667 • Number of events 3 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.15%
1/666 • Number of events 1 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
0.60%
4/667 • Number of events 5 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.15%
1/666 • Number of events 1 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
0.15%
1/667 • Number of events 1 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
|
Respiratory, thoracic and mediastinal disorders
Lupus pneumonitis
|
0.15%
1/666 • Number of events 1 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
0.15%
1/667 • Number of events 1 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.15%
1/666 • Number of events 1 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
0.00%
0/667 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.15%
1/666 • Number of events 1 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
0.00%
0/667 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
|
Respiratory, thoracic and mediastinal disorders
Cellulitis
|
0.15%
1/666 • Number of events 1 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
0.00%
0/667 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic sinusitis
|
0.15%
1/666 • Number of events 1 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
0.00%
0/667 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
|
Respiratory, thoracic and mediastinal disorders
H1N1 influenza
|
0.15%
1/666 • Number of events 1 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
0.00%
0/667 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
|
Respiratory, thoracic and mediastinal disorders
Lung adenocarcinoma
|
0.15%
1/666 • Number of events 1 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
0.00%
0/667 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.15%
1/666 • Number of events 1 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
0.00%
0/667 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
|
Respiratory, thoracic and mediastinal disorders
Lung neoplasm malignant
|
0.15%
1/666 • Number of events 1 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
0.00%
0/667 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
|
Respiratory, thoracic and mediastinal disorders
Metapneumovirus infection
|
0.15%
1/666 • Number of events 1 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
0.00%
0/667 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.15%
1/666 • Number of events 1 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
0.00%
0/667 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.15%
1/666 • Number of events 1 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
0.00%
0/667 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.15%
1/666 • Number of events 1 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
0.00%
0/667 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia respiratory syncytial viral
|
0.15%
1/666 • Number of events 1 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
0.00%
0/667 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia streptococcal
|
0.15%
1/666 • Number of events 1 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
0.00%
0/667 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.15%
1/666 • Number of events 1 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
0.00%
0/667 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.15%
1/666 • Number of events 1 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
0.00%
0/667 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory acidosis
|
0.15%
1/666 • Number of events 1 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
0.00%
0/667 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract hemorrhage
|
0.15%
1/666 • Number of events 1 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
0.00%
0/667 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.00%
0/666 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
0.45%
3/667 • Number of events 4 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
0.00%
0/666 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
0.30%
2/667 • Number of events 2 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/666 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
0.30%
2/667 • Number of events 2 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
0.00%
0/666 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
0.30%
2/667 • Number of events 2 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory syncytial virus infection
|
0.00%
0/666 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
0.60%
4/667 • Number of events 5 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
|
Respiratory, thoracic and mediastinal disorders
Acute sinusitis
|
0.00%
0/666 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
0.15%
1/667 • Number of events 1 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
|
Respiratory, thoracic and mediastinal disorders
Lower respiratory tract infection
|
0.00%
0/666 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
0.15%
1/667 • Number of events 1 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
0.00%
0/666 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
0.15%
1/667 • Number of events 1 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia bacterial
|
0.00%
0/666 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
0.15%
1/667 • Number of events 1 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia haemophilus
|
0.00%
0/666 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
0.15%
1/667 • Number of events 1 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia staphylococcal
|
0.00%
0/666 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
0.15%
1/667 • Number of events 1 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/666 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
0.15%
1/667 • Number of events 1 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory syncytial virus test positive
|
0.00%
0/666 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
0.15%
1/667 • Number of events 1 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract infection
|
0.00%
0/666 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
0.15%
1/667 • Number of events 1 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinovirus infection
|
0.00%
0/666 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
0.15%
1/667 • Number of events 1 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
|
Respiratory, thoracic and mediastinal disorders
Squamous cell carcinoma
|
0.00%
0/666 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
0.15%
1/667 • Number of events 1 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
|
Respiratory, thoracic and mediastinal disorders
Tracheobronchitis
|
0.00%
0/666 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
0.15%
1/667 • Number of events 1 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
Other adverse events
| Measure |
Tyvaso
n=666 participants at risk
The Tyvaso group will consist of patients receiving Tyvaso and may be receiving another FDA approved PAH therapy as part of routine care.
inhaled prostacyclin: Tyvaso
|
Control
n=667 participants at risk
The control group will consist of patients with no previous Tyvaso exposure and not taking Tyvaso at the time of the Baseline visit, but receiving any other FDA approved PAH therapy as part of routine care.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
8.6%
57/666 • Number of events 75 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
8.4%
56/667 • Number of events 73 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.3%
122/666 • Number of events 155 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
15.9%
106/667 • Number of events 119 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
14.9%
99/666 • Number of events 129 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
17.2%
115/667 • Number of events 158 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
13.4%
89/666 • Number of events 117 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
12.0%
80/667 • Number of events 109 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.3%
55/666 • Number of events 63 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
9.9%
66/667 • Number of events 85 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
8.3%
55/666 • Number of events 62 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
8.1%
54/667 • Number of events 70 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
7.5%
50/666 • Number of events 62 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
9.1%
61/667 • Number of events 81 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
6.6%
44/666 • Number of events 55 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
7.2%
48/667 • Number of events 63 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
6.2%
41/666 • Number of events 52 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
9.4%
63/667 • Number of events 73 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
5.9%
39/666 • Number of events 43 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
1.8%
12/667 • Number of events 13 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.6%
37/666 • Number of events 43 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
4.5%
30/667 • Number of events 32 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
3.9%
26/666 • Number of events 31 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
5.5%
37/667 • Number of events 37 • Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Any publication of the result of this trial must be consistent with the United Therapeutics publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
- Publication restrictions are in place
Restriction type: OTHER