Trial Outcomes & Findings for BUILD 3: Bosentan Use in Interstitial Lung Disease (NCT NCT00391443)
NCT ID: NCT00391443
Last Updated: 2025-02-04
Results Overview
Disease worsening was defined as an event of worsening of pulmonary function tests (PFT) or acute exacerbation of idiopathic pulmonary fibrosis (IPF).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
616 participants
Primary outcome timeframe
36 months
Results posted on
2025-02-04
Participant Flow
Participant milestones
| Measure |
Placebo
Initial dose: 62.5 mg twice daily (b.i.d.) for 4 weeks. Target dose: - body weight \> 40 kg (90 lb): 125 mg b.i.d., (if the initial dose is well tolerated); - body weight \< 40 kg (90 lb): 62.5 mg b.i.d.
|
Bosentan
Initial dose: 62.5 mg twice daily (b.i.d.) for 4 weeks. Target dose: - body weight \> 40 kg (90 lb): 125 mg b.i.d., (if the initial dose is well tolerated); - body weight \< 40 kg (90 lb): 62.5 mg b.i.d.
|
|---|---|---|
|
Overall Study
STARTED
|
209
|
407
|
|
Overall Study
COMPLETED
|
209
|
407
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
BUILD 3: Bosentan Use in Interstitial Lung Disease
Baseline characteristics by cohort
| Measure |
Placebo
n=209 Participants
Initial dose: 62.5 mg twice daily (b.i.d.) for 4 weeks. Target dose: - body weight \> 40 kg (90 lb): 125 mg b.i.d., (if the initial dose is well tolerated); - body weight \< 40 kg (90 lb): 62.5 mg b.i.d.
|
Bosentan
n=407 Participants
Initial dose: 62.5 mg twice daily (b.i.d.) for 4 weeks. Target dose: - body weight \> 40 kg (90 lb): 125 mg b.i.d., (if the initial dose is well tolerated); - body weight \< 40 kg (90 lb): 62.5 mg b.i.d.
|
Total
n=616 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.2 years
STANDARD_DEVIATION 9.1 • n=99 Participants
|
63.8 years
STANDARD_DEVIATION 8.4 • n=107 Participants
|
63.6 years
STANDARD_DEVIATION 8.6 • n=206 Participants
|
|
Age, Customized
Between 18 and 40 years
|
4 participants
n=99 Participants
|
5 participants
n=107 Participants
|
9 participants
n=206 Participants
|
|
Age, Customized
Between 41 and 60 years
|
74 participants
n=99 Participants
|
119 participants
n=107 Participants
|
193 participants
n=206 Participants
|
|
Age, Customized
Between 61 and 70 years
|
87 participants
n=99 Participants
|
195 participants
n=107 Participants
|
282 participants
n=206 Participants
|
|
Age, Customized
> 70 years
|
44 participants
n=99 Participants
|
88 participants
n=107 Participants
|
132 participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
76 Participants
n=99 Participants
|
111 Participants
n=107 Participants
|
187 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
133 Participants
n=99 Participants
|
296 Participants
n=107 Participants
|
429 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
99 participants
n=99 Participants
|
185 participants
n=107 Participants
|
284 participants
n=206 Participants
|
|
Region of Enrollment
Serbia
|
2 participants
n=99 Participants
|
0 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Region of Enrollment
Spain
|
7 participants
n=99 Participants
|
15 participants
n=107 Participants
|
22 participants
n=206 Participants
|
|
Region of Enrollment
Ireland
|
2 participants
n=99 Participants
|
2 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Region of Enrollment
Austria
|
3 participants
n=99 Participants
|
4 participants
n=107 Participants
|
7 participants
n=206 Participants
|
|
Region of Enrollment
Israel
|
7 participants
n=99 Participants
|
16 participants
n=107 Participants
|
23 participants
n=206 Participants
|
|
Region of Enrollment
Switzerland
|
5 participants
n=99 Participants
|
8 participants
n=107 Participants
|
13 participants
n=206 Participants
|
|
Region of Enrollment
Italy
|
8 participants
n=99 Participants
|
14 participants
n=107 Participants
|
22 participants
n=206 Participants
|
|
Region of Enrollment
United Kingdom
|
3 participants
n=99 Participants
|
7 participants
n=107 Participants
|
10 participants
n=206 Participants
|
|
Region of Enrollment
France
|
9 participants
n=99 Participants
|
14 participants
n=107 Participants
|
23 participants
n=206 Participants
|
|
Region of Enrollment
Czech Republic
|
5 participants
n=99 Participants
|
9 participants
n=107 Participants
|
14 participants
n=206 Participants
|
|
Region of Enrollment
Canada
|
14 participants
n=99 Participants
|
30 participants
n=107 Participants
|
44 participants
n=206 Participants
|
|
Region of Enrollment
Belgium
|
1 participants
n=99 Participants
|
2 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Region of Enrollment
Croatia
|
0 participants
n=99 Participants
|
2 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Region of Enrollment
Australia
|
11 participants
n=99 Participants
|
22 participants
n=107 Participants
|
33 participants
n=206 Participants
|
|
Region of Enrollment
Germany
|
10 participants
n=99 Participants
|
26 participants
n=107 Participants
|
36 participants
n=206 Participants
|
|
Region of Enrollment
Netherlands
|
0 participants
n=99 Participants
|
2 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Region of Enrollment
Japan
|
14 participants
n=99 Participants
|
26 participants
n=107 Participants
|
40 participants
n=206 Participants
|
|
Region of Enrollment
Korea, Republic of
|
9 participants
n=99 Participants
|
23 participants
n=107 Participants
|
32 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 36 monthsPopulation: The primary analysis was performed on the Intent To Treat (ITT) population.
Disease worsening was defined as an event of worsening of pulmonary function tests (PFT) or acute exacerbation of idiopathic pulmonary fibrosis (IPF).
Outcome measures
| Measure |
Placebo
n=209 Participants
Initial dose: 62.5 mg twice daily (b.i.d.) for 4 weeks. Target dose: - body weight \> 40 kg (90 lb): 125 mg b.i.d., (if the initial dose is well tolerated); - body weight \< 40 kg (90 lb): 62.5 mg b.i.d.
|
Bosentan
n=407 Participants
Initial dose: 62.5 mg twice daily (b.i.d.) for 4 weeks. Target dose: - body weight \> 40 kg (90 lb): 125 mg b.i.d., (if the initial dose is well tolerated); - body weight \< 40 kg (90 lb): 62.5 mg b.i.d.
|
|---|---|---|
|
Time to Occurrence of Disease Worsening or Death up to End of Study.
month 4 (122 days)
|
10 participants with event
|
18 participants with event
|
|
Time to Occurrence of Disease Worsening or Death up to End of Study.
month 8 (244 days)
|
22 participants with event
|
40 participants with event
|
|
Time to Occurrence of Disease Worsening or Death up to End of Study.
month12 (366 days)
|
43 participants with event
|
74 participants with event
|
|
Time to Occurrence of Disease Worsening or Death up to End of Study.
month 18 (549 days)
|
74 participants with event
|
117 participants with event
|
|
Time to Occurrence of Disease Worsening or Death up to End of Study.
month 24 (732 days)
|
88 participants with event
|
145 participants with event
|
|
Time to Occurrence of Disease Worsening or Death up to End of Study.
month 30 (915 days)
|
94 participants with event
|
156 participants with event
|
|
Time to Occurrence of Disease Worsening or Death up to End of Study.
month 36 (1098 days)
|
94 participants with event
|
158 participants with event
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: ITT population
Disease worsening was defined as an event of worsening of pulmonary function tests (PFT) or acute exacerbation of idiopathic pulmonary fibrosis (IPF).
Outcome measures
| Measure |
Placebo
n=209 Participants
Initial dose: 62.5 mg twice daily (b.i.d.) for 4 weeks. Target dose: - body weight \> 40 kg (90 lb): 125 mg b.i.d., (if the initial dose is well tolerated); - body weight \< 40 kg (90 lb): 62.5 mg b.i.d.
|
Bosentan
n=407 Participants
Initial dose: 62.5 mg twice daily (b.i.d.) for 4 weeks. Target dose: - body weight \> 40 kg (90 lb): 125 mg b.i.d., (if the initial dose is well tolerated); - body weight \< 40 kg (90 lb): 62.5 mg b.i.d.
|
|---|---|---|
|
Percentage of Patients Who Experienced Either Disease Worsening or Death at 1 Year.
|
23.9 percentage of participants with event
Interval 18.3 to 30.3
|
19.9 percentage of participants with event
Interval 16.1 to 24.1
|
Adverse Events
Placebo
Serious events: 74 serious events
Other events: 200 other events
Deaths: 0 deaths
Bosentan
Serious events: 129 serious events
Other events: 386 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=209 participants at risk
Initial dose: 62.5 mg twice daily (b.i.d.) for 4 weeks. Target dose: - body weight \> 40 kg (90 lb): 125 mg b.i.d., (if the initial dose is well tolerated); - body weight \< 40 kg (90 lb): 62.5 mg b.i.d.
|
Bosentan
n=406 participants at risk
Initial dose: 62.5 mg twice daily (b.i.d.) for 4 weeks. Target dose: - body weight \> 40 kg (90 lb): 125 mg b.i.d., (if the initial dose is well tolerated); - body weight \< 40 kg (90 lb): 62.5 mg b.i.d.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
IDIOPATHIC PULMONARY FIBROSIS
|
8.1%
17/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
10.1%
41/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.00%
0/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
1.5%
6/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.48%
1/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.99%
4/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.48%
1/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.99%
4/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE
|
0.00%
0/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.49%
2/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY HYPERTENSION
|
0.00%
0/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.49%
2/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY DISTRESS SYNDROME
|
0.48%
1/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.25%
1/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.48%
1/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.25%
1/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE INTERSTITIAL PNEUMONITIS
|
0.00%
0/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.25%
1/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHOSPASM
|
0.00%
0/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.25%
1/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
|
0.00%
0/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.25%
1/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOPTYSIS
|
0.00%
0/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.25%
1/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
0.00%
0/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.25%
1/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.00%
0/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.25%
1/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY OEDEMA
|
0.00%
0/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.25%
1/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
|
0.96%
2/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.00%
0/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
0.48%
1/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.00%
0/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Infections and infestations
PNEUMONIA
|
4.8%
10/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
3.9%
16/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
2.4%
5/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
1.7%
7/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Infections and infestations
BRONCHITIS
|
1.4%
3/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.49%
2/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Infections and infestations
CLOSTRIDIUM DIFFICILE COLITIS
|
0.48%
1/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.49%
2/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Infections and infestations
APPENDICITIS
|
0.96%
2/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.25%
1/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Infections and infestations
DEVICE RELATED INFECTION
|
0.00%
0/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.25%
1/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Infections and infestations
DIVERTICULITIS
|
0.00%
0/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.25%
1/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Infections and infestations
HERPES ZOSTER OPHTHALMIC
|
0.00%
0/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.25%
1/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Infections and infestations
PILONIDAL CYST
|
0.00%
0/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.25%
1/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Infections and infestations
PYELONEPHRITIS
|
0.00%
0/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.25%
1/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Infections and infestations
UROSEPSIS
|
0.00%
0/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.25%
1/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Infections and infestations
VIRAL UPPER RESPIRATORY TRACT INFECTION
|
0.00%
0/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.25%
1/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
1.4%
3/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.00%
0/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Infections and infestations
LOBAR PNEUMONIA
|
0.96%
2/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.00%
0/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Infections and infestations
ANAL ABSCESS
|
0.48%
1/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.00%
0/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Infections and infestations
ARTHRITIS BACTERIAL
|
0.48%
1/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.00%
0/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Infections and infestations
CELLULITIS
|
0.48%
1/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.00%
0/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Infections and infestations
HERPES ZOSTER OTICUS
|
0.48%
1/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.00%
0/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Infections and infestations
TRACHEOBRONCHITIS
|
0.48%
1/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.00%
0/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.48%
1/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.00%
0/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Infections and infestations
VIRAL LABYRINTHITIS
|
0.48%
1/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.00%
0/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
0.48%
1/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
1.5%
6/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.48%
1/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.99%
4/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.74%
3/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Cardiac disorders
ANGINA UNSTABLE
|
0.00%
0/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.49%
2/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
1.4%
3/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.25%
1/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Cardiac disorders
CORONARY ARTERY STENOSIS
|
0.48%
1/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.25%
1/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Cardiac disorders
ACUTE CORONARY SYNDROME
|
0.00%
0/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.25%
1/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Cardiac disorders
ATRIAL FLUTTER
|
0.00%
0/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.25%
1/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Cardiac disorders
CARDIAC ARREST
|
0.00%
0/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.25%
1/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Cardiac disorders
SUPRAVENTRICULAR TACHYCARDIA
|
0.00%
0/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.25%
1/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Cardiac disorders
ANGINA PECTORIS
|
1.9%
4/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.00%
0/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Cardiac disorders
CARDIAC FAILURE
|
0.48%
1/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.00%
0/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Cardiac disorders
VENTRICULAR HYPOKINESIA
|
0.48%
1/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.00%
0/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATE CANCER
|
0.00%
0/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.99%
4/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BLADDER CANCER
|
0.00%
0/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.49%
2/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
COLON CANCER
|
0.00%
0/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.25%
1/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG ADENOCARCINOMA
|
0.00%
0/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.25%
1/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG NEOPLASM
|
0.00%
0/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.25%
1/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NON-HODGKIN'S LYMPHOMA
|
0.00%
0/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.25%
1/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA OF SKIN
|
0.00%
0/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.25%
1/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG NEOPLASM MALIGNANT
|
0.48%
1/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.00%
0/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Injury, poisoning and procedural complications
ROAD TRAFFIC ACCIDENT
|
0.00%
0/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.49%
2/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Injury, poisoning and procedural complications
FALL
|
0.48%
1/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.25%
1/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Injury, poisoning and procedural complications
ANKLE FRACTURE
|
0.00%
0/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.25%
1/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Injury, poisoning and procedural complications
EXCORIATION
|
0.00%
0/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.25%
1/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Injury, poisoning and procedural complications
LUMBAR VERTEBRAL FRACTURE
|
0.00%
0/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.25%
1/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Injury, poisoning and procedural complications
RIB FRACTURE
|
0.00%
0/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.25%
1/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Injury, poisoning and procedural complications
TENDON RUPTURE
|
0.00%
0/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.25%
1/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Injury, poisoning and procedural complications
UPPER LIMB FRACTURE
|
0.00%
0/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.25%
1/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Injury, poisoning and procedural complications
CONTUSION
|
0.48%
1/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.00%
0/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Injury, poisoning and procedural complications
HIP FRACTURE
|
0.48%
1/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.00%
0/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
1.4%
3/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.74%
3/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
0.48%
1/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.49%
2/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.00%
0/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.25%
1/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Musculoskeletal and connective tissue disorders
ROTATOR CUFF SYNDROME
|
0.00%
0/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.25%
1/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Musculoskeletal and connective tissue disorders
SJOGREN'S SYNDROME
|
0.00%
0/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.25%
1/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Musculoskeletal and connective tissue disorders
BURSITIS
|
0.48%
1/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.00%
0/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Musculoskeletal and connective tissue disorders
COSTOCHONDRITIS
|
0.48%
1/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.00%
0/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Musculoskeletal and connective tissue disorders
FRACTURE NONUNION
|
0.48%
1/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.00%
0/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Musculoskeletal and connective tissue disorders
JOINT EFFUSION
|
0.48%
1/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.00%
0/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Musculoskeletal and connective tissue disorders
POLYARTHRITIS
|
0.48%
1/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.00%
0/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Musculoskeletal and connective tissue disorders
SPINAL COLUMN STENOSIS
|
0.48%
1/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.00%
0/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
General disorders
CHEST PAIN
|
0.96%
2/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.49%
2/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
General disorders
PYREXIA
|
0.48%
1/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.49%
2/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
General disorders
GENERAL PHYSICAL HEALTH DETERIORATION
|
0.00%
0/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.25%
1/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
General disorders
IMPAIRED HEALING
|
0.00%
0/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.25%
1/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
General disorders
CHEST DISCOMFORT
|
0.48%
1/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.00%
0/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
0.48%
1/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.00%
0/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Investigations
LIVER FUNCTION TEST ABNORMAL
|
0.00%
0/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.99%
4/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Investigations
PULMONARY FUNCTION TEST DECREASED
|
0.00%
0/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.49%
2/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Gastrointestinal disorders
COLITIS
|
0.00%
0/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.25%
1/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Gastrointestinal disorders
COLONIC POLYP
|
0.00%
0/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.25%
1/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Gastrointestinal disorders
GASTRITIS
|
0.00%
0/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.25%
1/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.25%
1/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Gastrointestinal disorders
ANAL HAEMORRHAGE
|
0.48%
1/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.00%
0/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Gastrointestinal disorders
DIVERTICULUM INTESTINAL HAEMORRHAGIC
|
0.48%
1/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.00%
0/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Gastrointestinal disorders
DYSKINESIA OESOPHAGEAL
|
0.48%
1/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.00%
0/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Gastrointestinal disorders
INGUINAL HERNIA
|
0.48%
1/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.00%
0/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
|
0.48%
1/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.00%
0/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Gastrointestinal disorders
LOWER GASTROINTESTINAL HAEMORRHAGE
|
0.48%
1/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.00%
0/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Gastrointestinal disorders
MESENTERIC ARTERIOSCLEROSIS
|
0.48%
1/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.00%
0/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Gastrointestinal disorders
PERITONITIS
|
0.48%
1/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.00%
0/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Nervous system disorders
SYNCOPE
|
0.96%
2/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.25%
1/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Nervous system disorders
DIZZINESS
|
0.48%
1/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.25%
1/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Nervous system disorders
CEREBRAL HAEMORRHAGE
|
0.00%
0/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.25%
1/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
|
0.00%
0/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.25%
1/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Nervous system disorders
CAROTID ARTERY OCCLUSION
|
0.48%
1/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.00%
0/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Nervous system disorders
DEMENTIA
|
0.48%
1/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.00%
0/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Nervous system disorders
HAEMORRHAGIC STROKE
|
0.48%
1/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.00%
0/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
0.48%
1/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.00%
0/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Nervous system disorders
SOMNOLENCE
|
0.48%
1/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.00%
0/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Renal and urinary disorders
HAEMATURIA
|
0.00%
0/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.74%
3/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Renal and urinary disorders
RENAL MASS
|
0.00%
0/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.25%
1/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
0.48%
1/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.00%
0/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.48%
1/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.49%
2/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Vascular disorders
HYPOTENSION
|
0.48%
1/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.25%
1/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Vascular disorders
INTERMITTENT CLAUDICATION
|
0.00%
0/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.25%
1/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Vascular disorders
ORTHOSTATIC HYPOTENSION
|
0.00%
0/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.25%
1/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Vascular disorders
HYPERTENSION
|
0.48%
1/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.00%
0/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Vascular disorders
TEMPORAL ARTERITIS
|
0.48%
1/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.00%
0/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Vascular disorders
VASCULITIS
|
0.48%
1/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.00%
0/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.00%
0/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.25%
1/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Blood and lymphatic system disorders
LYMPHADENOPATHY
|
0.00%
0/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.25%
1/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Ear and labyrinth disorders
MENIERE'S DISEASE
|
0.00%
0/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.25%
1/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Ear and labyrinth disorders
VERTIGO
|
0.00%
0/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.25%
1/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Hepatobiliary disorders
BILE DUCT STONE
|
0.00%
0/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.25%
1/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.00%
0/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.25%
1/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Hepatobiliary disorders
HEPATITIS ACUTE
|
0.00%
0/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.25%
1/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.96%
2/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.00%
0/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Hepatobiliary disorders
CHOLECYSTITIS ACUTE
|
0.48%
1/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.00%
0/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.48%
1/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.25%
1/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Metabolism and nutrition disorders
HYPOVOLAEMIA
|
0.00%
0/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.25%
1/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Surgical and medical procedures
CHOLECYSTECTOMY
|
0.00%
0/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.25%
1/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Surgical and medical procedures
TRANSURETHRAL PROSTATECTOMY
|
0.00%
0/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.25%
1/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Surgical and medical procedures
LUNG TRANSPLANT
|
0.48%
1/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.00%
0/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Immune system disorders
ALLERGIC OEDEMA
|
0.00%
0/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.25%
1/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Immune system disorders
DRUG HYPERSENSITIVITY
|
0.00%
0/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.25%
1/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Psychiatric disorders
ANXIETY
|
0.00%
0/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.25%
1/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Psychiatric disorders
DEPRESSION
|
0.00%
0/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.25%
1/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Psychiatric disorders
PANIC DISORDER
|
0.00%
0/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.25%
1/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Reproductive system and breast disorders
BENIGN PROSTATIC HYPERPLASIA
|
0.00%
0/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.25%
1/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Reproductive system and breast disorders
PROSTATISM
|
0.48%
1/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.00%
0/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Skin and subcutaneous tissue disorders
PRURITUS ALLERGIC
|
0.00%
0/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.25%
1/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Endocrine disorders
GOITRE
|
0.48%
1/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
0.00%
0/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
Other adverse events
| Measure |
Placebo
n=209 participants at risk
Initial dose: 62.5 mg twice daily (b.i.d.) for 4 weeks. Target dose: - body weight \> 40 kg (90 lb): 125 mg b.i.d., (if the initial dose is well tolerated); - body weight \< 40 kg (90 lb): 62.5 mg b.i.d.
|
Bosentan
n=406 participants at risk
Initial dose: 62.5 mg twice daily (b.i.d.) for 4 weeks. Target dose: - body weight \> 40 kg (90 lb): 125 mg b.i.d., (if the initial dose is well tolerated); - body weight \< 40 kg (90 lb): 62.5 mg b.i.d.
|
|---|---|---|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
28.2%
59/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
28.1%
114/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Respiratory, thoracic and mediastinal disorders
IDIOPATHIC PULMONARY FIBROSIS
|
28.2%
59/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
22.7%
92/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
24.4%
51/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
19.2%
78/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
11.5%
24/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
14.0%
57/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
General disorders
FATIGUE
|
7.2%
15/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
11.3%
46/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Infections and infestations
BRONCHITIS
|
13.4%
28/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
10.8%
44/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Nervous system disorders
HEADACHE
|
10.5%
22/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
10.8%
44/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Infections and infestations
NASOPHARYNGITIS
|
10.5%
22/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
9.9%
40/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Infections and infestations
SINUSITIS
|
8.6%
18/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
9.4%
38/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
General disorders
OEDEMA PERIPHERAL
|
11.0%
23/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
9.1%
37/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
8.1%
17/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
7.4%
30/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Gastrointestinal disorders
NAUSEA
|
7.2%
15/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
6.7%
27/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
3.3%
7/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
6.7%
27/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
8.6%
18/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
6.4%
26/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Investigations
LIVER FUNCTION TEST ABNORMAL
|
0.00%
0/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
6.4%
26/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Nervous system disorders
DIZZINESS
|
8.1%
17/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
5.9%
24/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
7.7%
16/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
5.9%
24/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
General disorders
CHEST PAIN
|
5.7%
12/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
5.9%
24/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
2.9%
6/209 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
5.7%
23/406 • All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
One subject who did not receive study treatment (bosentan) was excluded from the safety population. Events listed as idiopathic pulmonary fibrosis were reported as worsening of idiopathic pulmonary fibrosis.
|
Additional Information
Isabelle Leconte,PhD -Data Science Group Leader, Director
Actelion Pharmaceuticals Ltd
Phone: +41 61 565 64 18
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Actelion, with steering committee, shall complete the review and provide any modifications required to protect Actelion's patent rights and confidential information within sixty (60) days of receipt of the proposed publication. During this period, Investigator shall not permit publication. If Actelion reasonably anticipates filing a patent application claiming an invention arising out of the Study, such publication shall be delayed until after the application is filed.
- Publication restrictions are in place
Restriction type: OTHER