Trial Outcomes & Findings for Sildenafil to Improve Exercise Capacity in People With Thalassemia and Pulmonary Hypertension (NCT NCT00872170)
NCT ID: NCT00872170
Last Updated: 2014-02-21
Results Overview
Change in six-minute walk test (6MWT) distance was calculated as 6MWT at week 12 minus 6MWT at baseline.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
27 participants
Primary outcome timeframe
Baseline and Week 12
Results posted on
2014-02-21
Participant Flow
Participant milestones
| Measure |
Sildenafil
Participants with thalassemia who have pulmonary hypertension received sildenafil for 12 weeks.
Sildenafil : Participants received sildenafil for 12 weeks with the following therapy:
50 mg of oral sildenafil three times a day (TID) increased to 100 mg TID as tolerated in adults and children greater than 50 kg; 1 mg/kg sildenafil TID without dose escalation in children less than 50 kg
|
Control
Participants with thalassemia who do not have pulmonary hypertension were part of a control group and were only undergoing screening/baseline assessments.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
13
|
|
Overall Study
COMPLETED
|
13
|
13
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Sildenafil
Participants with thalassemia who have pulmonary hypertension received sildenafil for 12 weeks.
Sildenafil : Participants received sildenafil for 12 weeks with the following therapy:
50 mg of oral sildenafil three times a day (TID) increased to 100 mg TID as tolerated in adults and children greater than 50 kg; 1 mg/kg sildenafil TID without dose escalation in children less than 50 kg
|
Control
Participants with thalassemia who do not have pulmonary hypertension were part of a control group and were only undergoing screening/baseline assessments.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
Baseline Characteristics
Sildenafil to Improve Exercise Capacity in People With Thalassemia and Pulmonary Hypertension
Baseline characteristics by cohort
| Measure |
Sildenafil
n=14 Participants
Participants with thalassemia who have pulmonary hypertension received sildenafil for 12 weeks.
Sildenafil : Participants received sildenafil for 12 weeks with the following therapy:
50 mg of oral sildenafil three times a day (TID) increased to 100 mg TID as tolerated in adults and children greater than 50 kg; 1 mg/kg sildenafil TID without dose escalation in children less than 50 kg
|
Control
n=13 Participants
Participants with thalassemia who do not have pulmonary hypertension were part of a control group and were only undergoing screening/baseline assessments.
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.6 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
33.7 years
STANDARD_DEVIATION 12.6 • n=7 Participants
|
34.7 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
6 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Region of Enrollment
Lebanon
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Of 14 patients in the Sildenafil arm, 4 patients with discrepant Tricuspid Regurgitant Jet Velocity (TRV) measurements between the local site, core lab and NHLBI readings and 2 patients who had no 6MWT at 12 weeks were excluded. Patients in control group were only assessed at baseline. Therefore, 8 Sildenafil and 0 control patients were used.
Change in six-minute walk test (6MWT) distance was calculated as 6MWT at week 12 minus 6MWT at baseline.
Outcome measures
| Measure |
Sildenafil
n=8 Participants
Participants with thalassemia who have pulmonary hypertension received sildenafil for 12 weeks.
Sildenafil : Participants received sildenafil for 12 weeks with the following therapy:
50 mg of oral sildenafil three times a day (TID) increased to 100 mg TID as tolerated in adults and children greater than 50 kg; 1 mg/kg sildenafil TID without dose escalation in children less than 50 kg
|
|---|---|
|
Change in Six-minute Walk Test (6MWT) Distance From Baseline to Week 12 Among Sildenafil Group
|
-1.38 meters
Standard Error 16.01
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Of 14 patients in the Sildenafil arm, 4 patients with discrepant Tricuspid Regurgitant Jet Velocity (TRV) measurements between the local site, core lab and NHLBI readings and one patient who withdrew from the study were excluded. Patients in control group were only assessed at baseline. Therefore, 9 Sildenafil and 0 control patients were used.
Change in tricuspid regurgitant jet velocity (TRV) was calculated as TRV at week 12 minus TRV at baseline. The TRV provides an estimate of pulmonary artery pressure.
Outcome measures
| Measure |
Sildenafil
n=9 Participants
Participants with thalassemia who have pulmonary hypertension received sildenafil for 12 weeks.
Sildenafil : Participants received sildenafil for 12 weeks with the following therapy:
50 mg of oral sildenafil three times a day (TID) increased to 100 mg TID as tolerated in adults and children greater than 50 kg; 1 mg/kg sildenafil TID without dose escalation in children less than 50 kg
|
|---|---|
|
Change in Tricuspid Regurgitant Jet Velocity (TRV) From Baseline to Week 12 Among Sildenafil Group
|
-0.45 m/s
Standard Error 0.18
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Of 14 patients in the Sildenafil arm, 4 patients with discrepant Tricuspid Regurgitant Jet Velocity (TRV) measurements between the local site, core lab and NHLBI readings and one patient who withdrew from the study were excluded. Patients in control group were only assessed at baseline. Therefore, 9 Sildenafil and 0 control patients were used.
Change in echo left ventricular end systolic volume (LVESV) was calculated as LVESV at week 12 minus LVESV at baseline.
Outcome measures
| Measure |
Sildenafil
n=9 Participants
Participants with thalassemia who have pulmonary hypertension received sildenafil for 12 weeks.
Sildenafil : Participants received sildenafil for 12 weeks with the following therapy:
50 mg of oral sildenafil three times a day (TID) increased to 100 mg TID as tolerated in adults and children greater than 50 kg; 1 mg/kg sildenafil TID without dose escalation in children less than 50 kg
|
|---|---|
|
Change in Echo Left Ventricular End Systolic Volume (LVESV) From Baseline to Week 12 Among Sildenafil Group
|
-3.82 ml
Standard Error 0.98
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Of 14 patients in the Sildenafil arm, 4 patients with discrepant Tricuspid Regurgitant Jet Velocity (TRV) measurements between the local site, core lab and NHLBI readings and one patient who withdrew from the study were excluded. Patients in control group were only assessed at baseline. Therefore, 9 Sildenafil and 0 control patients were used.
Change in echo left ventricular end diastolic volume (LVEDV) was calculated as LVEDV at week 12 minus LVEDV at baseline.
Outcome measures
| Measure |
Sildenafil
n=9 Participants
Participants with thalassemia who have pulmonary hypertension received sildenafil for 12 weeks.
Sildenafil : Participants received sildenafil for 12 weeks with the following therapy:
50 mg of oral sildenafil three times a day (TID) increased to 100 mg TID as tolerated in adults and children greater than 50 kg; 1 mg/kg sildenafil TID without dose escalation in children less than 50 kg
|
|---|---|
|
Change in Echo Left Ventricular End Diastolic Volume (LVEDV) From Baseline to Week 12 Among Sildenafil Group
|
-7.89 ml
Standard Error 2.71
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Of 14 patients in the Sildenafil arm, 4 patients with discrepant Tricuspid Regurgitant Jet Velocity (TRV) measurements between the local site, core lab and NHLBI readings and one patient who withdrew from the study were excluded. Patients in control group were only assessed at baseline. Therefore, 9 Sildenafil and 0 control patients were used.
Change in Plasma Arginine was calculated as Plasma Arginine at week 12 minus Plasma Arginine at baseline.
Outcome measures
| Measure |
Sildenafil
n=9 Participants
Participants with thalassemia who have pulmonary hypertension received sildenafil for 12 weeks.
Sildenafil : Participants received sildenafil for 12 weeks with the following therapy:
50 mg of oral sildenafil three times a day (TID) increased to 100 mg TID as tolerated in adults and children greater than 50 kg; 1 mg/kg sildenafil TID without dose escalation in children less than 50 kg
|
|---|---|
|
Change in Plasma Arginine From Baseline to Week 12 Among Sildenafil Group
|
31.77 µM
Standard Error 15.81
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Of 14 patients in the Sildenafil arm, 4 patients with discrepant Tricuspid Regurgitant Jet Velocity (TRV) measurements between the local site, core lab and NHLBI readings and one patient who withdrew from the study were excluded. Patients in control group were only assessed at baseline. Therefore, 9 Sildenafil and 0 control patients were used.
Change in Red Blood Cell (RBC) Arginine was calculated as Red Blood Cell (RBC) Arginine at week 12 minus Red Blood Cell (RBC) Arginine at baseline.
Outcome measures
| Measure |
Sildenafil
n=9 Participants
Participants with thalassemia who have pulmonary hypertension received sildenafil for 12 weeks.
Sildenafil : Participants received sildenafil for 12 weeks with the following therapy:
50 mg of oral sildenafil three times a day (TID) increased to 100 mg TID as tolerated in adults and children greater than 50 kg; 1 mg/kg sildenafil TID without dose escalation in children less than 50 kg
|
|---|---|
|
Change in Red Blood Cell (RBC) Arginine From Baseline to Week 12 Among Sildenafil Group
|
3.67 µM
Standard Error 1.45
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Of 14 patients in the Sildenafil arm, 4 patients with discrepant Tricuspid Regurgitant Jet Velocity (TRV) measurements between the local site, core lab and NHLBI readings and one patient who withdrew from the study were excluded. Patients in control group were only assessed at baseline. Therefore, 9 Sildenafil and 0 control patients were used.
Change in Soluble platelet selectin (sP-SELECTIN) was calculated as sP-SELECTIN at week 12 minus sP-SELECTIN at baseline.
Outcome measures
| Measure |
Sildenafil
n=9 Participants
Participants with thalassemia who have pulmonary hypertension received sildenafil for 12 weeks.
Sildenafil : Participants received sildenafil for 12 weeks with the following therapy:
50 mg of oral sildenafil three times a day (TID) increased to 100 mg TID as tolerated in adults and children greater than 50 kg; 1 mg/kg sildenafil TID without dose escalation in children less than 50 kg
|
|---|---|
|
Change in Soluble Platelet Selectin (sP-SELECTIN) From Baseline to Week 12 Among Sildenafil Group
|
121.13 ng/ml
Standard Error 57.56
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Of 14 patients in the Sildenafil arm, 4 patients with discrepant Tricuspid Regurgitant Jet Velocity (TRV) measurements between the local site, core lab and NHLBI readings and 2 patients who had no LDH at 12 weeks were excluded. Patients in control group were only assessed at baseline. Therefore, 8 Sildenafil and 0 control patients were used.
Change in Lactate dehydrogenase (LDH) was calculated as LDH at week 12 minus LDH at baseline.
Outcome measures
| Measure |
Sildenafil
n=8 Participants
Participants with thalassemia who have pulmonary hypertension received sildenafil for 12 weeks.
Sildenafil : Participants received sildenafil for 12 weeks with the following therapy:
50 mg of oral sildenafil three times a day (TID) increased to 100 mg TID as tolerated in adults and children greater than 50 kg; 1 mg/kg sildenafil TID without dose escalation in children less than 50 kg
|
|---|---|
|
Change in Lactate Dehydrogenase (LDH) From Baseline to Week 12 Among Sildenafil Group
|
23.37 U/L
Standard Error 35.98
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Of 14 patients in the Sildenafil arm, 4 patients with discrepant Tricuspid Regurgitant Jet Velocity (TRV) measurements between the local site, core lab and NHLBI readings and one patient who withdrew from the study were excluded. Patients in control group were only assessed at baseline. Therefore, 9 Sildenafil and 0 control patients were used.
Change in Cell Free Hemoglobin was calculated as Cell Free Hemoglobin at week 12 minus Cell Free Hemoglobin at baseline.
Outcome measures
| Measure |
Sildenafil
n=9 Participants
Participants with thalassemia who have pulmonary hypertension received sildenafil for 12 weeks.
Sildenafil : Participants received sildenafil for 12 weeks with the following therapy:
50 mg of oral sildenafil three times a day (TID) increased to 100 mg TID as tolerated in adults and children greater than 50 kg; 1 mg/kg sildenafil TID without dose escalation in children less than 50 kg
|
|---|---|
|
Change in Cell Free Hemoglobin From Baseline to Week 12 Among Sildenafil Group
|
-67.60 ug/ml
Standard Error 48.03
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Of 14 patients in the Sildenafil arm, 4 patients with discrepant Tricuspid Regurgitant Jet Velocity (TRV) measurements between the local site, core lab and NHLBI readings and one patient who withdrew from the study were excluded. Patients in control group were only assessed at baseline. Therefore, 9 Sildenafil and 0 control patients were used.
Change in Arginase concentration was calculated as Arginase concentration at week 12 minus Arginase concentration at baseline.
Outcome measures
| Measure |
Sildenafil
n=9 Participants
Participants with thalassemia who have pulmonary hypertension received sildenafil for 12 weeks.
Sildenafil : Participants received sildenafil for 12 weeks with the following therapy:
50 mg of oral sildenafil three times a day (TID) increased to 100 mg TID as tolerated in adults and children greater than 50 kg; 1 mg/kg sildenafil TID without dose escalation in children less than 50 kg
|
|---|---|
|
Change in Arginase Concentration From Baseline to Week 12 Among Sildenafil Group
|
-17.06 ng/ml
Standard Error 16.25
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Of 14 patients in the Sildenafil arm, 4 patients with discrepant Tricuspid Regurgitant Jet Velocity (TRV) measurements between the local site, core lab and NHLBI readings and one patient who withdrew from the study were excluded. Patients in control group were only assessed at baseline. Therefore, 9 Sildenafil and 0 control patients were used.
Change in Arginase activity was calculated as Arginase activity at week 12 minus Arginase activity at baseline.
Outcome measures
| Measure |
Sildenafil
n=9 Participants
Participants with thalassemia who have pulmonary hypertension received sildenafil for 12 weeks.
Sildenafil : Participants received sildenafil for 12 weeks with the following therapy:
50 mg of oral sildenafil three times a day (TID) increased to 100 mg TID as tolerated in adults and children greater than 50 kg; 1 mg/kg sildenafil TID without dose escalation in children less than 50 kg
|
|---|---|
|
Change in Arginase Activity From Baseline to Week 12 Among Sildenafil Group
|
0.33 U/L
Standard Error 2.88
|
Adverse Events
Sildenafil
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sildenafil
n=14 participants at risk
Participants with thalassemia who have pulmonary hypertension received sildenafil for 12 weeks.
Sildenafil : Participants received sildenafil for 12 weeks with the following therapy:
50 mg of oral sildenafil three times a day (TID) increased to 100 mg TID as tolerated in adults and children greater than 50 kg; 1 mg/kg sildenafil TID without dose escalation in children less than 50 kg
|
Control
Participants with thalassemia who do not have pulmonary hypertension were part of a control group and were only undergoing screening/baseline assessments.
|
|---|---|---|
|
Eye disorders
Vision/color disturbance
|
7.1%
1/14 • Number of events 1 • up to Week 12
At each follow-up visit, Sildenafil patients were interviewed for medical conditions, medical changes, and symptoms that have occurred since the last visit. An Adverse Event (AE) form was completed if any AE was reported. A Serious Adverse Event form was completed for all AEs rated as serious. No AEs were collected for the control group.
|
—
0/0 • up to Week 12
At each follow-up visit, Sildenafil patients were interviewed for medical conditions, medical changes, and symptoms that have occurred since the last visit. An Adverse Event (AE) form was completed if any AE was reported. A Serious Adverse Event form was completed for all AEs rated as serious. No AEs were collected for the control group.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.1%
1/14 • Number of events 1 • up to Week 12
At each follow-up visit, Sildenafil patients were interviewed for medical conditions, medical changes, and symptoms that have occurred since the last visit. An Adverse Event (AE) form was completed if any AE was reported. A Serious Adverse Event form was completed for all AEs rated as serious. No AEs were collected for the control group.
|
—
0/0 • up to Week 12
At each follow-up visit, Sildenafil patients were interviewed for medical conditions, medical changes, and symptoms that have occurred since the last visit. An Adverse Event (AE) form was completed if any AE was reported. A Serious Adverse Event form was completed for all AEs rated as serious. No AEs were collected for the control group.
|
Other adverse events
| Measure |
Sildenafil
n=14 participants at risk
Participants with thalassemia who have pulmonary hypertension received sildenafil for 12 weeks.
Sildenafil : Participants received sildenafil for 12 weeks with the following therapy:
50 mg of oral sildenafil three times a day (TID) increased to 100 mg TID as tolerated in adults and children greater than 50 kg; 1 mg/kg sildenafil TID without dose escalation in children less than 50 kg
|
Control
Participants with thalassemia who do not have pulmonary hypertension were part of a control group and were only undergoing screening/baseline assessments.
|
|---|---|---|
|
General disorders
Fatigue
|
7.1%
1/14 • Number of events 1 • up to Week 12
At each follow-up visit, Sildenafil patients were interviewed for medical conditions, medical changes, and symptoms that have occurred since the last visit. An Adverse Event (AE) form was completed if any AE was reported. A Serious Adverse Event form was completed for all AEs rated as serious. No AEs were collected for the control group.
|
—
0/0 • up to Week 12
At each follow-up visit, Sildenafil patients were interviewed for medical conditions, medical changes, and symptoms that have occurred since the last visit. An Adverse Event (AE) form was completed if any AE was reported. A Serious Adverse Event form was completed for all AEs rated as serious. No AEs were collected for the control group.
|
|
Eye disorders
Photophobia
|
7.1%
1/14 • Number of events 1 • up to Week 12
At each follow-up visit, Sildenafil patients were interviewed for medical conditions, medical changes, and symptoms that have occurred since the last visit. An Adverse Event (AE) form was completed if any AE was reported. A Serious Adverse Event form was completed for all AEs rated as serious. No AEs were collected for the control group.
|
—
0/0 • up to Week 12
At each follow-up visit, Sildenafil patients were interviewed for medical conditions, medical changes, and symptoms that have occurred since the last visit. An Adverse Event (AE) form was completed if any AE was reported. A Serious Adverse Event form was completed for all AEs rated as serious. No AEs were collected for the control group.
|
|
Nervous system disorders
Headache
|
35.7%
5/14 • Number of events 6 • up to Week 12
At each follow-up visit, Sildenafil patients were interviewed for medical conditions, medical changes, and symptoms that have occurred since the last visit. An Adverse Event (AE) form was completed if any AE was reported. A Serious Adverse Event form was completed for all AEs rated as serious. No AEs were collected for the control group.
|
—
0/0 • up to Week 12
At each follow-up visit, Sildenafil patients were interviewed for medical conditions, medical changes, and symptoms that have occurred since the last visit. An Adverse Event (AE) form was completed if any AE was reported. A Serious Adverse Event form was completed for all AEs rated as serious. No AEs were collected for the control group.
|
|
Eye disorders
Vision/color disturbance
|
14.3%
2/14 • Number of events 3 • up to Week 12
At each follow-up visit, Sildenafil patients were interviewed for medical conditions, medical changes, and symptoms that have occurred since the last visit. An Adverse Event (AE) form was completed if any AE was reported. A Serious Adverse Event form was completed for all AEs rated as serious. No AEs were collected for the control group.
|
—
0/0 • up to Week 12
At each follow-up visit, Sildenafil patients were interviewed for medical conditions, medical changes, and symptoms that have occurred since the last visit. An Adverse Event (AE) form was completed if any AE was reported. A Serious Adverse Event form was completed for all AEs rated as serious. No AEs were collected for the control group.
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
7.1%
1/14 • Number of events 1 • up to Week 12
At each follow-up visit, Sildenafil patients were interviewed for medical conditions, medical changes, and symptoms that have occurred since the last visit. An Adverse Event (AE) form was completed if any AE was reported. A Serious Adverse Event form was completed for all AEs rated as serious. No AEs were collected for the control group.
|
—
0/0 • up to Week 12
At each follow-up visit, Sildenafil patients were interviewed for medical conditions, medical changes, and symptoms that have occurred since the last visit. An Adverse Event (AE) form was completed if any AE was reported. A Serious Adverse Event form was completed for all AEs rated as serious. No AEs were collected for the control group.
|
|
General disorders
Edema limbs
|
14.3%
2/14 • Number of events 2 • up to Week 12
At each follow-up visit, Sildenafil patients were interviewed for medical conditions, medical changes, and symptoms that have occurred since the last visit. An Adverse Event (AE) form was completed if any AE was reported. A Serious Adverse Event form was completed for all AEs rated as serious. No AEs were collected for the control group.
|
—
0/0 • up to Week 12
At each follow-up visit, Sildenafil patients were interviewed for medical conditions, medical changes, and symptoms that have occurred since the last visit. An Adverse Event (AE) form was completed if any AE was reported. A Serious Adverse Event form was completed for all AEs rated as serious. No AEs were collected for the control group.
|
|
General disorders
Dizziness
|
7.1%
1/14 • Number of events 1 • up to Week 12
At each follow-up visit, Sildenafil patients were interviewed for medical conditions, medical changes, and symptoms that have occurred since the last visit. An Adverse Event (AE) form was completed if any AE was reported. A Serious Adverse Event form was completed for all AEs rated as serious. No AEs were collected for the control group.
|
—
0/0 • up to Week 12
At each follow-up visit, Sildenafil patients were interviewed for medical conditions, medical changes, and symptoms that have occurred since the last visit. An Adverse Event (AE) form was completed if any AE was reported. A Serious Adverse Event form was completed for all AEs rated as serious. No AEs were collected for the control group.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.1%
1/14 • Number of events 1 • up to Week 12
At each follow-up visit, Sildenafil patients were interviewed for medical conditions, medical changes, and symptoms that have occurred since the last visit. An Adverse Event (AE) form was completed if any AE was reported. A Serious Adverse Event form was completed for all AEs rated as serious. No AEs were collected for the control group.
|
—
0/0 • up to Week 12
At each follow-up visit, Sildenafil patients were interviewed for medical conditions, medical changes, and symptoms that have occurred since the last visit. An Adverse Event (AE) form was completed if any AE was reported. A Serious Adverse Event form was completed for all AEs rated as serious. No AEs were collected for the control group.
|
|
Musculoskeletal and connective tissue disorders
Pain-other: sciatic pain of left leg with associated back pain
|
7.1%
1/14 • Number of events 1 • up to Week 12
At each follow-up visit, Sildenafil patients were interviewed for medical conditions, medical changes, and symptoms that have occurred since the last visit. An Adverse Event (AE) form was completed if any AE was reported. A Serious Adverse Event form was completed for all AEs rated as serious. No AEs were collected for the control group.
|
—
0/0 • up to Week 12
At each follow-up visit, Sildenafil patients were interviewed for medical conditions, medical changes, and symptoms that have occurred since the last visit. An Adverse Event (AE) form was completed if any AE was reported. A Serious Adverse Event form was completed for all AEs rated as serious. No AEs were collected for the control group.
|
|
Hepatobiliary disorders
INR increased
|
7.1%
1/14 • Number of events 1 • up to Week 12
At each follow-up visit, Sildenafil patients were interviewed for medical conditions, medical changes, and symptoms that have occurred since the last visit. An Adverse Event (AE) form was completed if any AE was reported. A Serious Adverse Event form was completed for all AEs rated as serious. No AEs were collected for the control group.
|
—
0/0 • up to Week 12
At each follow-up visit, Sildenafil patients were interviewed for medical conditions, medical changes, and symptoms that have occurred since the last visit. An Adverse Event (AE) form was completed if any AE was reported. A Serious Adverse Event form was completed for all AEs rated as serious. No AEs were collected for the control group.
|
|
Injury, poisoning and procedural complications
Phlebitis
|
7.1%
1/14 • Number of events 1 • up to Week 12
At each follow-up visit, Sildenafil patients were interviewed for medical conditions, medical changes, and symptoms that have occurred since the last visit. An Adverse Event (AE) form was completed if any AE was reported. A Serious Adverse Event form was completed for all AEs rated as serious. No AEs were collected for the control group.
|
—
0/0 • up to Week 12
At each follow-up visit, Sildenafil patients were interviewed for medical conditions, medical changes, and symptoms that have occurred since the last visit. An Adverse Event (AE) form was completed if any AE was reported. A Serious Adverse Event form was completed for all AEs rated as serious. No AEs were collected for the control group.
|
|
Eye disorders
Vision blurred
|
7.1%
1/14 • Number of events 1 • up to Week 12
At each follow-up visit, Sildenafil patients were interviewed for medical conditions, medical changes, and symptoms that have occurred since the last visit. An Adverse Event (AE) form was completed if any AE was reported. A Serious Adverse Event form was completed for all AEs rated as serious. No AEs were collected for the control group.
|
—
0/0 • up to Week 12
At each follow-up visit, Sildenafil patients were interviewed for medical conditions, medical changes, and symptoms that have occurred since the last visit. An Adverse Event (AE) form was completed if any AE was reported. A Serious Adverse Event form was completed for all AEs rated as serious. No AEs were collected for the control group.
|
|
Eye disorders
Ocular/visual - other (shining outline on objects)
|
7.1%
1/14 • Number of events 1 • up to Week 12
At each follow-up visit, Sildenafil patients were interviewed for medical conditions, medical changes, and symptoms that have occurred since the last visit. An Adverse Event (AE) form was completed if any AE was reported. A Serious Adverse Event form was completed for all AEs rated as serious. No AEs were collected for the control group.
|
—
0/0 • up to Week 12
At each follow-up visit, Sildenafil patients were interviewed for medical conditions, medical changes, and symptoms that have occurred since the last visit. An Adverse Event (AE) form was completed if any AE was reported. A Serious Adverse Event form was completed for all AEs rated as serious. No AEs were collected for the control group.
|
|
Reproductive system and breast disorders
Prolonged erection (priapism)
|
7.1%
1/14 • Number of events 2 • up to Week 12
At each follow-up visit, Sildenafil patients were interviewed for medical conditions, medical changes, and symptoms that have occurred since the last visit. An Adverse Event (AE) form was completed if any AE was reported. A Serious Adverse Event form was completed for all AEs rated as serious. No AEs were collected for the control group.
|
—
0/0 • up to Week 12
At each follow-up visit, Sildenafil patients were interviewed for medical conditions, medical changes, and symptoms that have occurred since the last visit. An Adverse Event (AE) form was completed if any AE was reported. A Serious Adverse Event form was completed for all AEs rated as serious. No AEs were collected for the control group.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
14.3%
2/14 • Number of events 2 • up to Week 12
At each follow-up visit, Sildenafil patients were interviewed for medical conditions, medical changes, and symptoms that have occurred since the last visit. An Adverse Event (AE) form was completed if any AE was reported. A Serious Adverse Event form was completed for all AEs rated as serious. No AEs were collected for the control group.
|
—
0/0 • up to Week 12
At each follow-up visit, Sildenafil patients were interviewed for medical conditions, medical changes, and symptoms that have occurred since the last visit. An Adverse Event (AE) form was completed if any AE was reported. A Serious Adverse Event form was completed for all AEs rated as serious. No AEs were collected for the control group.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place