Trial Outcomes & Findings for Studying the Treatment Effect of Pirfenidone in Chronic Lung Allograft Dysfunction (STOP-CLAD) (NCT NCT03473340)
NCT ID: NCT03473340
Last Updated: 2022-08-17
Results Overview
Evaluate if pirfenidone compared to placebo will stabilize progression of fSAD by comparison of inspiratory and expiratory high resolution computed tomography (HRCT) images through co-registration to provide quantitative measures of fSAD.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
Baseline, 24 weeks
Results posted on
2022-08-17
Participant Flow
Participant milestones
| Measure |
Pirfenidone Capsule
Method of Administration: Oral (capsule)
Dosing:
* Days 1 through 7, 267 mg three times daily;
* Days 8 through 14, 534 mg three times daily;
* Days 15 through end of treatment (24 weeks), 801 mg three times daily
Pirfenidone Capsule: Dosing:
Days 1 through 7, 267 mg three times daily; Days 8 through 14, 534 mg three times daily; Days 15 through end of treatment (24 weeks), 801 mg three times daily duration: 24 weeks
|
Placebo Capsule
Method of Administration: Oral (capsule)
Dosing:
* Days 1 through 7, 267 mg three times daily;
* Days 8 through 14, 534 mg three times daily;
* Days 15 through end of treatment (24 weeks), 801 mg three times daily
Placebo Capsule: Dosing:
* Days 1 through 7, 267 mg three times daily;
* Days 8 through 14, 534 mg three times daily;
* Days 15 through end of treatment (24 weeks), 801 mg three times daily duration: 24 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
11
|
|
Overall Study
COMPLETED
|
8
|
9
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
Reasons for withdrawal
| Measure |
Pirfenidone Capsule
Method of Administration: Oral (capsule)
Dosing:
* Days 1 through 7, 267 mg three times daily;
* Days 8 through 14, 534 mg three times daily;
* Days 15 through end of treatment (24 weeks), 801 mg three times daily
Pirfenidone Capsule: Dosing:
Days 1 through 7, 267 mg three times daily; Days 8 through 14, 534 mg three times daily; Days 15 through end of treatment (24 weeks), 801 mg three times daily duration: 24 weeks
|
Placebo Capsule
Method of Administration: Oral (capsule)
Dosing:
* Days 1 through 7, 267 mg three times daily;
* Days 8 through 14, 534 mg three times daily;
* Days 15 through end of treatment (24 weeks), 801 mg three times daily
Placebo Capsule: Dosing:
* Days 1 through 7, 267 mg three times daily;
* Days 8 through 14, 534 mg three times daily;
* Days 15 through end of treatment (24 weeks), 801 mg three times daily duration: 24 weeks
|
|---|---|---|
|
Overall Study
Follow up not possible due to COVID restrictions
|
3
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
Baseline Characteristics
Studying the Treatment Effect of Pirfenidone in Chronic Lung Allograft Dysfunction (STOP-CLAD)
Baseline characteristics by cohort
| Measure |
Pirfenidone Capsule
n=13 Participants
Method of Administration: Oral (capsule)
Dosing:
* Days 1 through 7, 267 mg three times daily;
* Days 8 through 14, 534 mg three times daily;
* Days 15 through end of treatment (24 weeks), 801 mg three times daily
Pirfenidone Capsule: Dosing:
Days 1 through 7, 267 mg three times daily; Days 8 through 14, 534 mg three times daily; Days 15 through end of treatment (24 weeks), 801 mg three times daily duration: 24 weeks
|
Placebo Capsule
n=11 Participants
Method of Administration: Oral (capsule)
Dosing:
* Days 1 through 7, 267 mg three times daily;
* Days 8 through 14, 534 mg three times daily;
* Days 15 through end of treatment (24 weeks), 801 mg three times daily
Placebo Capsule: Dosing:
* Days 1 through 7, 267 mg three times daily;
* Days 8 through 14, 534 mg three times daily;
* Days 15 through end of treatment (24 weeks), 801 mg three times daily duration: 24 weeks
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.6 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
57.5 years
STANDARD_DEVIATION 13.5 • n=7 Participants
|
58.6 years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Lung Function FEV 1, FVC,
FEV1
|
1.400769 liters
STANDARD_DEVIATION 0.5887057 • n=5 Participants
|
1.410909 liters
STANDARD_DEVIATION 0.4713906 • n=7 Participants
|
1.41 liters
STANDARD_DEVIATION 0.527 • n=5 Participants
|
|
Lung Function FEV 1, FVC,
FVC
|
2.544615 liters
STANDARD_DEVIATION 0.8378904 • n=5 Participants
|
2.517273 liters
STANDARD_DEVIATION 0.7226353 • n=7 Participants
|
2.53 liters
STANDARD_DEVIATION 0.77 • n=5 Participants
|
|
CLAD Phenotype
FEV1 First Decline
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
CLAD Phenotype
Concurrent FEV1 and FVC Decline
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 24 weeksPopulation: Baseline measures taken from all participants. Post treatment percentage measurements taken only from participants who completed the study.
Evaluate if pirfenidone compared to placebo will stabilize progression of fSAD by comparison of inspiratory and expiratory high resolution computed tomography (HRCT) images through co-registration to provide quantitative measures of fSAD.
Outcome measures
| Measure |
Pirfenidone Capsule
n=13 Participants
Method of Administration: Oral (capsule)
Dosing:
* Days 1 through 7, 267 mg three times daily;
* Days 8 through 14, 534 mg three times daily;
* Days 15 through end of treatment (24 weeks), 801 mg three times daily
Pirfenidone Capsule: Dosing:
Days 1 through 7, 267 mg three times daily; Days 8 through 14, 534 mg three times daily; Days 15 through end of treatment (24 weeks), 801 mg three times daily duration: 24 weeks
|
Placebo Capsule
n=11 Participants
Method of Administration: Oral (capsule)
Dosing:
* Days 1 through 7, 267 mg three times daily;
* Days 8 through 14, 534 mg three times daily;
* Days 15 through end of treatment (24 weeks), 801 mg three times daily
Placebo Capsule: Dosing:
* Days 1 through 7, 267 mg three times daily;
* Days 8 through 14, 534 mg three times daily;
* Days 15 through end of treatment (24 weeks), 801 mg three times daily duration: 24 weeks
|
|---|---|---|
|
Change in Percent of Functional Small Airways Disease (fSAD) as Measured by Parametric Response Mapping
Baseline percentage fSAD
|
14.21 percentage of change of fsad
Standard Deviation 8.80
|
11.90 percentage of change of fsad
Standard Deviation 13.08
|
|
Change in Percent of Functional Small Airways Disease (fSAD) as Measured by Parametric Response Mapping
Post treatment percentage fSAD
|
17.10 percentage of change of fsad
Standard Deviation 6.43
|
10.62 percentage of change of fsad
Standard Deviation 9.25
|
|
Change in Percent of Functional Small Airways Disease (fSAD) as Measured by Parametric Response Mapping
Net change
|
-5.8620625 percentage of change of fsad
Standard Deviation 6.636287
|
0.4497328 percentage of change of fsad
Standard Deviation 10.91197
|
SECONDARY outcome
Timeframe: Baseline, 24 weeksPopulation: Baseline measures taken from all participants. Post treatment percentage measurements taken only from participants with available FEV1 results at 24-week mark.
Measured by spirometry
Outcome measures
| Measure |
Pirfenidone Capsule
n=13 Participants
Method of Administration: Oral (capsule)
Dosing:
* Days 1 through 7, 267 mg three times daily;
* Days 8 through 14, 534 mg three times daily;
* Days 15 through end of treatment (24 weeks), 801 mg three times daily
Pirfenidone Capsule: Dosing:
Days 1 through 7, 267 mg three times daily; Days 8 through 14, 534 mg three times daily; Days 15 through end of treatment (24 weeks), 801 mg three times daily duration: 24 weeks
|
Placebo Capsule
n=11 Participants
Method of Administration: Oral (capsule)
Dosing:
* Days 1 through 7, 267 mg three times daily;
* Days 8 through 14, 534 mg three times daily;
* Days 15 through end of treatment (24 weeks), 801 mg three times daily
Placebo Capsule: Dosing:
* Days 1 through 7, 267 mg three times daily;
* Days 8 through 14, 534 mg three times daily;
* Days 15 through end of treatment (24 weeks), 801 mg three times daily duration: 24 weeks
|
|---|---|---|
|
Change in Forced Expiratory Volume 1 Over 24 Weeks (FEV1)
Change in FEV1
|
-0.12 liters
Standard Deviation 0.13
|
-0.09 liters
Standard Deviation 0.30
|
|
Change in Forced Expiratory Volume 1 Over 24 Weeks (FEV1)
Baseline FEV1
|
1.40 liters
Standard Deviation 0.59
|
1.41 liters
Standard Deviation 0.47
|
|
Change in Forced Expiratory Volume 1 Over 24 Weeks (FEV1)
24 week FEV1
|
1.36 liters
Standard Deviation 0.57
|
1.35 liters
Standard Deviation 0.54
|
SECONDARY outcome
Timeframe: Baseline, 24 weeksPopulation: Baseline measures taken from all participants. Post treatment percentage measurements taken only from participants with available FVC results at 24-week mark.
Measured by spirometry
Outcome measures
| Measure |
Pirfenidone Capsule
n=13 Participants
Method of Administration: Oral (capsule)
Dosing:
* Days 1 through 7, 267 mg three times daily;
* Days 8 through 14, 534 mg three times daily;
* Days 15 through end of treatment (24 weeks), 801 mg three times daily
Pirfenidone Capsule: Dosing:
Days 1 through 7, 267 mg three times daily; Days 8 through 14, 534 mg three times daily; Days 15 through end of treatment (24 weeks), 801 mg three times daily duration: 24 weeks
|
Placebo Capsule
n=11 Participants
Method of Administration: Oral (capsule)
Dosing:
* Days 1 through 7, 267 mg three times daily;
* Days 8 through 14, 534 mg three times daily;
* Days 15 through end of treatment (24 weeks), 801 mg three times daily
Placebo Capsule: Dosing:
* Days 1 through 7, 267 mg three times daily;
* Days 8 through 14, 534 mg three times daily;
* Days 15 through end of treatment (24 weeks), 801 mg three times daily duration: 24 weeks
|
|---|---|---|
|
Change in Forced Vital Capacity (FVC) Over 24 Weeks
Baseline FVC
|
2.54 liters
Standard Deviation 0.84
|
2.52 liters
Standard Deviation 0.72
|
|
Change in Forced Vital Capacity (FVC) Over 24 Weeks
24-week FVC
|
2.52 liters
Standard Deviation 0.87
|
2.36 liters
Standard Deviation 0.86
|
|
Change in Forced Vital Capacity (FVC) Over 24 Weeks
Change in FVC
|
-0.06 liters
Standard Deviation 0.25
|
-0.12 liters
Standard Deviation 0.40
|
SECONDARY outcome
Timeframe: 28 weeksSafety of pirfenidone will be measured by adverse events determined to be related to the study drug through review of medical history, physical exam and laboratory findings.
Outcome measures
| Measure |
Pirfenidone Capsule
n=13 Participants
Method of Administration: Oral (capsule)
Dosing:
* Days 1 through 7, 267 mg three times daily;
* Days 8 through 14, 534 mg three times daily;
* Days 15 through end of treatment (24 weeks), 801 mg three times daily
Pirfenidone Capsule: Dosing:
Days 1 through 7, 267 mg three times daily; Days 8 through 14, 534 mg three times daily; Days 15 through end of treatment (24 weeks), 801 mg three times daily duration: 24 weeks
|
Placebo Capsule
n=11 Participants
Method of Administration: Oral (capsule)
Dosing:
* Days 1 through 7, 267 mg three times daily;
* Days 8 through 14, 534 mg three times daily;
* Days 15 through end of treatment (24 weeks), 801 mg three times daily
Placebo Capsule: Dosing:
* Days 1 through 7, 267 mg three times daily;
* Days 8 through 14, 534 mg three times daily;
* Days 15 through end of treatment (24 weeks), 801 mg three times daily duration: 24 weeks
|
|---|---|---|
|
Number of Adverse Events Related to Study Treatment
AE Definitely Related
|
0 Adverse Events
|
0 Adverse Events
|
|
Number of Adverse Events Related to Study Treatment
AE Probably Related
|
4 Adverse Events
|
0 Adverse Events
|
|
Number of Adverse Events Related to Study Treatment
AE Possibly Related
|
15 Adverse Events
|
10 Adverse Events
|
|
Number of Adverse Events Related to Study Treatment
AE Unlikely to be Related
|
8 Adverse Events
|
10 Adverse Events
|
|
Number of Adverse Events Related to Study Treatment
AE Definitely Not Related
|
1 Adverse Events
|
12 Adverse Events
|
SECONDARY outcome
Timeframe: 24 weeksSubjects permanently discontinuing study medication before 24 weeks
Outcome measures
| Measure |
Pirfenidone Capsule
n=13 Participants
Method of Administration: Oral (capsule)
Dosing:
* Days 1 through 7, 267 mg three times daily;
* Days 8 through 14, 534 mg three times daily;
* Days 15 through end of treatment (24 weeks), 801 mg three times daily
Pirfenidone Capsule: Dosing:
Days 1 through 7, 267 mg three times daily; Days 8 through 14, 534 mg three times daily; Days 15 through end of treatment (24 weeks), 801 mg three times daily duration: 24 weeks
|
Placebo Capsule
n=11 Participants
Method of Administration: Oral (capsule)
Dosing:
* Days 1 through 7, 267 mg three times daily;
* Days 8 through 14, 534 mg three times daily;
* Days 15 through end of treatment (24 weeks), 801 mg three times daily
Placebo Capsule: Dosing:
* Days 1 through 7, 267 mg three times daily;
* Days 8 through 14, 534 mg three times daily;
* Days 15 through end of treatment (24 weeks), 801 mg three times daily duration: 24 weeks
|
|---|---|---|
|
Number of Subjects With Treatment Intolerance
Drug Discontinued
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Treatment Intolerance
Drug Not Discontinued, but Held or Dose Reduced
|
5 Participants
|
3 Participants
|
|
Number of Subjects With Treatment Intolerance
Drug Tolerated
|
4 Participants
|
6 Participants
|
Adverse Events
Pirfenidone Capsule
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Placebo Capsule
Serious events: 4 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pirfenidone Capsule
n=13 participants at risk
Method of Administration: Oral (capsule)
Dosing:
* Days 1 through 7, 267 mg three times daily;
* Days 8 through 14, 534 mg three times daily;
* Days 15 through end of treatment (24 weeks), 801 mg three times daily
Pirfenidone Capsule: Dosing:
Days 1 through 7, 267 mg three times daily; Days 8 through 14, 534 mg three times daily; Days 15 through end of treatment (24 weeks), 801 mg three times daily duration: 24 weeks
|
Placebo Capsule
n=11 participants at risk
Method of Administration: Oral (capsule)
Dosing:
* Days 1 through 7, 267 mg three times daily;
* Days 8 through 14, 534 mg three times daily;
* Days 15 through end of treatment (24 weeks), 801 mg three times daily
Placebo Capsule: Dosing:
* Days 1 through 7, 267 mg three times daily;
* Days 8 through 14, 534 mg three times daily;
* Days 15 through end of treatment (24 weeks), 801 mg three times daily duration: 24 weeks
|
|---|---|---|
|
Infections and infestations
C. difficile colitis
|
0.00%
0/13 • 28 weeks from start of treatment
|
9.1%
1/11 • 28 weeks from start of treatment
|
|
Infections and infestations
Respiratory infection
|
0.00%
0/13 • 28 weeks from start of treatment
|
18.2%
2/11 • 28 weeks from start of treatment
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/13 • 28 weeks from start of treatment
|
9.1%
1/11 • 28 weeks from start of treatment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/13 • 28 weeks from start of treatment
|
9.1%
1/11 • 28 weeks from start of treatment
|
Other adverse events
| Measure |
Pirfenidone Capsule
n=13 participants at risk
Method of Administration: Oral (capsule)
Dosing:
* Days 1 through 7, 267 mg three times daily;
* Days 8 through 14, 534 mg three times daily;
* Days 15 through end of treatment (24 weeks), 801 mg three times daily
Pirfenidone Capsule: Dosing:
Days 1 through 7, 267 mg three times daily; Days 8 through 14, 534 mg three times daily; Days 15 through end of treatment (24 weeks), 801 mg three times daily duration: 24 weeks
|
Placebo Capsule
n=11 participants at risk
Method of Administration: Oral (capsule)
Dosing:
* Days 1 through 7, 267 mg three times daily;
* Days 8 through 14, 534 mg three times daily;
* Days 15 through end of treatment (24 weeks), 801 mg three times daily
Placebo Capsule: Dosing:
* Days 1 through 7, 267 mg three times daily;
* Days 8 through 14, 534 mg three times daily;
* Days 15 through end of treatment (24 weeks), 801 mg three times daily duration: 24 weeks
|
|---|---|---|
|
General disorders
Edema
|
0.00%
0/13 • 28 weeks from start of treatment
|
9.1%
1/11 • 28 weeks from start of treatment
|
|
General disorders
Fatigue
|
7.7%
1/13 • 28 weeks from start of treatment
|
9.1%
1/11 • 28 weeks from start of treatment
|
|
General disorders
Fever
|
0.00%
0/13 • 28 weeks from start of treatment
|
9.1%
1/11 • 28 weeks from start of treatment
|
|
General disorders
Headache
|
15.4%
2/13 • 28 weeks from start of treatment
|
0.00%
0/11 • 28 weeks from start of treatment
|
|
General disorders
Leukocytosis
|
0.00%
0/13 • 28 weeks from start of treatment
|
9.1%
1/11 • 28 weeks from start of treatment
|
|
General disorders
Lightheadedness/syncope
|
7.7%
1/13 • 28 weeks from start of treatment
|
0.00%
0/11 • 28 weeks from start of treatment
|
|
General disorders
Myalgias
|
7.7%
1/13 • 28 weeks from start of treatment
|
9.1%
1/11 • 28 weeks from start of treatment
|
|
General disorders
Sleep disturbance
|
7.7%
1/13 • 28 weeks from start of treatment
|
0.00%
0/11 • 28 weeks from start of treatment
|
|
General disorders
Weight gain
|
0.00%
0/13 • 28 weeks from start of treatment
|
9.1%
1/11 • 28 weeks from start of treatment
|
|
Gastrointestinal disorders
Belching
|
7.7%
1/13 • 28 weeks from start of treatment
|
9.1%
1/11 • 28 weeks from start of treatment
|
|
Gastrointestinal disorders
Constipation
|
7.7%
1/13 • 28 weeks from start of treatment
|
0.00%
0/11 • 28 weeks from start of treatment
|
|
Gastrointestinal disorders
Diarrhea
|
30.8%
4/13 • 28 weeks from start of treatment
|
27.3%
3/11 • 28 weeks from start of treatment
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/13 • 28 weeks from start of treatment
|
9.1%
1/11 • 28 weeks from start of treatment
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
23.1%
3/13 • 28 weeks from start of treatment
|
0.00%
0/11 • 28 weeks from start of treatment
|
|
Gastrointestinal disorders
Gastrointestinal upset
|
15.4%
2/13 • 28 weeks from start of treatment
|
9.1%
1/11 • 28 weeks from start of treatment
|
|
Gastrointestinal disorders
Nausea
|
61.5%
8/13 • 28 weeks from start of treatment
|
18.2%
2/11 • 28 weeks from start of treatment
|
|
Hepatobiliary disorders
Liver function test abnormalities
|
0.00%
0/13 • 28 weeks from start of treatment
|
9.1%
1/11 • 28 weeks from start of treatment
|
|
Infections and infestations
Respiratory infection
|
7.7%
1/13 • 28 weeks from start of treatment
|
18.2%
2/11 • 28 weeks from start of treatment
|
|
Skin and subcutaneous tissue disorders
Acne
|
7.7%
1/13 • 28 weeks from start of treatment
|
9.1%
1/11 • 28 weeks from start of treatment
|
|
Skin and subcutaneous tissue disorders
Dry eyes
|
0.00%
0/13 • 28 weeks from start of treatment
|
9.1%
1/11 • 28 weeks from start of treatment
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/13 • 28 weeks from start of treatment
|
18.2%
2/11 • 28 weeks from start of treatment
|
|
Skin and subcutaneous tissue disorders
Facial hair growth
|
0.00%
0/13 • 28 weeks from start of treatment
|
9.1%
1/11 • 28 weeks from start of treatment
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.7%
1/13 • 28 weeks from start of treatment
|
0.00%
0/11 • 28 weeks from start of treatment
|
|
Skin and subcutaneous tissue disorders
Salty lips
|
0.00%
0/13 • 28 weeks from start of treatment
|
9.1%
1/11 • 28 weeks from start of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.7%
1/13 • 28 weeks from start of treatment
|
9.1%
1/11 • 28 weeks from start of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory congestion
|
7.7%
1/13 • 28 weeks from start of treatment
|
18.2%
2/11 • 28 weeks from start of treatment
|
|
Cardiac disorders
Atrial fibrillation
|
7.7%
1/13 • 28 weeks from start of treatment
|
0.00%
0/11 • 28 weeks from start of treatment
|
|
Cardiac disorders
Chest pain
|
0.00%
0/13 • 28 weeks from start of treatment
|
9.1%
1/11 • 28 weeks from start of treatment
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/13 • 28 weeks from start of treatment
|
9.1%
1/11 • 28 weeks from start of treatment
|
|
Renal and urinary disorders
Overactive bladder
|
0.00%
0/13 • 28 weeks from start of treatment
|
9.1%
1/11 • 28 weeks from start of treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place