Trial Outcomes & Findings for A Pilot Study of the Use of 129Xe and 1H MRI to Measure the Modulation of Eosinophil-Related Inflammation by Mepolizumab In COPD (NCT NCT05138250)
NCT ID: NCT05138250
Last Updated: 2026-05-07
Results Overview
The within subject change in VDP assessed by XeMRI from baseline to 12 weeks of treatment with mepolizumab. Since the protocol was written, the convention has been to report ventilation defect, the percentage of lung that is not ventilated, rather than %VV, the percentage that is ventilated. A decrease in ventilation defect is an improvement in ventilation.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
31 participants
Primary outcome timeframe
Baseline to 12 weeks of treatment
Results posted on
2026-05-07
Participant Flow
This is not a randomised controlled trial, so all participants who were confirmed as eligible after the screening visit were allocated to receive the study drug.
Participant milestones
| Measure |
Participants Who Received the Study Drug (All Eligible Participants)
Participants who received the study drug (All eligible participants)
|
|---|---|
|
Participants completing assessment 1
STARTED
|
31
|
|
Participants completing assessment 1
COMPLETED
|
31
|
|
Participants completing assessment 1
NOT COMPLETED
|
0
|
|
Participants completing assessment 2
STARTED
|
31
|
|
Participants completing assessment 2
COMPLETED
|
25
|
|
Participants completing assessment 2
NOT COMPLETED
|
6
|
|
Participants completing assessment 3
STARTED
|
27
|
|
Participants completing assessment 3
COMPLETED
|
21
|
|
Participants completing assessment 3
NOT COMPLETED
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Pilot Study of the Use of 129Xe and 1H MRI to Measure the Modulation of Eosinophil-Related Inflammation by Mepolizumab In COPD
Baseline characteristics by cohort
| Measure |
Participants Completing Assessment 2
n=25 Participants
Participants who completed the 12 week MRI assessment visit
|
|---|---|
|
Age, Continuous
|
67.6 years
STANDARD_DEVIATION 9.77 • n=54 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=54 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=54 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=54 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=54 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
PRIMARY outcome
Timeframe: Baseline to 12 weeks of treatmentThe within subject change in VDP assessed by XeMRI from baseline to 12 weeks of treatment with mepolizumab. Since the protocol was written, the convention has been to report ventilation defect, the percentage of lung that is not ventilated, rather than %VV, the percentage that is ventilated. A decrease in ventilation defect is an improvement in ventilation.
Outcome measures
| Measure |
Treatment Arm (All Participants, Not Randomised)
n=25 Participants
All participants will be treated with mepolizumab, a 100mg dose every 4 weeks for 1 year (13 doses)
Mepolizumab 100 MG: participants will receive 100mg of mepolizumab every 4 weeks for 52 weeks
|
High Exacerbators
Participants who had \> 2 moderate or severe exacerbations in 12months
|
|---|---|---|
|
Change in Percentage Ventilated Defect Percent (VDP)
|
-0.14 % change in VDP
Standard Deviation 6.5
|
—
|
PRIMARY outcome
Timeframe: From Baseline to 12 weeks of treatmentPopulation: There was missing data for 4 participants for this measure.
The within participant change in membrane (M)/gas (the ratio of xenon dissolved in the alveolar membrane to gaseous xenon in the airspaces, a measure of alveolar membrane absorption) assessed by XeMRI from baseline to 12 weeks of mepolizumab as an index of pulmonary inflammation. M/gas is a measure of alveolar thickness, which is an index of pulmonary inflammation. An decrease in M/gas indicates reduced inflammation.
Outcome measures
| Measure |
Treatment Arm (All Participants, Not Randomised)
n=21 Participants
All participants will be treated with mepolizumab, a 100mg dose every 4 weeks for 1 year (13 doses)
Mepolizumab 100 MG: participants will receive 100mg of mepolizumab every 4 weeks for 52 weeks
|
High Exacerbators
Participants who had \> 2 moderate or severe exacerbations in 12months
|
|---|---|---|
|
Change in Pulmonary Inflammation
|
-0.00009 ratio
Interval -0.00025 to 0.00026
|
—
|
SECONDARY outcome
Timeframe: From Baseline to 12 weeks of treatmentPopulation: Moderate and severe exacerbations were counted for the 20 participants who completed the full 52 weeks of the study, of these data was collected for this outcome measure in 17 participants. The two groups were similar in terms of age, sex, smoking status, breathlessness, CAT score, and spirometry. Baseline eosinophil count and FeNO was similar and only differed in exacerbation number.
Comparison of change in MRI metrics (Longitudinal relaxation time (T1)) from baseline to 12 weeks in groups with a) low or b) high total 52 week exacerbation (groups defined by median split of total exacerbations over 52 weeks assessed by EXACT-Pro). Longitudinal relaxation time (T1) is intrinsic MRI relaxation time affected by changes in tissue water content, this measure is expected to increase with inflammation.
Outcome measures
| Measure |
Treatment Arm (All Participants, Not Randomised)
n=11 Participants
All participants will be treated with mepolizumab, a 100mg dose every 4 weeks for 1 year (13 doses)
Mepolizumab 100 MG: participants will receive 100mg of mepolizumab every 4 weeks for 52 weeks
|
High Exacerbators
n=6 Participants
Participants who had \> 2 moderate or severe exacerbations in 12months
|
|---|---|---|
|
Change in MRI Metrics in Low and High Exacerbation Groups - Longitudinal Relaxation Time (T1)
|
53 ms
Standard Deviation 147
|
-4 ms
Standard Deviation 81
|
SECONDARY outcome
Timeframe: From Baseline to 12 weeks of treatmentPopulation: Moderate and severe exacerbations were counted for the 20 participants who completed the full 52 weeks of the study, data for this outcome measure was collected in 17 participants. The two groups were similar in terms of age, sex, smoking status, breathlessness, CAT score, and spirometry. Baseline eosinophil count and FeNO was similar and only differed in exacerbation number.
Comparison of change in MRI metrics (Proton spin density (M0)) from baseline to 12 weeks in groups with a) low or b) high total 52 week exacerbation (groups defined by median split of total exacerbations over 52 weeks assessed by EXACT-Pro). Proton spin density (M0) is a measure of parenchymal density affected by changes in tissue water content, this measure is expected to increase with inflammation.
Outcome measures
| Measure |
Treatment Arm (All Participants, Not Randomised)
n=11 Participants
All participants will be treated with mepolizumab, a 100mg dose every 4 weeks for 1 year (13 doses)
Mepolizumab 100 MG: participants will receive 100mg of mepolizumab every 4 weeks for 52 weeks
|
High Exacerbators
n=6 Participants
Participants who had \> 2 moderate or severe exacerbations in 12months
|
|---|---|---|
|
Change in MRI Metrics in Low and High Exacerbation Groups - M0
|
36 arbitrary units
Standard Deviation 206
|
-3 arbitrary units
Standard Deviation 130
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From Baseline to 52 weeks of treatmentChange in MRI indices of ventilation. %VV at 52 weeks compared to baseline, as measured by Xenon MRI scan. An increase in ventilated volume indicates an increase in the area of lung that oxygen can reach.
Outcome measures
| Measure |
Treatment Arm (All Participants, Not Randomised)
n=20 Participants
All participants will be treated with mepolizumab, a 100mg dose every 4 weeks for 1 year (13 doses)
Mepolizumab 100 MG: participants will receive 100mg of mepolizumab every 4 weeks for 52 weeks
|
High Exacerbators
Participants who had \> 2 moderate or severe exacerbations in 12months
|
|---|---|---|
|
Change in MRI Indices of Ventilation - 52 Weeks
|
68.1 % Ventilated lung volume
Standard Deviation 13.9
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From Baseline to 12 weeks of treatmentPopulation: 25 individuals had usable data for this outcome measure at week 12. 286 correlations were made between physiological measures and MRI measures of lung function
Correlation of change in physiological measures and MRI measures of lung function and inflammation at 12 weeks. Correlations were made between the change in 13 lung function measurements and 22 MRI measurements between 0-12 weeks.
Outcome measures
| Measure |
Treatment Arm (All Participants, Not Randomised)
n=286 correlations
All participants will be treated with mepolizumab, a 100mg dose every 4 weeks for 1 year (13 doses)
Mepolizumab 100 MG: participants will receive 100mg of mepolizumab every 4 weeks for 52 weeks
|
High Exacerbators
Participants who had \> 2 moderate or severe exacerbations in 12months
|
|---|---|---|
|
Correlation of Changes to Measures of Lung Function and Inflammation (MRI and Physiological)
|
14 significant correlations
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From Baseline to 12 weeks of treatmentPopulation: 25 participants had usable data at this time point 188 correlations were made between ken physiological measures and MRI determined measures of ventilation, perfusion and inflammation
Correlations of change in 4 key physiological and MRI determined measures of ventilation, perfusion and inflammation (47 measures) at 12 weeks from baseline were calculated.
Outcome measures
| Measure |
Treatment Arm (All Participants, Not Randomised)
n=188 correlations
All participants will be treated with mepolizumab, a 100mg dose every 4 weeks for 1 year (13 doses)
Mepolizumab 100 MG: participants will receive 100mg of mepolizumab every 4 weeks for 52 weeks
|
High Exacerbators
Participants who had \> 2 moderate or severe exacerbations in 12months
|
|---|---|---|
|
Various Correlations of Change of Ventilation, Perfusion and Inflammation Measures
|
15 significant correlations
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From Baseline to 12 weeks of treatmentPopulation: 25 participants had usable data at this timepoint CAT was correlated with 36 measures of lung function by physiology and MRI.
Comparison of change of COPD Assessment Test from baseline to 12 weeks within participants compare to changes in measures of lung function by physiology and MRI.
Outcome measures
| Measure |
Treatment Arm (All Participants, Not Randomised)
n=36 correlations
All participants will be treated with mepolizumab, a 100mg dose every 4 weeks for 1 year (13 doses)
Mepolizumab 100 MG: participants will receive 100mg of mepolizumab every 4 weeks for 52 weeks
|
High Exacerbators
Participants who had \> 2 moderate or severe exacerbations in 12months
|
|---|---|---|
|
Overall Impact of Mepolizumab Treatment on HRQoL in COPD (12 Weeks)
|
0 significant correlations
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From Baseline to 52 weeks of treatmentPopulation: 20 participants had usable data at this timepoint CAT scores were correlated with 36 measures of lung function by physiology and MRI
Comparison of change of COPD Assessment Test from baseline to 52 weeks within participants compare to changes in measures of lung function by physiology and MRI (36 measures).
Outcome measures
| Measure |
Treatment Arm (All Participants, Not Randomised)
n=36 correlations
All participants will be treated with mepolizumab, a 100mg dose every 4 weeks for 1 year (13 doses)
Mepolizumab 100 MG: participants will receive 100mg of mepolizumab every 4 weeks for 52 weeks
|
High Exacerbators
Participants who had \> 2 moderate or severe exacerbations in 12months
|
|---|---|---|
|
Overall Impact of Mepolizumab Treatment on HRQoL in COPD (52 Weeks)
|
4 significant correlations
|
—
|
Adverse Events
All Participants Entering the Study
Serious events: 7 serious events
Other events: 31 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
All Participants Entering the Study
n=31 participants at risk
All participants from the point of consent (31) whether or not they received study drug.
|
|---|---|
|
Nervous system disorders
Hemiplegic Migraine
|
3.2%
1/31 • Number of events 3 • Consent to end of participant involvement. maximum 16months
Definitions as per clinicaltrials.gov definitions Acute exacerbations of COPD were not included in AE assessment as these were captured as endpoint data
|
|
Immune system disorders
Anaphylaxis
|
6.5%
2/31 • Number of events 2 • Consent to end of participant involvement. maximum 16months
Definitions as per clinicaltrials.gov definitions Acute exacerbations of COPD were not included in AE assessment as these were captured as endpoint data
|
|
Renal and urinary disorders
Renal Failure
|
3.2%
1/31 • Number of events 1 • Consent to end of participant involvement. maximum 16months
Definitions as per clinicaltrials.gov definitions Acute exacerbations of COPD were not included in AE assessment as these were captured as endpoint data
|
|
Infections and infestations
Pneumonia
|
3.2%
1/31 • Number of events 1 • Consent to end of participant involvement. maximum 16months
Definitions as per clinicaltrials.gov definitions Acute exacerbations of COPD were not included in AE assessment as these were captured as endpoint data
|
|
Renal and urinary disorders
Pyelonephritis
|
3.2%
1/31 • Number of events 1 • Consent to end of participant involvement. maximum 16months
Definitions as per clinicaltrials.gov definitions Acute exacerbations of COPD were not included in AE assessment as these were captured as endpoint data
|
|
Renal and urinary disorders
Benign prostatic hyperplasia (BPH)
|
3.2%
1/31 • Number of events 1 • Consent to end of participant involvement. maximum 16months
Definitions as per clinicaltrials.gov definitions Acute exacerbations of COPD were not included in AE assessment as these were captured as endpoint data
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
3.2%
1/31 • Number of events 1 • Consent to end of participant involvement. maximum 16months
Definitions as per clinicaltrials.gov definitions Acute exacerbations of COPD were not included in AE assessment as these were captured as endpoint data
|
|
Gastrointestinal disorders
Acute Cholecystitis
|
3.2%
1/31 • Number of events 2 • Consent to end of participant involvement. maximum 16months
Definitions as per clinicaltrials.gov definitions Acute exacerbations of COPD were not included in AE assessment as these were captured as endpoint data
|
|
Gastrointestinal disorders
Constipation
|
3.2%
1/31 • Number of events 1 • Consent to end of participant involvement. maximum 16months
Definitions as per clinicaltrials.gov definitions Acute exacerbations of COPD were not included in AE assessment as these were captured as endpoint data
|
Other adverse events
| Measure |
All Participants Entering the Study
n=31 participants at risk
All participants from the point of consent (31) whether or not they received study drug.
|
|---|---|
|
Injury, poisoning and procedural complications
Arthropod bite
|
6.5%
2/31 • Number of events 2 • Consent to end of participant involvement. maximum 16months
Definitions as per clinicaltrials.gov definitions Acute exacerbations of COPD were not included in AE assessment as these were captured as endpoint data
|
|
Investigations
Blood pressure increased
|
6.5%
2/31 • Number of events 2 • Consent to end of participant involvement. maximum 16months
Definitions as per clinicaltrials.gov definitions Acute exacerbations of COPD were not included in AE assessment as these were captured as endpoint data
|
|
Investigations
Weight decreased
|
6.5%
2/31 • Number of events 2 • Consent to end of participant involvement. maximum 16months
Definitions as per clinicaltrials.gov definitions Acute exacerbations of COPD were not included in AE assessment as these were captured as endpoint data
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.5%
2/31 • Number of events 2 • Consent to end of participant involvement. maximum 16months
Definitions as per clinicaltrials.gov definitions Acute exacerbations of COPD were not included in AE assessment as these were captured as endpoint data
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.5%
2/31 • Number of events 2 • Consent to end of participant involvement. maximum 16months
Definitions as per clinicaltrials.gov definitions Acute exacerbations of COPD were not included in AE assessment as these were captured as endpoint data
|
|
General disorders
Chest pain
|
9.7%
3/31 • Number of events 3 • Consent to end of participant involvement. maximum 16months
Definitions as per clinicaltrials.gov definitions Acute exacerbations of COPD were not included in AE assessment as these were captured as endpoint data
|
|
Infections and infestations
COVID-19
|
9.7%
3/31 • Number of events 3 • Consent to end of participant involvement. maximum 16months
Definitions as per clinicaltrials.gov definitions Acute exacerbations of COPD were not included in AE assessment as these were captured as endpoint data
|
|
Infections and infestations
Diverticulitis
|
9.7%
3/31 • Number of events 3 • Consent to end of participant involvement. maximum 16months
Definitions as per clinicaltrials.gov definitions Acute exacerbations of COPD were not included in AE assessment as these were captured as endpoint data
|
|
Infections and infestations
Urinary tract infection
|
9.7%
3/31 • Number of events 3 • Consent to end of participant involvement. maximum 16months
Definitions as per clinicaltrials.gov definitions Acute exacerbations of COPD were not included in AE assessment as these were captured as endpoint data
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.7%
3/31 • Number of events 3 • Consent to end of participant involvement. maximum 16months
Definitions as per clinicaltrials.gov definitions Acute exacerbations of COPD were not included in AE assessment as these were captured as endpoint data
|
|
Nervous system disorders
Syncope
|
9.7%
3/31 • Number of events 3 • Consent to end of participant involvement. maximum 16months
Definitions as per clinicaltrials.gov definitions Acute exacerbations of COPD were not included in AE assessment as these were captured as endpoint data
|
|
Psychiatric disorders
Anxiety
|
9.7%
3/31 • Number of events 3 • Consent to end of participant involvement. maximum 16months
Definitions as per clinicaltrials.gov definitions Acute exacerbations of COPD were not included in AE assessment as these were captured as endpoint data
|
|
Psychiatric disorders
Claustrophobia
|
9.7%
3/31 • Number of events 3 • Consent to end of participant involvement. maximum 16months
Definitions as per clinicaltrials.gov definitions Acute exacerbations of COPD were not included in AE assessment as these were captured as endpoint data
|
|
Psychiatric disorders
Insomnia
|
9.7%
3/31 • Number of events 3 • Consent to end of participant involvement. maximum 16months
Definitions as per clinicaltrials.gov definitions Acute exacerbations of COPD were not included in AE assessment as these were captured as endpoint data
|
|
Cardiac disorders
Atrioventricular block first degree
|
6.5%
2/31 • Number of events 2 • Consent to end of participant involvement. maximum 16months
Definitions as per clinicaltrials.gov definitions Acute exacerbations of COPD were not included in AE assessment as these were captured as endpoint data
|
|
Gastrointestinal disorders
Abdominal distension
|
6.5%
2/31 • Number of events 2 • Consent to end of participant involvement. maximum 16months
Definitions as per clinicaltrials.gov definitions Acute exacerbations of COPD were not included in AE assessment as these were captured as endpoint data
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
6.5%
2/31 • Number of events 2 • Consent to end of participant involvement. maximum 16months
Definitions as per clinicaltrials.gov definitions Acute exacerbations of COPD were not included in AE assessment as these were captured as endpoint data
|
|
General disorders
Injection site pain
|
6.5%
2/31 • Number of events 2 • Consent to end of participant involvement. maximum 16months
Definitions as per clinicaltrials.gov definitions Acute exacerbations of COPD were not included in AE assessment as these were captured as endpoint data
|
|
General disorders
Vaccination site bruising
|
6.5%
2/31 • Number of events 2 • Consent to end of participant involvement. maximum 16months
Definitions as per clinicaltrials.gov definitions Acute exacerbations of COPD were not included in AE assessment as these were captured as endpoint data
|
|
Hepatobiliary disorders
Cholecystitis acute
|
6.5%
2/31 • Number of events 2 • Consent to end of participant involvement. maximum 16months
Definitions as per clinicaltrials.gov definitions Acute exacerbations of COPD were not included in AE assessment as these were captured as endpoint data
|
|
Infections and infestations
Oral candidiasis
|
6.5%
2/31 • Number of events 2 • Consent to end of participant involvement. maximum 16months
Definitions as per clinicaltrials.gov definitions Acute exacerbations of COPD were not included in AE assessment as these were captured as endpoint data
|
|
Infections and infestations
Tonsillitis
|
6.5%
2/31 • Number of events 2 • Consent to end of participant involvement. maximum 16months
Definitions as per clinicaltrials.gov definitions Acute exacerbations of COPD were not included in AE assessment as these were captured as endpoint data
|
|
Infections and infestations
Upper respiratory tract infection
|
38.7%
12/31 • Number of events 12 • Consent to end of participant involvement. maximum 16months
Definitions as per clinicaltrials.gov definitions Acute exacerbations of COPD were not included in AE assessment as these were captured as endpoint data
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
35.5%
11/31 • Number of events 11 • Consent to end of participant involvement. maximum 16months
Definitions as per clinicaltrials.gov definitions Acute exacerbations of COPD were not included in AE assessment as these were captured as endpoint data
|
|
Nervous system disorders
Headache
|
25.8%
8/31 • Number of events 8 • Consent to end of participant involvement. maximum 16months
Definitions as per clinicaltrials.gov definitions Acute exacerbations of COPD were not included in AE assessment as these were captured as endpoint data
|
|
Gastrointestinal disorders
Vomiting
|
16.1%
5/31 • Number of events 5 • Consent to end of participant involvement. maximum 16months
Definitions as per clinicaltrials.gov definitions Acute exacerbations of COPD were not included in AE assessment as these were captured as endpoint data
|
|
Injury, poisoning and procedural complications
Fall
|
16.1%
5/31 • Number of events 5 • Consent to end of participant involvement. maximum 16months
Definitions as per clinicaltrials.gov definitions Acute exacerbations of COPD were not included in AE assessment as these were captured as endpoint data
|
|
Injury, poisoning and procedural complications
Contusion
|
12.9%
4/31 • Number of events 4 • Consent to end of participant involvement. maximum 16months
Definitions as per clinicaltrials.gov definitions Acute exacerbations of COPD were not included in AE assessment as these were captured as endpoint data
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.9%
4/31 • Number of events 4 • Consent to end of participant involvement. maximum 16months
Definitions as per clinicaltrials.gov definitions Acute exacerbations of COPD were not included in AE assessment as these were captured as endpoint data
|
|
Renal and urinary disorders
Haematuria
|
12.9%
4/31 • Number of events 4 • Consent to end of participant involvement. maximum 16months
Definitions as per clinicaltrials.gov definitions Acute exacerbations of COPD were not included in AE assessment as these were captured as endpoint data
|
|
Vascular disorders
Haematoma
|
12.9%
4/31 • Number of events 4 • Consent to end of participant involvement. maximum 16months
Definitions as per clinicaltrials.gov definitions Acute exacerbations of COPD were not included in AE assessment as these were captured as endpoint data
|
|
Cardiac disorders
Cardiac failure
|
9.7%
3/31 • Number of events 3 • Consent to end of participant involvement. maximum 16months
Definitions as per clinicaltrials.gov definitions Acute exacerbations of COPD were not included in AE assessment as these were captured as endpoint data
|
|
Gastrointestinal disorders
Constipation
|
9.7%
3/31 • Number of events 3 • Consent to end of participant involvement. maximum 16months
Definitions as per clinicaltrials.gov definitions Acute exacerbations of COPD were not included in AE assessment as these were captured as endpoint data
|
|
Gastrointestinal disorders
Diarrhoea
|
9.7%
3/31 • Number of events 3 • Consent to end of participant involvement. maximum 16months
Definitions as per clinicaltrials.gov definitions Acute exacerbations of COPD were not included in AE assessment as these were captured as endpoint data
|
|
Gastrointestinal disorders
Gastritis
|
9.7%
3/31 • Number of events 3 • Consent to end of participant involvement. maximum 16months
Definitions as per clinicaltrials.gov definitions Acute exacerbations of COPD were not included in AE assessment as these were captured as endpoint data
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
6.5%
2/31 • Number of events 2 • Consent to end of participant involvement. maximum 16months
Definitions as per clinicaltrials.gov definitions Acute exacerbations of COPD were not included in AE assessment as these were captured as endpoint data
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.5%
2/31 • Number of events 2 • Consent to end of participant involvement. maximum 16months
Definitions as per clinicaltrials.gov definitions Acute exacerbations of COPD were not included in AE assessment as these were captured as endpoint data
|
|
Surgical and medical procedures
Cataract operation
|
6.5%
2/31 • Number of events 2 • Consent to end of participant involvement. maximum 16months
Definitions as per clinicaltrials.gov definitions Acute exacerbations of COPD were not included in AE assessment as these were captured as endpoint data
|
|
Vascular disorders
Deep vein thrombosis
|
6.5%
2/31 • Number of events 2 • Consent to end of participant involvement. maximum 16months
Definitions as per clinicaltrials.gov definitions Acute exacerbations of COPD were not included in AE assessment as these were captured as endpoint data
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place