Trial Outcomes & Findings for QVA Mechanistic Efficacy Study (Receptor Effects, Etc) (NCT NCT02634983)
NCT ID: NCT02634983
Last Updated: 2021-01-05
Results Overview
The global distribution of inhaled gas within the lung was assessed using an inhaled gaseous contrast agent, Hyperpolarized Helium (3He) Lung Imaging. The Global Ventilated Lung Volume was expressed in percentage (%VV) of total lung volume.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
31 participants
Primary outcome timeframe
Day 8 to Day 10 (each treatment period)
Results posted on
2021-01-05
Participant Flow
The study took place in 3 clinical sites in United-Kingdom
31 patients were randomized, all of whom were included in the safety set and PD analysis sets (primary population of interest)
Participant milestones
| Measure |
QVA149 110/50 mcg Then Matching Placebo
QVA149, followed by matching placebo. Each treatment 8-10 days.
|
Matching Placebo Then QVA149 110/50 mcg
Matching placebo, followed by QVA149. Each treatment 8-10 days.
|
|---|---|---|
|
Period One (First Treatment, 8-10 Days)
STARTED
|
16
|
15
|
|
Period One (First Treatment, 8-10 Days)
COMPLETED
|
16
|
15
|
|
Period One (First Treatment, 8-10 Days)
NOT COMPLETED
|
0
|
0
|
|
Washout (Approximately 7-14 Days)
STARTED
|
16
|
15
|
|
Washout (Approximately 7-14 Days)
COMPLETED
|
16
|
15
|
|
Washout (Approximately 7-14 Days)
NOT COMPLETED
|
0
|
0
|
|
Period 2 (Second Treatment, 8-10 Days)
STARTED
|
16
|
15
|
|
Period 2 (Second Treatment, 8-10 Days)
COMPLETED
|
14
|
15
|
|
Period 2 (Second Treatment, 8-10 Days)
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
QVA149 110/50 mcg Then Matching Placebo
QVA149, followed by matching placebo. Each treatment 8-10 days.
|
Matching Placebo Then QVA149 110/50 mcg
Matching placebo, followed by QVA149. Each treatment 8-10 days.
|
|---|---|---|
|
Period 2 (Second Treatment, 8-10 Days)
Adverse Event
|
2
|
0
|
Baseline Characteristics
QVA Mechanistic Efficacy Study (Receptor Effects, Etc)
Baseline characteristics by cohort
| Measure |
All Study Participants
n=31 Participants
Participants who were randomized to receive either QVA149 110/50 mcg or Placebo matching QVA149 110/50 mcg
|
|---|---|
|
Age, Continuous
|
65.9 Years
STANDARD_DEVIATION 6.31 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Forced Expiratory Volume in 1 Second
0 Minutes Pre Inhalation
|
1.1584 Liter
STANDARD_DEVIATION 0.35206 • n=5 Participants
|
|
Forced Expiratory Volume in 1 Second
60 Minutes Post Inhalation
|
1.3987 Liter
STANDARD_DEVIATION 0.37266 • n=5 Participants
|
|
Percent Predicted FEV1
0 Minutes Pre Inhalation
|
43.90 Percent
STANDARD_DEVIATION 10.873 • n=5 Participants
|
|
Percent Predicted FEV1
60 Minutes Post Inhalation
|
53.10 Percent
STANDARD_DEVIATION 11.680 • n=5 Participants
|
|
Forced Vital Capacity
0 Minutes Pre Inhalation
|
2.7426 Liter
STANDARD_DEVIATION 0.73932 • n=5 Participants
|
|
Forced Vital Capacity
60 Minutes Post Inhalation
|
3.0781 Liter
STANDARD_DEVIATION 0.81113 • n=5 Participants
|
|
FEV1/FVC ratio
0 Minutes Pre Inhalation
|
42.968 Percent ((FEV1/FVC)*100)
STANDARD_DEVIATION 8.9797 • n=5 Participants
|
|
FEV1/FVC ratio
60 Minutes Post Inhalation
|
46.365 Percent ((FEV1/FVC)*100)
STANDARD_DEVIATION 8.8240 • n=5 Participants
|
|
Reversibility
|
9.19 Percent
STANDARD_DEVIATION 4.743 • n=5 Participants
|
PRIMARY outcome
Timeframe: Day 8 to Day 10 (each treatment period)Population: The PD Analysis Set, which consisted of all participants with valid results assessed in each treatment period, was considered.
The global distribution of inhaled gas within the lung was assessed using an inhaled gaseous contrast agent, Hyperpolarized Helium (3He) Lung Imaging. The Global Ventilated Lung Volume was expressed in percentage (%VV) of total lung volume.
Outcome measures
| Measure |
QVA149 110/50 mcg
n=31 Participants
Single daily dose of 110/50 μg QVA149 for 8-10 days.
|
Matching Placebo
n=28 Participants
Single daily dose of matching placebo for 8-10 days.
|
|---|---|---|
|
Global Ventilated Lung Volume
|
61.73 Percentage of total lung volume
Interval 56.16 to 67.3
|
56.73 Percentage of total lung volume
Interval 51.07 to 62.39
|
SECONDARY outcome
Timeframe: Day 8 to Day 10 (each treatment period)Population: The PD Analysis Set, which consisted of all participants with valid results assessed in each treatment period, was considered.
The regional distribution of inhaled gas within the lung was assessed using an inhaled gaseous contrast agent, Hyperpolarized Helium (3He) Lung Imaging. The Regional Ventilated Lung Volume was expressed in percentage (% VDV) of total lung volume for each lobar region.
Outcome measures
| Measure |
QVA149 110/50 mcg
n=31 Participants
Single daily dose of 110/50 μg QVA149 for 8-10 days.
|
Matching Placebo
n=28 Participants
Single daily dose of matching placebo for 8-10 days.
|
|---|---|---|
|
Regional Ventilated Lung Volume
Lung, Left Upper Lobe Ventilation
|
64.17 Percentage of total lung volume
Interval 57.95 to 70.39
|
59.20 Percentage of total lung volume
Interval 52.87 to 65.53
|
|
Regional Ventilated Lung Volume
Lung, Left Ventilation
|
61.94 Percentage of total lung volume
Interval 56.04 to 67.83
|
57.16 Percentage of total lung volume
Interval 51.17 to 63.15
|
|
Regional Ventilated Lung Volume
Lung, Left Lower Lobe Ventilation
|
58.97 Percentage of total lung volume
Interval 52.63 to 65.31
|
54.01 Percentage of total lung volume
Interval 47.52 to 60.49
|
|
Regional Ventilated Lung Volume
Lung, Right Ventilation
|
61.63 Percentage of total lung volume
Interval 55.9 to 67.36
|
56.24 Percentage of total lung volume
Interval 50.4 to 62.08
|
|
Regional Ventilated Lung Volume
Lung, Right Lower Lobe Ventilation
|
60.92 Percentage of total lung volume
Interval 54.62 to 67.21
|
57.65 Percentage of total lung volume
Interval 51.26 to 64.04
|
|
Regional Ventilated Lung Volume
Lung, Right Middle Lobe Ventilation
|
59.59 Percentage of total lung volume
Interval 52.85 to 66.34
|
53.98 Percentage of total lung volume
Interval 47.01 to 60.95
|
|
Regional Ventilated Lung Volume
Lung, Right Upper Lobe Ventilation
|
63.25 Percentage of total lung volume
Interval 56.71 to 69.79
|
55.53 Percentage of total lung volume
Interval 48.85 to 62.2
|
SECONDARY outcome
Timeframe: Day 8 to Day 10 (each treatment period)Population: The PD Analysis Set, which consisted of all participants with valid results assessed in each treatment period, was considered.
Lung Perfusion Imaging, or MR perfusion imaging of the lung with gadolinium contrast agent, was performed to determine whether vascular abnormalities producing perfusion deficits corresponded to abnormalities in ventilation (hypoxic vasoconstriction). Pulmonary Perfusion was expressed in ml/100 g lung tissue/min of each lobar region.
Outcome measures
| Measure |
QVA149 110/50 mcg
n=27 Participants
Single daily dose of 110/50 μg QVA149 for 8-10 days.
|
Matching Placebo
n=26 Participants
Single daily dose of matching placebo for 8-10 days.
|
|---|---|---|
|
Pulmonary Perfusion
Lung Perfusion
|
13.96 ml/100 g lung tissue/min
Interval 12.5 to 15.41
|
13.03 ml/100 g lung tissue/min
Interval 11.56 to 14.5
|
|
Pulmonary Perfusion
Lung, Left Perfusion
|
14.42 ml/100 g lung tissue/min
Interval 12.94 to 15.9
|
13.08 ml/100 g lung tissue/min
Interval 11.58 to 14.57
|
|
Pulmonary Perfusion
Lung, Left Lower Lobe Perfusion
|
13.48 ml/100 g lung tissue/min
Interval 11.91 to 15.06
|
12.79 ml/100 g lung tissue/min
Interval 11.2 to 14.38
|
|
Pulmonary Perfusion
Lung, Left Upper Lobe Perfusion
|
15.35 ml/100 g lung tissue/min
Interval 13.69 to 17.01
|
13.45 ml/100 g lung tissue/min
Interval 11.77 to 15.12
|
|
Pulmonary Perfusion
Lung, Right Perfusion
|
13.54 ml/100 g lung tissue/min
Interval 12.07 to 15.01
|
12.97 ml/100 g lung tissue/min
Interval 11.49 to 14.46
|
|
Pulmonary Perfusion
Lung, Right Lower Lobe Perfusion
|
13.26 ml/100 g lung tissue/min
Interval 11.74 to 14.79
|
13.25 ml/100 g lung tissue/min
Interval 11.71 to 14.79
|
|
Pulmonary Perfusion
Lung, Right Middle Lobe Perfusion
|
14.86 ml/100 g lung tissue/min
Interval 12.72 to 17.0
|
13.36 ml/100 g lung tissue/min
Interval 11.19 to 15.53
|
|
Pulmonary Perfusion
Lung, Right Upper Lobe Perfusion
|
13.57 ml/100 g lung tissue/min
Interval 11.91 to 15.23
|
12.70 ml/100 g lung tissue/min
Interval 11.03 to 14.37
|
SECONDARY outcome
Timeframe: Day 1 (0.25, 1 and 2 hours post-dose), Day 8 (-0.75, -0.25, 0.25, 1 and 2 hours post-dose) (each treatment period)Population: The PD Analysis Set, which consisted of all participants with valid results assessed in each treatment period, was considered.
The Forced Expiratory Volume in one second (FEV1) was calculated as the volume of air forcibly exhaled in one second as measured by a spirometer.
Outcome measures
| Measure |
QVA149 110/50 mcg
n=31 Participants
Single daily dose of 110/50 μg QVA149 for 8-10 days.
|
Matching Placebo
n=31 Participants
Single daily dose of matching placebo for 8-10 days.
|
|---|---|---|
|
Forced Expiratory Volume in 1 Second (FEV1)
FEV1 Day 1 (1 hrs post-dose)
|
1.32 Liter
Interval 1.29 to 1.36
|
1.12 Liter
Interval 1.09 to 1.16
|
|
Forced Expiratory Volume in 1 Second (FEV1)
FEV1 Day 8 (-0.25 hrs post-dose)
|
1.33 Liter
Interval 1.29 to 1.37
|
1.11 Liter
Interval 1.07 to 1.15
|
|
Forced Expiratory Volume in 1 Second (FEV1)
FEV1 Day 8 (0.25 hrs post-dose)
|
1.38 Liter
Interval 1.35 to 1.42
|
1.10 Liter
Interval 1.06 to 1.14
|
|
Forced Expiratory Volume in 1 Second (FEV1)
FEV1 Day 8 (1 hrs post-dose)
|
1.45 Liter
Interval 1.41 to 1.49
|
1.13 Liter
Interval 1.09 to 1.17
|
|
Forced Expiratory Volume in 1 Second (FEV1)
FEV1 Day 8 (2 hrs post-dose)
|
1.43 Liter
Interval 1.39 to 1.47
|
1.11 Liter
Interval 1.07 to 1.15
|
|
Forced Expiratory Volume in 1 Second (FEV1)
FEV1 Day 1 (0.25 hrs post-dose)
|
1.27 Liter
Interval 1.25 to 1.3
|
1.13 Liter
Interval 1.1 to 1.15
|
|
Forced Expiratory Volume in 1 Second (FEV1)
FEV1 Day 1 (2 hrs post-dose)
|
1.34 Liter
Interval 1.3 to 1.38
|
1.15 Liter
Interval 1.11 to 1.19
|
|
Forced Expiratory Volume in 1 Second (FEV1)
FEV1 Day 8 (-0.75 hrs post-dose)
|
1.30 Liter
Interval 1.26 to 1.34
|
1.09 Liter
Interval 1.05 to 1.13
|
SECONDARY outcome
Timeframe: Day 1 (0.25, 1 and 2 hours post-dose), Day 8 (-0.75, -0.25, 0.25, 1 and 2 hours post-dose) (each treatment period)Population: The PD Analysis Set, which consisted of all participants with valid results assessed in each treatment period, was considered.
Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed via spirometry. An increase in FVC indicates improvement in lung function.
Outcome measures
| Measure |
QVA149 110/50 mcg
n=31 Participants
Single daily dose of 110/50 μg QVA149 for 8-10 days.
|
Matching Placebo
n=31 Participants
Single daily dose of matching placebo for 8-10 days.
|
|---|---|---|
|
Forced Vital Capacity (FVC)
FVC Day 8 (2 hrs post-dose)
|
3.06 Liter
Interval 2.98 to 3.13
|
2.62 Liter
Interval 2.54 to 2.7
|
|
Forced Vital Capacity (FVC)
FVC Day 1 (0.25 hrs post-dose)
|
2.92 Liter
Interval 2.85 to 2.98
|
2.68 Liter
Interval 2.61 to 2.74
|
|
Forced Vital Capacity (FVC)
FVC Day 1 (1 hrs post-dose)
|
2.99 Liter
Interval 2.91 to 3.06
|
2.63 Liter
Interval 2.56 to 2.71
|
|
Forced Vital Capacity (FVC)
FVC Day 1 (2 hrs post-dose)
|
2.99 Liter
Interval 2.91 to 3.07
|
2.68 Liter
Interval 2.59 to 2.76
|
|
Forced Vital Capacity (FVC)
FVC Day 8 (-0.75 hrs post-dose)
|
2.91 Liter
Interval 2.84 to 2.98
|
2.56 Liter
Interval 2.49 to 2.64
|
|
Forced Vital Capacity (FVC)
FVC Day 8 (-0.25 hrs post-dose)
|
2.91 Liter
Interval 2.84 to 2.98
|
2.63 Liter
Interval 2.56 to 2.7
|
|
Forced Vital Capacity (FVC)
FVC Day 8 (0.25 hrs post-dose)
|
3.02 Liter
Interval 2.95 to 3.09
|
2.59 Liter
Interval 2.51 to 2.66
|
|
Forced Vital Capacity (FVC)
FVC Day 8 (1 hrs post-dose)
|
3.10 Liter
Interval 3.04 to 3.17
|
2.65 Liter
Interval 2.58 to 2.72
|
SECONDARY outcome
Timeframe: Day 1 (0.25, 1 and 2 hours post-dose), Day 8 (-0.75, -0.25, 0.25, 1 and 2 hours post-dose) (each treatment period)Population: The PD Analysis Set, which consisted of all participants with valid results assessed in each treatment period, was considered.
The FEV1/FVC ratio is the proportion of a person's vital capacity that they are able to expire in the first second of forced expiration (FEV1) to the full, forced vital capacity (FVC). The result of this ratio is expressed as FEV1%.
Outcome measures
| Measure |
QVA149 110/50 mcg
n=31 Participants
Single daily dose of 110/50 μg QVA149 for 8-10 days.
|
Matching Placebo
n=31 Participants
Single daily dose of matching placebo for 8-10 days.
|
|---|---|---|
|
FEV1/FVC Ratio
FEV1/FVC Day 1 (2 hrs post-dose)
|
45.25 FEV1 Percentage
Interval 44.42 to 46.08
|
42.93 FEV1 Percentage
Interval 42.08 to 43.79
|
|
FEV1/FVC Ratio
FEV1/FVC Day 1 (0.25 hrs post-dose)
|
44.31 FEV1 Percentage
Interval 43.59 to 45.02
|
42.14 FEV1 Percentage
Interval 41.39 to 42.89
|
|
FEV1/FVC Ratio
FEV1/FVC Day 1 (1 hrs post-dose)
|
44.97 FEV1 Percentage
Interval 44.05 to 45.88
|
42.91 FEV1 Percentage
Interval 41.95 to 43.87
|
|
FEV1/FVC Ratio
FEV1/FVC Day 8 (-0.75 hrs post-dose)
|
45.05 FEV1 Percentage
Interval 44.05 to 46.05
|
42.23 FEV1 Percentage
Interval 41.16 to 43.3
|
|
FEV1/FVC Ratio
FEV1/FVC Day 8 (-0.25 hrs post-dose)
|
45.97 FEV1 Percentage
Interval 45.05 to 46.89
|
42.17 FEV1 Percentage
Interval 41.19 to 43.15
|
|
FEV1/FVC Ratio
FEV1/FVC Day 8 (0.25 hrs post-dose)
|
46.34 FEV1 Percentage
Interval 45.43 to 47.26
|
42.60 FEV1 Percentage
Interval 41.63 to 43.58
|
|
FEV1/FVC Ratio
FEV1/FVC Day 8 (1 hrs post-dose)
|
47.32 FEV1 Percentage
Interval 46.31 to 48.33
|
42.72 FEV1 Percentage
Interval 41.64 to 43.8
|
|
FEV1/FVC Ratio
FEV1/FVC Day 8 (2 hrs post-dose)
|
47.39 FEV1 Percentage
Interval 46.39 to 48.4
|
42.42 FEV1 Percentage
Interval 41.35 to 43.48
|
SECONDARY outcome
Timeframe: Day 8 (each treatment period)Population: The PD Analysis Set, which consisted of all participants with valid results assessed in each treatment period, was considered.
Multiple Breath Nitrogen Washout (MBNW) was performed after 2 hours post-dose spirometry assessments using a multiple breath inert gas washout technique. The device provides the global index of ventilation inhomogeneity assessment (LCI = Cumulative Expired Volume/Functional Residual Capacity).
Outcome measures
| Measure |
QVA149 110/50 mcg
n=29 Participants
Single daily dose of 110/50 μg QVA149 for 8-10 days.
|
Matching Placebo
n=26 Participants
Single daily dose of matching placebo for 8-10 days.
|
|---|---|---|
|
Lung Clearance Index by Multiple Breath Nitrogen Washout (MBNW)
|
10.80 Ratio
Interval 10.22 to 11.37
|
10.81 Ratio
Interval 10.2 to 11.41
|
SECONDARY outcome
Timeframe: Day 8 (each treatment period)Population: The PD Analysis Set, which consisted of all participants with valid results assessed in each treatment period, was considered.
The diffusing capacity of the lung for carbon monoxide (DLCO) is a measure of how easily carbon monoxide (CO) molecules transfer from the alveolar gas to the hemoglobin of the red cells in the pulmonary circulation. To measure the DLCO, the patient inhales a single breath containing a minute amount of CO and holds it for 10 seconds. The breath is then exhaled and the exhaled breath is analyzed for CO. The change in the concentration of the CO is then multiplied by the single breath TLC to calculate the DLCO.
Outcome measures
| Measure |
QVA149 110/50 mcg
n=29 Participants
Single daily dose of 110/50 μg QVA149 for 8-10 days.
|
Matching Placebo
n=26 Participants
Single daily dose of matching placebo for 8-10 days.
|
|---|---|---|
|
Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)
|
16.38 mL/min/mmHg
Interval 14.77 to 18.0
|
15.73 mL/min/mmHg
Interval 14.1 to 17.35
|
Adverse Events
QVA149 110/50 mcg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Matching Placebo
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
QVA149 110/50 mcg
n=31 participants at risk
Single daily dose of 110/50 μg QVA149 for 8-10 days.
|
Matching Placebo
n=31 participants at risk
Single daily dose of matching placebo for 8-10 days.
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/31 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
|
3.2%
1/31 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/31 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
|
3.2%
1/31 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
|
Other adverse events
| Measure |
QVA149 110/50 mcg
n=31 participants at risk
Single daily dose of 110/50 μg QVA149 for 8-10 days.
|
Matching Placebo
n=31 participants at risk
Single daily dose of matching placebo for 8-10 days.
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
3.2%
1/31 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
|
0.00%
0/31 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
|
|
General disorders
Facial pain
|
3.2%
1/31 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
|
0.00%
0/31 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.2%
1/31 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
|
0.00%
0/31 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/31 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
|
3.2%
1/31 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
|
|
Nervous system disorders
Headache
|
3.2%
1/31 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
|
0.00%
0/31 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
|
|
Nervous system disorders
Migraine
|
3.2%
1/31 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
|
0.00%
0/31 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
6.5%
2/31 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
|
0.00%
0/31 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.2%
1/31 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
|
0.00%
0/31 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/31 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
|
3.2%
1/31 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
3.2%
1/31 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
|
3.2%
1/31 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER