Trial Outcomes & Findings for Long Term Safety and Tolerability of QVA149 Versus Tiotropium in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD) (NCT NCT01285492)
NCT ID: NCT01285492
Last Updated: 2013-12-27
Results Overview
An AE was the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event was not considered to be related to study drug. Study drug includes the investigational drug under evaluation and the comparator drug or placebo that was given during any phase of the study. Adverse events starting on or after the time of the first inhalation of study drug were classified as a treatment emergent adverse event.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
160 participants
Primary outcome timeframe
52 weeks
Results posted on
2013-12-27
Participant Flow
121 patients were randomized to the QVA149 group; however, demographics was on safety set and excluded 2 patients who did not take study drug
There was a pre-screening visit where informed consent was obtained and current COPD medications reviewed and in suitable patients, if necessary, arrangements were made to adjust prohibited COPD therapy to allowable COPD therapy. The interval between Visit 2 and 3 was a 7-days run-in period used to assess eligibility and to collect baseline values.
Participant milestones
| Measure |
QVA149
QVA149 110/50 μg o.d. (once a day)
|
Tiotropium
tiotropium 18 μg o.d.
|
|---|---|---|
|
Overall Study
STARTED
|
121
|
39
|
|
Overall Study
Safety Set (for Demographics)
|
119
|
39
|
|
Overall Study
COMPLETED
|
104
|
38
|
|
Overall Study
NOT COMPLETED
|
17
|
1
|
Reasons for withdrawal
| Measure |
QVA149
QVA149 110/50 μg o.d. (once a day)
|
Tiotropium
tiotropium 18 μg o.d.
|
|---|---|---|
|
Overall Study
Adverse Event
|
11
|
0
|
|
Overall Study
Protocol Violation
|
3
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
Death
|
1
|
0
|
Baseline Characteristics
Long Term Safety and Tolerability of QVA149 Versus Tiotropium in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD)
Baseline characteristics by cohort
| Measure |
QVA149
n=119 Participants
QVA149 110/50 μg once a day (o.d)
|
Tiotropium
n=39 Participants
tiotropium 18 μg o.d.
|
Total
n=158 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.3 years
STANDARD_DEVIATION 6.79 • n=5 Participants
|
69.4 years
STANDARD_DEVIATION 6.90 • n=7 Participants
|
69.3 years
STANDARD_DEVIATION 6.80 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
114 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
151 Participants
n=5 Participants
|
|
Baseline Weight
|
60.38 kg
STANDARD_DEVIATION 9.613 • n=5 Participants
|
61.44 kg
STANDARD_DEVIATION 8.788 • n=7 Participants
|
60.64 kg
STANDARD_DEVIATION 9.400 • n=5 Participants
|
|
Baseline Height
|
164.4 cm
STANDARD_DEVIATION 7.08 • n=5 Participants
|
163.3 cm
STANDARD_DEVIATION 6.38 • n=7 Participants
|
164.1 cm
STANDARD_DEVIATION 6.91 • n=5 Participants
|
|
Baseline Body Mass Index
|
22.31 kg/m^2
STANDARD_DEVIATION 3.067 • n=5 Participants
|
23.02 kg/m^2
STANDARD_DEVIATION 2.919 • n=7 Participants
|
22.49 kg/m^2
STANDARD_DEVIATION 3.037 • n=5 Participants
|
PRIMARY outcome
Timeframe: 52 weeksPopulation: The safety set included all patients who received at least one dose of study drug.
An AE was the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event was not considered to be related to study drug. Study drug includes the investigational drug under evaluation and the comparator drug or placebo that was given during any phase of the study. Adverse events starting on or after the time of the first inhalation of study drug were classified as a treatment emergent adverse event.
Outcome measures
| Measure |
QVA149
n=119 Participants
QVA149 110/50 μg once a day (o.d)
|
Tiotropium
n=39 Participants
tiotropium 18 μg o.d.
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) or Death
Adverse Events (AEs)
|
101 Participants
|
28 Participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) or Death
Serious Advers Events (SAEs)
|
19 Participants
|
2 Participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) or Death
Death
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: The safety set included all patients who received at least one dose of study drug.
Clinically notable hematology values were: hemoglobin - male \<11.5g/dL, female \<9.5 g/dL; hematocrit - male \<37%, female \<32%; white cell count - \<2800µL or \>16000µL; platelets - \<7.5 10\*4/µL or \>70.0 10\*4/µL
Outcome measures
| Measure |
QVA149
n=119 Participants
QVA149 110/50 μg once a day (o.d)
|
Tiotropium
n=39 Participants
tiotropium 18 μg o.d.
|
|---|---|---|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Hematology Values at Any Timepoint Over the Whole Treatment Period
Platelets < 7.5 (n = 118, 38)
|
0 Participants
|
0 Participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Hematology Values at Any Timepoint Over the Whole Treatment Period
Hemoglobin: male (n = 113, 36)
|
3 Participants
|
0 Participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Hematology Values at Any Timepoint Over the Whole Treatment Period
Hemoglobin: female (n = 5, 2)
|
0 Participants
|
0 Participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Hematology Values at Any Timepoint Over the Whole Treatment Period
Hematocrit: male (n = 113, 36)
|
6 Participants
|
0 Participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Hematology Values at Any Timepoint Over the Whole Treatment Period
Hematocrit: female (n = 5, 2)
|
0 Participants
|
0 Participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Hematology Values at Any Timepoint Over the Whole Treatment Period
White Cell Count < 2800 (n = 118, 38)
|
0 Participants
|
0 Participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Hematology Values at Any Timepoint Over the Whole Treatment Period
White Cell Count > 2800 (n = 118, 38)
|
0 Participants
|
0 Participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Hematology Values at Any Timepoint Over the Whole Treatment Period
Platelets > 70.0 (n = 118, 38)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: The safety set included all patients who received at least one dose of study drug.
Clinically notable biochemistry values were: total protein - \<4.0 g/dL or \>9.5 g/dL; albumin \<2.5 g/dL; bilirubin (total) \>1.9 mg/dL; BUN \>27 mg/dL; creatinine \>1.99 mg/dL; AST \>3 x ULN U/L; ALT \>3 x ULN U/L; ALP \>3 x ULN U/L; y-GTP \>3 x ULN U/L; sodium \<125 mEq/L or \>160 mEq/L; potassium \<3.0 mEq/L or \>6.0 mEq/L; glucose \<51.0 mg/dL or \>180.0 mg/dL
Outcome measures
| Measure |
QVA149
n=119 Participants
QVA149 110/50 μg once a day (o.d)
|
Tiotropium
n=39 Participants
tiotropium 18 μg o.d.
|
|---|---|---|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Time-point Over the Treatment Period
glucose >180.0 mg/dL (n = 118, 38)
|
7 Participants
|
3 Participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Time-point Over the Treatment Period
Total protein - <4.0 g/dL (n = 118, 38)
|
0 Participants
|
0 Participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Time-point Over the Treatment Period
Total protein - > 9.5 g/dL (n = 118, 38)
|
0 Participants
|
0 Participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Time-point Over the Treatment Period
albumin <2.5 g/dL (n = 118, 38)
|
0 Participants
|
0 Participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Time-point Over the Treatment Period
bilirubin (total) >1.9 mg/dL (n = 118, 38)
|
0 Participants
|
0 Participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Time-point Over the Treatment Period
BUN >27 mg/dL (n = 118, 38)
|
1 Participants
|
0 Participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Time-point Over the Treatment Period
creatinine >1.99 mg/dL (n = 118, 38)
|
0 Participants
|
0 Participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Time-point Over the Treatment Period
AST >3 x ULN U/L (n = 118, 38)
|
0 Participants
|
0 Participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Time-point Over the Treatment Period
ALT >3 x ULN U/L (n = 118, 38)
|
0 Participants
|
0 Participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Time-point Over the Treatment Period
ALP >3 x ULN U/L (n = 118, 38)
|
0 Participants
|
0 Participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Time-point Over the Treatment Period
y-GTP >3 x ULN (n = 118, 38)
|
2 Participants
|
2 Participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Time-point Over the Treatment Period
sodium <125 mEq/L (n = 118, 38)
|
0 Participants
|
0 Participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Time-point Over the Treatment Period
sodium >160 mEq/L (n = 118, 38)
|
0 Participants
|
0 Participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Time-point Over the Treatment Period
potassium <3.0 mEq/ (n = 118, 38)
|
0 Participants
|
0 Participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Time-point Over the Treatment Period
potassium >6.0 mEq/ (n = 118, 38)
|
0 Participants
|
0 Participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Time-point Over the Treatment Period
glucose <51.0 mg/dL (n = 118, 38)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: The safety set included all patients who received at least one dose of study drug.
Clinically notable vital sign values were: pulse rate - low, \<40 bpm or \<=50 bpm and decrease from baseline \>=15bpm; pulse rate high, \>130 bpm or \>=120bpm and increase from baseline \>=15 bpm. Systolic blood pressure - low, \<75 mmHg or \<=90 mmHg and decrease from baseline \>=20 mmHg; high, \>200 mmHg or \>=180 mmHg and increase from baseline \>=20 mmHg. Diastolic blood pressure - low, \<40 mmHg or \<=50 mmHg and decrease from baseline \>=15 mmHg; high, \>115 mmHg or \>=105 mmHg and increase from baseline \>=15 mmHg.
Outcome measures
| Measure |
QVA149
n=119 Participants
QVA149 110/50 μg once a day (o.d)
|
Tiotropium
n=39 Participants
tiotropium 18 μg o.d.
|
|---|---|---|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Vital Signs Values at Any Time-point Over the Whole Treatment Period
Pulse rate: low
|
0 Participants
|
0 Participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Vital Signs Values at Any Time-point Over the Whole Treatment Period
Pulse rate: high
|
0 Participants
|
0 Participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Vital Signs Values at Any Time-point Over the Whole Treatment Period
Pulse rate: low or high
|
0 Participants
|
0 Participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Vital Signs Values at Any Time-point Over the Whole Treatment Period
Systolic blood pressure - low
|
4 Participants
|
0 Participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Vital Signs Values at Any Time-point Over the Whole Treatment Period
Systolic blood pressure - high
|
0 Participants
|
1 Participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Vital Signs Values at Any Time-point Over the Whole Treatment Period
Systolic blood pressure - low or high
|
4 Participants
|
1 Participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Vital Signs Values at Any Time-point Over the Whole Treatment Period
Diastolic blood pressure - low
|
3 Participants
|
0 Participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Vital Signs Values at Any Time-point Over the Whole Treatment Period
Diastolic blood pressure - high
|
2 Participants
|
1 Participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Vital Signs Values at Any Time-point Over the Whole Treatment Period
Diastolic blood pressure - low or high
|
5 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: The safety set included all patients who received at least one dose of study drug.
Clinically notable change from baseline was an increase from baseline of 30 or greater milliseconds (ms).
Outcome measures
| Measure |
QVA149
n=119 Participants
QVA149 110/50 μg once a day (o.d)
|
Tiotropium
n=39 Participants
tiotropium 18 μg o.d.
|
|---|---|---|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Fridericia's QTc Values at Any Time-point Over the Whole Treatment Period
Males: QTc > 450 ms (n = 111, 36)
|
6 Participants
|
0 Participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Fridericia's QTc Values at Any Time-point Over the Whole Treatment Period
Females: QTc > 470 ms (n = 5, 2)
|
0 Participants
|
0 Participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Fridericia's QTc Values at Any Time-point Over the Whole Treatment Period
Increase from baseline 30 to 60 ms (n = 116, 38)
|
12 Participants
|
3 Participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Fridericia's QTc Values at Any Time-point Over the Whole Treatment Period
Increase from baseline > 60 ms (n = 116, 38)
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Weeks 3, 6, 12, 24, 36, 52Population: Full Analysis Set (FAS) included all randomized patients who received at least one dose of study drug.
Pre-dose FEV1 is defined as the average of the measurements at 45 and 15 min pre-dose. Baseline is defined as the pre-dose FEV1 value on Day 1 (Week 1).
Outcome measures
| Measure |
QVA149
n=119 Participants
QVA149 110/50 μg once a day (o.d)
|
Tiotropium
n=39 Participants
tiotropium 18 μg o.d.
|
|---|---|---|
|
Change in Pre-dose Forced Expiratory Volume in One Second (FEV1) From Baseline
Week 3 (117, 38)
|
0.206 Litres
Standard Deviation 0.1534
|
0.093 Litres
Standard Deviation 0.0977
|
|
Change in Pre-dose Forced Expiratory Volume in One Second (FEV1) From Baseline
Week 6 (115, 38)
|
0.202 Litres
Standard Deviation 0.1668
|
0.083 Litres
Standard Deviation 0.1201
|
|
Change in Pre-dose Forced Expiratory Volume in One Second (FEV1) From Baseline
Week 12 (113, 38)
|
0.209 Litres
Standard Deviation 0.1725
|
0.139 Litres
Standard Deviation 0.1562
|
|
Change in Pre-dose Forced Expiratory Volume in One Second (FEV1) From Baseline
Week 24 (113, 37)
|
0.198 Litres
Standard Deviation 0.1735
|
0.115 Litres
Standard Deviation 0.1400
|
|
Change in Pre-dose Forced Expiratory Volume in One Second (FEV1) From Baseline
Week 36 (105, 37)
|
0.182 Litres
Standard Deviation 0.1619
|
0.082 Litres
Standard Deviation 0.1465
|
|
Change in Pre-dose Forced Expiratory Volume in One Second (FEV1) From Baseline
Week 52 (104, 37)
|
0.189 Litres
Standard Deviation 0.1762
|
0.052 Litres
Standard Deviation 0.1688
|
SECONDARY outcome
Timeframe: Weeks 3, 6, 12, 24, 36, 52Population: Full Analysis Set (FAS) included all randomized patients who received at least one dose of study drug.
Pre-dose FVC is defined as the average of the measurements at 45 and 15 min pre-dose. Baseline is defined as the pre-dose FVC value on Day 1 (Week 1).
Outcome measures
| Measure |
QVA149
n=119 Participants
QVA149 110/50 μg once a day (o.d)
|
Tiotropium
n=39 Participants
tiotropium 18 μg o.d.
|
|---|---|---|
|
Change in Pre-dose Forced Vital Capacity (FVC) From Baseline
Week 24 (113, 37)
|
0.330 Litres
Standard Deviation 0.3248
|
0.206 Litres
Standard Deviation 0.2367
|
|
Change in Pre-dose Forced Vital Capacity (FVC) From Baseline
Week 3 (117, 38)
|
0.314 Litres
Standard Deviation 0.2882
|
0.213 Litres
Standard Deviation 0.2369
|
|
Change in Pre-dose Forced Vital Capacity (FVC) From Baseline
Week 6 (115, 38)
|
0.310 Litres
Standard Deviation 0.3178
|
0.173 Litres
Standard Deviation 0.2162
|
|
Change in Pre-dose Forced Vital Capacity (FVC) From Baseline
Week 12 (113, 38)
|
0.335 Litres
Standard Deviation 0.2948
|
0.279 Litres
Standard Deviation 0.2942
|
|
Change in Pre-dose Forced Vital Capacity (FVC) From Baseline
Week 36 (105, 37)
|
0.264 Litres
Standard Deviation 0.2706
|
0.167 Litres
Standard Deviation 0.2438
|
|
Change in Pre-dose Forced Vital Capacity (FVC) From Baseline
Week 52 (104, 37)
|
0.261 Litres
Standard Deviation 0.3047
|
0.112 Litres
Standard Deviation 0.2462
|
Adverse Events
QVA149
Serious events: 19 serious events
Other events: 66 other events
Deaths: 0 deaths
Tiotropium
Serious events: 2 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
QVA149
n=119 participants at risk
QVA149 110/50 μg once a day (o.d)
|
Tiotropium
n=39 participants at risk
tiotropium 18 μg o.d.
|
|---|---|---|
|
Congenital, familial and genetic disorders
Arrhythmogenic right ventricular dysplasia
|
0.84%
1/119
|
0.00%
0/39
|
|
Gastrointestinal disorders
Colonic polyp
|
2.5%
3/119
|
0.00%
0/39
|
|
Hepatobiliary disorders
Bile duct stone
|
1.7%
2/119
|
0.00%
0/39
|
|
Hepatobiliary disorders
Cholangitis
|
0.84%
1/119
|
0.00%
0/39
|
|
Immune system disorders
Anaphylactic shock
|
0.84%
1/119
|
0.00%
0/39
|
|
Infections and infestations
Bronchopneumonia
|
0.84%
1/119
|
0.00%
0/39
|
|
Infections and infestations
Cellulitis
|
0.84%
1/119
|
0.00%
0/39
|
|
Infections and infestations
Lower respiratory tract infection
|
0.84%
1/119
|
0.00%
0/39
|
|
Infections and infestations
Pneumonia
|
1.7%
2/119
|
0.00%
0/39
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.84%
1/119
|
2.6%
1/39
|
|
Metabolism and nutrition disorders
Dehydration
|
0.84%
1/119
|
0.00%
0/39
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.84%
1/119
|
0.00%
0/39
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.84%
1/119
|
0.00%
0/39
|
|
Nervous system disorders
Cerebral infarction
|
0.84%
1/119
|
0.00%
0/39
|
|
Nervous system disorders
Thrombotic cerebral infarction
|
0.84%
1/119
|
0.00%
0/39
|
|
Renal and urinary disorders
Urinary retention
|
0.84%
1/119
|
0.00%
0/39
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.84%
1/119
|
0.00%
0/39
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
3.4%
4/119
|
0.00%
0/39
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.84%
1/119
|
0.00%
0/39
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/119
|
2.6%
1/39
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.84%
1/119
|
0.00%
0/39
|
Other adverse events
| Measure |
QVA149
n=119 participants at risk
QVA149 110/50 μg once a day (o.d)
|
Tiotropium
n=39 participants at risk
tiotropium 18 μg o.d.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
2.5%
3/119
|
5.1%
2/39
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/119
|
5.1%
2/39
|
|
Infections and infestations
Bronchitis
|
4.2%
5/119
|
7.7%
3/39
|
|
Infections and infestations
Influenza
|
1.7%
2/119
|
5.1%
2/39
|
|
Infections and infestations
Nasopharyngitis
|
33.6%
40/119
|
30.8%
12/39
|
|
Infections and infestations
Pharyngitis
|
4.2%
5/119
|
2.6%
1/39
|
|
Infections and infestations
Pneumonia
|
5.9%
7/119
|
2.6%
1/39
|
|
Infections and infestations
Upper respiratory tract infection
|
7.6%
9/119
|
15.4%
6/39
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/119
|
7.7%
3/39
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/119
|
5.1%
2/39
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.0%
6/119
|
2.6%
1/39
|
|
Nervous system disorders
Headache
|
3.4%
4/119
|
2.6%
1/39
|
|
Psychiatric disorders
Insomnia
|
3.4%
4/119
|
5.1%
2/39
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
24.4%
29/119
|
20.5%
8/39
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
4.2%
5/119
|
2.6%
1/39
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.7%
2/119
|
5.1%
2/39
|
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 pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER