Trial Outcomes & Findings for Long Term Safety and Tolerability of NVA237 Versus Tiotropium in Japanese Patients (NCT NCT01119937)
NCT ID: NCT01119937
Last Updated: 2013-01-18
Results Overview
Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal lab finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgments of the investigators represent significant hazards.
COMPLETED
PHASE3
211 participants
52 weeks
2013-01-18
Participant Flow
211 participants entered screening. 163 participants entered treatment.
Participant milestones
| Measure |
NVA237
50µg once daily
|
Tiotropium
18µg once daily
|
|---|---|---|
|
Overall Study
STARTED
|
123
|
40
|
|
Overall Study
COMPLETED
|
104
|
33
|
|
Overall Study
NOT COMPLETED
|
19
|
7
|
Reasons for withdrawal
| Measure |
NVA237
50µg once daily
|
Tiotropium
18µg once daily
|
|---|---|---|
|
Overall Study
Adverse Event
|
11
|
5
|
|
Overall Study
Protocol deviation
|
3
|
1
|
|
Overall Study
Unsatisfactory therapeutic effect
|
3
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
Baseline Characteristics
Long Term Safety and Tolerability of NVA237 Versus Tiotropium in Japanese Patients
Baseline characteristics by cohort
| Measure |
NVA237
n=123 Participants
50µg once daily
|
Tiotropium
n=40 Participants
18µg once daily
|
Total
n=163 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
68.4 years
STANDARD_DEVIATION 7.29 • n=5 Participants
|
69.4 years
STANDARD_DEVIATION 7.48 • n=7 Participants
|
68.7 years
STANDARD_DEVIATION 7.32 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
121 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
159 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 52 weeksPopulation: Safety population - all patients who received at least one dose of study drug
Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal lab finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgments of the investigators represent significant hazards.
Outcome measures
| Measure |
NVA237
n=123 Participants
50µg once daily
|
Tiotropium
n=40 Participants
18µg once daily
|
|---|---|---|
|
Number of Participants With Adverse Events, Serious Adverse Events or Death
Serious adverse events
|
16 participants
|
6 participants
|
|
Number of Participants With Adverse Events, Serious Adverse Events or Death
Death
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events, Serious Adverse Events or Death
Adverse events
|
102 participants
|
33 participants
|
SECONDARY outcome
Timeframe: Weeks 12, 24, 36 and 52Population: Intent-to-treat (ITT) population - included all randomized patients who received at least one dose of study drug. Only participants with measurements at both baseline and the specified timepoint were included in the analysis for the specific timepoint.
Pre-dose FEV1 is defined as the average of the measurements at 45 and 15 minutes pre-dose.
Outcome measures
| Measure |
NVA237
n=110 Participants
50µg once daily
|
Tiotropium
n=37 Participants
18µg once daily
|
|---|---|---|
|
Change in Pre-dose FEV1 From Baseline
Week 52 (n = 103, 33)
|
0.068 liters
Standard Deviation 0.1829
|
0.127 liters
Standard Deviation 0.2566
|
|
Change in Pre-dose FEV1 From Baseline
Week 36 (n = 106, 36)
|
0.084 liters
Standard Deviation 0.1558
|
0.112 liters
Standard Deviation 0.2200
|
|
Change in Pre-dose FEV1 From Baseline
Week 24
|
0.094 liters
Standard Deviation 0.1614
|
0.144 liters
Standard Deviation 0.1435
|
|
Change in Pre-dose FEV1 From Baseline
Week 12
|
0.101 liters
Standard Deviation 0.1455
|
0.173 liters
Standard Deviation 0.1976
|
SECONDARY outcome
Timeframe: Weeks 12, 24, 36 and 52Population: Intent-to-treat (ITT) population - included all randomized patients who received at least one dose of study drug. Only participants with measurements at both baseline and the specified timepoint were included in the analysis for the specific timepoint.
Pre-dose FVC is defined as the average of the measurements at 45 and 15 minutes pre-dose.
Outcome measures
| Measure |
NVA237
n=110 Participants
50µg once daily
|
Tiotropium
n=37 Participants
18µg once daily
|
|---|---|---|
|
Change in Pre-dose FVC From Baseline
Week 12
|
0.221 liters
Standard Deviation 0.3057
|
0.220 liters
Standard Deviation 0.3029
|
|
Change in Pre-dose FVC From Baseline
Week 24
|
0.218 liters
Standard Deviation 0.2798
|
0.179 liters
Standard Deviation 0.2285
|
|
Change in Pre-dose FVC From Baseline
Week 36 (n = 106, 36)
|
0.208 liters
Standard Deviation 0.3204
|
0.146 liters
Standard Deviation 0.2547
|
|
Change in Pre-dose FVC From Baseline
Week 52 (n = 103, 33)
|
0.195 liters
Standard Deviation 0.3739
|
0.126 liters
Standard Deviation 0.2889
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Intent-to-treat (ITT) population - included all randomized patients who received at least one dose of study drug
Moderate COPD exacerbations were defined as: worsening of 2 or more of the following major symptoms for at least 2 consecutive days - dyspnea, sputum volume and sputum purulence; OR a worsening of any 1 major symptom with any 1 of the following minor symptoms for at least 2 consecutive days - sore throat, colds, fever without other cause, increased cough or increased wheeze, requiring treatment with systemic glucocorticosteroids or antibiotics or both. Severe COPD exacerbations were defined as: conditions for Moderate COPD exacerbation and hospitalization was required. Participants who withdraw from the study and do not experience a moderate or severe exacerbation are censored at the date of withdrawal. Participants who complete the study and do not experience a moderate or severe exacerbation are censored at the completion visit date.
Outcome measures
| Measure |
NVA237
n=123 Participants
50µg once daily
|
Tiotropium
n=40 Participants
18µg once daily
|
|---|---|---|
|
Time From Randomization Until the Start of the First Moderate or Severe COPD Exacerbation
|
362 days
Interval 2.0 to 372.0
|
359 days
Interval 4.0 to 368.0
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Intent-to-treat (ITT) population - included all randomized patients who received at least one dose of study drug
Moderate COPD exacerbations were defined as: worsening of 2 or more of the following major symptoms for at least 2 consecutive days - dyspnea, sputum volume and sputum purulence; OR a worsening of any 1 major symptom with any 1 of the following minor symptoms for at least 2 consecutive days - sore throat, colds, fever without other cause, increased cough or increased wheeze, requiring treatment with systemic glucocorticosteroids or antibiotics or both. Severe COPD exacerbations were defined as: conditions for Moderate COPD exacerbation and hospitalization was required.
Outcome measures
| Measure |
NVA237
n=123 Participants
50µg once daily
|
Tiotropium
n=40 Participants
18µg once daily
|
|---|---|---|
|
Number of Patients With Moderate or Severe COPD Exacerbations
0 exacerbations
|
99 participants
|
31 participants
|
|
Number of Patients With Moderate or Severe COPD Exacerbations
1 exacerbation
|
17 participants
|
5 participants
|
|
Number of Patients With Moderate or Severe COPD Exacerbations
2 exacerbations
|
5 participants
|
3 participants
|
|
Number of Patients With Moderate or Severe COPD Exacerbations
3 exacerbations
|
1 participants
|
0 participants
|
|
Number of Patients With Moderate or Severe COPD Exacerbations
> = 4 exacerbations
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Weeks 12, 24, 36, 52Population: Intent-to-treat (ITT) population - included all randomized patients who received at least one dose of study drug. Only participants with measurements at both baseline and the specified timepoint were included in the analysis for the specific timepoint.
SGRQ is a health related quality of life questionnaire consisting of 51 items in three components: symptoms, activity, and impacts. The lowest possible value is zero and the highest 100. Higher values correspond to greater impairment in quality of life.
Outcome measures
| Measure |
NVA237
n=121 Participants
50µg once daily
|
Tiotropium
n=40 Participants
18µg once daily
|
|---|---|---|
|
Change in St. George Respiratory Questionnaire From Baseline
Week 12
|
-2.57 score on a scale
Standard Deviation 8.506
|
-2.31 score on a scale
Standard Deviation 13.654
|
|
Change in St. George Respiratory Questionnaire From Baseline
Week 24
|
-1.77 score on a scale
Standard Deviation 9.466
|
-3.24 score on a scale
Standard Deviation 12.908
|
|
Change in St. George Respiratory Questionnaire From Baseline
Week 36
|
-2.54 score on a scale
Standard Deviation 9.614
|
-0.93 score on a scale
Standard Deviation 14.214
|
|
Change in St. George Respiratory Questionnaire From Baseline
Week 52
|
-2.68 score on a scale
Standard Deviation 10.505
|
0.36 score on a scale
Standard Deviation 15.389
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Intent-to-treat (ITT) population - included all randomized patients who received at least one dose of study drug
Patients recorded rescue medication use in a paper patient diary. If a patient required the use of salbutamol as rescue medication due to an increase in COPD symptoms, the number of inhalations (puffs) taken was recorded in the patient diary.
Outcome measures
| Measure |
NVA237
n=123 Participants
50µg once daily
|
Tiotropium
n=40 Participants
18µg once daily
|
|---|---|---|
|
Change From Baseline in Mean Daily Number of Puffs of Rescue Medication Over the Whole Treatment Period
|
-0.16 change in puffs
Standard Deviation 1.039
|
-0.27 change in puffs
Standard Deviation 0.859
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Safety population - all patients who received at least one dose of study drug. Only participants with the required measurements were included for each specific value.
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 |
NVA237
n=123 Participants
50µg once daily
|
Tiotropium
n=40 Participants
18µg once daily
|
|---|---|---|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Hematology Values at Any Timepoint Over the Whole Treatment Period
Hemoglobin - male (n = 121, 38)
|
3 participants
|
2 participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Hematology Values at Any Timepoint Over the Whole Treatment Period
Hemoglobin - female (n = 121, 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
Hematocrit - male (n = 121, 38)
|
3 participants
|
4 participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Hematology Values at Any Timepoint Over the Whole Treatment Period
Hematocrit - female (n = 121, 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/µL
|
0 participants
|
1 participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Hematology Values at Any Timepoint Over the Whole Treatment Period
White cell count - >16000/µL
|
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 - <7.5 10*4/µL
|
1 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 10*4/µL
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Safety population - 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 |
NVA237
n=123 Participants
50µg once daily
|
Tiotropium
n=40 Participants
18µg once daily
|
|---|---|---|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Timepoint Over the Whole Treatment Period
Total protein - <4.0 g/dL
|
0 participants
|
0 participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Timepoint Over the Whole Treatment Period
Total protein - >9.5 g/dL
|
0 participants
|
0 participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Timepoint Over the Whole Treatment Period
Albumin - <2.5 g/dL
|
0 participants
|
0 participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Timepoint Over the Whole Treatment Period
Bilirubin (total) - >1.9 mg/dL
|
2 participants
|
0 participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Timepoint Over the Whole Treatment Period
BUN - >27 mg/dL
|
3 participants
|
0 participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Timepoint Over the Whole Treatment Period
Creatinine - >1.99 mg/dL
|
0 participants
|
0 participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Timepoint Over the Whole Treatment Period
AST - >3 x ULN U/L
|
1 participants
|
0 participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Timepoint Over the Whole Treatment Period
ALT - >3 x ULN U/L
|
0 participants
|
0 participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Timepoint Over the Whole Treatment Period
ALP - >3 x ULN U/L
|
0 participants
|
1 participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Timepoint Over the Whole Treatment Period
Y-GTP - >3 x ULN U/L
|
5 participants
|
4 participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Timepoint Over the Whole Treatment Period
Sodium - <125 mEq/L
|
0 participants
|
0 participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Timepoint Over the Whole Treatment Period
Sodium - >160 mEq/L
|
0 participants
|
0 participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Timepoint Over the Whole Treatment Period
Potassium - <3.0 mEq/L
|
1 participants
|
0 participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Timepoint Over the Whole Treatment Period
Potassium - >6.0 mEq/L
|
0 participants
|
0 participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Timepoint Over the Whole Treatment Period
Glucose - <51.0 mg/dL
|
0 participants
|
0 participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Timepoint Over the Whole Treatment Period
Glucose - >180.0 mg/dL
|
11 participants
|
3 participants
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Safety population - 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 |
NVA237
n=123 Participants
50µg once daily
|
Tiotropium
n=40 Participants
18µg once daily
|
|---|---|---|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Vital Signs Values at Any Timepoint Over the Whole Treatment Period
Systolic blood pressure - low
|
0 participants
|
0 participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Vital Signs Values at Any Timepoint Over the Whole Treatment Period
Systolic blood pressure - high
|
1 participants
|
0 participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Vital Signs Values at Any Timepoint Over the Whole Treatment Period
Systolic blood pressure - low or high
|
1 participants
|
0 participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Vital Signs Values at Any Timepoint Over the Whole Treatment Period
Diastolic blood pressure - low
|
1 participants
|
0 participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Vital Signs Values at Any Timepoint Over the Whole Treatment Period
Diastolic blood pressure - high
|
2 participants
|
0 participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Vital Signs Values at Any Timepoint Over the Whole Treatment Period
Diastolic blood pressure - low or high
|
3 participants
|
0 participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Vital Signs Values at Any Timepoint Over the Whole Treatment Period
Pulse rate - low
|
0 participants
|
1 participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Vital Signs Values at Any Timepoint 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 Timepoint Over the Whole Treatment Period
Pulse rate - low or high
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Safety population - all patients who received at least one dose of study drug
Clinically notable change from baseline was and increase from baseline of 30 or greater milliseconds (ms).
Outcome measures
| Measure |
NVA237
n=123 Participants
50µg once daily
|
Tiotropium
n=40 Participants
18µg once daily
|
|---|---|---|
|
Number of Patients With Notable Change From Baseline in Fridericia's QTc Values at Any Timepoint Over the Whole Treatment Period
Increase from baseline 30 to 60 ms
|
6 participants
|
1 participants
|
|
Number of Patients With Notable Change From Baseline in Fridericia's QTc Values at Any Timepoint Over the Whole Treatment Period
Increase from baseline >60 ms
|
2 participants
|
0 participants
|
Adverse Events
NVA237
Tiotropium
Serious adverse events
| Measure |
NVA237
n=123 participants at risk
50µg once daily
|
Tiotropium
n=40 participants at risk
18µg once daily
|
|---|---|---|
|
Cardiac disorders
Angina unstable
|
0.00%
0/123
|
2.5%
1/40
|
|
Cardiac disorders
Cardiac failure
|
0.81%
1/123
|
0.00%
0/40
|
|
Eye disorders
Cataract
|
0.81%
1/123
|
0.00%
0/40
|
|
Eye disorders
Macular hole
|
0.81%
1/123
|
0.00%
0/40
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.81%
1/123
|
0.00%
0/40
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/123
|
2.5%
1/40
|
|
Infections and infestations
Bronchitis
|
0.81%
1/123
|
0.00%
0/40
|
|
Infections and infestations
Bronchopneumonia
|
0.81%
1/123
|
0.00%
0/40
|
|
Infections and infestations
Diverticulitis
|
0.81%
1/123
|
0.00%
0/40
|
|
Infections and infestations
Nasopharyngitis
|
0.81%
1/123
|
0.00%
0/40
|
|
Infections and infestations
Pneumonia
|
0.00%
0/123
|
5.0%
2/40
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.81%
1/123
|
0.00%
0/40
|
|
Infections and infestations
Sepsis
|
0.81%
1/123
|
0.00%
0/40
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/123
|
2.5%
1/40
|
|
Injury, poisoning and procedural complications
Heat illness
|
0.00%
0/123
|
2.5%
1/40
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.81%
1/123
|
0.00%
0/40
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.81%
1/123
|
0.00%
0/40
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.81%
1/123
|
0.00%
0/40
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.81%
1/123
|
2.5%
1/40
|
|
Nervous system disorders
Loss of consciousness
|
0.81%
1/123
|
0.00%
0/40
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.81%
1/123
|
0.00%
0/40
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.6%
2/123
|
0.00%
0/40
|
Other adverse events
| Measure |
NVA237
n=123 participants at risk
50µg once daily
|
Tiotropium
n=40 participants at risk
18µg once daily
|
|---|---|---|
|
Ear and labyrinth disorders
Meniere's disease
|
0.00%
0/123
|
2.5%
1/40
|
|
Ear and labyrinth disorders
Vertigo
|
1.6%
2/123
|
5.0%
2/40
|
|
Eye disorders
Cataract
|
0.81%
1/123
|
2.5%
1/40
|
|
Eye disorders
Conjunctivitis
|
0.81%
1/123
|
2.5%
1/40
|
|
Eye disorders
Dry eye
|
0.00%
0/123
|
2.5%
1/40
|
|
Gastrointestinal disorders
Abdominal distension
|
0.81%
1/123
|
2.5%
1/40
|
|
Gastrointestinal disorders
Constipation
|
4.9%
6/123
|
7.5%
3/40
|
|
Gastrointestinal disorders
Diarrhoea
|
0.81%
1/123
|
2.5%
1/40
|
|
Gastrointestinal disorders
Dry mouth
|
1.6%
2/123
|
5.0%
2/40
|
|
Gastrointestinal disorders
Gastric xanthoma
|
0.00%
0/123
|
2.5%
1/40
|
|
Gastrointestinal disorders
Gastritis
|
0.81%
1/123
|
7.5%
3/40
|
|
Gastrointestinal disorders
Gastritis atrophic
|
2.4%
3/123
|
2.5%
1/40
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
4.1%
5/123
|
0.00%
0/40
|
|
Gastrointestinal disorders
Gingivitis
|
1.6%
2/123
|
2.5%
1/40
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/123
|
2.5%
1/40
|
|
Gastrointestinal disorders
Intestinal polyp
|
0.81%
1/123
|
2.5%
1/40
|
|
Gastrointestinal disorders
Nausea
|
0.81%
1/123
|
2.5%
1/40
|
|
Gastrointestinal disorders
Toothache
|
0.81%
1/123
|
5.0%
2/40
|
|
General disorders
Fatigue
|
0.00%
0/123
|
2.5%
1/40
|
|
General disorders
Metaplasia
|
0.00%
0/123
|
2.5%
1/40
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.81%
1/123
|
5.0%
2/40
|
|
Infections and infestations
Arthritis infective
|
0.00%
0/123
|
2.5%
1/40
|
|
Infections and infestations
Bronchitis
|
4.9%
6/123
|
12.5%
5/40
|
|
Infections and infestations
Eczema impetiginous
|
0.00%
0/123
|
2.5%
1/40
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/123
|
2.5%
1/40
|
|
Infections and infestations
Gastroenteritis
|
2.4%
3/123
|
2.5%
1/40
|
|
Infections and infestations
Gastroenteritis viral
|
0.81%
1/123
|
2.5%
1/40
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/123
|
5.0%
2/40
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/123
|
2.5%
1/40
|
|
Infections and infestations
Lower respiratory tract infection
|
2.4%
3/123
|
5.0%
2/40
|
|
Infections and infestations
Nasopharyngitis
|
30.1%
37/123
|
32.5%
13/40
|
|
Infections and infestations
Oral herpes
|
0.81%
1/123
|
2.5%
1/40
|
|
Infections and infestations
Pharyngitis
|
4.9%
6/123
|
2.5%
1/40
|
|
Infections and infestations
Pneumonia
|
0.81%
1/123
|
5.0%
2/40
|
|
Infections and infestations
Sinusitis
|
0.00%
0/123
|
2.5%
1/40
|
|
Infections and infestations
Skin candida
|
0.00%
0/123
|
2.5%
1/40
|
|
Infections and infestations
Tinea infection
|
0.00%
0/123
|
2.5%
1/40
|
|
Infections and infestations
Upper respiratory tract infection
|
4.9%
6/123
|
7.5%
3/40
|
|
Infections and infestations
Upper respiratory tract infection bacterial
|
4.9%
6/123
|
5.0%
2/40
|
|
Infections and infestations
Urinary tract infection
|
0.81%
1/123
|
2.5%
1/40
|
|
Injury, poisoning and procedural complications
Contusion
|
2.4%
3/123
|
2.5%
1/40
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/123
|
2.5%
1/40
|
|
Injury, poisoning and procedural complications
Fractured sacrum
|
0.00%
0/123
|
2.5%
1/40
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/123
|
2.5%
1/40
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/123
|
2.5%
1/40
|
|
Investigations
Blood creatinine increased
|
0.00%
0/123
|
2.5%
1/40
|
|
Investigations
Blood potassium increased
|
0.00%
0/123
|
2.5%
1/40
|
|
Investigations
Blood pressure increased
|
0.81%
1/123
|
2.5%
1/40
|
|
Investigations
Electrocardiogram T wave abnormal
|
0.00%
0/123
|
2.5%
1/40
|
|
Investigations
Gamma-glutamyltransferase increased
|
2.4%
3/123
|
0.00%
0/40
|
|
Investigations
Platelet count increased
|
0.00%
0/123
|
2.5%
1/40
|
|
Investigations
White blood cell count increased
|
0.00%
0/123
|
2.5%
1/40
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
2.4%
3/123
|
0.00%
0/40
|
|
Metabolism and nutrition disorders
Gout
|
0.81%
1/123
|
2.5%
1/40
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.6%
2/123
|
2.5%
1/40
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.9%
6/123
|
2.5%
1/40
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.81%
1/123
|
2.5%
1/40
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/123
|
2.5%
1/40
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.00%
0/123
|
2.5%
1/40
|
|
Nervous system disorders
Dizziness
|
0.81%
1/123
|
2.5%
1/40
|
|
Nervous system disorders
Intracranial aneurysm
|
0.00%
0/123
|
2.5%
1/40
|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/123
|
2.5%
1/40
|
|
Psychiatric disorders
Depression
|
0.00%
0/123
|
2.5%
1/40
|
|
Psychiatric disorders
Insomnia
|
2.4%
3/123
|
2.5%
1/40
|
|
Renal and urinary disorders
Dysuria
|
2.4%
3/123
|
0.00%
0/40
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
1.6%
2/123
|
2.5%
1/40
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/123
|
2.5%
1/40
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
22.8%
28/123
|
32.5%
13/40
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
4.9%
6/123
|
5.0%
2/40
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/123
|
5.0%
2/40
|
|
Respiratory, thoracic and mediastinal disorders
Lower respiratory tract inflammation
|
0.81%
1/123
|
2.5%
1/40
|
|
Respiratory, thoracic and mediastinal disorders
Sputum retention
|
3.3%
4/123
|
0.00%
0/40
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
3.3%
4/123
|
2.5%
1/40
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.81%
1/123
|
2.5%
1/40
|
|
Skin and subcutaneous tissue disorders
Eczema
|
2.4%
3/123
|
0.00%
0/40
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
1.6%
2/123
|
5.0%
2/40
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/123
|
5.0%
2/40
|
|
Skin and subcutaneous tissue disorders
Xeroderma
|
0.00%
0/123
|
2.5%
1/40
|
|
Vascular disorders
Hypertension
|
5.7%
7/123
|
12.5%
5/40
|
Additional Information
Study Director
Novartis Pharmaceuticals
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 (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER