Trial Outcomes & Findings for Effect of Omalizumab in Patients With Severe Persistent Non-atopic Uncontrolled Asthma (NCT NCT01007149)
NCT ID: NCT01007149
Last Updated: 2012-07-20
Results Overview
Venous blood samples were collected at screening and at Week 16. Flow cytometry analysis determined the FcεRI receptors expression of blood basophils (mean fluorescence intensity(MFI)). Relative change in mean fluorescence intensity at the end of study was expressed as a percentage of baseline value.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
79 participants
Primary outcome timeframe
Baseline and 16 weeks
Results posted on
2012-07-20
Participant Flow
79 patients were screened. 41 patients received study medication.
Participant milestones
| Measure |
Omalizumab
Participants received subcutaneous injections of omalizumab every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
|
Placebo
Participants received subcutaneous injections of placebo to omalizumab every 2 weeks or every 4 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
21
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Omalizumab
Participants received subcutaneous injections of omalizumab every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
|
Placebo
Participants received subcutaneous injections of placebo to omalizumab every 2 weeks or every 4 weeks.
|
|---|---|---|
|
Overall Study
Administrative problems
|
0
|
1
|
Baseline Characteristics
Effect of Omalizumab in Patients With Severe Persistent Non-atopic Uncontrolled Asthma
Baseline characteristics by cohort
| Measure |
Omalizumab
n=20 Participants
Participants received subcutaneous injections of omalizumab every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
|
Placebo
n=21 Participants
Participants received subcutaneous injections of placebo to omalizumab every 2 weeks or every 4 weeks.
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
55.0 years
STANDARD_DEVIATION 9.67 • n=5 Participants
|
54.6 years
STANDARD_DEVIATION 12.78 • n=7 Participants
|
54.8 years
STANDARD_DEVIATION 11.23 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 16 weeksPopulation: Intent to Treat FcεRI analyzable population - all randomized patients who received at least one dose of study drug and had at least one post-baseline efficacy assessment, and who had a valid baseline and post-treatment measurement of FcεRI
Venous blood samples were collected at screening and at Week 16. Flow cytometry analysis determined the FcεRI receptors expression of blood basophils (mean fluorescence intensity(MFI)). Relative change in mean fluorescence intensity at the end of study was expressed as a percentage of baseline value.
Outcome measures
| Measure |
Omalizumab
n=20 Participants
Participants received subcutaneous injections of omalizumab every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
|
Placebo
n=21 Participants
Participants received subcutaneous injections of placebo to omalizumab every 2 weeks or every 4 weeks.
|
|---|---|---|
|
Change From Baseline in the Expression of FcεRI Receptors of Blood Basophils
|
-84.4 Percent change in MFI
Standard Deviation 17.80
|
27.7 Percent change in MFI
Standard Deviation 87.90
|
PRIMARY outcome
Timeframe: Baseline and 16 weeksPopulation: Intent to Treat FcεRI analyzable population - all randomized patients who received at least one dose of study drug and had at least one post-baseline efficacy assessment, and who had a valid baseline and post-treatment measurement of FcεRI
Venous blood samples were collected at screening and at Week 16. Flow cytometry analysis determined the FcεRI receptors expression of dendritic cells (mean fluorescence intensity (MFI)). Relative change in mean fluorescence intensity at the end of study was expressed as a percentage of baseline value.
Outcome measures
| Measure |
Omalizumab
n=19 Participants
Participants received subcutaneous injections of omalizumab every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
|
Placebo
n=20 Participants
Participants received subcutaneous injections of placebo to omalizumab every 2 weeks or every 4 weeks.
|
|---|---|---|
|
Change From Baseline in the Expression of FcεRI Receptors of Dendritic Cells
|
-56.7 Percent change in MFI
Standard Deviation 19.74
|
24.8 Percent change in MFI
Standard Deviation 111.71
|
SECONDARY outcome
Timeframe: Baseline and 4, 8, 12 and 16 weeksPopulation: Intent to Treat population - all randomized patients who received at least one dose of study drug and had at least one post-baseline efficacy assessment. During different time points, participants with observations at that time point were included in the analysis.
FeNO was measured at baseline, and after 4, 8, 12 and 16 weeks of treatment. Absolute change in FeNO was expressed at each time point versus baseline value.
Outcome measures
| Measure |
Omalizumab
n=19 Participants
Participants received subcutaneous injections of omalizumab every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
|
Placebo
n=20 Participants
Participants received subcutaneous injections of placebo to omalizumab every 2 weeks or every 4 weeks.
|
|---|---|---|
|
Change in Fractional Exhaled Nitric Oxide (FeNO)
Week 16 (N = 18, 19)
|
2.4 parts per billion (ppb)
Standard Deviation 18.19
|
0.7 parts per billion (ppb)
Standard Deviation 17.57
|
|
Change in Fractional Exhaled Nitric Oxide (FeNO)
Week 4 (N = 19, 19)
|
2.5 parts per billion (ppb)
Standard Deviation 21.28
|
-5.9 parts per billion (ppb)
Standard Deviation 29.72
|
|
Change in Fractional Exhaled Nitric Oxide (FeNO)
Week 8 (N = 18, 20)
|
4.3 parts per billion (ppb)
Standard Deviation 25.48
|
-7.4 parts per billion (ppb)
Standard Deviation 30.19
|
|
Change in Fractional Exhaled Nitric Oxide (FeNO)
Week 12 (N = 19, 18)
|
1.0 parts per billion (ppb)
Standard Deviation 17.29
|
1.3 parts per billion (ppb)
Standard Deviation 30.26
|
SECONDARY outcome
Timeframe: Baseline and 16 weeksPopulation: Intent to Treat population - all randomized patients who received at least one dose of study drug and had at least one post-baseline efficacy assessment. Only patients with measurements at both baseline and week 16 were included in this analysis.
The induced sputum eosinophil count was measured in a subset of patients in selected centers. Sputum samples were collected at screening and Week 16. Sputum eosinophil count was expressed as a percentage of total nonsquamous cells. Absolute change in sputum eosinophil count was expressed versus baseline value.
Outcome measures
| Measure |
Omalizumab
n=9 Participants
Participants received subcutaneous injections of omalizumab every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
|
Placebo
n=6 Participants
Participants received subcutaneous injections of placebo to omalizumab every 2 weeks or every 4 weeks.
|
|---|---|---|
|
Change From Baseline in Induced Sputum Eosinophil Count
|
-10.2 Percentage of total nonsquamous cells
Standard Deviation 32.38
|
2.2 Percentage of total nonsquamous cells
Standard Deviation 10.94
|
SECONDARY outcome
Timeframe: Baseline and 16 weeksPopulation: Intent to Treat Population - all randomized patients who received at least one dose of study drug and had at least one post-baseline efficacy assessment
The shortened version of the asthma control questionnaire (symptoms plus β2-agonist) consists of 6 subscores (nighttime waking, symptoms on waking, activity limitation, shortness of breath, wheeze and rescue short-acting β2-agonist use) between 0 and 6 (0 = no impairment; 6 = maximum impairment) and a total score between 0 and 6 (subscores mean value). Absolute change in total score and subscores count was expressed versus baseline value. A decrease in score indicates improvement.
Outcome measures
| Measure |
Omalizumab
n=20 Participants
Participants received subcutaneous injections of omalizumab every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
|
Placebo
n=21 Participants
Participants received subcutaneous injections of placebo to omalizumab every 2 weeks or every 4 weeks.
|
|---|---|---|
|
Change From Baseline in Score of the Shortened Version of the Asthma Control Questionnaire (Symptoms Plus Short-acting β2-agonist)
Shortness of breath
|
-0.9 Score units
Standard Deviation 1.29
|
-0.6 Score units
Standard Deviation 1.75
|
|
Change From Baseline in Score of the Shortened Version of the Asthma Control Questionnaire (Symptoms Plus Short-acting β2-agonist)
Total score
|
-0.5 Score units
Standard Deviation 0.98
|
-0.5 Score units
Standard Deviation 1.43
|
|
Change From Baseline in Score of the Shortened Version of the Asthma Control Questionnaire (Symptoms Plus Short-acting β2-agonist)
Nighttime waking
|
0.1 Score units
Standard Deviation 1.61
|
-0.8 Score units
Standard Deviation 1.69
|
|
Change From Baseline in Score of the Shortened Version of the Asthma Control Questionnaire (Symptoms Plus Short-acting β2-agonist)
Symptoms on waking
|
-0.6 Score units
Standard Deviation 1.32
|
-0.9 Score units
Standard Deviation 1.73
|
|
Change From Baseline in Score of the Shortened Version of the Asthma Control Questionnaire (Symptoms Plus Short-acting β2-agonist)
Activity limitation
|
-0.7 Score units
Standard Deviation 1.34
|
-0.5 Score units
Standard Deviation 1.94
|
|
Change From Baseline in Score of the Shortened Version of the Asthma Control Questionnaire (Symptoms Plus Short-acting β2-agonist)
Wheeze (N = 19, 21)
|
-0.8 Score units
Standard Deviation 1.62
|
-0.3 Score units
Standard Deviation 1.79
|
|
Change From Baseline in Score of the Shortened Version of the Asthma Control Questionnaire (Symptoms Plus Short-acting β2-agonist)
Use of rescue short-acting β2-agonist
|
-0.3 Score units
Standard Deviation 0.57
|
0.3 Score units
Standard Deviation 1.45
|
SECONDARY outcome
Timeframe: Baseline and 16 weeksPopulation: Intent to Treat Population - all randomized patients who received at least one dose of study drug and had at least one post-baseline efficacy assessment
Nasal symptom score calculated from six scales assessing the nasal symptom severity (sneezing, runny nose, congestion, itchy nose, postnasal drip and nasal symptoms overall). These six scores were rated on a scale from 1 to 7, with 7 being the worst rating. Absolute changes in these six scores were expressed versus baseline values. A negative change indicates improvement. The range of the global score was from 1 to 7, since this is the mean value of all the subscores.
Outcome measures
| Measure |
Omalizumab
n=20 Participants
Participants received subcutaneous injections of omalizumab every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
|
Placebo
n=21 Participants
Participants received subcutaneous injections of placebo to omalizumab every 2 weeks or every 4 weeks.
|
|---|---|---|
|
Change From Baseline in Nasal Symptom Global Score and Individual Components
Global score
|
-0.8 Score units
Standard Deviation 0.74
|
-0.3 Score units
Standard Deviation 1.38
|
|
Change From Baseline in Nasal Symptom Global Score and Individual Components
Sneezing
|
-1.1 Score units
Standard Deviation 1.10
|
-0.4 Score units
Standard Deviation 1.12
|
|
Change From Baseline in Nasal Symptom Global Score and Individual Components
Runny nose
|
-0.9 Score units
Standard Deviation 1.20
|
-0.6 Score units
Standard Deviation 1.83
|
|
Change From Baseline in Nasal Symptom Global Score and Individual Components
Congestion
|
-0.6 Score units
Standard Deviation 1.39
|
-0.7 Score units
Standard Deviation 2.24
|
|
Change From Baseline in Nasal Symptom Global Score and Individual Components
Itchy nose
|
-0.4 Score units
Standard Deviation 0.84
|
0.1 Score units
Standard Deviation 1.92
|
|
Change From Baseline in Nasal Symptom Global Score and Individual Components
Postnasal drip
|
-0.6 Score units
Standard Deviation 1.50
|
0.3 Score units
Standard Deviation 1.37
|
|
Change From Baseline in Nasal Symptom Global Score and Individual Components
Nasal symptoms overall
|
-1.2 Score units
Standard Deviation 1.44
|
-0.2 Score units
Standard Deviation 1.81
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: Intent to Treat Population - all randomized patients who received at least one dose of study drug and had at least one post-baseline efficacy assessment
The GETE is an assessment of asthma symptoms controlled in response to asthma treatment. The evaluation was performed independently by both investigator and patient using the same 5 point scale. The scale points are: excellent, good, moderate, poor and worsening. A good or excellent response is suggested as a means of defining a patient who has responded to treatment.
Outcome measures
| Measure |
Omalizumab
n=20 Participants
Participants received subcutaneous injections of omalizumab every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
|
Placebo
n=21 Participants
Participants received subcutaneous injections of placebo to omalizumab every 2 weeks or every 4 weeks.
|
|---|---|---|
|
Physician and Patient Global Evaluation of Treatment Effectiveness
Physician's evaluation - Excellent
|
2 Participants
|
1 Participants
|
|
Physician and Patient Global Evaluation of Treatment Effectiveness
Physician's evaluation - Moderate
|
3 Participants
|
8 Participants
|
|
Physician and Patient Global Evaluation of Treatment Effectiveness
Physician's evaluation - Poor
|
9 Participants
|
6 Participants
|
|
Physician and Patient Global Evaluation of Treatment Effectiveness
Physician's evaluation - Worsening
|
0 Participants
|
2 Participants
|
|
Physician and Patient Global Evaluation of Treatment Effectiveness
Patient's evaluation - Poor
|
5 Participants
|
4 Participants
|
|
Physician and Patient Global Evaluation of Treatment Effectiveness
Patient's evaluation - Worsening
|
0 Participants
|
2 Participants
|
|
Physician and Patient Global Evaluation of Treatment Effectiveness
Patient's evaluation - Excellent
|
2 Participants
|
0 Participants
|
|
Physician and Patient Global Evaluation of Treatment Effectiveness
Patient's evaluation - Good
|
7 Participants
|
5 Participants
|
|
Physician and Patient Global Evaluation of Treatment Effectiveness
Patient's evaluation - Moderate
|
6 Participants
|
9 Participants
|
|
Physician and Patient Global Evaluation of Treatment Effectiveness
Physician's evaluation - Good
|
6 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline and 16 weeksPopulation: Intent to Treat Population - all randomized patients who received at least one dose of study drug and had at least one post-baseline efficacy assessment
Spirometry was conducted according to internationally accepted standards. At least three maneuvers were performed at each sampling timepoint. The FEV1 recorded was taken from the maneuver obtained from the single best test curve. The best test curve was defined as the spirogram that gave the largest FEV1.
Outcome measures
| Measure |
Omalizumab
n=20 Participants
Participants received subcutaneous injections of omalizumab every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
|
Placebo
n=21 Participants
Participants received subcutaneous injections of placebo to omalizumab every 2 weeks or every 4 weeks.
|
|---|---|---|
|
Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline to 16 Weeks
|
0.25 Liters
Standard Deviation 0.38
|
0.00 Liters
Standard Deviation 0.20
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: Intent to Treat Population - all randomized patients who received at least one dose of study drug and had at least one post-baseline efficacy assessment
Asthma-related events were: unscheduled medical visits, emergency room visits and hospitalizations. Details of exacerbations requiring oral or IV corticosteroids were recorded at each visit.
Outcome measures
| Measure |
Omalizumab
n=20 Participants
Participants received subcutaneous injections of omalizumab every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
|
Placebo
n=21 Participants
Participants received subcutaneous injections of placebo to omalizumab every 2 weeks or every 4 weeks.
|
|---|---|---|
|
Number of Patients With at Least One Asthma-related Event Over 16 Weeks
|
9 Participants
|
11 Participants
|
Adverse Events
Omalizumab
Serious events: 2 serious events
Other events: 16 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Omalizumab
n=20 participants at risk
Participants received subcutaneous injections of omalizumab every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
|
Placebo
n=21 participants at risk
Participants received subcutaneous injections of placebo to omalizumab every 2 weeks or every 4 weeks.
|
|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/20
Safety population - all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
|
4.8%
1/21
Safety population - all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
10.0%
2/20
Safety population - all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
|
0.00%
0/21
Safety population - all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
|
Other adverse events
| Measure |
Omalizumab
n=20 participants at risk
Participants received subcutaneous injections of omalizumab every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
|
Placebo
n=21 participants at risk
Participants received subcutaneous injections of placebo to omalizumab every 2 weeks or every 4 weeks.
|
|---|---|---|
|
Cardiac disorders
Tachycardia
|
10.0%
2/20
Safety population - all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
|
0.00%
0/21
Safety population - all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
|
|
Ear and labyrinth disorders
Vertigo
|
5.0%
1/20
Safety population - all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
|
4.8%
1/21
Safety population - all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
|
|
Gastrointestinal disorders
Abdominal distension
|
5.0%
1/20
Safety population - all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
|
0.00%
0/21
Safety population - all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.0%
1/20
Safety population - all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
|
0.00%
0/21
Safety population - all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.0%
1/20
Safety population - all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
|
0.00%
0/21
Safety population - all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
|
|
Gastrointestinal disorders
Lip oedema
|
5.0%
1/20
Safety population - all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
|
0.00%
0/21
Safety population - all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
|
|
Gastrointestinal disorders
Nausea
|
5.0%
1/20
Safety population - all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
|
9.5%
2/21
Safety population - all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
|
|
Gastrointestinal disorders
Vomiting
|
5.0%
1/20
Safety population - all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
|
0.00%
0/21
Safety population - all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
|
|
General disorders
Asthenia
|
5.0%
1/20
Safety population - all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
|
4.8%
1/21
Safety population - all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
|
|
General disorders
Chest pain
|
5.0%
1/20
Safety population - all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
|
4.8%
1/21
Safety population - all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
|
|
General disorders
Face oedema
|
5.0%
1/20
Safety population - all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
|
0.00%
0/21
Safety population - all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
|
|
General disorders
Gait disturbance
|
5.0%
1/20
Safety population - all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
|
0.00%
0/21
Safety population - all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
|
|
General disorders
Injection site pain
|
5.0%
1/20
Safety population - all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
|
0.00%
0/21
Safety population - all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
|
|
General disorders
Injection site pruritus
|
5.0%
1/20
Safety population - all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
|
0.00%
0/21
Safety population - all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
|
|
General disorders
Oedema peripheral
|
10.0%
2/20
Safety population - all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
|
0.00%
0/21
Safety population - all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
|
|
Infections and infestations
Acarodermatitis
|
5.0%
1/20
Safety population - all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
|
0.00%
0/21
Safety population - all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
|
|
Infections and infestations
Bronchitis
|
10.0%
2/20
Safety population - all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
|
9.5%
2/21
Safety population - all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
|
|
Infections and infestations
Ear infection
|
0.00%
0/20
Safety population - all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
|
9.5%
2/21
Safety population - all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
|
|
Infections and infestations
Gastroenteritis
|
5.0%
1/20
Safety population - all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
|
0.00%
0/21
Safety population - all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
|
|
Infections and infestations
Nasopharyngitis
|
5.0%
1/20
Safety population - all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
|
4.8%
1/21
Safety population - all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
|
|
Infections and infestations
Rhinitis
|
15.0%
3/20
Safety population - all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
|
0.00%
0/21
Safety population - all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
|
|
Infections and infestations
Sinusitis
|
5.0%
1/20
Safety population - all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
|
9.5%
2/21
Safety population - all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
5.0%
1/20
Safety population - all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
|
0.00%
0/21
Safety population - all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.0%
3/20
Safety population - all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
|
0.00%
0/21
Safety population - all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.0%
1/20
Safety population - all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
|
0.00%
0/21
Safety population - all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.0%
1/20
Safety population - all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
|
0.00%
0/21
Safety population - all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
5.0%
1/20
Safety population - all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
|
0.00%
0/21
Safety population - all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
|
|
Nervous system disorders
Headache
|
15.0%
3/20
Safety population - all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
|
14.3%
3/21
Safety population - all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
|
|
Nervous system disorders
Paraesthesia
|
10.0%
2/20
Safety population - all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
|
0.00%
0/21
Safety population - all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
|
|
Nervous system disorders
Sciatica
|
5.0%
1/20
Safety population - all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
|
0.00%
0/21
Safety population - all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
|
|
Nervous system disorders
Tremor
|
5.0%
1/20
Safety population - all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
|
0.00%
0/21
Safety population - all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
30.0%
6/20
Safety population - all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
|
57.1%
12/21
Safety population - all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
4/20
Safety population - all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
|
9.5%
2/21
Safety population - all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.0%
2/20
Safety population - all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
|
4.8%
1/21
Safety population - all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.0%
1/20
Safety population - all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
|
0.00%
0/21
Safety population - all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.0%
1/20
Safety population - all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
|
0.00%
0/21
Safety population - all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.0%
1/20
Safety population - all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
|
4.8%
1/21
Safety population - all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.0%
1/20
Safety population - all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
|
0.00%
0/21
Safety population - all patients who received at least one dose of study drug and had at least one post-baseline safety assessment
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862-778-8300
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