Trial Outcomes & Findings for Study to Assess the Efficacy and Safety of Omalizumab Treatment on ICS Reduction for Severe IgE-mediated Asthma (NCT NCT01912872)
NCT ID: NCT01912872
Last Updated: 2019-07-02
Results Overview
prescribed budesonide dose (in μg) at Baseline in intention to treat population and in intention to treat population
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
112 participants
Primary outcome timeframe
Baseline
Results posted on
2019-07-02
Participant Flow
Participant milestones
| Measure |
Pediatric Patients: Omalizumab + Budesonide and Formoterol
Participants received omalizumab injection for s.c. use 2 or 4 weeks according to the IgE level and body weight and budesonide + formoterol administered through an inhaler device.
|
Pediatric Patients: Budesonide and Formoterol
Participants received budesonide + formoterol administered through an inhaler device.
|
Adult Patients: Omalizumab + Budesonide and Formoterol
Participants received Omalizumab every 2 or 4 weeks as a subcutaneous injection dose according to the IgE level and body weight. Participants also received and budesonide + formoterol administered through an inhaler device.
|
Adult Patients: Budesonide and Formoterol
Participants receive budesonide + formoterol administered through an inhaler device.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
16
|
17
|
40
|
39
|
|
Overall Study
Completed Study Treatment at Month 12
|
11
|
13
|
30
|
27
|
|
Overall Study
Discontinued Treatment Prior to Month 12
|
5
|
4
|
10
|
11
|
|
Overall Study
COMPLETED
|
11
|
13
|
30
|
27
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
10
|
12
|
Reasons for withdrawal
| Measure |
Pediatric Patients: Omalizumab + Budesonide and Formoterol
Participants received omalizumab injection for s.c. use 2 or 4 weeks according to the IgE level and body weight and budesonide + formoterol administered through an inhaler device.
|
Pediatric Patients: Budesonide and Formoterol
Participants received budesonide + formoterol administered through an inhaler device.
|
Adult Patients: Omalizumab + Budesonide and Formoterol
Participants received Omalizumab every 2 or 4 weeks as a subcutaneous injection dose according to the IgE level and body weight. Participants also received and budesonide + formoterol administered through an inhaler device.
|
Adult Patients: Budesonide and Formoterol
Participants receive budesonide + formoterol administered through an inhaler device.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
5
|
5
|
|
Overall Study
Other unspecified
|
3
|
1
|
3
|
0
|
|
Overall Study
Informed consent withdrawn
|
0
|
0
|
1
|
1
|
|
Overall Study
Non-compliance with lab inc/exclusion
|
0
|
0
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
0
|
|
Overall Study
Unsatisfactory therapeutic effect
|
0
|
0
|
0
|
2
|
|
Overall Study
Withdrawal of study medication
|
0
|
0
|
0
|
2
|
|
Overall Study
Missing
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Study to Assess the Efficacy and Safety of Omalizumab Treatment on ICS Reduction for Severe IgE-mediated Asthma
Baseline characteristics by cohort
| Measure |
Pediatric Patients: Omalizumab + Budesonide and Formoterol
n=16 Participants
Participants received omalizumab injection for s.c. use 2 or 4 weeks according to the IgE level and body weight and budesonide + formoterol administered through an inhaler device.
|
Pediatric Patients: Budesonide and Formoterol
n=17 Participants
Participants received budesonide + formoterol administered through an inhaler device.
|
Adult Patients: Omalizumab + Budesonide and Formoterol
n=40 Participants
Participants received Omalizumab every 2 or 4 weeks as a subcutaneous injection dose according to the IgE level and body weight. Participants also received and budesonide + formoterol administered through an inhaler device.
|
Adult Patients: Budesonide and Formoterol
n=39 Participants
Participants receive budesonide + formoterol administered through an inhaler device.
|
Total
n=112 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
11.1 years
STANDARD_DEVIATION 3.32 • n=93 Participants
|
12.4 years
STANDARD_DEVIATION 1.80 • n=4 Participants
|
37.6 years
STANDARD_DEVIATION 10.01 • n=27 Participants
|
38.7 years
STANDARD_DEVIATION 10.30 • n=483 Participants
|
30.4 years
STANDARD_DEVIATION 14.84 • n=36 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
28 Participants
n=483 Participants
|
70 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
11 Participants
n=483 Participants
|
42 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: Pediatric and Adult intent-to-treat (ITT) and per protocol (PP) populations. ITT population received at least one dose of study drug and one post-baseline assessment of the primary/secondary efficacy variables. PP population was participants that completed 12 months of treatment, had a valid assessment of the primary efficacy variable at Week 24.
prescribed budesonide dose (in μg) at Baseline in intention to treat population and in intention to treat population
Outcome measures
| Measure |
Pediatric Patients: Omalizumab + Budesonide and Formoterol
n=16 Participants
Participants received omalizumab injection for s.c. use 2 or 4 weeks according to the IgE level and body weight and budesonide + formoterol administered through an inhaler device.
|
Pediatric Patients: Budesonide and Formoterol
n=17 Participants
Participants received budesonide + formoterol administered through an inhaler device.
|
Adult Patients: Omalizumab + Budesonide and Formoterol
n=40 Participants
Participants received Omalizumab every 2 or 4 weeks as a subcutaneous injection dose according to the IgE level and body weight. Participants also received and budesonide + formoterol administered through an inhaler device.
|
Adult Patients: Budesonide and Formoterol
n=39 Participants
Participants receive budesonide + formoterol administered through an inhaler device.
|
|---|---|---|---|---|
|
The Mean Prescribed Budesonide Dose (μg) at Baseline
ITT
|
337.5 μg
Standard Deviation 95.74
|
270.6 μg
Standard Deviation 98.52
|
580.0 μg
Standard Deviation 201.53
|
533.3 μg
Standard Deviation 248.50
|
|
The Mean Prescribed Budesonide Dose (μg) at Baseline
PP
|
363.6 μg
Standard Deviation 80.90
|
250.0 μg
Standard Deviation 90.45
|
575.0 μg
Standard Deviation 201.61
|
533.3 μg
Standard Deviation 258.20
|
SECONDARY outcome
Timeframe: 12 month treatment durationPopulation: Pediatric and Adult ITT population. ITT population received at least one dose of study drug and one post-baseline assessment of the primary/secondary efficacy variables.
A hospital admission is defined as admissions to hospital involving a stay of at least 24 hours.
Outcome measures
| Measure |
Pediatric Patients: Omalizumab + Budesonide and Formoterol
n=16 Participants
Participants received omalizumab injection for s.c. use 2 or 4 weeks according to the IgE level and body weight and budesonide + formoterol administered through an inhaler device.
|
Pediatric Patients: Budesonide and Formoterol
n=17 Participants
Participants received budesonide + formoterol administered through an inhaler device.
|
Adult Patients: Omalizumab + Budesonide and Formoterol
n=40 Participants
Participants received Omalizumab every 2 or 4 weeks as a subcutaneous injection dose according to the IgE level and body weight. Participants also received and budesonide + formoterol administered through an inhaler device.
|
Adult Patients: Budesonide and Formoterol
n=39 Participants
Participants receive budesonide + formoterol administered through an inhaler device.
|
|---|---|---|---|---|
|
Number of Hospital Admissions Due to Asthma Exacerbation
|
0 hospital admissions
|
1 hospital admissions
|
0 hospital admissions
|
0 hospital admissions
|
SECONDARY outcome
Timeframe: 12 month treatment durationPopulation: Pediatric and Adult ITT population. ITT population received at least one dose of study drug and one post-baseline assessment of the primary/secondary efficacy variables.
Participants /parent/legal guarding reported number of missed days of school or work at each study visit via diaries.
Outcome measures
| Measure |
Pediatric Patients: Omalizumab + Budesonide and Formoterol
n=16 Participants
Participants received omalizumab injection for s.c. use 2 or 4 weeks according to the IgE level and body weight and budesonide + formoterol administered through an inhaler device.
|
Pediatric Patients: Budesonide and Formoterol
n=17 Participants
Participants received budesonide + formoterol administered through an inhaler device.
|
Adult Patients: Omalizumab + Budesonide and Formoterol
n=40 Participants
Participants received Omalizumab every 2 or 4 weeks as a subcutaneous injection dose according to the IgE level and body weight. Participants also received and budesonide + formoterol administered through an inhaler device.
|
Adult Patients: Budesonide and Formoterol
n=39 Participants
Participants receive budesonide + formoterol administered through an inhaler device.
|
|---|---|---|---|---|
|
Days Missed in School/Work Due to Asthma Exacerbation Episodes
Missed school days
|
2 days
|
3 days
|
1 days
|
0 days
|
|
Days Missed in School/Work Due to Asthma Exacerbation Episodes
Missed work days
|
0 days
|
1 days
|
0 days
|
1 days
|
SECONDARY outcome
Timeframe: 12 month treatment durationPopulation: Pediatric and Adult ITT population. ITT population received at least one dose of study drug and one post-baseline assessment of the primary/secondary efficacy variables.
The clinical control of asthma was defined according to the following criteria (GINA 2012): 1-Daytime symptoms: none or less than twice a week 2-Limitations of daily activities: none 3-Nocturnal symptoms or awakening because of asthma: none 4-Need of relief or rescue medication: none or less than twice a week 5-Lung function (PEF or FEV1) without administration of bronchodilator: normal
Outcome measures
| Measure |
Pediatric Patients: Omalizumab + Budesonide and Formoterol
n=16 Participants
Participants received omalizumab injection for s.c. use 2 or 4 weeks according to the IgE level and body weight and budesonide + formoterol administered through an inhaler device.
|
Pediatric Patients: Budesonide and Formoterol
n=17 Participants
Participants received budesonide + formoterol administered through an inhaler device.
|
Adult Patients: Omalizumab + Budesonide and Formoterol
n=40 Participants
Participants received Omalizumab every 2 or 4 weeks as a subcutaneous injection dose according to the IgE level and body weight. Participants also received and budesonide + formoterol administered through an inhaler device.
|
Adult Patients: Budesonide and Formoterol
n=39 Participants
Participants receive budesonide + formoterol administered through an inhaler device.
|
|---|---|---|---|---|
|
Control of Asthma Symptoms- Daytime Symptoms
|
62.5 percentage of participants
|
70.6 percentage of participants
|
82.5 percentage of participants
|
71.8 percentage of participants
|
SECONDARY outcome
Timeframe: 12 month treatment durationPopulation: Pediatric and Adult ITT population. ITT population received at least one dose of study drug and one post-baseline assessment of the primary/secondary efficacy variables.
The clinical control of asthma was defined according to the following criteria (GINA 2012): 1-Daytime symptoms: none or less than twice a week 2-Limitations of daily activities: none 3-Nocturnal symptoms or awakening because of asthma: none 4-Need of relief or rescue medication: none or less than twice a week 5-Lung function (PEF or FEV1) without administration of bronchodilator: normal
Outcome measures
| Measure |
Pediatric Patients: Omalizumab + Budesonide and Formoterol
n=16 Participants
Participants received omalizumab injection for s.c. use 2 or 4 weeks according to the IgE level and body weight and budesonide + formoterol administered through an inhaler device.
|
Pediatric Patients: Budesonide and Formoterol
n=17 Participants
Participants received budesonide + formoterol administered through an inhaler device.
|
Adult Patients: Omalizumab + Budesonide and Formoterol
n=40 Participants
Participants received Omalizumab every 2 or 4 weeks as a subcutaneous injection dose according to the IgE level and body weight. Participants also received and budesonide + formoterol administered through an inhaler device.
|
Adult Patients: Budesonide and Formoterol
n=39 Participants
Participants receive budesonide + formoterol administered through an inhaler device.
|
|---|---|---|---|---|
|
Control of Asthma Symptoms
Wheezing
|
15.4 Number of days
Standard Deviation 23.43
|
21.1 Number of days
Standard Deviation 32.84
|
25.4 Number of days
Standard Deviation 28.89
|
29.0 Number of days
Standard Deviation 36.30
|
|
Control of Asthma Symptoms
Night time cough
|
12.8 Number of days
Standard Deviation 7.75
|
20.8 Number of days
Standard Deviation 27.24
|
20.6 Number of days
Standard Deviation 22.09
|
32.3 Number of days
Standard Deviation 42.50
|
SECONDARY outcome
Timeframe: 12 month treatment durationPopulation: Pediatric and Adult ITT population. ITT population received at least one dose of study drug and one post-baseline assessment of the primary/secondary efficacy variables.
The clinical control of asthma was defined according to the following criteria (GINA 2012): 1-Daytime symptoms: none or less than twice a week 2-Limitations of daily activities: none 3-Nocturnal symptoms or awakening because of asthma: none 4-Need of relief or rescue medication: none or less than twice a week 5-Lung function (PEF or FEV1) without administration of bronchodilator: normal
Outcome measures
| Measure |
Pediatric Patients: Omalizumab + Budesonide and Formoterol
n=16 Participants
Participants received omalizumab injection for s.c. use 2 or 4 weeks according to the IgE level and body weight and budesonide + formoterol administered through an inhaler device.
|
Pediatric Patients: Budesonide and Formoterol
n=17 Participants
Participants received budesonide + formoterol administered through an inhaler device.
|
Adult Patients: Omalizumab + Budesonide and Formoterol
n=40 Participants
Participants received Omalizumab every 2 or 4 weeks as a subcutaneous injection dose according to the IgE level and body weight. Participants also received and budesonide + formoterol administered through an inhaler device.
|
Adult Patients: Budesonide and Formoterol
n=39 Participants
Participants receive budesonide + formoterol administered through an inhaler device.
|
|---|---|---|---|---|
|
Control of Asthma Symptoms- Rescue Medication Use
|
9 participants
|
15 participants
|
34 participants
|
33 participants
|
SECONDARY outcome
Timeframe: 12 month treatment durationPopulation: Number of patients requiring oral systemic corticosteroids within the ITT Pediatric and Adult population.
Number of days of concomitant medications use reported by participants at all visits via diaries.
Outcome measures
| Measure |
Pediatric Patients: Omalizumab + Budesonide and Formoterol
n=3 Participants
Participants received omalizumab injection for s.c. use 2 or 4 weeks according to the IgE level and body weight and budesonide + formoterol administered through an inhaler device.
|
Pediatric Patients: Budesonide and Formoterol
n=2 Participants
Participants received budesonide + formoterol administered through an inhaler device.
|
Adult Patients: Omalizumab + Budesonide and Formoterol
n=5 Participants
Participants received Omalizumab every 2 or 4 weeks as a subcutaneous injection dose according to the IgE level and body weight. Participants also received and budesonide + formoterol administered through an inhaler device.
|
Adult Patients: Budesonide and Formoterol
n=9 Participants
Participants receive budesonide + formoterol administered through an inhaler device.
|
|---|---|---|---|---|
|
Participants Requiring Oral Systemic Corticosteroids During the 12 Month Study Duration
|
7.3 Number of days
Standard Deviation 4.62
|
16.5 Number of days
Standard Deviation 19.09
|
28.0 Number of days
Standard Deviation 35.67
|
16.3 Number of days
Standard Deviation 17.35
|
SECONDARY outcome
Timeframe: BaselinePopulation: Number of participants with a baseline measurement within the ITT Pediatric and Adult population.
The Asthma Control Questionnaire (ACQ) has six questions to be answered by the participants, each with a 7 point scale (0-good control, 6-poor control), and one question where the actual pre-bronchodilator Forced expiratory volume in 1 second (FEV1) value expressed in % of predicted FEV1 was classified to scores from 0 (\> 95% of predicted) to 6 (\< 50% of predicted). The overall score is the average of the 7 questions; a minimum overall score of 0 = good control of asthma whereas a maximum overall score of 6 = poor control of asthma.
Outcome measures
| Measure |
Pediatric Patients: Omalizumab + Budesonide and Formoterol
n=15 Participants
Participants received omalizumab injection for s.c. use 2 or 4 weeks according to the IgE level and body weight and budesonide + formoterol administered through an inhaler device.
|
Pediatric Patients: Budesonide and Formoterol
n=17 Participants
Participants received budesonide + formoterol administered through an inhaler device.
|
Adult Patients: Omalizumab + Budesonide and Formoterol
n=40 Participants
Participants received Omalizumab every 2 or 4 weeks as a subcutaneous injection dose according to the IgE level and body weight. Participants also received and budesonide + formoterol administered through an inhaler device.
|
Adult Patients: Budesonide and Formoterol
n=39 Participants
Participants receive budesonide + formoterol administered through an inhaler device.
|
|---|---|---|---|---|
|
Asthma Control Questionnaire (ACQ) at Baseline
|
3.3 scores on a scale
Standard Deviation 1.31
|
3.3 scores on a scale
Standard Deviation 1.26
|
3.6 scores on a scale
Standard Deviation 1.09
|
3.3 scores on a scale
Standard Deviation 1.35
|
SECONDARY outcome
Timeframe: BaselinePopulation: Number of participants with a baseline measurement within the ITT Pediatric and Adult population.
The quality of life will be measured by the standardized version of the Asthma Quality of Life Questionnaire (AQLQ\[S\]) score for adults and the pediatric version of the AQLQ(S) for pediatric participants (PAQLQ\[S\]) . The AQLQ(S) and PAQLQ(S0 contain 4 domains (activity limitations, symptoms, emotional function, and environmental stimuli), with a total of 32 items; each item is measured in a 7-point Likert scale of 1 to 7 (1 = severe impairment, 7 = no impairment). All items are weighted equally. Mean score is calculated across all items within each domain and the overall score is the mean score of the 32 items.
Outcome measures
| Measure |
Pediatric Patients: Omalizumab + Budesonide and Formoterol
n=15 Participants
Participants received omalizumab injection for s.c. use 2 or 4 weeks according to the IgE level and body weight and budesonide + formoterol administered through an inhaler device.
|
Pediatric Patients: Budesonide and Formoterol
n=17 Participants
Participants received budesonide + formoterol administered through an inhaler device.
|
Adult Patients: Omalizumab + Budesonide and Formoterol
n=40 Participants
Participants received Omalizumab every 2 or 4 weeks as a subcutaneous injection dose according to the IgE level and body weight. Participants also received and budesonide + formoterol administered through an inhaler device.
|
Adult Patients: Budesonide and Formoterol
n=39 Participants
Participants receive budesonide + formoterol administered through an inhaler device.
|
|---|---|---|---|---|
|
Asthma Quality of Life Questionnaire (AQLQ) at Baseline
Overall
|
3.2 scores on a scale
Standard Deviation 1.21
|
3.4 scores on a scale
Standard Deviation 1.54
|
2.9 scores on a scale
Standard Deviation 1.04
|
3.4 scores on a scale
Standard Deviation 1.25
|
|
Asthma Quality of Life Questionnaire (AQLQ) at Baseline
Symptoms domain
|
3.2 scores on a scale
Standard Deviation 1.49
|
3.3 scores on a scale
Standard Deviation 1.48
|
2.8 scores on a scale
Standard Deviation 1.16
|
3.5 scores on a scale
Standard Deviation 1.37
|
|
Asthma Quality of Life Questionnaire (AQLQ) at Baseline
Activity limitations domain
|
3.2 scores on a scale
Standard Deviation 1.18
|
3.3 scores on a scale
Standard Deviation 1.47
|
3.2 scores on a scale
Standard Deviation 1.07
|
3.5 scores on a scale
Standard Deviation 1.25
|
|
Asthma Quality of Life Questionnaire (AQLQ) at Baseline
Emotional functions domain
|
3.2 scores on a scale
Standard Deviation 1.47
|
3.6 scores on a scale
Standard Deviation 1.76
|
2.5 scores on a scale
Standard Deviation 1.16
|
3.2 scores on a scale
Standard Deviation 1.49
|
|
Asthma Quality of Life Questionnaire (AQLQ) at Baseline
Environmental stimuli domain
|
NA scores on a scale
Standard Deviation NA
Environment domain is non-existent for pediatric population.
|
NA scores on a scale
Standard Deviation NA
Environment domain is non-existent for pediatric population.
|
2.7 scores on a scale
Standard Deviation 1.24
|
3.1 scores on a scale
Standard Deviation 1.47
|
Adverse Events
Pediatric Patients: Omalizumab + Budesonide and Formoterol
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Pediatric Patients: Budesonide and Formoterol
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Adult Patients: Omalizumab + Budesonide and Formoterol
Serious events: 2 serious events
Other events: 27 other events
Deaths: 0 deaths
Adult Patients: Budesonide and Formoterol
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pediatric Patients: Omalizumab + Budesonide and Formoterol
n=16 participants at risk
Participants received omalizumab injection for s.c. use 2 or 4 weeks according to the IgE level and body weight and budesonide + formoterol administered through an inhaler device.
|
Pediatric Patients: Budesonide and Formoterol
n=17 participants at risk
Participants received budesonide + formoterol administered through an inhaler device.
|
Adult Patients: Omalizumab + Budesonide and Formoterol
n=40 participants at risk
Participants received Omalizumab every 2 or 4 weeks as a subcutaneous injection dose according to the IgE level and body weight. Participants also received and budesonide + formoterol administered through an inhaler device.
|
Adult Patients: Budesonide and Formoterol
n=39 participants at risk
Participants receive budesonide + formoterol administered through an inhaler device.
|
|---|---|---|---|---|
|
Immune system disorders
Food allergy
|
0.00%
0/16 • Up to 12 months.
|
5.9%
1/17 • Up to 12 months.
|
0.00%
0/40 • Up to 12 months.
|
0.00%
0/39 • Up to 12 months.
|
|
Pregnancy, puerperium and perinatal conditions
Maternal exposure during pregnancy
|
0.00%
0/16 • Up to 12 months.
|
0.00%
0/17 • Up to 12 months.
|
2.5%
1/40 • Up to 12 months.
|
2.6%
1/39 • Up to 12 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/16 • Up to 12 months.
|
5.9%
1/17 • Up to 12 months.
|
0.00%
0/40 • Up to 12 months.
|
0.00%
0/39 • Up to 12 months.
|
|
Reproductive system and breast disorders
Pelvic inflammatory disease
|
0.00%
0/16 • Up to 12 months.
|
0.00%
0/17 • Up to 12 months.
|
2.5%
1/40 • Up to 12 months.
|
0.00%
0/39 • Up to 12 months.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/16 • Up to 12 months.
|
5.9%
1/17 • Up to 12 months.
|
0.00%
0/40 • Up to 12 months.
|
0.00%
0/39 • Up to 12 months.
|
|
Product Issues
Expired product administered
|
6.2%
1/16 • Up to 12 months.
|
0.00%
0/17 • Up to 12 months.
|
0.00%
0/40 • Up to 12 months.
|
0.00%
0/39 • Up to 12 months.
|
Other adverse events
| Measure |
Pediatric Patients: Omalizumab + Budesonide and Formoterol
n=16 participants at risk
Participants received omalizumab injection for s.c. use 2 or 4 weeks according to the IgE level and body weight and budesonide + formoterol administered through an inhaler device.
|
Pediatric Patients: Budesonide and Formoterol
n=17 participants at risk
Participants received budesonide + formoterol administered through an inhaler device.
|
Adult Patients: Omalizumab + Budesonide and Formoterol
n=40 participants at risk
Participants received Omalizumab every 2 or 4 weeks as a subcutaneous injection dose according to the IgE level and body weight. Participants also received and budesonide + formoterol administered through an inhaler device.
|
Adult Patients: Budesonide and Formoterol
n=39 participants at risk
Participants receive budesonide + formoterol administered through an inhaler device.
|
|---|---|---|---|---|
|
Endocrine disorders
Increased hunger
|
0.00%
0/16 • Up to 12 months.
|
0.00%
0/17 • Up to 12 months.
|
10.0%
4/40 • Up to 12 months.
|
0.00%
0/39 • Up to 12 months.
|
|
Eye disorders
Burning in the eye
|
0.00%
0/16 • Up to 12 months.
|
0.00%
0/17 • Up to 12 months.
|
2.5%
1/40 • Up to 12 months.
|
5.1%
2/39 • Up to 12 months.
|
|
Eye disorders
Conjuntivitis - bacterial
|
0.00%
0/16 • Up to 12 months.
|
5.9%
1/17 • Up to 12 months.
|
0.00%
0/40 • Up to 12 months.
|
0.00%
0/39 • Up to 12 months.
|
|
Eye disorders
Pruritus - ocular
|
0.00%
0/16 • Up to 12 months.
|
5.9%
1/17 • Up to 12 months.
|
0.00%
0/40 • Up to 12 months.
|
2.6%
1/39 • Up to 12 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/16 • Up to 12 months.
|
5.9%
1/17 • Up to 12 months.
|
0.00%
0/40 • Up to 12 months.
|
0.00%
0/39 • Up to 12 months.
|
|
Gastrointestinal disorders
Abdominal pain -localized
|
0.00%
0/16 • Up to 12 months.
|
5.9%
1/17 • Up to 12 months.
|
0.00%
0/40 • Up to 12 months.
|
0.00%
0/39 • Up to 12 months.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/16 • Up to 12 months.
|
0.00%
0/17 • Up to 12 months.
|
0.00%
0/40 • Up to 12 months.
|
5.1%
2/39 • Up to 12 months.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/16 • Up to 12 months.
|
0.00%
0/17 • Up to 12 months.
|
2.5%
1/40 • Up to 12 months.
|
5.1%
2/39 • Up to 12 months.
|
|
Gastrointestinal disorders
Epigastric pain - food-related
|
0.00%
0/16 • Up to 12 months.
|
5.9%
1/17 • Up to 12 months.
|
2.5%
1/40 • Up to 12 months.
|
0.00%
0/39 • Up to 12 months.
|
|
Gastrointestinal disorders
Gastroenteritis - acute
|
0.00%
0/16 • Up to 12 months.
|
0.00%
0/17 • Up to 12 months.
|
5.0%
2/40 • Up to 12 months.
|
0.00%
0/39 • Up to 12 months.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/16 • Up to 12 months.
|
0.00%
0/17 • Up to 12 months.
|
7.5%
3/40 • Up to 12 months.
|
2.6%
1/39 • Up to 12 months.
|
|
Gastrointestinal disorders
Hepatic steatosis
|
0.00%
0/16 • Up to 12 months.
|
5.9%
1/17 • Up to 12 months.
|
0.00%
0/40 • Up to 12 months.
|
0.00%
0/39 • Up to 12 months.
|
|
Gastrointestinal disorders
Nausea
|
6.2%
1/16 • Up to 12 months.
|
0.00%
0/17 • Up to 12 months.
|
2.5%
1/40 • Up to 12 months.
|
2.6%
1/39 • Up to 12 months.
|
|
Gastrointestinal disorders
Pyelonephritis - acute
|
6.2%
1/16 • Up to 12 months.
|
0.00%
0/17 • Up to 12 months.
|
0.00%
0/40 • Up to 12 months.
|
0.00%
0/39 • Up to 12 months.
|
|
General disorders
Adynamia
|
6.2%
1/16 • Up to 12 months.
|
0.00%
0/17 • Up to 12 months.
|
2.5%
1/40 • Up to 12 months.
|
0.00%
0/39 • Up to 12 months.
|
|
General disorders
Anxiety
|
6.2%
1/16 • Up to 12 months.
|
0.00%
0/17 • Up to 12 months.
|
12.5%
5/40 • Up to 12 months.
|
2.6%
1/39 • Up to 12 months.
|
|
General disorders
Asthenia
|
6.2%
1/16 • Up to 12 months.
|
0.00%
0/17 • Up to 12 months.
|
2.5%
1/40 • Up to 12 months.
|
0.00%
0/39 • Up to 12 months.
|
|
General disorders
Fatigue
|
0.00%
0/16 • Up to 12 months.
|
0.00%
0/17 • Up to 12 months.
|
5.0%
2/40 • Up to 12 months.
|
2.6%
1/39 • Up to 12 months.
|
|
General disorders
Fever
|
6.2%
1/16 • Up to 12 months.
|
0.00%
0/17 • Up to 12 months.
|
7.5%
3/40 • Up to 12 months.
|
5.1%
2/39 • Up to 12 months.
|
|
General disorders
Pain
|
0.00%
0/16 • Up to 12 months.
|
0.00%
0/17 • Up to 12 months.
|
5.0%
2/40 • Up to 12 months.
|
2.6%
1/39 • Up to 12 months.
|
|
General disorders
Palpitations
|
6.2%
1/16 • Up to 12 months.
|
0.00%
0/17 • Up to 12 months.
|
10.0%
4/40 • Up to 12 months.
|
2.6%
1/39 • Up to 12 months.
|
|
General disorders
Tachycardia
|
6.2%
1/16 • Up to 12 months.
|
0.00%
0/17 • Up to 12 months.
|
10.0%
4/40 • Up to 12 months.
|
5.1%
2/39 • Up to 12 months.
|
|
Infections and infestations
Diarrhea - Acute
|
6.2%
1/16 • Up to 12 months.
|
0.00%
0/17 • Up to 12 months.
|
0.00%
0/40 • Up to 12 months.
|
0.00%
0/39 • Up to 12 months.
|
|
Infections and infestations
External Otitis
|
6.2%
1/16 • Up to 12 months.
|
0.00%
0/17 • Up to 12 months.
|
0.00%
0/40 • Up to 12 months.
|
0.00%
0/39 • Up to 12 months.
|
|
Infections and infestations
Flu - common
|
0.00%
0/16 • Up to 12 months.
|
0.00%
0/17 • Up to 12 months.
|
0.00%
0/40 • Up to 12 months.
|
7.7%
3/39 • Up to 12 months.
|
|
Infections and infestations
flu-like symptoms
|
0.00%
0/16 • Up to 12 months.
|
0.00%
0/17 • Up to 12 months.
|
12.5%
5/40 • Up to 12 months.
|
10.3%
4/39 • Up to 12 months.
|
|
Infections and infestations
Influenza virus infection
|
6.2%
1/16 • Up to 12 months.
|
0.00%
0/17 • Up to 12 months.
|
0.00%
0/40 • Up to 12 months.
|
0.00%
0/39 • Up to 12 months.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/16 • Up to 12 months.
|
0.00%
0/17 • Up to 12 months.
|
5.0%
2/40 • Up to 12 months.
|
2.6%
1/39 • Up to 12 months.
|
|
Infections and infestations
Pharyngitis - Acute
|
6.2%
1/16 • Up to 12 months.
|
0.00%
0/17 • Up to 12 months.
|
2.5%
1/40 • Up to 12 months.
|
2.6%
1/39 • Up to 12 months.
|
|
Infections and infestations
Pharyngitis - bacterial
|
12.5%
2/16 • Up to 12 months.
|
5.9%
1/17 • Up to 12 months.
|
2.5%
1/40 • Up to 12 months.
|
2.6%
1/39 • Up to 12 months.
|
|
Infections and infestations
Pharyngotonsillitis
|
12.5%
2/16 • Up to 12 months.
|
5.9%
1/17 • Up to 12 months.
|
7.5%
3/40 • Up to 12 months.
|
17.9%
7/39 • Up to 12 months.
|
|
Infections and infestations
Rhinopharyngitis
|
12.5%
2/16 • Up to 12 months.
|
0.00%
0/17 • Up to 12 months.
|
0.00%
0/40 • Up to 12 months.
|
2.6%
1/39 • Up to 12 months.
|
|
Infections and infestations
Sinusitis
|
6.2%
1/16 • Up to 12 months.
|
0.00%
0/17 • Up to 12 months.
|
0.00%
0/40 • Up to 12 months.
|
2.6%
1/39 • Up to 12 months.
|
|
Infections and infestations
Sore throat
|
0.00%
0/16 • Up to 12 months.
|
0.00%
0/17 • Up to 12 months.
|
10.0%
4/40 • Up to 12 months.
|
2.6%
1/39 • Up to 12 months.
|
|
Infections and infestations
Tonsillitis - acute
|
0.00%
0/16 • Up to 12 months.
|
0.00%
0/17 • Up to 12 months.
|
2.5%
1/40 • Up to 12 months.
|
5.1%
2/39 • Up to 12 months.
|
|
Injury, poisoning and procedural complications
Pruritus - injection site reaction
|
0.00%
0/16 • Up to 12 months.
|
0.00%
0/17 • Up to 12 months.
|
5.0%
2/40 • Up to 12 months.
|
0.00%
0/39 • Up to 12 months.
|
|
Injury, poisoning and procedural complications
Sea food allergy
|
0.00%
0/16 • Up to 12 months.
|
5.9%
1/17 • Up to 12 months.
|
0.00%
0/40 • Up to 12 months.
|
0.00%
0/39 • Up to 12 months.
|
|
Musculoskeletal and connective tissue disorders
Hands tremor
|
0.00%
0/16 • Up to 12 months.
|
0.00%
0/17 • Up to 12 months.
|
5.0%
2/40 • Up to 12 months.
|
0.00%
0/39 • Up to 12 months.
|
|
Musculoskeletal and connective tissue disorders
Lower Limb cramp
|
0.00%
0/16 • Up to 12 months.
|
0.00%
0/17 • Up to 12 months.
|
5.0%
2/40 • Up to 12 months.
|
7.7%
3/39 • Up to 12 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
0.00%
0/16 • Up to 12 months.
|
0.00%
0/17 • Up to 12 months.
|
5.0%
2/40 • Up to 12 months.
|
2.6%
1/39 • Up to 12 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle pain - localized
|
0.00%
0/16 • Up to 12 months.
|
0.00%
0/17 • Up to 12 months.
|
2.5%
1/40 • Up to 12 months.
|
5.1%
2/39 • Up to 12 months.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/16 • Up to 12 months.
|
0.00%
0/17 • Up to 12 months.
|
5.0%
2/40 • Up to 12 months.
|
0.00%
0/39 • Up to 12 months.
|
|
Musculoskeletal and connective tissue disorders
Pain - leg
|
0.00%
0/16 • Up to 12 months.
|
0.00%
0/17 • Up to 12 months.
|
0.00%
0/40 • Up to 12 months.
|
5.1%
2/39 • Up to 12 months.
|
|
Musculoskeletal and connective tissue disorders
Pain - localized
|
12.5%
2/16 • Up to 12 months.
|
0.00%
0/17 • Up to 12 months.
|
12.5%
5/40 • Up to 12 months.
|
0.00%
0/39 • Up to 12 months.
|
|
Musculoskeletal and connective tissue disorders
Tremor
|
6.2%
1/16 • Up to 12 months.
|
0.00%
0/17 • Up to 12 months.
|
5.0%
2/40 • Up to 12 months.
|
2.6%
1/39 • Up to 12 months.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/16 • Up to 12 months.
|
0.00%
0/17 • Up to 12 months.
|
5.0%
2/40 • Up to 12 months.
|
2.6%
1/39 • Up to 12 months.
|
|
Nervous system disorders
Head trauma
|
0.00%
0/16 • Up to 12 months.
|
5.9%
1/17 • Up to 12 months.
|
0.00%
0/40 • Up to 12 months.
|
2.6%
1/39 • Up to 12 months.
|
|
Nervous system disorders
Headache
|
12.5%
2/16 • Up to 12 months.
|
17.6%
3/17 • Up to 12 months.
|
12.5%
5/40 • Up to 12 months.
|
7.7%
3/39 • Up to 12 months.
|
|
Nervous system disorders
Insomnia
|
6.2%
1/16 • Up to 12 months.
|
0.00%
0/17 • Up to 12 months.
|
2.5%
1/40 • Up to 12 months.
|
0.00%
0/39 • Up to 12 months.
|
|
Nervous system disorders
Lipothymia
|
0.00%
0/16 • Up to 12 months.
|
0.00%
0/17 • Up to 12 months.
|
5.0%
2/40 • Up to 12 months.
|
0.00%
0/39 • Up to 12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic asthma
|
6.2%
1/16 • Up to 12 months.
|
0.00%
0/17 • Up to 12 months.
|
0.00%
0/40 • Up to 12 months.
|
0.00%
0/39 • Up to 12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma exacerbation
|
6.2%
1/16 • Up to 12 months.
|
0.00%
0/17 • Up to 12 months.
|
10.0%
4/40 • Up to 12 months.
|
2.6%
1/39 • Up to 12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough - dry
|
6.2%
1/16 • Up to 12 months.
|
0.00%
0/17 • Up to 12 months.
|
5.0%
2/40 • Up to 12 months.
|
0.00%
0/39 • Up to 12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough - with sputum
|
6.2%
1/16 • Up to 12 months.
|
0.00%
0/17 • Up to 12 months.
|
0.00%
0/40 • Up to 12 months.
|
2.6%
1/39 • Up to 12 months.
|
|
Respiratory, thoracic and mediastinal disorders
CRUP syndrome
|
6.2%
1/16 • Up to 12 months.
|
0.00%
0/17 • Up to 12 months.
|
0.00%
0/40 • Up to 12 months.
|
0.00%
0/39 • Up to 12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/16 • Up to 12 months.
|
0.00%
0/17 • Up to 12 months.
|
5.0%
2/40 • Up to 12 months.
|
5.1%
2/39 • Up to 12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/16 • Up to 12 months.
|
0.00%
0/17 • Up to 12 months.
|
2.5%
1/40 • Up to 12 months.
|
5.1%
2/39 • Up to 12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Flu illness
|
6.2%
1/16 • Up to 12 months.
|
5.9%
1/17 • Up to 12 months.
|
5.0%
2/40 • Up to 12 months.
|
0.00%
0/39 • Up to 12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/16 • Up to 12 months.
|
5.9%
1/17 • Up to 12 months.
|
7.5%
3/40 • Up to 12 months.
|
2.6%
1/39 • Up to 12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal obstruction
|
0.00%
0/16 • Up to 12 months.
|
0.00%
0/17 • Up to 12 months.
|
5.0%
2/40 • Up to 12 months.
|
2.6%
1/39 • Up to 12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Nose bleeding
|
6.2%
1/16 • Up to 12 months.
|
0.00%
0/17 • Up to 12 months.
|
0.00%
0/40 • Up to 12 months.
|
0.00%
0/39 • Up to 12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Odinofagia
|
6.2%
1/16 • Up to 12 months.
|
0.00%
0/17 • Up to 12 months.
|
12.5%
5/40 • Up to 12 months.
|
0.00%
0/39 • Up to 12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Otorhinolaryngological examination
|
0.00%
0/16 • Up to 12 months.
|
0.00%
0/17 • Up to 12 months.
|
5.0%
2/40 • Up to 12 months.
|
0.00%
0/39 • Up to 12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis - acute
|
0.00%
0/16 • Up to 12 months.
|
5.9%
1/17 • Up to 12 months.
|
0.00%
0/40 • Up to 12 months.
|
5.1%
2/39 • Up to 12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis - allergic
|
0.00%
0/16 • Up to 12 months.
|
0.00%
0/17 • Up to 12 months.
|
10.0%
4/40 • Up to 12 months.
|
2.6%
1/39 • Up to 12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
6.2%
1/16 • Up to 12 months.
|
0.00%
0/17 • Up to 12 months.
|
12.5%
5/40 • Up to 12 months.
|
0.00%
0/39 • Up to 12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinosinusitis
|
6.2%
1/16 • Up to 12 months.
|
5.9%
1/17 • Up to 12 months.
|
5.0%
2/40 • Up to 12 months.
|
2.6%
1/39 • Up to 12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Runny nose
|
0.00%
0/16 • Up to 12 months.
|
5.9%
1/17 • Up to 12 months.
|
10.0%
4/40 • Up to 12 months.
|
10.3%
4/39 • Up to 12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/16 • Up to 12 months.
|
0.00%
0/17 • Up to 12 months.
|
7.5%
3/40 • Up to 12 months.
|
2.6%
1/39 • Up to 12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/16 • Up to 12 months.
|
5.9%
1/17 • Up to 12 months.
|
12.5%
5/40 • Up to 12 months.
|
7.7%
3/39 • Up to 12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum
|
0.00%
0/16 • Up to 12 months.
|
5.9%
1/17 • Up to 12 months.
|
12.5%
5/40 • Up to 12 months.
|
5.1%
2/39 • Up to 12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum increase
|
0.00%
0/16 • Up to 12 months.
|
0.00%
0/17 • Up to 12 months.
|
12.5%
5/40 • Up to 12 months.
|
2.6%
1/39 • Up to 12 months.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
6.2%
1/16 • Up to 12 months.
|
0.00%
0/17 • Up to 12 months.
|
2.5%
1/40 • Up to 12 months.
|
0.00%
0/39 • Up to 12 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus - allergic
|
0.00%
0/16 • Up to 12 months.
|
0.00%
0/17 • Up to 12 months.
|
5.0%
2/40 • Up to 12 months.
|
0.00%
0/39 • Up to 12 months.
|
Additional Information
Clinical Disclosure Office
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