Trial Outcomes & Findings for Local Phase 4 Pan-European SMART Study (NCT NCT00463866)
NCT ID: NCT00463866
Last Updated: 2010-03-22
Results Overview
Time to first severe asthma exacerbation, translated to mean number of severe asthma exacerbations per participant. A severe asthma exacerbation is defined as deterioration in asthma requiring oral/systemic glucocorticosteroids for at least 3 days and/or hospitalisation/emergency room visit with oral/systemic glucocorticosteroid treatment.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
8424 participants
Primary outcome timeframe
6 months
Results posted on
2010-03-22
Participant Flow
This was a 6-month, randomised, open label, parallel-group, active controlled, multinational study, in participants with uncontrolled/partly controlled asthma, who were symptomatic despite daily use of inhaled glucocorticosteroid (IGCS) with or without Long-Acting β2 agonist (LABA).
Participant milestones
| Measure |
Symbicort® SMART®) 1*2
1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.
|
Symbicort® SMART®) 2*2
2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.
|
|---|---|---|
|
Overall Study
STARTED
|
4008
|
4045
|
|
Overall Study
COMPLETED
|
3699
|
3705
|
|
Overall Study
NOT COMPLETED
|
309
|
340
|
Reasons for withdrawal
| Measure |
Symbicort® SMART®) 1*2
1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.
|
Symbicort® SMART®) 2*2
2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.
|
|---|---|---|
|
Overall Study
Adverse Event
|
70
|
93
|
|
Overall Study
Withdrawal by Subject
|
81
|
79
|
|
Overall Study
Lost to Follow-up
|
46
|
55
|
|
Overall Study
Incorrect Enrolment
|
64
|
66
|
|
Overall Study
Severe Non-Compliance to Protocol
|
25
|
21
|
|
Overall Study
Safety Reason
|
1
|
3
|
|
Overall Study
Mis-Randomization of subject
|
0
|
1
|
|
Overall Study
Other
|
22
|
22
|
Baseline Characteristics
Local Phase 4 Pan-European SMART Study
Baseline characteristics by cohort
| Measure |
Symbicort® SMART®) 1*2
n=4008 Participants
1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.
|
Symbicort® SMART®) 2*2
n=4045 Participants
2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.
|
Total
n=8053 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
47.8 Years
n=5 Participants
|
47.9 Years
n=7 Participants
|
47.8 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2483 Participants
n=5 Participants
|
2512 Participants
n=7 Participants
|
4995 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1525 Participants
n=5 Participants
|
1533 Participants
n=7 Participants
|
3058 Participants
n=5 Participants
|
|
Treatment with Long-Acting β2 agonist (LABA) at baseline.
Number of participants using LABA at baseline.
|
3108 Participants
n=5 Participants
|
3118 Participants
n=7 Participants
|
6226 Participants
n=5 Participants
|
|
Treatment with Long-Acting β2 agonist (LABA) at baseline.
Number of participants without LABA at baseline.
|
900 Participants
n=5 Participants
|
927 Participants
n=7 Participants
|
1827 Participants
n=5 Participants
|
|
Asthma control questionnaire (ACQ5) score at study entry
ACQ5 score at study entry
|
1.85 Units on a scale
STANDARD_DEVIATION 0.98 • n=5 Participants
|
1.86 Units on a scale
STANDARD_DEVIATION 1.01 • n=7 Participants
|
1.85 Units on a scale
STANDARD_DEVIATION 0.99 • n=5 Participants
|
|
Exacerbations past 12 months before study start.
|
1.47 Number of exacerbations per participant
STANDARD_DEVIATION 2.42 • n=5 Participants
|
1.42 Number of exacerbations per participant
STANDARD_DEVIATION 2.42 • n=7 Participants
|
1.45 Number of exacerbations per participant
STANDARD_DEVIATION 2.42 • n=5 Participants
|
|
Inhaled glucocorticosteroids (IGCS) dose at study entry.
IGCS dose at study entry
|
1046 μg/day
STANDARD_DEVIATION 595 • n=5 Participants
|
1037 μg/day
STANDARD_DEVIATION 575 • n=7 Participants
|
1042 μg/day
STANDARD_DEVIATION 585 • n=5 Participants
|
|
Participants with a well controlled asthma week at study entry.
|
11.97 Percentage of participants
n=5 Participants
|
11.77 Percentage of participants
n=7 Participants
|
11.87 Percentage of participants
n=5 Participants
|
|
Pulmonary function test at baseline.
Percent Included
|
90.8 Percent of predicted normal value of PEF
n=5 Participants
|
90.1 Percent of predicted normal value of PEF
n=7 Participants
|
90.4 Percent of predicted normal value of PEF
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsTime to first severe asthma exacerbation, translated to mean number of severe asthma exacerbations per participant. A severe asthma exacerbation is defined as deterioration in asthma requiring oral/systemic glucocorticosteroids for at least 3 days and/or hospitalisation/emergency room visit with oral/systemic glucocorticosteroid treatment.
Outcome measures
| Measure |
Symbicort® SMART®) 2*2
n=4045 Participants
2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.
|
Symbicort® SMART®) 1*2
n=4008 Participants
1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.
|
|---|---|---|
|
Number of Severe Asthma Exacerbations Per Participant.
|
0.080 Severe exacerbations per participant
Full Range 0 • Interval 0.0 to 5.0
|
0.097 Severe exacerbations per participant
Full Range 0 • Interval 0.0 to 4.0
|
SECONDARY outcome
Timeframe: 6 months.The total number of severe asthma exacerbations was calculated for each participant. A severe asthma exacerbation is defined as deterioration in asthma requiring oral/systemic glucocorticosteroids for at least 3 days and/or hospitalisation/emergency room visit with oral/systemic glucocorticosteroid treatment.
Outcome measures
| Measure |
Symbicort® SMART®) 2*2
n=4045 Participants
2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.
|
Symbicort® SMART®) 1*2
n=4008 Participants
1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.
|
|---|---|---|
|
Fraction of Participants With Severe Asthma Exacerbation
|
0.07955 Fraction of participants with event
95% Confidence Interval 0.06927 • Interval 0.06927 to 0.09135
|
0.09686 Fraction of participants with event
95% Confidence Interval 0.08528 • Interval 0.08528 to 0.11
|
SECONDARY outcome
Timeframe: 6 months.A severe asthma exacerbation is defined as deterioration in asthma requiring oral/systemic glucocorticosteroids for at least 3 days and/or hospitalisation/emergency room visit with oral/systemic glucocorticosteroid treatment. Number of events per participant
Outcome measures
| Measure |
Symbicort® SMART®) 2*2
n=4045 Participants
2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.
|
Symbicort® SMART®) 1*2
n=4008 Participants
1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.
|
|---|---|---|
|
Total Number of Severe Asthma Exacerbations That Led to Hospitalisation and/or Emergency Room Treatment.
|
0.0091 Number of events per participant
Full Range 0 • Interval 0.0 to 2.0
|
0.0120 Number of events per participant
Full Range 0 • Interval 0.0 to 3.0
|
SECONDARY outcome
Timeframe: 6 months.Total number of days with oral/systemic glucocorticosteroids during severe exacerbation calculated for each participant. A severe asthma exacerbation is defined as deterioration in asthma requiring oral/systemic glucocorticosteroids for at least 3 days and/or hospitalisation/emergency room visit with oral/systemic glucocorticosteroid treatment.
Outcome measures
| Measure |
Symbicort® SMART®) 2*2
n=4045 Participants
2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.
|
Symbicort® SMART®) 1*2
n=4008 Participants
1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.
|
|---|---|---|
|
Total Number of Days Per Participant With Oral/Systemic Glucocorticosteroids During Severe Asthma Exacerbation
|
9.1 Days per participant
Standard Deviation 5.5
|
9.6 Days per participant
Standard Deviation 8.1
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: Inhalations of as-needed medication recorded by 3880 participants in the Symbicort SMART 1\*2 Reporting Group and recorded by 3881 participants in the Symbicort SMART 2\*2 Reporting Group
The number of as-needed inhalations was measured 2 times during 2 weeks before 13 weeks and 26 weeks of treatment.
Outcome measures
| Measure |
Symbicort® SMART®) 2*2
n=3881 Participants
2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.
|
Symbicort® SMART®) 1*2
n=3880 Participants
1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.
|
|---|---|---|
|
Mean Daily Number of Inhalations of As-needed Medication.
|
0.625 Inhalations per day per participant
Full Range 0 • Interval 0.0 to 9.07
|
0.897 Inhalations per day per participant
Full Range 0 • Interval 0.0 to 9.14
|
SECONDARY outcome
Timeframe: 6 months.Population: Data for this measure recorded by 3714 participants in the Symbicort SMART 1\*2 Reporting Group and recorded by 3718 participants in the Symbicort SMART 2\*2 Reporting Group.
The mean percent of participants fulfilling the criteria for a well controlled asthma week in each treatment. A well controlled asthma week is defined as a week with no exacerbations and no night-time awakenings due to asthma and a maximum of 2 days with symptoms and as-needed inhalation use.
Outcome measures
| Measure |
Symbicort® SMART®) 2*2
n=3718 Participants
2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.
|
Symbicort® SMART®) 1*2
n=3714 Participants
1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.
|
|---|---|---|
|
Percent of Participants With a Well Controlled Asthma Week.
|
54.26 Percentage of participants
Full Range 0 • Interval 0.0 to 100.0
|
43.69 Percentage of participants
Full Range 0 • Interval 0.0 to 100.0
|
SECONDARY outcome
Timeframe: 6 months.Population: Data for this measure recorded by 3709 participants in the Symbicort SMART 1\*2 Reporting Group and recorded by 3735 participants in the Symbicort SMART 2\*2 Reporting Group.
The ACQ5 was used. The lower value the better with a full range from 0=no impairment, 6= maximum impairment. Awakenings, morning symptoms, limitations, shortness of breath and wheeze.
Outcome measures
| Measure |
Symbicort® SMART®) 2*2
n=3735 Participants
2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.
|
Symbicort® SMART®) 1*2
n=3709 Participants
1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.
|
|---|---|---|
|
Mean Overall Asthma Control Questionnaire (ACQ) Score
|
1.089 Scores in a scale
Full Range 0 • Interval 0.0 to 5.0
|
1.18 Scores in a scale
Full Range 0 • Interval 0.0 to 5.7
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: : Data for this measure recorded by 3874 participants in the Symbicort SMART 1\*2 Reporting Group and recorded by 3873 participants in the Symbicort SMART 2\*2 Reporting Group.
The mean total daily dose of steroids from Symbicort was calculated as the sum of the maintenance dose and the as-needed dose.
Outcome measures
| Measure |
Symbicort® SMART®) 2*2
n=3873 Participants
2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.
|
Symbicort® SMART®) 1*2
n=3874 Participants
1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.
|
|---|---|---|
|
The Mean Total Daily Dose of Steroids From Symbicort.
|
736.58 μg budesonide per day
Standard Deviation 152.70
|
462.96 μg budesonide per day
Standard Deviation 179.10
|
SECONDARY outcome
Timeframe: 6 monthsMean cost is calculated for each country using participants from the whole study and country specific costs. Mean value for the whole study can not be calculated.
Outcome measures
Outcome data not reported
Adverse Events
Symbicort® SMART®) 1*2
Serious events: 77 serious events
Other events: 0 other events
Deaths: 0 deaths
Symbicort® SMART®) 2*2
Serious events: 88 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Symbicort® SMART®) 1*2
n=4008 participants at risk
1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.
|
Symbicort® SMART®) 2*2
n=4045 participants at risk
2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.
|
|---|---|---|
|
Nervous system disorders
Cerebrovascular Accident
|
0.02%
1/4008
|
0.05%
2/4045
|
|
Nervous system disorders
Haemorrhage Intracranial
|
0.02%
1/4008
|
0.00%
0/4045
|
|
Nervous system disorders
Haemorrhagic Stroke
|
0.02%
1/4008
|
0.00%
0/4045
|
|
Nervous system disorders
Ischaemic Cerebral Infarction
|
0.02%
1/4008
|
0.00%
0/4045
|
|
Nervous system disorders
Loss Of Consciousness
|
0.02%
1/4008
|
0.00%
0/4045
|
|
Blood and lymphatic system disorders
Anaemia
|
0.02%
1/4008
|
0.02%
1/4045
|
|
Cardiac disorders
Angina Pectoris
|
0.02%
1/4008
|
0.02%
1/4045
|
|
Cardiac disorders
Atrial Fibrillation
|
0.05%
2/4008
|
0.02%
1/4045
|
|
Cardiac disorders
Atrioventricular Block
|
0.02%
1/4008
|
0.00%
0/4045
|
|
Cardiac disorders
Coronary Artery Disease
|
0.02%
1/4008
|
0.00%
0/4045
|
|
Cardiac disorders
Myocardial Infarction
|
0.02%
1/4008
|
0.02%
1/4045
|
|
Cardiac disorders
Tachyarrhythmia
|
0.02%
1/4008
|
0.00%
0/4045
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/4008
|
0.02%
1/4045
|
|
Congenital, familial and genetic disorders
Exomphalos
|
0.02%
1/4008
|
0.00%
0/4045
|
|
Ear and labyrinth disorders
Vertigo
|
0.02%
1/4008
|
0.00%
0/4045
|
|
Eye disorders
Cataract
|
0.00%
0/4008
|
0.05%
2/4045
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.02%
1/4008
|
0.00%
0/4045
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
0.02%
1/4008
|
0.00%
0/4045
|
|
Gastrointestinal disorders
Colitis
|
0.05%
2/4008
|
0.00%
0/4045
|
|
Gastrointestinal disorders
Constipation
|
0.02%
1/4008
|
0.00%
0/4045
|
|
Gastrointestinal disorders
Crohn's Disease
|
0.02%
1/4008
|
0.00%
0/4045
|
|
Gastrointestinal disorders
Diarrhoea
|
0.05%
2/4008
|
0.00%
0/4045
|
|
Gastrointestinal disorders
Diverticulum Intestinal
|
0.00%
0/4008
|
0.02%
1/4045
|
|
Gastrointestinal disorders
Gastrointestinal Disorder
|
0.02%
1/4008
|
0.00%
0/4045
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.02%
1/4008
|
0.02%
1/4045
|
|
Gastrointestinal disorders
Pancreatitis
|
0.02%
1/4008
|
0.00%
0/4045
|
|
Gastrointestinal disorders
Pancreatitis Acute
|
0.02%
1/4008
|
0.00%
0/4045
|
|
Gastrointestinal disorders
Peritonitis
|
0.02%
1/4008
|
0.00%
0/4045
|
|
Gastrointestinal disorders
Reflux Oesophagitis
|
0.02%
1/4008
|
0.00%
0/4045
|
|
Gastrointestinal disorders
Salivary Gland Enlargement
|
0.00%
0/4008
|
0.02%
1/4045
|
|
Gastrointestinal disorders
Umbilical Hernia
|
0.02%
1/4008
|
0.02%
1/4045
|
|
Gastrointestinal disorders
Vomiting
|
0.02%
1/4008
|
0.00%
0/4045
|
|
General disorders
Chest Pain
|
0.05%
2/4008
|
0.02%
1/4045
|
|
General disorders
Cyst
|
0.00%
0/4008
|
0.02%
1/4045
|
|
General disorders
Death
|
0.02%
1/4008
|
0.02%
1/4045
|
|
General disorders
Non-Cardiac Chest Pain
|
0.02%
1/4008
|
0.00%
0/4045
|
|
General disorders
Pain
|
0.02%
1/4008
|
0.00%
0/4045
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/4008
|
0.02%
1/4045
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.00%
0/4008
|
0.02%
1/4045
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/4008
|
0.10%
4/4045
|
|
Immune system disorders
Food Allergy
|
0.00%
0/4008
|
0.02%
1/4045
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/4008
|
0.02%
1/4045
|
|
Immune system disorders
Sarcoidosis
|
0.00%
0/4008
|
0.02%
1/4045
|
|
Infections and infestations
Appendicitis
|
0.02%
1/4008
|
0.02%
1/4045
|
|
Infections and infestations
Bronchiectasis
|
0.02%
1/4008
|
0.00%
0/4045
|
|
Infections and infestations
Bronchitis
|
0.00%
0/4008
|
0.05%
2/4045
|
|
Infections and infestations
Campylobacter Gastroenteritis
|
0.02%
1/4008
|
0.00%
0/4045
|
|
Infections and infestations
Chronic Sinusitis
|
0.00%
0/4008
|
0.02%
1/4045
|
|
Infections and infestations
Epstein-Barr Virus Infection
|
0.00%
0/4008
|
0.02%
1/4045
|
|
Infections and infestations
Erysipelas
|
0.02%
1/4008
|
0.02%
1/4045
|
|
Infections and infestations
Gastroenteritis
|
0.02%
1/4008
|
0.02%
1/4045
|
|
Infections and infestations
Influenza
|
0.02%
1/4008
|
0.00%
0/4045
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.02%
1/4008
|
0.02%
1/4045
|
|
Infections and infestations
Lung Infection
|
0.00%
0/4008
|
0.02%
1/4045
|
|
Infections and infestations
Meningitis Viral
|
0.00%
0/4008
|
0.02%
1/4045
|
|
Infections and infestations
Pilonidal Cyst
|
0.00%
0/4008
|
0.02%
1/4045
|
|
Infections and infestations
Pneumonia
|
0.07%
3/4008
|
0.07%
3/4045
|
|
Infections and infestations
Respiratory Tract Infection
|
0.02%
1/4008
|
0.00%
0/4045
|
|
Infections and infestations
Sinusitis
|
0.00%
0/4008
|
0.02%
1/4045
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/4008
|
0.02%
1/4045
|
|
Infections and infestations
Tracheobronchitis
|
0.02%
1/4008
|
0.00%
0/4045
|
|
Injury, poisoning and procedural complications
Animal Bite
|
0.00%
0/4008
|
0.02%
1/4045
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
0.02%
1/4008
|
0.00%
0/4045
|
|
Injury, poisoning and procedural complications
Fall
|
0.02%
1/4008
|
0.02%
1/4045
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.02%
1/4008
|
0.00%
0/4045
|
|
Injury, poisoning and procedural complications
Fibula Fracture
|
0.02%
1/4008
|
0.00%
0/4045
|
|
Injury, poisoning and procedural complications
Joint Dislocation
|
0.02%
1/4008
|
0.02%
1/4045
|
|
Injury, poisoning and procedural complications
Joint Injury
|
0.00%
0/4008
|
0.02%
1/4045
|
|
Injury, poisoning and procedural complications
Ligament Rupture
|
0.02%
1/4008
|
0.00%
0/4045
|
|
Injury, poisoning and procedural complications
Lower Limb Fracture
|
0.00%
0/4008
|
0.05%
2/4045
|
|
Injury, poisoning and procedural complications
Meniscus Lesion
|
0.02%
1/4008
|
0.00%
0/4045
|
|
Injury, poisoning and procedural complications
Multiple Drug Overdose
|
0.00%
0/4008
|
0.02%
1/4045
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/4008
|
0.02%
1/4045
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
0.00%
0/4008
|
0.02%
1/4045
|
|
Injury, poisoning and procedural complications
Tibia Fracture
|
0.02%
1/4008
|
0.00%
0/4045
|
|
Injury, poisoning and procedural complications
Traumatic Fracture
|
0.00%
0/4008
|
0.02%
1/4045
|
|
Injury, poisoning and procedural complications
Upper Limb Fracture
|
0.02%
1/4008
|
0.02%
1/4045
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4008
|
0.02%
1/4045
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/4008
|
0.02%
1/4045
|
|
Metabolism and nutrition disorders
Type 2 Diabetes Mellitus
|
0.00%
0/4008
|
0.02%
1/4045
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4008
|
0.05%
2/4045
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.00%
0/4008
|
0.02%
1/4045
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.02%
1/4008
|
0.05%
2/4045
|
|
Musculoskeletal and connective tissue disorders
Muscle Mass
|
0.02%
1/4008
|
0.00%
0/4045
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.00%
0/4008
|
0.02%
1/4045
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.02%
1/4008
|
0.00%
0/4045
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.07%
3/4008
|
0.07%
3/4045
|
|
Musculoskeletal and connective tissue disorders
Spinal Disorder
|
0.00%
0/4008
|
0.02%
1/4045
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.02%
1/4008
|
0.00%
0/4045
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.00%
0/4008
|
0.02%
1/4045
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Neoplasm
|
0.02%
1/4008
|
0.00%
0/4045
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.00%
0/4008
|
0.10%
4/4045
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases To Liver
|
0.00%
0/4008
|
0.02%
1/4045
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid Tumour Benign
|
0.00%
0/4008
|
0.02%
1/4045
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.00%
0/4008
|
0.02%
1/4045
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine Leiomyoma
|
0.02%
1/4008
|
0.02%
1/4045
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vocal Cord Neoplasm
|
0.00%
0/4008
|
0.02%
1/4045
|
|
Nervous system disorders
Carotid Sinus Syndrome
|
0.02%
1/4008
|
0.00%
0/4045
|
|
Nervous system disorders
Migraine
|
0.02%
1/4008
|
0.00%
0/4045
|
|
Nervous system disorders
Syncope
|
0.00%
0/4008
|
0.02%
1/4045
|
|
Pregnancy, puerperium and perinatal conditions
Abortion Spontaneous
|
0.02%
1/4008
|
0.00%
0/4045
|
|
Reproductive system and breast disorders
Endometriosis
|
0.00%
0/4008
|
0.02%
1/4045
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.02%
1/4008
|
0.00%
0/4045
|
|
Reproductive system and breast disorders
Vaginal Haemorrhage
|
0.02%
1/4008
|
0.00%
0/4045
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.32%
13/4008
|
0.22%
9/4045
|
|
Respiratory, thoracic and mediastinal disorders
Asthmatic Crisis
|
0.00%
0/4008
|
0.02%
1/4045
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.00%
0/4008
|
0.02%
1/4045
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4008
|
0.02%
1/4045
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.02%
1/4008
|
0.05%
2/4045
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/4008
|
0.02%
1/4045
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal Disorder
|
0.00%
0/4008
|
0.02%
1/4045
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.02%
1/4008
|
0.00%
0/4045
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/4008
|
0.05%
2/4045
|
|
Respiratory, thoracic and mediastinal disorders
Sleep Apnoea Syndrome
|
0.02%
1/4008
|
0.02%
1/4045
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.02%
1/4008
|
0.00%
0/4045
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER