Trial Outcomes & Findings for A Clinical Study to Evaluate Symbicort Turbuhaler Used 'as Needed' in Adults and Adolescents With Asthma. (NCT NCT02149199)
NCT ID: NCT02149199
Last Updated: 2019-11-15
Results Overview
A well-controlled asthma week is defined as the fulfilment of both conditions A) and B) below: A) Two or more of the following criteria are fulfilled: - No more than 2 days with a daily asthma symptom score \>1 - No more than 2 days of 'as needed' medication use, up to a maximum of 4 occasions per week (multiple occasions per day should be regarded as separate occasions) - Morning PEF ≥80% of Predicted Normal every day B) Both of the following criteria are fulfilled: - No nighttime awakenings due to asthma - No additional inhaled and/or systemic glucocorticosteroid treatment due to asthma. The binary variable well-controlled asthma week was derived for each patient and study week. In addition, for each week, the percent of patients with well-controlled asthma week was derived. It is required that the eDiary had to be completed on at least 5 days in a week to be a well-controlled asthma week.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
3850 participants
Primary outcome timeframe
Weekly, up to 52 weeks
Results posted on
2019-11-15
Participant Flow
5721 patients enrolled; 5003 run-in, 718 not run-in; 3849 randomised, 1154 not randomised: 1022 did not meet incl/excl criteria, 4 adverse event, 5 severe non-compliance to protocol, 104 subject decision, 7 subject lost to follow-up, 12 other reason.
Eligibility was assessed at Visits 1, 2, 3. IC obtained at V1. At V2, eligible patients stopped prescribed asthma medication and entered a 2-4 week run-in period, treated only with SABA Bricanyl Turbuhaler 0.5 mg, 'as needed'. Lung function was performed by spirometry to confirm eligibility. Eligible patients were randomised at Visit 3.
Participant milestones
| Measure |
Placebo Bid + Symbicort 'as Needed'
Placebo for budesonide (Placebo Turbuhaler) + Symbicort Turbuhaler (budesonide/formoterol 160/4.5 μg)
|
Placebo Bid + Terbutaline 'as Needed'
Placebo for budesonide (Placebo Turbuhaler) + Terbutaline Turbuhaler 0.4 mg 'as needed'
|
Pulmicort Bid + Terbutaline 'as Needed'
Pulmicort Turbuhaler (budesonide 200 μg) + Terbutaline Turbuhaler 0.4 mg 'as needed'
|
|---|---|---|---|
|
Overall Study
STARTED
|
1277
|
1277
|
1282
|
|
Overall Study
COMPLETED
|
1144
|
1084
|
1135
|
|
Overall Study
NOT COMPLETED
|
133
|
193
|
147
|
Reasons for withdrawal
| Measure |
Placebo Bid + Symbicort 'as Needed'
Placebo for budesonide (Placebo Turbuhaler) + Symbicort Turbuhaler (budesonide/formoterol 160/4.5 μg)
|
Placebo Bid + Terbutaline 'as Needed'
Placebo for budesonide (Placebo Turbuhaler) + Terbutaline Turbuhaler 0.4 mg 'as needed'
|
Pulmicort Bid + Terbutaline 'as Needed'
Pulmicort Turbuhaler (budesonide 200 μg) + Terbutaline Turbuhaler 0.4 mg 'as needed'
|
|---|---|---|---|
|
Overall Study
Study specific withdrawal criteria
|
4
|
21
|
6
|
|
Overall Study
Other
|
20
|
25
|
20
|
|
Overall Study
Eligibility criteria not fulfilled
|
9
|
14
|
8
|
|
Overall Study
Withdrawal by Subject
|
75
|
93
|
77
|
|
Overall Study
Protocol Violation
|
16
|
13
|
15
|
|
Overall Study
Lost to Follow-up
|
3
|
12
|
11
|
|
Overall Study
Death
|
0
|
0
|
1
|
|
Overall Study
Adverse Event
|
6
|
15
|
9
|
Baseline Characteristics
Full Analysis Set
Baseline characteristics by cohort
| Measure |
Placebo Bid + Symbicort 'as Needed'
n=1277 Participants
Placebo for budesonide (Placebo Turbuhaler) + Symbicort Turbuhaler (budesonide/formoterol 160/4.5 μg)
|
Placebo Bid + Terbutaline 'as Needed'
n=1277 Participants
Placebo for budesonide (Placebo Turbuhaler) + Terbutaline Turbuhaler 0.4 mg 'as needed'
|
Pulmicort Bid + Terbutaline 'as Needed'
n=1282 Participants
Pulmicort Turbuhaler (budesonide 200 μg) + Terbutaline Turbuhaler 0.4 mg 'as needed'
|
Total
n=3836 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
>=12 - <18
|
161 Participants
n=5 Participants
|
144 Participants
n=7 Participants
|
173 Participants
n=5 Participants
|
478 Participants
n=4 Participants
|
|
Age, Customized
>=18 - <50
|
711 Participants
n=5 Participants
|
739 Participants
n=7 Participants
|
736 Participants
n=5 Participants
|
2186 Participants
n=4 Participants
|
|
Age, Customized
>=50 - <65
|
308 Participants
n=5 Participants
|
315 Participants
n=7 Participants
|
285 Participants
n=5 Participants
|
908 Participants
n=4 Participants
|
|
Age, Customized
>=65 - <85
|
97 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
262 Participants
n=4 Participants
|
|
Age, Customized
>=85
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
777 Participants
n=5 Participants
|
771 Participants
n=7 Participants
|
797 Participants
n=5 Participants
|
2345 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
500 Participants
n=5 Participants
|
506 Participants
n=7 Participants
|
485 Participants
n=5 Participants
|
1491 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian Or Alaska Native
|
74 Participants
n=5 Participants • Full Analysis Set
|
73 Participants
n=7 Participants • Full Analysis Set
|
73 Participants
n=5 Participants • Full Analysis Set
|
220 Participants
n=4 Participants • Full Analysis Set
|
|
Race/Ethnicity, Customized
Asian
|
340 Participants
n=5 Participants • Full Analysis Set
|
336 Participants
n=7 Participants • Full Analysis Set
|
347 Participants
n=5 Participants • Full Analysis Set
|
1023 Participants
n=4 Participants • Full Analysis Set
|
|
Race/Ethnicity, Customized
Native Hawaiian Or Other Pacific Islander
|
1 Participants
n=5 Participants • Full Analysis Set
|
0 Participants
n=7 Participants • Full Analysis Set
|
0 Participants
n=5 Participants • Full Analysis Set
|
1 Participants
n=4 Participants • Full Analysis Set
|
|
Race/Ethnicity, Customized
Black Or African American
|
24 Participants
n=5 Participants • Full Analysis Set
|
33 Participants
n=7 Participants • Full Analysis Set
|
24 Participants
n=5 Participants • Full Analysis Set
|
81 Participants
n=4 Participants • Full Analysis Set
|
|
Race/Ethnicity, Customized
White
|
721 Participants
n=5 Participants • Full Analysis Set
|
726 Participants
n=7 Participants • Full Analysis Set
|
728 Participants
n=5 Participants • Full Analysis Set
|
2175 Participants
n=4 Participants • Full Analysis Set
|
|
Race/Ethnicity, Customized
Other
|
117 Participants
n=5 Participants • Full Analysis Set
|
109 Participants
n=7 Participants • Full Analysis Set
|
110 Participants
n=5 Participants • Full Analysis Set
|
336 Participants
n=4 Participants • Full Analysis Set
|
PRIMARY outcome
Timeframe: Weekly, up to 52 weeksPopulation: Full analysis set. Patients with no evaluable weeks are not included in the analysis.
A well-controlled asthma week is defined as the fulfilment of both conditions A) and B) below: A) Two or more of the following criteria are fulfilled: - No more than 2 days with a daily asthma symptom score \>1 - No more than 2 days of 'as needed' medication use, up to a maximum of 4 occasions per week (multiple occasions per day should be regarded as separate occasions) - Morning PEF ≥80% of Predicted Normal every day B) Both of the following criteria are fulfilled: - No nighttime awakenings due to asthma - No additional inhaled and/or systemic glucocorticosteroid treatment due to asthma. The binary variable well-controlled asthma week was derived for each patient and study week. In addition, for each week, the percent of patients with well-controlled asthma week was derived. It is required that the eDiary had to be completed on at least 5 days in a week to be a well-controlled asthma week.
Outcome measures
| Measure |
Placebo Bid + Symbicort 'as Needed'
n=1277 Participants
Placebo for budesonide (Placebo Turbuhaler) + Symbicort Turbuhaler (budesonide/formoterol 160/4.5 μg)
|
Placebo Bid + Terbutaline 'as Needed'
n=1277 Participants
Placebo for budesonide (Placebo Turbuhaler) + Terbutaline Turbuhaler 0.4 mg 'as needed'
|
Pulmicort Bid + Terbutaline 'as Needed'
n=1282 Participants
Pulmicort Turbuhaler (budesonide 200 μg) + Terbutaline Turbuhaler 0.4 mg 'as needed'
|
|---|---|---|---|
|
'Well-controlled Asthma Week' - a Derived Binary Variable (Yes/No)
|
34.4 Percentage
Standard Deviation 36.02
|
31.1 Percentage
Standard Deviation 34.90
|
44.4 Percentage
Standard Deviation 39.10
|
SECONDARY outcome
Timeframe: Day 1 up to 52 weeksPopulation: Full analysis set
A severe exacerbation is defined as a deterioration of asthma requiring any of the following: use of systemic glucocorticosteroids (GCS) for at least 3 days, inpatient hospitalization, or emergency room visit due to asthma that required systemic steroids
Outcome measures
| Measure |
Placebo Bid + Symbicort 'as Needed'
n=1277 Participants
Placebo for budesonide (Placebo Turbuhaler) + Symbicort Turbuhaler (budesonide/formoterol 160/4.5 μg)
|
Placebo Bid + Terbutaline 'as Needed'
n=1277 Participants
Placebo for budesonide (Placebo Turbuhaler) + Terbutaline Turbuhaler 0.4 mg 'as needed'
|
Pulmicort Bid + Terbutaline 'as Needed'
n=1282 Participants
Pulmicort Turbuhaler (budesonide 200 μg) + Terbutaline Turbuhaler 0.4 mg 'as needed'
|
|---|---|---|---|
|
Number of Participants Experiencing at Least One Severe Asthma Exacerbation
|
71 Participants
|
152 Participants
|
78 Participants
|
SECONDARY outcome
Timeframe: Day 1 up to 52 weeksPopulation: Full analysis set
A moderate exacerbation is defined as a deterioration of asthma requiring a change in treatment, i.e. initiation of prescribed additional ICS treatment to avoid progression of the worsening of asthma to a severe exacerbation. A severe exacerbation is defined as a deterioration of asthma requiring any of the following: use of systemic glucocorticosteroids (GCS) for at least 3 days, inpatient hospitalization, or emergency room visit due to asthma that required systemic steroids
Outcome measures
| Measure |
Placebo Bid + Symbicort 'as Needed'
n=1277 Participants
Placebo for budesonide (Placebo Turbuhaler) + Symbicort Turbuhaler (budesonide/formoterol 160/4.5 μg)
|
Placebo Bid + Terbutaline 'as Needed'
n=1277 Participants
Placebo for budesonide (Placebo Turbuhaler) + Terbutaline Turbuhaler 0.4 mg 'as needed'
|
Pulmicort Bid + Terbutaline 'as Needed'
n=1282 Participants
Pulmicort Turbuhaler (budesonide 200 μg) + Terbutaline Turbuhaler 0.4 mg 'as needed'
|
|---|---|---|---|
|
Number of Participants Experiencing at Least One Moderate or Severe Asthma Exacerbation
|
131 Participants
|
274 Participants
|
143 Participants
|
SECONDARY outcome
Timeframe: Study weeks 0,4,16,28,40,52Population: Full analysis set.
Overall estimate of FEV1 (mL) pre-bronchodilator change from baseline. Baseline is the measurement at Visit 3 (prior to first dose of Investigational Product) from MMRM (mixed model repeated measures analysis).
Outcome measures
| Measure |
Placebo Bid + Symbicort 'as Needed'
n=1277 Participants
Placebo for budesonide (Placebo Turbuhaler) + Symbicort Turbuhaler (budesonide/formoterol 160/4.5 μg)
|
Placebo Bid + Terbutaline 'as Needed'
n=1277 Participants
Placebo for budesonide (Placebo Turbuhaler) + Terbutaline Turbuhaler 0.4 mg 'as needed'
|
Pulmicort Bid + Terbutaline 'as Needed'
n=1282 Participants
Pulmicort Turbuhaler (budesonide 200 μg) + Terbutaline Turbuhaler 0.4 mg 'as needed'
|
|---|---|---|---|
|
Average Change From Baseline in Pre-dose Forced Expiratory Volume in 1 Second (FEV1)
|
65 mL
Interval 47.6 to 82.4
|
11.2 mL
Interval -6.4 to 28.9
|
119.3 mL
Interval 101.9 to 136.7
|
SECONDARY outcome
Timeframe: up to 52 weeksPopulation: Full analysis set.
Morning peak expiratory flow (eDiary) change from baseline over the randomised treatment period. Baseline is defined as the mean of all non-missing morning measurements during the last 10 days of the run-in period.
Outcome measures
| Measure |
Placebo Bid + Symbicort 'as Needed'
n=1277 Participants
Placebo for budesonide (Placebo Turbuhaler) + Symbicort Turbuhaler (budesonide/formoterol 160/4.5 μg)
|
Placebo Bid + Terbutaline 'as Needed'
n=1277 Participants
Placebo for budesonide (Placebo Turbuhaler) + Terbutaline Turbuhaler 0.4 mg 'as needed'
|
Pulmicort Bid + Terbutaline 'as Needed'
n=1282 Participants
Pulmicort Turbuhaler (budesonide 200 μg) + Terbutaline Turbuhaler 0.4 mg 'as needed'
|
|---|---|---|---|
|
Average Change From Baseline in Morning Peak Expiratory Flow (PEF)
|
-3.97 L/min
Interval -6.86 to -1.09
|
-15.92 L/min
Interval -18.8 to -13.04
|
6.01 L/min
Interval 3.13 to 8.88
|
SECONDARY outcome
Timeframe: up to 52 weeksPopulation: Full analysis set
Evening peak expiratory flow (eDiary) change from baseline during the randomised treatment period. Baseline is defined as the mean of all non-missing evening measurements during the last 10 days of the run-in period.
Outcome measures
| Measure |
Placebo Bid + Symbicort 'as Needed'
n=1277 Participants
Placebo for budesonide (Placebo Turbuhaler) + Symbicort Turbuhaler (budesonide/formoterol 160/4.5 μg)
|
Placebo Bid + Terbutaline 'as Needed'
n=1277 Participants
Placebo for budesonide (Placebo Turbuhaler) + Terbutaline Turbuhaler 0.4 mg 'as needed'
|
Pulmicort Bid + Terbutaline 'as Needed'
n=1282 Participants
Pulmicort Turbuhaler (budesonide 200 μg) + Terbutaline Turbuhaler 0.4 mg 'as needed'
|
|---|---|---|---|
|
Average Change From Baseline in Evening PEF
|
-11.20 L/min
Interval -14.01 to -8.39
|
-22.15 L/min
Interval -24.96 to -19.34
|
-4.97 L/min
Interval -7.77 to -2.17
|
SECONDARY outcome
Timeframe: up to 52 weeksPopulation: Full analysis set.
'As needed' inhalations change from baseline over the randomised treatment period. Baseline is defined as the last 10 days of the run-in period. 'As needed' use was calculated as the cumulative doses of 'as needed' medication over the randomised treatment period divided by the follow-up time (number of days - 1). ie, average number of inhalations per day.
Outcome measures
| Measure |
Placebo Bid + Symbicort 'as Needed'
n=1277 Participants
Placebo for budesonide (Placebo Turbuhaler) + Symbicort Turbuhaler (budesonide/formoterol 160/4.5 μg)
|
Placebo Bid + Terbutaline 'as Needed'
n=1277 Participants
Placebo for budesonide (Placebo Turbuhaler) + Terbutaline Turbuhaler 0.4 mg 'as needed'
|
Pulmicort Bid + Terbutaline 'as Needed'
n=1282 Participants
Pulmicort Turbuhaler (budesonide 200 μg) + Terbutaline Turbuhaler 0.4 mg 'as needed'
|
|---|---|---|---|
|
Average Change From Baseline in Number of Inhalations of 'as Needed' Medication.
|
-0.95 Number of inhalations per day
Standard Deviation 0.82
|
-0.82 Number of inhalations per day
Standard Deviation 0.92
|
-1.06 Number of inhalations per day
Standard Deviation 0.90
|
SECONDARY outcome
Timeframe: up to 52 weeksPopulation: Full analysis set
Asthma symptom score (eDiary) change from baseline during the randomised treatment period. Symptom score is entered morning and evening by the patient on a 4-point scale from 0 to 3 with higher values indicating more severe symptoms. Asthma symptom score is then the sum of the day and night scores, which implies a range of scores from 0 - 6, with higher values indicating more severe symptoms. Baseline is defined as the mean of all non-missing measurements during the last 10 days of the run-in period.
Outcome measures
| Measure |
Placebo Bid + Symbicort 'as Needed'
n=1277 Participants
Placebo for budesonide (Placebo Turbuhaler) + Symbicort Turbuhaler (budesonide/formoterol 160/4.5 μg)
|
Placebo Bid + Terbutaline 'as Needed'
n=1277 Participants
Placebo for budesonide (Placebo Turbuhaler) + Terbutaline Turbuhaler 0.4 mg 'as needed'
|
Pulmicort Bid + Terbutaline 'as Needed'
n=1282 Participants
Pulmicort Turbuhaler (budesonide 200 μg) + Terbutaline Turbuhaler 0.4 mg 'as needed'
|
|---|---|---|---|
|
Average Change From Baseline in Asthma Symptom Score
|
-0.23 units on a scale
Interval -0.27 to -0.19
|
-0.11 units on a scale
Interval -0.15 to -0.07
|
-0.32 units on a scale
Interval -0.36 to -0.28
|
SECONDARY outcome
Timeframe: up to 52 weeksPopulation: Full analysis set.
Night-time awakenings (%) due to asthma change from baseline. Variable analysed is the proportion (%) of nights during the relevant period with night-time awakenings. Baseline refers to the last 10 nights of the run-in period.
Outcome measures
| Measure |
Placebo Bid + Symbicort 'as Needed'
n=1277 Participants
Placebo for budesonide (Placebo Turbuhaler) + Symbicort Turbuhaler (budesonide/formoterol 160/4.5 μg)
|
Placebo Bid + Terbutaline 'as Needed'
n=1277 Participants
Placebo for budesonide (Placebo Turbuhaler) + Terbutaline Turbuhaler 0.4 mg 'as needed'
|
Pulmicort Bid + Terbutaline 'as Needed'
n=1282 Participants
Pulmicort Turbuhaler (budesonide 200 μg) + Terbutaline Turbuhaler 0.4 mg 'as needed'
|
|---|---|---|---|
|
Change From Baseline in the Percentage of Nighttime Awakenings Due to Asthma
|
-7.5 % of nights
Standard Deviation 24.0
|
-4.6 % of nights
Standard Deviation 23.4
|
-9.8 % of nights
Standard Deviation 22.7
|
SECONDARY outcome
Timeframe: up to 52 weeksPopulation: Full analysis set
Symptom-free days (%) change from baseline during the randomised treatment period.Variable analysed is the proportion (%) of symptom-free days during the relevant period. Baseline refers to the last 10 days of the run-in period.
Outcome measures
| Measure |
Placebo Bid + Symbicort 'as Needed'
n=1277 Participants
Placebo for budesonide (Placebo Turbuhaler) + Symbicort Turbuhaler (budesonide/formoterol 160/4.5 μg)
|
Placebo Bid + Terbutaline 'as Needed'
n=1277 Participants
Placebo for budesonide (Placebo Turbuhaler) + Terbutaline Turbuhaler 0.4 mg 'as needed'
|
Pulmicort Bid + Terbutaline 'as Needed'
n=1282 Participants
Pulmicort Turbuhaler (budesonide 200 μg) + Terbutaline Turbuhaler 0.4 mg 'as needed'
|
|---|---|---|---|
|
Change From Baseline in Percentage of Symptom-free Days
|
4.2 % of days
Standard Deviation 25.9
|
1.3 % of days
Standard Deviation 24.8
|
6.8 % of days
Standard Deviation 27.6
|
SECONDARY outcome
Timeframe: up to 52 weeksPopulation: Full analysis set
'As needed' free days (%) change from baseline during the randomised treatment period. An 'as needed' free day is defined as a day and night with no use of 'as needed' medication. Variable analysed is the proportion (%) of 'as needed' free days during the relevant period. Baseline refers to the last 10 days of the run-in period.
Outcome measures
| Measure |
Placebo Bid + Symbicort 'as Needed'
n=1277 Participants
Placebo for budesonide (Placebo Turbuhaler) + Symbicort Turbuhaler (budesonide/formoterol 160/4.5 μg)
|
Placebo Bid + Terbutaline 'as Needed'
n=1277 Participants
Placebo for budesonide (Placebo Turbuhaler) + Terbutaline Turbuhaler 0.4 mg 'as needed'
|
Pulmicort Bid + Terbutaline 'as Needed'
n=1282 Participants
Pulmicort Turbuhaler (budesonide 200 μg) + Terbutaline Turbuhaler 0.4 mg 'as needed'
|
|---|---|---|---|
|
Change From Baseline in Percentage of 'As Needed' Free Days
|
44.2 % of days
Standard Deviation 31.0
|
45.0 % of days
Standard Deviation 30.7
|
51.7 % of days
Standard Deviation 30.6
|
SECONDARY outcome
Timeframe: up to 52 weeksPopulation: Full analysis set
Asthma control days (%) change from baseline. An asthma control day is defined as the fulfilment of all of the following criteria; a day and night with no asthma symptoms, a night with no awakenings due to asthma symptoms and a day and night with no use of 'as needed' medication. Variable analysed is the proportion (%) of asthma control days during the randomised treatment period. Baseline refers to the last 10 days of the run-in period.
Outcome measures
| Measure |
Placebo Bid + Symbicort 'as Needed'
n=1277 Participants
Placebo for budesonide (Placebo Turbuhaler) + Symbicort Turbuhaler (budesonide/formoterol 160/4.5 μg)
|
Placebo Bid + Terbutaline 'as Needed'
n=1277 Participants
Placebo for budesonide (Placebo Turbuhaler) + Terbutaline Turbuhaler 0.4 mg 'as needed'
|
Pulmicort Bid + Terbutaline 'as Needed'
n=1282 Participants
Pulmicort Turbuhaler (budesonide 200 μg) + Terbutaline Turbuhaler 0.4 mg 'as needed'
|
|---|---|---|---|
|
Change From Baseline in Percentage of Asthma Control Days
|
13.2 % of days
Standard Deviation 23.9
|
12.8 % of days
Standard Deviation 23.3
|
18.5 % of days
Standard Deviation 28.4
|
SECONDARY outcome
Timeframe: up to 52 weeksPopulation: Full Analysis Set
Study specific asthma related discontinuation
Outcome measures
| Measure |
Placebo Bid + Symbicort 'as Needed'
n=1277 Participants
Placebo for budesonide (Placebo Turbuhaler) + Symbicort Turbuhaler (budesonide/formoterol 160/4.5 μg)
|
Placebo Bid + Terbutaline 'as Needed'
n=1277 Participants
Placebo for budesonide (Placebo Turbuhaler) + Terbutaline Turbuhaler 0.4 mg 'as needed'
|
Pulmicort Bid + Terbutaline 'as Needed'
n=1282 Participants
Pulmicort Turbuhaler (budesonide 200 μg) + Terbutaline Turbuhaler 0.4 mg 'as needed'
|
|---|---|---|---|
|
Number of Patients With Study Specific Asthma Related Discontinuation
|
4 Participants
|
21 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Weekly for up to 52 weeksPopulation: Full analysis set
A poorly-controlled asthma week is defined as a week meeting any one of the following conditions: Two or more consecutive days with awakenings due to asthma on both nights; A recorded use of 'as needed' medication for symptom relief of at least 3 occasions per day, for at least 2 consecutive days; Additional systemic GCS treatment required for severe exacerbation. If there were sufficient data within a week available to confirm the week was not poorly-controlled, the week is labelled as 'does not meet criteria for poorly-controlled'.
Outcome measures
| Measure |
Placebo Bid + Symbicort 'as Needed'
n=1277 Participants
Placebo for budesonide (Placebo Turbuhaler) + Symbicort Turbuhaler (budesonide/formoterol 160/4.5 μg)
|
Placebo Bid + Terbutaline 'as Needed'
n=1277 Participants
Placebo for budesonide (Placebo Turbuhaler) + Terbutaline Turbuhaler 0.4 mg 'as needed'
|
Pulmicort Bid + Terbutaline 'as Needed'
n=1282 Participants
Pulmicort Turbuhaler (budesonide 200 μg) + Terbutaline Turbuhaler 0.4 mg 'as needed'
|
|---|---|---|---|
|
Poorly Controlled Asthma Weeks
|
7.7 weeks
Standard Deviation 13.3
|
9.7 weeks
Standard Deviation 13.8
|
6.7 weeks
Standard Deviation 12.7
|
SECONDARY outcome
Timeframe: Day 1 up to 52 weeksPopulation: Full analysis set
Additional steroids for asthma includes any additional inhaled and/or systemic glucocorticosteroids treatment due to asthma while in the randomised treatment period.
Outcome measures
| Measure |
Placebo Bid + Symbicort 'as Needed'
n=1277 Participants
Placebo for budesonide (Placebo Turbuhaler) + Symbicort Turbuhaler (budesonide/formoterol 160/4.5 μg)
|
Placebo Bid + Terbutaline 'as Needed'
n=1277 Participants
Placebo for budesonide (Placebo Turbuhaler) + Terbutaline Turbuhaler 0.4 mg 'as needed'
|
Pulmicort Bid + Terbutaline 'as Needed'
n=1282 Participants
Pulmicort Turbuhaler (budesonide 200 μg) + Terbutaline Turbuhaler 0.4 mg 'as needed'
|
|---|---|---|---|
|
Number of Participants Experiencing at Least One Occasion With Additional Steroids for Asthma
|
164 Participants
|
345 Participants
|
187 Participants
|
SECONDARY outcome
Timeframe: Study weeks 0,4,16,28,40,52Population: Full analysis set.
Asthma Control Questionnaire 5-item version score change from baseline. ACQ questionnaire contains five questions on patients' symptoms, which are assessed on a 7-point scale from 0 (representing good control) to 6 (representing poor control). The score is the mean score of all questions for which responses are provided.
Outcome measures
| Measure |
Placebo Bid + Symbicort 'as Needed'
n=1277 Participants
Placebo for budesonide (Placebo Turbuhaler) + Symbicort Turbuhaler (budesonide/formoterol 160/4.5 μg)
|
Placebo Bid + Terbutaline 'as Needed'
n=1277 Participants
Placebo for budesonide (Placebo Turbuhaler) + Terbutaline Turbuhaler 0.4 mg 'as needed'
|
Pulmicort Bid + Terbutaline 'as Needed'
n=1282 Participants
Pulmicort Turbuhaler (budesonide 200 μg) + Terbutaline Turbuhaler 0.4 mg 'as needed'
|
|---|---|---|---|
|
Average Change From Baseline in Asthma Control Questionnaire (ACQ-5)
|
-0.33 units on a scale
Interval -0.36 to -0.29
|
-0.17 units on a scale
Interval -0.21 to -0.14
|
-0.48 units on a scale
Interval -0.51 to -0.44
|
SECONDARY outcome
Timeframe: Study weeks 0,16,28,40,52Population: Full analysis set.
Asthma Quality of Life Questionnaire Standardised Version (AQLQ (S) overall score change from baseline. AQLQ(S) consists of 32 questions in 4 domains. Each question is assessed on a 7-point scale from 1 to 7, with higher values indicating better health-related quality of life. The overall score is calculated as the mean score of all 32 items.
Outcome measures
| Measure |
Placebo Bid + Symbicort 'as Needed'
n=1277 Participants
Placebo for budesonide (Placebo Turbuhaler) + Symbicort Turbuhaler (budesonide/formoterol 160/4.5 μg)
|
Placebo Bid + Terbutaline 'as Needed'
n=1277 Participants
Placebo for budesonide (Placebo Turbuhaler) + Terbutaline Turbuhaler 0.4 mg 'as needed'
|
Pulmicort Bid + Terbutaline 'as Needed'
n=1282 Participants
Pulmicort Turbuhaler (budesonide 200 μg) + Terbutaline Turbuhaler 0.4 mg 'as needed'
|
|---|---|---|---|
|
Average Change From Baseline in Asthma Quality of Life Questionnaire; Standard Version (AQLQ(S))
|
0.313 units on a scale
Interval 0.276 to 0.351
|
0.186 units on a scale
Interval 0.148 to 0.225
|
0.415 units on a scale
Interval 0.377 to 0.453
|
SECONDARY outcome
Timeframe: up to 52 weeksPopulation: Full analysis set.
ICS controller use days (%) during the randomised treatment period is calculated as the cumulative number of days when any controller medication (containing ICS) was taken including maintenance (Pulmicort bid group) and 'as needed' medication (Symbicort 'as needed' group) and additional prescribed ICS for asthma exacerbations and/or long term poor asthma control (all treatment groups), divided by the number of days in the randomised treatment period.
Outcome measures
| Measure |
Placebo Bid + Symbicort 'as Needed'
n=1277 Participants
Placebo for budesonide (Placebo Turbuhaler) + Symbicort Turbuhaler (budesonide/formoterol 160/4.5 μg)
|
Placebo Bid + Terbutaline 'as Needed'
n=1277 Participants
Placebo for budesonide (Placebo Turbuhaler) + Terbutaline Turbuhaler 0.4 mg 'as needed'
|
Pulmicort Bid + Terbutaline 'as Needed'
n=1282 Participants
Pulmicort Turbuhaler (budesonide 200 μg) + Terbutaline Turbuhaler 0.4 mg 'as needed'
|
|---|---|---|---|
|
Percentage of Controller Use Days
|
30.8 % of days
Standard Deviation 28.7
|
5.6 % of days
Standard Deviation 16.8
|
85.6 % of days
Standard Deviation 19.5
|
SECONDARY outcome
Timeframe: up to 52 weeksPopulation: Full analysis set
Severe asthma exacerbations over the randomised treatment period.
Outcome measures
| Measure |
Placebo Bid + Symbicort 'as Needed'
n=1277 Participants
Placebo for budesonide (Placebo Turbuhaler) + Symbicort Turbuhaler (budesonide/formoterol 160/4.5 μg)
|
Placebo Bid + Terbutaline 'as Needed'
n=1277 Participants
Placebo for budesonide (Placebo Turbuhaler) + Terbutaline Turbuhaler 0.4 mg 'as needed'
|
Pulmicort Bid + Terbutaline 'as Needed'
n=1282 Participants
Pulmicort Turbuhaler (budesonide 200 μg) + Terbutaline Turbuhaler 0.4 mg 'as needed'
|
|---|---|---|---|
|
Annual Severe Asthma Exacerbation Rate
|
0.07 exacerbations per year
Interval 0.06 to 0.09
|
0.20 exacerbations per year
Interval 0.16 to 0.24
|
0.09 exacerbations per year
Interval 0.07 to 0.11
|
SECONDARY outcome
Timeframe: up to 52 weeksPopulation: Full analysis set
Moderate or severe asthma exacerbations during the randomised treatment period.
Outcome measures
| Measure |
Placebo Bid + Symbicort 'as Needed'
n=1277 Participants
Placebo for budesonide (Placebo Turbuhaler) + Symbicort Turbuhaler (budesonide/formoterol 160/4.5 μg)
|
Placebo Bid + Terbutaline 'as Needed'
n=1277 Participants
Placebo for budesonide (Placebo Turbuhaler) + Terbutaline Turbuhaler 0.4 mg 'as needed'
|
Pulmicort Bid + Terbutaline 'as Needed'
n=1282 Participants
Pulmicort Turbuhaler (budesonide 200 μg) + Terbutaline Turbuhaler 0.4 mg 'as needed'
|
|---|---|---|---|
|
Annual Moderate or Severe Asthma Exacerbation Rate
|
0.14 exacerbations per year
Interval 0.12 to 0.17
|
0.36 exacerbations per year
Interval 0.31 to 0.42
|
0.15 exacerbations per year
Interval 0.13 to 0.18
|
Adverse Events
Placebo Bid + Symbicort 'as Needed'
Serious events: 38 serious events
Other events: 295 other events
Deaths: 0 deaths
Placebo Bid + Terbutaline 'as Needed'
Serious events: 50 serious events
Other events: 378 other events
Deaths: 0 deaths
Pulmicort Bid + Terbutaline 'as Needed'
Serious events: 37 serious events
Other events: 360 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Placebo Bid + Symbicort 'as Needed'
n=1277 participants at risk
Placebo for budesonide (Placebo Turbuhaler) + Symbicort Turbuhaler (budesonide/formoterol 160/4.5 μg)
|
Placebo Bid + Terbutaline 'as Needed'
n=1277 participants at risk
Placebo for budesonide (Placebo Turbuhaler) + Terbutaline Turbuhaler 0.4 mg 'as needed'
|
Pulmicort Bid + Terbutaline 'as Needed'
n=1282 participants at risk
Pulmicort Turbuhaler (budesonide 200 μg) + Terbutaline Turbuhaler 0.4 mg 'as needed'
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.08%
1/1277 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.16%
2/1282 • Number of events 2 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.08%
1/1277 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1282 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Gastrointestinal disorders
Anal fissure
|
0.08%
1/1277 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1282 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Infections and infestations
Abcess intestinal
|
0.08%
1/1277 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1282 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.08%
1/1282 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Infections and infestations
Atypical mycobacterial pneumonia
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.08%
1/1277 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1282 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.08%
1/1277 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1282 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Infections and infestations
Cholecystitis infective
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.08%
1/1277 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1282 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.23%
3/1282 • Number of events 3 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.08%
1/1277 • Number of events 2 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1282 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Infections and infestations
Cystitis
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.08%
1/1282 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Infections and infestations
Dengue fever
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.08%
1/1282 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.08%
1/1277 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1282 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.08%
1/1282 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Infections and infestations
Keratitis viral
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.08%
1/1277 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1282 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.08%
1/1282 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Infections and infestations
Osteomyelitis
|
0.08%
1/1277 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1282 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Infections and infestations
Peritoneal abscess
|
0.08%
1/1277 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1282 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Infections and infestations
Peritonitis
|
0.08%
1/1277 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1282 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Infections and infestations
Pneumonia
|
0.16%
2/1277 • Number of events 2 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.16%
2/1277 • Number of events 2 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.16%
2/1282 • Number of events 2 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.08%
1/1277 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1282 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.08%
1/1277 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1282 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Infections and infestations
Sinusitis
|
0.08%
1/1277 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1282 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.08%
1/1282 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Infections and infestations
Tonsillitis
|
0.08%
1/1277 • Number of events 2 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1282 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Infections and infestations
Tonsillitis bacterial
|
0.08%
1/1277 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1282 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.08%
1/1282 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer female
|
0.16%
2/1277 • Number of events 3 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1282 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.08%
1/1277 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1282 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic adenoma
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.08%
1/1277 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1282 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leimyoma
|
0.08%
1/1277 • Number of events 2 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1282 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Immune system disorders
Anaphylactic shock
|
0.08%
1/1277 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1282 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.08%
1/1282 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Endocrine disorders
Goitre
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.08%
1/1282 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Psychiatric disorders
Adjustment disorder
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.08%
1/1277 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1282 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.08%
1/1282 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Nervous system disorders
Cerebrovascular insufficiency
|
0.08%
1/1277 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1282 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.08%
1/1277 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1282 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Nervous system disorders
Multiple sclerosis
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.08%
1/1282 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Nervous system disorders
Seizure
|
0.08%
1/1277 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1282 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.08%
1/1277 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1282 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Eye disorders
Amaurosis
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.08%
1/1282 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Eye disorders
Cataract
|
0.08%
1/1277 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1282 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.08%
1/1277 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1282 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.08%
1/1282 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.08%
1/1277 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1282 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.16%
2/1282 • Number of events 3 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Cardiac disorders
Atrial fibrillation
|
0.08%
1/1277 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1282 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.08%
1/1277 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1282 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.08%
1/1277 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1282 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.08%
1/1277 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1282 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Vascular disorders
Hypertension
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.08%
1/1282 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.47%
6/1277 • Number of events 6 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
1.3%
16/1277 • Number of events 22 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.62%
8/1282 • Number of events 8 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.08%
1/1277 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1282 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.08%
1/1277 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1282 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.08%
1/1282 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.08%
1/1277 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1282 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.08%
1/1277 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1282 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.08%
1/1277 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1282 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Gastrointestinal disorders
Hernial eventration
|
0.08%
1/1277 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1282 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.08%
1/1277 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.16%
2/1277 • Number of events 2 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1282 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.08%
1/1277 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1282 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.08%
1/1282 • Number of events 2 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.08%
1/1282 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.08%
1/1277 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1282 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Hepatobiliary disorders
Gallbladder polyp
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.08%
1/1282 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Skin and subcutaneous tissue disorders
Hidradenitis
|
0.08%
1/1277 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1282 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Skin and subcutaneous tissue disorders
Prurigo
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.08%
1/1277 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1282 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.08%
1/1282 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Musculoskeletal and connective tissue disorders
Chrondropathy
|
0.08%
1/1277 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1282 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.08%
1/1282 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.08%
1/1277 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1282 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.08%
1/1277 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1282 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Renal and urinary disorders
Nephrolothiasis
|
0.08%
1/1277 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.08%
1/1282 • Number of events 2 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Renal and urinary disorders
Obstructive uropathy
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.08%
1/1277 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1282 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Reproductive system and breast disorders
Adenomyosis
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.08%
1/1282 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Reproductive system and breast disorders
Endometriosis
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.08%
1/1277 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1282 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.08%
1/1277 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1282 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.08%
1/1277 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1282 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Reproductive system and breast disorders
Vaginal prolapse
|
0.08%
1/1277 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1282 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Investigations
Blood pressure increased
|
0.08%
1/1277 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1282 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.08%
1/1282 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.08%
1/1277 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1282 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.08%
1/1277 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1282 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.08%
1/1277 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.08%
1/1282 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.08%
1/1277 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1282 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Injury, poisoning and procedural complications
Intervertebral disc injury
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.08%
1/1277 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1282 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.08%
1/1277 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.08%
1/1282 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Injury, poisoning and procedural complications
Lumbar limb fracture
|
0.08%
1/1277 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1282 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.08%
1/1277 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1282 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.08%
1/1277 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1282 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.08%
1/1277 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1282 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.08%
1/1277 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1282 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.08%
1/1277 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1282 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Product Issues
Patient-device incompatibility
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.08%
1/1282 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/1277 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.08%
1/1277 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
0.08%
1/1282 • Number of events 1 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
Other adverse events
| Measure |
Placebo Bid + Symbicort 'as Needed'
n=1277 participants at risk
Placebo for budesonide (Placebo Turbuhaler) + Symbicort Turbuhaler (budesonide/formoterol 160/4.5 μg)
|
Placebo Bid + Terbutaline 'as Needed'
n=1277 participants at risk
Placebo for budesonide (Placebo Turbuhaler) + Terbutaline Turbuhaler 0.4 mg 'as needed'
|
Pulmicort Bid + Terbutaline 'as Needed'
n=1282 participants at risk
Pulmicort Turbuhaler (budesonide 200 μg) + Terbutaline Turbuhaler 0.4 mg 'as needed'
|
|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
5.6%
71/1277 • Number of events 86 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
6.0%
76/1277 • Number of events 95 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
7.3%
93/1282 • Number of events 125 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
5.9%
75/1277 • Number of events 90 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
6.2%
79/1277 • Number of events 95 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
6.6%
84/1282 • Number of events 98 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
2.5%
32/1277 • Number of events 40 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
7.4%
95/1277 • Number of events 125 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
3.9%
50/1282 • Number of events 61 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Infections and infestations
Pharyngitis
|
2.6%
33/1277 • Number of events 39 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
2.7%
34/1277 • Number of events 41 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
3.7%
48/1282 • Number of events 54 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Infections and infestations
Bronchitis
|
2.6%
33/1277 • Number of events 39 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
3.2%
41/1277 • Number of events 44 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
2.9%
37/1282 • Number of events 48 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Nervous system disorders
Headache
|
1.8%
23/1277 • Number of events 44 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
2.0%
25/1277 • Number of events 54 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
2.3%
29/1282 • Number of events 32 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
2.2%
28/1277 • Number of events 33 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
2.2%
28/1277 • Number of events 32 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
1.5%
19/1282 • Number of events 19 • Adverse events were summarised from Visit 2 up to the follow-up visit at week 54. Serious adverse events were recorded from the time of informed consent up to the follow-up visit at week 54.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place