Trial Outcomes & Findings for A 24-Week Efficacy and Safety Study to Assess Budesonide and Formoterol Fumarate Metered Dose Inhaler in Adult and Adolescent Participants With Inadequately Controlled Asthma (VATHOS) (NCT NCT05202262)
NCT ID: NCT05202262
Last Updated: 2026-01-28
Results Overview
Change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve 0 to 3 hours (AUC0-3) at Week 24. FEV1 AUC0-3 is calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time to report the result in liters. Treatment policy is implemented to handle all intercurrent events with the exception of initiation of new asthma therapy or administration of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of randomised study intervention, for which the composite strategy is implemented.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
645 participants
Primary outcome timeframe
At Week 24
Results posted on
2026-01-28
Participant Flow
Participants who have asthma which remains inadequately controlled (ACQ-7 total score ≥ 1.5) despite treatment with medium dose ICS or ICS/LABA were recruited at 147 sites across 7 countries. Participants were randomized in a 1:2:2:2 scheme to BFF MDI 160/9.6 μg, BFF MDI 320/9.6 μg, BD MDI 320 μg, or open-label Symbicort. Randomization was stratified by baseline asthma treatment and age. The treatment period was 24 weeks in duration with up to 8 in-clinic visits during screening and treatment.
All participants were on stable daily medium dose ICS or ICS/LABA for at least 8 weeks prior to Visit 1. After meeting the screening eligibility criteria, participants discontinued medium dose ICS or ICS/LABA at Visit 1 and initiated run-in BD MDI 320 µg taking BID until the randomization visit. A total of 581 patients were treated and included in the safety population. Of the 645 initially randomized, 64 were excluded (60 from 11 sites with GCP violation and 4 who did not receive therapy).
Participant milestones
| Measure |
Symbicort TBH 320/9 g
Open-Label Comparator Symbicort Turbuhaler 320/9 μg
|
BFF MDI 160/9.6 g
Budesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), 160/9.6 μg
|
BFF MDI 320/9.6 g
Budesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), 320/9.6 μg
|
BD MDI 320 g
Budesonide MDI (BD MDI), 320 μg
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
162
|
88
|
163
|
168
|
|
Overall Study
COMPLETED
|
151
|
81
|
150
|
155
|
|
Overall Study
NOT COMPLETED
|
11
|
7
|
13
|
13
|
Reasons for withdrawal
| Measure |
Symbicort TBH 320/9 g
Open-Label Comparator Symbicort Turbuhaler 320/9 μg
|
BFF MDI 160/9.6 g
Budesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), 160/9.6 μg
|
BFF MDI 320/9.6 g
Budesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), 320/9.6 μg
|
BD MDI 320 g
Budesonide MDI (BD MDI), 320 μg
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
4
|
|
Overall Study
Physician Decision
|
0
|
3
|
3
|
0
|
|
Overall Study
Pregnancy
|
1
|
0
|
0
|
0
|
|
Overall Study
Development of withdrawal Criteria
|
1
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
4
|
2
|
3
|
5
|
|
Overall Study
Various Reasons
|
4
|
2
|
5
|
3
|
|
Overall Study
Failure to meet randomization criteria
|
1
|
0
|
1
|
0
|
Baseline Characteristics
Two participants have missing pre-bronchodilator FEV1 at baseline.
Baseline characteristics by cohort
| Measure |
BD MDI 320 g
n=166 Participants
Budesonide MDI (BD MDI), 320 μg
|
Symbicort TBH 320/9 g
n=160 Participants
Open-Label Comparator Symbicort Turbuhaler 320/9 μg
|
Total
n=575 Participants
Total of all reporting groups
|
BFF MDI 160/9.6 g
n=87 Participants
Budesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), 160/9.6 μg
|
BFF MDI 320/9.6 g
n=162 Participants
Budesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), 320/9.6 μg
|
|---|---|---|---|---|---|
|
Age, Continuous
|
49.0 Years
STANDARD_DEVIATION 15.2 • n=166 Participants
|
51.3 Years
STANDARD_DEVIATION 15.3 • n=160 Participants
|
49.9 Years
STANDARD_DEVIATION 15.7 • n=575 Participants
|
49.4 Years
STANDARD_DEVIATION 17.2 • n=87 Participants
|
49.7 Years
STANDARD_DEVIATION 15.8 • n=162 Participants
|
|
Sex: Female, Male
Female
|
108 Participants
n=166 Participants
|
101 Participants
n=160 Participants
|
358 Participants
n=575 Participants
|
48 Participants
n=87 Participants
|
101 Participants
n=162 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=166 Participants
|
59 Participants
n=160 Participants
|
217 Participants
n=575 Participants
|
39 Participants
n=87 Participants
|
61 Participants
n=162 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
17 Participants
n=166 Participants
|
24 Participants
n=160 Participants
|
66 Participants
n=575 Participants
|
9 Participants
n=87 Participants
|
16 Participants
n=162 Participants
|
|
Race/Ethnicity, Customized
Asian
|
18 Participants
n=166 Participants
|
19 Participants
n=160 Participants
|
68 Participants
n=575 Participants
|
9 Participants
n=87 Participants
|
22 Participants
n=162 Participants
|
|
Race/Ethnicity, Customized
White
|
122 Participants
n=166 Participants
|
112 Participants
n=160 Participants
|
417 Participants
n=575 Participants
|
64 Participants
n=87 Participants
|
119 Participants
n=162 Participants
|
|
Race/Ethnicity, Customized
Other
|
9 Participants
n=166 Participants
|
5 Participants
n=160 Participants
|
24 Participants
n=575 Participants
|
5 Participants
n=87 Participants
|
5 Participants
n=162 Participants
|
|
Region of Enrollment
Global · Canada
|
10 Participants
n=166 Participants
|
8 Participants
n=160 Participants
|
37 Participants
n=575 Participants
|
6 Participants
n=87 Participants
|
13 Participants
n=162 Participants
|
|
Region of Enrollment
Global · Germany
|
39 Participants
n=166 Participants
|
30 Participants
n=160 Participants
|
129 Participants
n=575 Participants
|
27 Participants
n=87 Participants
|
33 Participants
n=162 Participants
|
|
Region of Enrollment
Global · Italy
|
1 Participants
n=166 Participants
|
6 Participants
n=160 Participants
|
15 Participants
n=575 Participants
|
4 Participants
n=87 Participants
|
4 Participants
n=162 Participants
|
|
Region of Enrollment
Global · Japan
|
8 Participants
n=166 Participants
|
9 Participants
n=160 Participants
|
33 Participants
n=575 Participants
|
4 Participants
n=87 Participants
|
12 Participants
n=162 Participants
|
|
Region of Enrollment
Global · Spain
|
7 Participants
n=166 Participants
|
6 Participants
n=160 Participants
|
22 Participants
n=575 Participants
|
3 Participants
n=87 Participants
|
6 Participants
n=162 Participants
|
|
Region of Enrollment
Global · United States
|
97 Participants
n=166 Participants
|
92 Participants
n=160 Participants
|
317 Participants
n=575 Participants
|
40 Participants
n=87 Participants
|
88 Participants
n=162 Participants
|
|
Region of Enrollment
Global · Vietnam
|
4 Participants
n=166 Participants
|
9 Participants
n=160 Participants
|
22 Participants
n=575 Participants
|
3 Participants
n=87 Participants
|
6 Participants
n=162 Participants
|
|
Prior asthma medication
ICS
|
20 Participants
n=166 Participants
|
19 Participants
n=160 Participants
|
67 Participants
n=575 Participants
|
11 Participants
n=87 Participants
|
17 Participants
n=162 Participants
|
|
Prior asthma medication
ICS/LABA
|
145 Participants
n=166 Participants
|
141 Participants
n=160 Participants
|
507 Participants
n=575 Participants
|
76 Participants
n=87 Participants
|
145 Participants
n=162 Participants
|
|
Prior asthma medication
ICS/LAMA/LABA
|
1 Participants
n=166 Participants
|
0 Participants
n=160 Participants
|
1 Participants
n=575 Participants
|
0 Participants
n=87 Participants
|
0 Participants
n=162 Participants
|
|
Baseline reversibility (%)
|
19.9 Percentage
STANDARD_DEVIATION 11.0 • n=166 Participants
|
20.0 Percentage
STANDARD_DEVIATION 15.9 • n=160 Participants
|
19.0 Percentage
STANDARD_DEVIATION 13.1 • n=575 Participants
|
18.5 Percentage
STANDARD_DEVIATION 11.3 • n=87 Participants
|
17.5 Percentage
STANDARD_DEVIATION 12.8 • n=162 Participants
|
|
Baseline pre-bronchodilator FEV1 (L)
|
2.132 Liter
STANDARD_DEVIATION 0.561 • n=166 Participants • Two participants have missing pre-bronchodilator FEV1 at baseline.
|
2.103 Liter
STANDARD_DEVIATION 0.589 • n=159 Participants • Two participants have missing pre-bronchodilator FEV1 at baseline.
|
2.160 Liter
STANDARD_DEVIATION 0.618 • n=573 Participants • Two participants have missing pre-bronchodilator FEV1 at baseline.
|
2.315 Liter
STANDARD_DEVIATION 0.666 • n=87 Participants • Two participants have missing pre-bronchodilator FEV1 at baseline.
|
2.163 Liter
STANDARD_DEVIATION 0.666 • n=161 Participants • Two participants have missing pre-bronchodilator FEV1 at baseline.
|
PRIMARY outcome
Timeframe: At Week 24Population: The Efficacy Set is defined as all participants who are randomized to study intervention and receive any amount of randomized study intervention. Participants are analyzed according to the treatment assigned at randomization, regardless of the actual treatment received. Only subjects with non-missing baseline covariates used in the analysis model are included in the analysis.
Change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve 0 to 3 hours (AUC0-3) at Week 24. FEV1 AUC0-3 is calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time to report the result in liters. Treatment policy is implemented to handle all intercurrent events with the exception of initiation of new asthma therapy or administration of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of randomised study intervention, for which the composite strategy is implemented.
Outcome measures
| Measure |
BFF MDI 160/9.6 μg
n=83 Participants
Budesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), 160/9.6 μg
|
BFF MDI 320/9.6 μg
n=155 Participants
Budesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), 320/9.6 μg
|
BD MDI 320 μg
n=160 Participants
Budesonide MDI (BD MDI), 320 μg
|
Symbicort TBH 320/9 μg
n=155 Participants
Open-Label Comparator Symbicort Turbuhaler 320/9 μg
|
|---|---|---|---|---|
|
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve 0 to 3 Hours (AUC0-3) at Week 24
|
0.276 Liter
Standard Error 0.0300
|
0.240 Liter
Standard Error 0.0219
|
0.067 Liter
Standard Error 0.0216
|
0.240 Liter
Standard Error 0.0220
|
SECONDARY outcome
Timeframe: At 24 WeeksPopulation: The Efficacy Set is defined as all participants who are randomized to study intervention and receive any amount of randomized study intervention. Participants are analyzed according to the treatment assigned at randomization, regardless of the actual treatment received. Only subjects with non-missing baseline covariates used in the analysis model are included in the analysis.
Change from baseline in morning pre-dose trough FEV1 at Week 24. Treatment policy is implemented to handle all intercurrent events with the exception of initiation of new asthma therapy or administration of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of randomised study intervention, for which the composite strategy is implemented.
Outcome measures
| Measure |
BFF MDI 160/9.6 μg
n=84 Participants
Budesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), 160/9.6 μg
|
BFF MDI 320/9.6 μg
n=155 Participants
Budesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), 320/9.6 μg
|
BD MDI 320 μg
n=161 Participants
Budesonide MDI (BD MDI), 320 μg
|
Symbicort TBH 320/9 μg
n=155 Participants
Open-Label Comparator Symbicort Turbuhaler 320/9 μg
|
|---|---|---|---|---|
|
Change From Baseline in Morning Pre-dose Trough FEV1 at Week 24
|
0.125 Liter
Standard Error 0.0293
|
0.099 Liter
Standard Error 0.0215
|
0.038 Liter
Standard Error 0.0211
|
0.131 Liter
Standard Error 0.0216
|
SECONDARY outcome
Timeframe: On Day 1Population: The Efficacy Set is defined as all participants who are randomized to study intervention and receive any amount of randomized study intervention. Participants are analyzed according to the treatment assigned at randomization, regardless of the actual treatment received. Only subjects with non-missing baseline covariates used in the analysis model are included in the analysis.
Onset of action on Day 1: Absolute change in FEV1 at 5 minutes on Day 1. Treatment policy is implemented to handle all intercurrent events with the exception of initiation of new asthma therapy or administration of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of randomised study intervention, for which the composite strategy is implemented.
Outcome measures
| Measure |
BFF MDI 160/9.6 μg
n=84 Participants
Budesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), 160/9.6 μg
|
BFF MDI 320/9.6 μg
n=159 Participants
Budesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), 320/9.6 μg
|
BD MDI 320 μg
n=158 Participants
Budesonide MDI (BD MDI), 320 μg
|
Symbicort TBH 320/9 μg
n=156 Participants
Open-Label Comparator Symbicort Turbuhaler 320/9 μg
|
|---|---|---|---|---|
|
Onset of Action on Day 1: Absolute Change in FEV1 at 5 Minutes on Day 1
|
0.236 Liter
Standard Error 0.0167
|
0.184 Liter
Standard Error 0.0122
|
0.041 Liter
Standard Error 0.0121
|
0.161 Liter
Standard Error 0.0123
|
SECONDARY outcome
Timeframe: Over 24 WeeksPopulation: The Efficacy Set is defined as all participants who are randomized to study intervention and receive any amount of randomized study intervention. Participants are analyzed according to the treatment assigned at randomization, regardless of the actual treatment received. Only subjects with non-missing baseline covariates used in the analysis model are included in the analysis.
Change from baseline in the mean number of puffs of rescue medication use (puffs/day) over 24 Weeks. Baseline is the average during the last 7 days before randomization. Over 24 weeks is the average from randomization up to week 24. Treatment policy is implemented to handle all intercurrent events with the exception of initiation of new asthma therapy or administration of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of randomised study intervention, for which the composite strategy is implemented.
Outcome measures
| Measure |
BFF MDI 160/9.6 μg
n=85 Participants
Budesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), 160/9.6 μg
|
BFF MDI 320/9.6 μg
n=157 Participants
Budesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), 320/9.6 μg
|
BD MDI 320 μg
n=163 Participants
Budesonide MDI (BD MDI), 320 μg
|
Symbicort TBH 320/9 μg
n=153 Participants
Open-Label Comparator Symbicort Turbuhaler 320/9 μg
|
|---|---|---|---|---|
|
Change From Baseline in the Mean Number of Puffs of Rescue Medication Use (Puffs/Day) Over 24 Weeks
|
-0.350 Puffs/Day
Standard Error 0.1061
|
-0.481 Puffs/Day
Standard Error 0.0781
|
-0.213 Puffs/Day
Standard Error 0.0764
|
-0.443 Puffs/Day
Standard Error 0.0791
|
SECONDARY outcome
Timeframe: At Week 24Population: The Efficacy Set is defined as all participants who are randomized to study intervention and receive any amount of randomized study intervention. Participants are analyzed according to the treatment assigned at randomization, regardless of the actual treatment received. Only subjects with non-missing baseline covariates used in the analysis model are included in the analysis.
Percentage of responders in ACQ-7 at Week 24, where responders are defined as participants with a ≥0.5 decrease in total score from baseline. Treatment policy is implemented to handle all intercurrent events with the exception of initiation of new asthma therapy or administration of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of randomised study intervention, for which the composite strategy is implemented.
Outcome measures
| Measure |
BFF MDI 160/9.6 μg
n=82 Participants
Budesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), 160/9.6 μg
|
BFF MDI 320/9.6 μg
n=155 Participants
Budesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), 320/9.6 μg
|
BD MDI 320 μg
n=161 Participants
Budesonide MDI (BD MDI), 320 μg
|
Symbicort TBH 320/9 μg
n=154 Participants
Open-Label Comparator Symbicort Turbuhaler 320/9 μg
|
|---|---|---|---|---|
|
Percentage of Responders in ACQ-7 (≥ 0.5 Decrease Equals Response) at Week 24
|
70.7 Percentage of participants
|
68.4 Percentage of participants
|
62.7 Percentage of participants
|
71.4 Percentage of participants
|
SECONDARY outcome
Timeframe: At Week 24Population: The Efficacy Set is defined as all participants who are randomized to study intervention and receive any amount of randomized study intervention. Participants are analyzed according to the treatment assigned at randomization, regardless of the actual treatment received. Only subjects with non-missing baseline covariates used in the analysis model are included in the analysis.
Percentage of responders in ACQ-5 at Week 24, where responders are defined as participants with a ≥0.5 decrease in total score from baseline. Treatment policy is implemented to handle all intercurrent events with the exception of initiation of new asthma therapy or administration of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of randomised study intervention, for which the composite strategy is implemented.
Outcome measures
| Measure |
BFF MDI 160/9.6 μg
n=82 Participants
Budesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), 160/9.6 μg
|
BFF MDI 320/9.6 μg
n=155 Participants
Budesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), 320/9.6 μg
|
BD MDI 320 μg
n=161 Participants
Budesonide MDI (BD MDI), 320 μg
|
Symbicort TBH 320/9 μg
n=154 Participants
Open-Label Comparator Symbicort Turbuhaler 320/9 μg
|
|---|---|---|---|---|
|
Percentage of Responders in ACQ-5 (≥ 0.5 Decrease Equals Response) at Week 24
|
75.6 Percentage of participants
|
71.6 Percentage of participants
|
65.8 Percentage of participants
|
68.8 Percentage of participants
|
SECONDARY outcome
Timeframe: At Week 24Population: The Efficacy Set is defined as all participants who are randomized to study intervention and receive any amount of randomized study intervention. Participants are analyzed according to the treatment assigned at randomization, regardless of the actual treatment received. Only subjects with non-missing baseline covariates used in the analysis model are included in the analysis.
Percentage of responders in the Asthma Quality of Life Questionnaire for 12 years and older (AQLQ(s)+12) at Week 24, where responders are defined as participants with a ≥0.5 increase in total score from baseline. Treatment policy is implemented to handle all intercurrent events with the exception of initiation of new asthma therapy or administration of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of randomised study intervention, for which the composite strategy is implemented.
Outcome measures
| Measure |
BFF MDI 160/9.6 μg
n=79 Participants
Budesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), 160/9.6 μg
|
BFF MDI 320/9.6 μg
n=149 Participants
Budesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), 320/9.6 μg
|
BD MDI 320 μg
n=157 Participants
Budesonide MDI (BD MDI), 320 μg
|
Symbicort TBH 320/9 μg
n=147 Participants
Open-Label Comparator Symbicort Turbuhaler 320/9 μg
|
|---|---|---|---|---|
|
Percentage of Responders in the Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(s)+12) (≥ 0.5 Increase Equals Response) at Week 24
|
53.2 Percentage of participants
|
57.7 Percentage of participants
|
47.1 Percentage of participants
|
50.3 Percentage of participants
|
SECONDARY outcome
Timeframe: 24 WeeksPopulation: The Efficacy Set is defined as all participants in VATHOS and LITHOS (NCT05755906) who are randomized to study intervention and receive any amount of randomized study intervention. Participants are analyzed according to the treatment assigned at randomization, regardless of the actual treatment received. Only subjects with non-missing baseline covariates used in the analysis model are included in the analysis.
As requested by a Health Authority, data from VATHOS and LITHOS (NCT05755906), two studies originally designed to assess lung function, were pooled to analyze the annualized rate of severe asthma exacerbations. This analysis was prespecified, uses data up to 12 weeks for LITHOS and 24 weeks for VATHOS, and was incorporated into the multiple testing procedure. An exacerbation is considered severe if it results in at least one of the following: a course of systemic corticosteroids (SCS) for ≥3 consecutive days to treat symptoms of asthma worsening, an ER or urgent care visit due to asthma requiring treatment with SCS, an in-patient hospitalization due to asthma, or death related to asthma. Treatment policy is implemented to handle all intercurrent events except for initiation of new asthma therapy or administration of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of randomised study intervention, for which the composite strategy is used.
Outcome measures
| Measure |
BFF MDI 160/9.6 μg
n=425 Participants
Budesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), 160/9.6 μg
|
BFF MDI 320/9.6 μg
n=335 Participants
Budesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), 320/9.6 μg
|
BD MDI 320 μg
Budesonide MDI (BD MDI), 320 μg
|
Symbicort TBH 320/9 μg
Open-Label Comparator Symbicort Turbuhaler 320/9 μg
|
|---|---|---|---|---|
|
Rate of Severe Asthma Exacerbation (Pooled LITHOS and VATHOS Data) During the Treatment Period (up to 24 Weeks)
|
0.35 Exacerbations/year
Standard Error 0.05
|
0.42 Exacerbations/year
Standard Error 0.07
|
—
|
—
|
SECONDARY outcome
Timeframe: 24 WeeksPopulation: The Efficacy Set is defined as all participants who are randomized to study intervention and receive any amount of randomized study intervention. Participants are analyzed according to the treatment assigned at randomization, regardless of the actual treatment received. Only subjects with non-missing baseline covariates used in the analysis model are included in the analysis.
Annualized rate of severe asthma exacerbation during the treatment period (up to 24 Weeks). An asthma exacerbation will be considered severe if it results in at least one of the following: a course of systemic corticosteroids for at least 3 consecutive days to treat symptoms of asthma worsening, an ER or urgent care visit due to asthma that required treatment with systemic corticosteroids, an in-patient hospitalization due to asthma, or death related to asthma. Treatment policy is implemented to handle all intercurrent events with the exception of initiation of new asthma therapy or administration of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of randomised study intervention, for which the composite strategy is implemented.
Outcome measures
| Measure |
BFF MDI 160/9.6 μg
n=87 Participants
Budesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), 160/9.6 μg
|
BFF MDI 320/9.6 μg
n=161 Participants
Budesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), 320/9.6 μg
|
BD MDI 320 μg
n=166 Participants
Budesonide MDI (BD MDI), 320 μg
|
Symbicort TBH 320/9 μg
n=159 Participants
Open-Label Comparator Symbicort Turbuhaler 320/9 μg
|
|---|---|---|---|---|
|
Rate of Severe Asthma Exacerbation During the Treatment Period (up to 24 Weeks)
|
0.26 Exacerbations/year
Standard Error 0.08
|
0.36 Exacerbations/year
Standard Error 0.07
|
0.35 Exacerbations/year
Standard Error 0.07
|
0.41 Exacerbations/year
Standard Error 0.07
|
Adverse Events
BFF MDI 160/9.6 g
Serious events: 3 serious events
Other events: 31 other events
Deaths: 0 deaths
BFF MDI 320/9.6 g
Serious events: 3 serious events
Other events: 45 other events
Deaths: 0 deaths
BD MDI 320 g
Serious events: 1 serious events
Other events: 40 other events
Deaths: 0 deaths
Symbicort TBH 320/9 g
Serious events: 7 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BFF MDI 160/9.6 g
n=88 participants at risk
Budesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), 160/9.6 μg
|
BFF MDI 320/9.6 g
n=163 participants at risk
Budesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), 320/9.6 μg
|
BD MDI 320 g
n=168 participants at risk
Budesonide MDI (BD MDI), 320 μg
|
Symbicort TBH 320/9 g
n=162 participants at risk
Open-Label Comparator Symbicort Turbuhaler 320/9 μg
|
|---|---|---|---|---|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/88 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
0.00%
0/163 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
0.00%
0/168 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
0.62%
1/162 • Number of events 1 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
|
Infections and infestations
Covid-19 pneumonia
|
0.00%
0/88 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
0.61%
1/163 • Number of events 1 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
0.00%
0/168 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
0.00%
0/162 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/88 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
0.00%
0/163 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
0.00%
0/168 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
0.62%
1/162 • Number of events 1 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
|
Infections and infestations
Localised infection
|
0.00%
0/88 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
0.00%
0/163 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
0.00%
0/168 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
0.62%
1/162 • Number of events 1 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
1.1%
1/88 • Number of events 1 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
0.00%
0/163 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
0.00%
0/168 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
0.00%
0/162 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/88 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
0.00%
0/163 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
0.60%
1/168 • Number of events 1 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
0.00%
0/162 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/88 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
0.00%
0/163 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
0.00%
0/168 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
0.62%
1/162 • Number of events 1 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/88 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
0.61%
1/163 • Number of events 1 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
0.00%
0/168 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
0.62%
1/162 • Number of events 1 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/88 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
0.61%
1/163 • Number of events 1 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
0.00%
0/168 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
0.00%
0/162 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
|
Gastrointestinal disorders
Gastric ulcer
|
1.1%
1/88 • Number of events 1 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
0.00%
0/163 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
0.00%
0/168 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
0.00%
0/162 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/88 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
0.00%
0/163 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
0.60%
1/168 • Number of events 1 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
0.00%
0/162 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
|
Gastrointestinal disorders
Inguinal hernia
|
1.1%
1/88 • Number of events 1 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
0.00%
0/163 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
0.00%
0/168 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
0.00%
0/162 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/88 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
0.00%
0/163 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
0.00%
0/168 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
0.62%
1/162 • Number of events 1 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
|
General disorders
Asthenia
|
0.00%
0/88 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
0.00%
0/163 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
0.00%
0/168 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
0.62%
1/162 • Number of events 1 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
Other adverse events
| Measure |
BFF MDI 160/9.6 g
n=88 participants at risk
Budesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), 160/9.6 μg
|
BFF MDI 320/9.6 g
n=163 participants at risk
Budesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), 320/9.6 μg
|
BD MDI 320 g
n=168 participants at risk
Budesonide MDI (BD MDI), 320 μg
|
Symbicort TBH 320/9 g
n=162 participants at risk
Open-Label Comparator Symbicort Turbuhaler 320/9 μg
|
|---|---|---|---|---|
|
Infections and infestations
Bronchitis bacterial
|
2.3%
2/88 • Number of events 2 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
1.2%
2/163 • Number of events 2 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
1.2%
2/168 • Number of events 2 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
1.2%
2/162 • Number of events 2 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
|
Infections and infestations
Covid-19
|
3.4%
3/88 • Number of events 3 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
9.2%
15/163 • Number of events 15 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
4.8%
8/168 • Number of events 8 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
6.8%
11/162 • Number of events 11 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
|
Infections and infestations
Nasopharyngitis
|
13.6%
12/88 • Number of events 13 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
9.2%
15/163 • Number of events 17 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
8.9%
15/168 • Number of events 20 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
8.0%
13/162 • Number of events 19 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
|
Infections and infestations
Upper respiratory tract infection
|
3.4%
3/88 • Number of events 3 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
4.9%
8/163 • Number of events 12 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
7.1%
12/168 • Number of events 15 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
5.6%
9/162 • Number of events 10 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
|
Infections and infestations
Viral upper respiratory tract infection
|
1.1%
1/88 • Number of events 1 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
1.8%
3/163 • Number of events 3 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
1.8%
3/168 • Number of events 3 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
3.1%
5/162 • Number of events 5 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
|
Metabolism and nutrition disorders
Gout
|
2.3%
2/88 • Number of events 4 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
0.61%
1/163 • Number of events 2 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
0.00%
0/168 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
0.00%
0/162 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.4%
3/88 • Number of events 3 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
0.61%
1/163 • Number of events 1 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
0.60%
1/168 • Number of events 1 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
1.2%
2/162 • Number of events 2 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
2.3%
2/88 • Number of events 2 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
1.8%
3/163 • Number of events 3 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
0.60%
1/168 • Number of events 1 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
0.00%
0/162 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
1.1%
1/88 • Number of events 1 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
2.5%
4/163 • Number of events 4 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
0.00%
0/168 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
0.62%
1/162 • Number of events 1 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
|
Vascular disorders
Hypertension
|
3.4%
3/88 • Number of events 3 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
0.61%
1/163 • Number of events 1 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
1.8%
3/168 • Number of events 3 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
0.62%
1/162 • Number of events 1 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
|
Gastrointestinal disorders
Diarrhoea
|
2.3%
2/88 • Number of events 2 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
0.00%
0/163 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
0.60%
1/168 • Number of events 1 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
0.00%
0/162 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
|
General disorders
Influenza like illness
|
2.3%
2/88 • Number of events 2 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
0.00%
0/163 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
0.00%
0/168 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
0.00%
0/162 • From the date of first dose of IP up to and including 1 day following the date of last IP dose, up to 24 weeks.
Adverse events were reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). The Investigator and any designees were responsible for detecting, documenting, and recording events that meet the definition of an AE. The Safety Set is defined as the Efficacy Set, but it also includes the 6 participants who were randomized multiple times at sites or studies
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place