Trial Outcomes & Findings for A Phase III Parallel Group Study, Comparing the Efficacy, Safety and Tolerability of the Fixed Dose Combination (FDC) of Fluticasone Furoate+Umeclidinium Bromide+Vilanterol (FF/UMEC/VI) With the FDC of FF/VI in Subjects With Inadequately Controlled Asthma (NCT NCT02924688)
NCT ID: NCT02924688
Last Updated: 2021-03-26
Results Overview
FEV1 is a measure of lung function and is defined as the maximal volume of air that can be forcefully exhaled in one second. Trough FEV1 on treatment is defined as the highest FEV1 value obtained prior to the morning dose of investigational product. Baseline value is the last acceptable/borderline acceptable pre-dose FEV1 prior to randomized treatment start date (pre-dose at Day 1). Change from Baseline value is the value at Week 24 minus the Baseline value. Intent-to-Treat (ITT) Population comprised of all randomized participants, excluding those who were randomized in error, who did not receive the study drug. Treatment policy estimand was assessed, including all on- and post-treatment data. Different participants may have been analyzed at different time points; thus, overall number of participants analyzed reflects everyone in ITT Population without missing covariate information, with Baseline and at least one post-baseline measurement. Mixed Model Repeated Measures(MMRM) was used.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
2436 participants
Primary outcome timeframe
Baseline (pre-dose at Day 1) and Week 24
Results posted on
2021-03-26
Participant Flow
Participants were enrolled from 322 centers across 15 countries.
Total 5185 participants were screened and 2436 participants were enrolled into the study and received the study treatment.
Participant milestones
| Measure |
FF/VI 100/25 mcg
Participants received Fluticasone Furoate/ Vilanterol (FF/VI) 100/25 micrograms (mcg) inhalation powder via dry powder inhaler (DPI), once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
FF/UMEC/VI 100/ 31.25/25 mcg
Participants received Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) 100/31.25/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
FF/UMEC/VI 100/62.5/25 mcg
Participants received FF/UMEC/VI 100/62.5/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
FF/VI 200/25 mcg
Participants received FF/VI 200/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
FF/UMEC/VI 200/ 31.25/25 mcg
Participants received FF/UMEC/VI 200/31.25/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
FF/UMEC/VI 200/62.5/25 mcg
Participants received FF/UMEC/VI 200/62.5/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
407
|
405
|
406
|
406
|
404
|
408
|
|
Overall Study
COMPLETED
|
374
|
374
|
383
|
378
|
381
|
384
|
|
Overall Study
NOT COMPLETED
|
33
|
31
|
23
|
28
|
23
|
24
|
Reasons for withdrawal
| Measure |
FF/VI 100/25 mcg
Participants received Fluticasone Furoate/ Vilanterol (FF/VI) 100/25 micrograms (mcg) inhalation powder via dry powder inhaler (DPI), once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
FF/UMEC/VI 100/ 31.25/25 mcg
Participants received Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) 100/31.25/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
FF/UMEC/VI 100/62.5/25 mcg
Participants received FF/UMEC/VI 100/62.5/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
FF/VI 200/25 mcg
Participants received FF/VI 200/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
FF/UMEC/VI 200/ 31.25/25 mcg
Participants received FF/UMEC/VI 200/31.25/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
FF/UMEC/VI 200/62.5/25 mcg
Participants received FF/UMEC/VI 200/62.5/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
9
|
3
|
2
|
2
|
3
|
2
|
|
Overall Study
Lack of Efficacy
|
2
|
3
|
4
|
2
|
1
|
1
|
|
Overall Study
Protocol Violation
|
3
|
7
|
5
|
6
|
2
|
2
|
|
Overall Study
Protocol defined withdrawal criteria met
|
1
|
0
|
1
|
1
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
4
|
2
|
4
|
2
|
4
|
|
Overall Study
Physician Decision
|
2
|
1
|
0
|
1
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
14
|
13
|
9
|
12
|
13
|
14
|
Baseline Characteristics
A Phase III Parallel Group Study, Comparing the Efficacy, Safety and Tolerability of the Fixed Dose Combination (FDC) of Fluticasone Furoate+Umeclidinium Bromide+Vilanterol (FF/UMEC/VI) With the FDC of FF/VI in Subjects With Inadequately Controlled Asthma
Baseline characteristics by cohort
| Measure |
FF/VI 100/25 mcg
n=407 Participants
Participants received Fluticasone Furoate/ Vilanterol (FF/VI) 100/25 micrograms (mcg) inhalation powder via dry powder inhaler (DPI), once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
FF/UMEC/VI 100/ 31.25/25 mcg
n=405 Participants
Participants received Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) 100/31.25/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
FF/UMEC/VI 100/62.5/25 mcg
n=406 Participants
Participants received FF/UMEC/VI 100/62.5/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
FF/VI 200/25 mcg
n=406 Participants
Participants received FF/VI 200/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
FF/UMEC/VI 200/ 31.25/25 mcg
n=404 Participants
Participants received FF/UMEC/VI 200/31.25/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
FF/UMEC/VI 200/62.5/25 mcg
n=408 Participants
Participants received FF/UMEC/VI 200/62.5/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
Total
n=2436 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
53.3 Years
STANDARD_DEVIATION 13.03 • n=5 Participants
|
51.7 Years
STANDARD_DEVIATION 13.27 • n=7 Participants
|
52.9 Years
STANDARD_DEVIATION 13.39 • n=5 Participants
|
53.9 Years
STANDARD_DEVIATION 13.30 • n=4 Participants
|
53.5 Years
STANDARD_DEVIATION 13.12 • n=21 Participants
|
53.7 Years
STANDARD_DEVIATION 12.50 • n=10 Participants
|
53.2 Years
STANDARD_DEVIATION 13.11 • n=115 Participants
|
|
Sex: Female, Male
Female
|
254 Participants
n=5 Participants
|
262 Participants
n=7 Participants
|
248 Participants
n=5 Participants
|
252 Participants
n=4 Participants
|
240 Participants
n=21 Participants
|
258 Participants
n=10 Participants
|
1514 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
153 Participants
n=5 Participants
|
143 Participants
n=7 Participants
|
158 Participants
n=5 Participants
|
154 Participants
n=4 Participants
|
164 Participants
n=21 Participants
|
150 Participants
n=10 Participants
|
922 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American (AA)
|
20 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
24 Participants
n=10 Participants
|
119 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Race · Asian-Central/South Asian Heritage (H.)
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
24 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Race · Asian-Japanese H./East Asian H./SouthEast Asian H.
|
54 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
55 Participants
n=21 Participants
|
52 Participants
n=10 Participants
|
319 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Race · Mixed Asian Race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
326 Participants
n=5 Participants
|
319 Participants
n=7 Participants
|
338 Participants
n=5 Participants
|
316 Participants
n=4 Participants
|
325 Participants
n=21 Participants
|
326 Participants
n=10 Participants
|
1950 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native and Black or AA
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native and White
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Race · Asian and Black or African American and White
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Race · Asian and White
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American and White
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
7 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Race · Missing
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Baseline (pre-dose at Day 1) and Week 24Population: ITT Population. Only those participants with data available at the specified data point were analyzed. Participants with Baseline value and at least one post-baseline measurement were analyzed.
FEV1 is a measure of lung function and is defined as the maximal volume of air that can be forcefully exhaled in one second. Trough FEV1 on treatment is defined as the highest FEV1 value obtained prior to the morning dose of investigational product. Baseline value is the last acceptable/borderline acceptable pre-dose FEV1 prior to randomized treatment start date (pre-dose at Day 1). Change from Baseline value is the value at Week 24 minus the Baseline value. Intent-to-Treat (ITT) Population comprised of all randomized participants, excluding those who were randomized in error, who did not receive the study drug. Treatment policy estimand was assessed, including all on- and post-treatment data. Different participants may have been analyzed at different time points; thus, overall number of participants analyzed reflects everyone in ITT Population without missing covariate information, with Baseline and at least one post-baseline measurement. Mixed Model Repeated Measures(MMRM) was used.
Outcome measures
| Measure |
FF/VI 100/25 mcg
n=400 Participants
Participants received Fluticasone Furoate/ Vilanterol (FF/VI) 100/25 micrograms (mcg) inhalation powder via dry powder inhaler (DPI), once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
FF/UMEC/VI 100/ 31.25/25 mcg
n=399 Participants
Participants received Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) 100/31.25/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period
|
FF/UMEC/VI 100/62.5/25 mcg
n=404 Participants
Participants received FF/UMEC/VI 100/62.5/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
FF/VI 200/25 mcg
n=403 Participants
Participants received FF/VI 200/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
FF/UMEC/VI 200/ 31.25/25 mcg
n=399 Participants
Participants received FF/UMEC/VI 200/31.25/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
FF/UMEC/VI 200/62.5/25 mcg
n=405 Participants
Participants received FF/UMEC/VI 200/62.5/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 24
|
0.024 Liters
Standard Error 0.0157
|
0.120 Liters
Standard Error 0.0157
|
0.134 Liters
Standard Error 0.0155
|
0.076 Liters
Standard Error 0.0156
|
0.157 Liters
Standard Error 0.0156
|
0.168 Liters
Standard Error 0.0155
|
SECONDARY outcome
Timeframe: Up to Week 52Population: ITT Population. Only participants with at least one day on study post-randomization were analyzed. Analysis used pooled data from two FF/UMEC/VI arms for each fixed UMEC dose compared to pooled data from two FF/VI arms to provide a more precise estimate for the treatment effect of the addition of UMEC to FF/VI.
A moderate asthma exacerbation is considered to be a deterioration in asthma symptoms or in lung function, or increased rescue bronchodilator use lasting for at least 2 days or more, but not be severe enough to warrant systemic corticosteroid use (or a doubling or more of the maintenance systemic corticosteroid dose, if applicable) for 3 days or more and/or hospitalization. It is an event that, when recognized, should result in a temporary change in treatment, to prevent it from becoming severe. A severe asthma exacerbation is defined as the deterioration of asthma requiring the use of systemic corticosteroids (tablets,suspension or injection), or an increase from a stable maintenance dose (For participants receiving maintenance systemic corticosteroids, at least double the maintenance systemic corticosteroid dose for at least 3 days is required), for at least 3 days or an inpatient hospitalization or emergency department visit because of asthma, requiring systemic corticosteroids.
Outcome measures
| Measure |
FF/VI 100/25 mcg
n=813 Participants
Participants received Fluticasone Furoate/ Vilanterol (FF/VI) 100/25 micrograms (mcg) inhalation powder via dry powder inhaler (DPI), once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
FF/UMEC/VI 100/ 31.25/25 mcg
n=809 Participants
Participants received Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) 100/31.25/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period
|
FF/UMEC/VI 100/62.5/25 mcg
n=814 Participants
Participants received FF/UMEC/VI 100/62.5/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
FF/VI 200/25 mcg
Participants received FF/VI 200/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
FF/UMEC/VI 200/ 31.25/25 mcg
Participants received FF/UMEC/VI 200/31.25/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
FF/UMEC/VI 200/62.5/25 mcg
Participants received FF/UMEC/VI 200/62.5/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
|---|---|---|---|---|---|---|
|
Annualized Rate of Moderate and Severe Asthma Exacerbations
|
0.70 Exacerbations per year
Interval 0.61 to 0.8
|
0.68 Exacerbations per year
Interval 0.6 to 0.78
|
0.61 Exacerbations per year
Interval 0.53 to 0.7
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (pre-dose at Day 1) and 3 hours post dose at Week 24Population: ITT Population. Only those participants with available Baseline and on-treatment data at Week 24 were analyzed.
FEV1 is a measure of lung function and is defined as the maximal volume of air that can be forcefully exhaled in one second. Baseline value is the last acceptable/borderline acceptable pre-dose FEV1 prior to randomized treatment start date (pre-dose at Day 1). Change from Baseline value is the value at Week 24 (recorded at 3 hours post dose) minus the Baseline value.
Outcome measures
| Measure |
FF/VI 100/25 mcg
n=369 Participants
Participants received Fluticasone Furoate/ Vilanterol (FF/VI) 100/25 micrograms (mcg) inhalation powder via dry powder inhaler (DPI), once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
FF/UMEC/VI 100/ 31.25/25 mcg
n=375 Participants
Participants received Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) 100/31.25/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period
|
FF/UMEC/VI 100/62.5/25 mcg
n=379 Participants
Participants received FF/UMEC/VI 100/62.5/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
FF/VI 200/25 mcg
n=377 Participants
Participants received FF/VI 200/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
FF/UMEC/VI 200/ 31.25/25 mcg
n=371 Participants
Participants received FF/UMEC/VI 200/31.25/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
FF/UMEC/VI 200/62.5/25 mcg
n=378 Participants
Participants received FF/UMEC/VI 200/62.5/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Clinic FEV1 at 3 Hours Post Study Treatment at Week 24
|
0.132 Liters
Standard Error 0.0160
|
0.220 Liters
Standard Error 0.0159
|
0.243 Liters
Standard Error 0.0158
|
0.168 Liters
Standard Error 0.0159
|
0.256 Liters
Standard Error 0.0160
|
0.286 Liters
Standard Error 0.0158
|
SECONDARY outcome
Timeframe: Baseline (pre-dose at Day 1) and Week 24Population: ITT Population. Participants with available data at Baseline and at least one time point post-baseline were analyzed. Analysis used pooled data from two FF/UMEC/VI arms for each fixed UMEC dose compared to pooled data from two FF/VI arms to provide a more precise estimate for the treatment effect of the addition of UMEC to FF/VI.
The ACQ-7 consists of 7 attributes of asthma control, of which 6 to be self-completed by participant in a 6-item questionnaire, enquire about frequency and/or severity of symptoms over the previous week on: nocturnal awakening, symptoms on waking in the morning, activity limitation, shortness of breath, wheeze, and rescue medication use. The seventh attribute measures the lung function, which was included via pre-bronchodilator FEV1 % predicted value. All 7 items of ACQ have response on 0-6 ordinal scale (0=no impairment/limitation, 6=total impairment/limitation). The total score is calculated as the average of all non-missing item responses, ranges from 0 to 6. Higher score indicates worst symptoms. Treatment policy estimand was assessed, including all on- and post-treatment data. Baseline value was at randomization visit (pre-dose,Day 1). Change from Baseline was defined as value at Week 24 minus Baseline value.
Outcome measures
| Measure |
FF/VI 100/25 mcg
n=784 Participants
Participants received Fluticasone Furoate/ Vilanterol (FF/VI) 100/25 micrograms (mcg) inhalation powder via dry powder inhaler (DPI), once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
FF/UMEC/VI 100/ 31.25/25 mcg
n=784 Participants
Participants received Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) 100/31.25/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period
|
FF/UMEC/VI 100/62.5/25 mcg
n=790 Participants
Participants received FF/UMEC/VI 100/62.5/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
FF/VI 200/25 mcg
Participants received FF/VI 200/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
FF/UMEC/VI 200/ 31.25/25 mcg
Participants received FF/UMEC/VI 200/31.25/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
FF/UMEC/VI 200/62.5/25 mcg
Participants received FF/UMEC/VI 200/62.5/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Asthma Control Questionnaire-7 (ACQ-7) Total Score at Week 24
|
-0.678 Scores on a scale
Standard Error 0.0240
|
-0.734 Scores on a scale
Standard Error 0.0240
|
-0.767 Scores on a scale
Standard Error 0.0238
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (pre-dose at Day 1) and Week 24Population: ITT Population. Participants with a Baseline value and at least one post-baseline measurement were analyzed. Analysis used pooled data from two FF/UMEC/VI arms for each fixed UMEC dose compared to pooled data from two FF/VI arms to provide a more precise estimate for the treatment effect of the addition of UMEC to FF/VI.
The SGRQ had 50 questions (scored from 0 to 100 where 0 indicates best and 100 indicates worst health) designed to measure quality of life (QoL) of participants with airway obstruction, measuring symptoms, impact, and activity. The questions are designed to be self-completed by the participant with a recall over the past 3 months. SGRQ total score was calculated by summing the pre-assigned weights of answers, dividing by the sum of the maximum weights for items in SGRQ and multiplying by 100. SGRQ total score ranges from 0 to 100 where 0 indicates best and 100 indicates worst health. A change of 4 points is considered a clinically relevant change. Treatment policy estimand was assessed, including all on- and post-treatment data. Baseline value was at randomization visit (pre-dose at Day 1). Change from Baseline value is the value at Week 24 minus the Baseline value.
Outcome measures
| Measure |
FF/VI 100/25 mcg
n=784 Participants
Participants received Fluticasone Furoate/ Vilanterol (FF/VI) 100/25 micrograms (mcg) inhalation powder via dry powder inhaler (DPI), once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
FF/UMEC/VI 100/ 31.25/25 mcg
n=782 Participants
Participants received Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) 100/31.25/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period
|
FF/UMEC/VI 100/62.5/25 mcg
n=795 Participants
Participants received FF/UMEC/VI 100/62.5/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
FF/VI 200/25 mcg
Participants received FF/VI 200/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
FF/UMEC/VI 200/ 31.25/25 mcg
Participants received FF/UMEC/VI 200/31.25/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
FF/UMEC/VI 200/62.5/25 mcg
Participants received FF/UMEC/VI 200/62.5/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at Week 24
|
-11.39 Scores on a scale
Standard Error 0.491
|
-10.29 Scores on a scale
Standard Error 0.494
|
-11.69 Scores on a scale
Standard Error 0.487
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (14 days prior to randomization) and Weeks 21 to 24Population: ITT Population. Participants with a Baseline value and at least one post-baseline measurement were analyzed. Analysis used pooled data from two FF/UMEC/VI arms for each fixed UMEC dose compared to pooled data from two FF/VI arms to provide a more precise estimate for the treatment effect of the addition of UMEC to FF/VI.
The E-RS in Chronic Obstructive Pulmonary Disease (COPD) consists of 11 items. E-RS captures information related to respiratory symptoms, i.e. breathlessness, cough, sputum production, chest congestion and chest tightness. The E-RS was completed daily and data was derived by 4-weekly intervals, requiring at least 50% of data to be present during a period. 7 items are scored from 0 (not at all) to 4 (extreme) and 4 items are scored from 0 (not at all) to 3 (extreme). The E-RS total score was calculated by taking sum of all the items. The E-RS total score has a scoring range of 0 to 40, with higher scores indicating more severe respiratory symptoms. Treatment policy estimand was assessed, including all on- and post-treatment data. Baseline value was the mean value of 14 days prior to randomization. Change from Baseline was calculated as post-baseline value (mean of daily E-RS total scores during Week 21 to 24 ) minus Baseline value.
Outcome measures
| Measure |
FF/VI 100/25 mcg
n=787 Participants
Participants received Fluticasone Furoate/ Vilanterol (FF/VI) 100/25 micrograms (mcg) inhalation powder via dry powder inhaler (DPI), once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
FF/UMEC/VI 100/ 31.25/25 mcg
n=796 Participants
Participants received Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) 100/31.25/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period
|
FF/UMEC/VI 100/62.5/25 mcg
n=802 Participants
Participants received FF/UMEC/VI 100/62.5/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
FF/VI 200/25 mcg
Participants received FF/VI 200/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
FF/UMEC/VI 200/ 31.25/25 mcg
Participants received FF/UMEC/VI 200/31.25/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
FF/UMEC/VI 200/62.5/25 mcg
Participants received FF/UMEC/VI 200/62.5/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Evaluating Respiratory Symptoms (E-RS) Total Score Over Weeks 21 to 24 (Inclusive) of the Treatment Period
|
-2.47 Scores on a scale
Standard Error 0.131
|
-2.60 Scores on a scale
Standard Error 0.130
|
-2.89 Scores on a scale
Standard Error 0.130
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 52Population: ITT Population
Adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, events associated with liver injury and impaired liver function, or any other situation according to medical or scientific judgment were categorized as SAE. Number of participants with any SAE and common (\>=3%) non-SAEs are presented.
Outcome measures
| Measure |
FF/VI 100/25 mcg
n=407 Participants
Participants received Fluticasone Furoate/ Vilanterol (FF/VI) 100/25 micrograms (mcg) inhalation powder via dry powder inhaler (DPI), once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
FF/UMEC/VI 100/ 31.25/25 mcg
n=405 Participants
Participants received Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) 100/31.25/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period
|
FF/UMEC/VI 100/62.5/25 mcg
n=406 Participants
Participants received FF/UMEC/VI 100/62.5/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
FF/VI 200/25 mcg
n=406 Participants
Participants received FF/VI 200/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
FF/UMEC/VI 200/ 31.25/25 mcg
n=404 Participants
Participants received FF/UMEC/VI 200/31.25/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
FF/UMEC/VI 200/62.5/25 mcg
n=408 Participants
Participants received FF/UMEC/VI 200/62.5/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Any Serious Adverse Event (SAE) and Common (>=3%) Non-SAE
Common non-SAE
|
136 Participants
|
150 Participants
|
135 Participants
|
122 Participants
|
127 Participants
|
122 Participants
|
|
Number of Participants With Any Serious Adverse Event (SAE) and Common (>=3%) Non-SAE
SAE
|
25 Participants
|
18 Participants
|
23 Participants
|
21 Participants
|
23 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: Up to Week 52Population: ITT Population. Only those participants with data available at the specified time point were analyzed.
Twelve-lead ECGs were performed during the study using an automated ECG machine. All ECG measurements were made with the participant in a supine position having rested in this position for approximately 5 minutes before each reading. The number of participants with worst case post-Baseline abnormal ECG findings were reported.
Outcome measures
| Measure |
FF/VI 100/25 mcg
n=401 Participants
Participants received Fluticasone Furoate/ Vilanterol (FF/VI) 100/25 micrograms (mcg) inhalation powder via dry powder inhaler (DPI), once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
FF/UMEC/VI 100/ 31.25/25 mcg
n=398 Participants
Participants received Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) 100/31.25/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period
|
FF/UMEC/VI 100/62.5/25 mcg
n=398 Participants
Participants received FF/UMEC/VI 100/62.5/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
FF/VI 200/25 mcg
n=397 Participants
Participants received FF/VI 200/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
FF/UMEC/VI 200/ 31.25/25 mcg
n=399 Participants
Participants received FF/UMEC/VI 200/31.25/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
FF/UMEC/VI 200/62.5/25 mcg
n=404 Participants
Participants received FF/UMEC/VI 200/62.5/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Electrocardiogram (ECG) Findings
|
115 Participants
|
118 Participants
|
109 Participants
|
109 Participants
|
106 Participants
|
108 Participants
|
SECONDARY outcome
Timeframe: Baseline (pre-dose at Day 1) and Week 24Population: ITT Population. Only those participants with data available at the specified data point were analyzed. Participants with a Baseline value and at least one post-baseline measurement were analyzed.
Blood pressure (systolic and diastolic) was measured in the sitting position after approximately 5 minutes rest. Baseline value is the last acceptable/borderline acceptable value prior to randomized treatment start date (pre-dose at Day 1). Change from Baseline value is the value at the clinic visit minus the Baseline value. Different participants may have been analyzed at different time points; thus, overall number of participants analyzed reflects everyone in ITT Population without missing covariate information, with Baseline and at least one post-baseline measurement.
Outcome measures
| Measure |
FF/VI 100/25 mcg
n=401 Participants
Participants received Fluticasone Furoate/ Vilanterol (FF/VI) 100/25 micrograms (mcg) inhalation powder via dry powder inhaler (DPI), once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
FF/UMEC/VI 100/ 31.25/25 mcg
n=398 Participants
Participants received Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) 100/31.25/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period
|
FF/UMEC/VI 100/62.5/25 mcg
n=399 Participants
Participants received FF/UMEC/VI 100/62.5/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
FF/VI 200/25 mcg
n=397 Participants
Participants received FF/VI 200/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
FF/UMEC/VI 200/ 31.25/25 mcg
n=399 Participants
Participants received FF/UMEC/VI 200/31.25/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
FF/UMEC/VI 200/62.5/25 mcg
n=402 Participants
Participants received FF/UMEC/VI 200/62.5/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 24
SBP
|
1.6 Millimeter of mercury
Standard Error 0.53
|
0.6 Millimeter of mercury
Standard Error 0.53
|
1.1 Millimeter of mercury
Standard Error 0.52
|
0.2 Millimeter of mercury
Standard Error 0.53
|
0.8 Millimeter of mercury
Standard Error 0.53
|
0.9 Millimeter of mercury
Standard Error 0.52
|
|
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 24
DBP
|
0.4 Millimeter of mercury
Standard Error 0.39
|
0.1 Millimeter of mercury
Standard Error 0.39
|
1.3 Millimeter of mercury
Standard Error 0.39
|
0.4 Millimeter of mercury
Standard Error 0.39
|
0.2 Millimeter of mercury
Standard Error 0.40
|
0.8 Millimeter of mercury
Standard Error 0.39
|
SECONDARY outcome
Timeframe: Baseline (pre-dose at Day 1) and Week 24Population: ITT Population. Only those participants with data available at the specified data point were analyzed. Participants with a Baseline value and at least one post-baseline measurement were analyzed.
Pulse Rate was measured in the sitting position after approximately 5 minutes rest. Baseline value is the last acceptable/borderline acceptable value prior to randomized treatment start date (pre-dose at Day 1). Change from Baseline value is the value at the clinic visit minus the Baseline value. Different participants may have been analyzed at different time points; thus, overall number of participants analyzed reflects everyone in ITT Population without missing covariate information, with Baseline and at least one post-baseline measurement.
Outcome measures
| Measure |
FF/VI 100/25 mcg
n=401 Participants
Participants received Fluticasone Furoate/ Vilanterol (FF/VI) 100/25 micrograms (mcg) inhalation powder via dry powder inhaler (DPI), once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
FF/UMEC/VI 100/ 31.25/25 mcg
n=398 Participants
Participants received Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) 100/31.25/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period
|
FF/UMEC/VI 100/62.5/25 mcg
n=399 Participants
Participants received FF/UMEC/VI 100/62.5/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
FF/VI 200/25 mcg
n=397 Participants
Participants received FF/VI 200/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
FF/UMEC/VI 200/ 31.25/25 mcg
n=399 Participants
Participants received FF/UMEC/VI 200/31.25/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
FF/UMEC/VI 200/62.5/25 mcg
n=402 Participants
Participants received FF/UMEC/VI 200/62.5/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Pulse Rate at Week 24
|
-1.1 Beats per minute
Standard Error 0.43
|
0.2 Beats per minute
Standard Error 0.43
|
-1.0 Beats per minute
Standard Error 0.43
|
-0.7 Beats per minute
Standard Error 0.43
|
-1.3 Beats per minute
Standard Error 0.44
|
-0.5 Beats per minute
Standard Error 0.43
|
SECONDARY outcome
Timeframe: Up to Week 52Population: ITT Population. Only those participants with data available at the specified time point were analyzed.
Blood samples were collected for assessment of clinical chemistry parameters, which included albumin, alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), direct bilirubin, total bilirubin, calcium, creatinine, glucose, potassium, protein, sodium and urea. Abnormal laboratory results are categorized as high or low with respect to their normal ranges. Participants having High and Low values from normal ranges for any parameter at any time post-baseline visits are presented.
Outcome measures
| Measure |
FF/VI 100/25 mcg
n=391 Participants
Participants received Fluticasone Furoate/ Vilanterol (FF/VI) 100/25 micrograms (mcg) inhalation powder via dry powder inhaler (DPI), once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
FF/UMEC/VI 100/ 31.25/25 mcg
n=392 Participants
Participants received Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) 100/31.25/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period
|
FF/UMEC/VI 100/62.5/25 mcg
n=394 Participants
Participants received FF/UMEC/VI 100/62.5/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
FF/VI 200/25 mcg
n=390 Participants
Participants received FF/VI 200/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
FF/UMEC/VI 200/ 31.25/25 mcg
n=391 Participants
Participants received FF/UMEC/VI 200/31.25/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
FF/UMEC/VI 200/62.5/25 mcg
n=397 Participants
Participants received FF/UMEC/VI 200/62.5/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Clinical Chemistry Values
Bilirubin, low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values
Direct bilirubin, high
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values
Albumin, low
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values
Albumin, high
|
1 Participants
|
6 Participants
|
5 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values
ALT, low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values
ALT, high
|
41 Participants
|
29 Participants
|
24 Participants
|
28 Participants
|
27 Participants
|
30 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values
AST, low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values
AST, high
|
29 Participants
|
27 Participants
|
14 Participants
|
21 Participants
|
23 Participants
|
16 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values
ALP, low
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values
ALP, high
|
21 Participants
|
15 Participants
|
10 Participants
|
12 Participants
|
16 Participants
|
12 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values
Direct bilirubin, low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values
Bilirubin, high
|
9 Participants
|
12 Participants
|
5 Participants
|
15 Participants
|
17 Participants
|
13 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values
Calcium, low
|
4 Participants
|
9 Participants
|
7 Participants
|
7 Participants
|
4 Participants
|
3 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values
Calcium, high
|
4 Participants
|
12 Participants
|
10 Participants
|
11 Participants
|
8 Participants
|
7 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values
Creatinine, low
|
54 Participants
|
62 Participants
|
49 Participants
|
63 Participants
|
60 Participants
|
64 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values
Creatinine, high
|
7 Participants
|
7 Participants
|
8 Participants
|
6 Participants
|
9 Participants
|
8 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values
Glucose, low
|
15 Participants
|
11 Participants
|
11 Participants
|
7 Participants
|
12 Participants
|
7 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values
Glucose, high
|
74 Participants
|
71 Participants
|
70 Participants
|
76 Participants
|
66 Participants
|
73 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values
Potassium, low
|
2 Participants
|
3 Participants
|
1 Participants
|
7 Participants
|
7 Participants
|
6 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values
Potassium, high
|
15 Participants
|
13 Participants
|
11 Participants
|
9 Participants
|
12 Participants
|
19 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values
Protein, low
|
3 Participants
|
0 Participants
|
5 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values
Protein, high
|
0 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values
Sodium, low
|
5 Participants
|
7 Participants
|
3 Participants
|
5 Participants
|
7 Participants
|
3 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values
Sodium, high
|
6 Participants
|
7 Participants
|
7 Participants
|
4 Participants
|
5 Participants
|
7 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values
Urea, low
|
3 Participants
|
4 Participants
|
5 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Values
Urea, high
|
13 Participants
|
17 Participants
|
3 Participants
|
11 Participants
|
11 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Up to Week 52Population: ITT Population. Only those participants with data available at the specified time point were analyzed (represented by n=X in category titles).
Blood samples were collected for assessment of hematology parameters, which included Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Erythrocytes, Hematocrit, Hemoglobin, Leukocytes, Platelets, Mean Corpuscular Hemoglobin (MCH) and Mean Corpuscular Volume (MCV). Abnormal laboratory results are categorized as high or low with respect to their normal ranges. Participants having High and Low values from normal ranges for any parameter at any time post-baseline visits are presented.
Outcome measures
| Measure |
FF/VI 100/25 mcg
n=391 Participants
Participants received Fluticasone Furoate/ Vilanterol (FF/VI) 100/25 micrograms (mcg) inhalation powder via dry powder inhaler (DPI), once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
FF/UMEC/VI 100/ 31.25/25 mcg
n=390 Participants
Participants received Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) 100/31.25/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period
|
FF/UMEC/VI 100/62.5/25 mcg
n=392 Participants
Participants received FF/UMEC/VI 100/62.5/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
FF/VI 200/25 mcg
n=391 Participants
Participants received FF/VI 200/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
FF/UMEC/VI 200/ 31.25/25 mcg
n=391 Participants
Participants received FF/UMEC/VI 200/31.25/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
FF/UMEC/VI 200/62.5/25 mcg
n=397 Participants
Participants received FF/UMEC/VI 200/62.5/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Hematology Values
Basophils, low, n=390,390,391,389,389,396
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematology Values
Basophils, high, n=390,390,391,389,389,396
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematology Values
Eosinophils, low, n=390,390,391,389,389,396
|
26 Participants
|
27 Participants
|
25 Participants
|
31 Participants
|
32 Participants
|
28 Participants
|
|
Number of Participants With Abnormal Hematology Values
Eosinophils, high, n=390,390,391,389,389,396
|
111 Participants
|
84 Participants
|
102 Participants
|
84 Participants
|
85 Participants
|
78 Participants
|
|
Number of Participants With Abnormal Hematology Values
Lymphocytes, low, n=390,390,391,389,389,396
|
13 Participants
|
11 Participants
|
13 Participants
|
8 Participants
|
13 Participants
|
10 Participants
|
|
Number of Participants With Abnormal Hematology Values
Lymphocytes, high, n=390,390,391,389,389,396
|
2 Participants
|
5 Participants
|
1 Participants
|
7 Participants
|
6 Participants
|
6 Participants
|
|
Number of Participants With Abnormal Hematology Values
Monocytes, low, n=390,390,391,389,389,396
|
60 Participants
|
68 Participants
|
57 Participants
|
64 Participants
|
51 Participants
|
63 Participants
|
|
Number of Participants With Abnormal Hematology Values
Monocytes, high, n=390,390,391,389,389,396
|
7 Participants
|
1 Participants
|
4 Participants
|
2 Participants
|
7 Participants
|
4 Participants
|
|
Number of Participants With Abnormal Hematology Values
Neutrophils, low, n=390,390,391,389,389,396
|
14 Participants
|
10 Participants
|
16 Participants
|
10 Participants
|
12 Participants
|
9 Participants
|
|
Number of Participants With Abnormal Hematology Values
Neutrophils, high, n=390,390,391,389,389,396
|
21 Participants
|
20 Participants
|
15 Participants
|
19 Participants
|
15 Participants
|
34 Participants
|
|
Number of Participants With Abnormal Hematology Values
Erythrocytes, low, n=391,390,392,391,391,397
|
14 Participants
|
16 Participants
|
11 Participants
|
15 Participants
|
21 Participants
|
22 Participants
|
|
Number of Participants With Abnormal Hematology Values
Erythrocytes, high, n=391,390,392,391,391,397
|
24 Participants
|
21 Participants
|
13 Participants
|
12 Participants
|
17 Participants
|
17 Participants
|
|
Number of Participants With Abnormal Hematology Values
Hematocrit, low, n=391,390,392,391,391,397
|
21 Participants
|
28 Participants
|
16 Participants
|
20 Participants
|
20 Participants
|
26 Participants
|
|
Number of Participants With Abnormal Hematology Values
Hematocrit, high, n=391,390,392,391,391,397
|
60 Participants
|
52 Participants
|
50 Participants
|
47 Participants
|
49 Participants
|
49 Participants
|
|
Number of Participants With Abnormal Hematology Values
Hemoglobin, low, n=391,390,392,391,391,397
|
32 Participants
|
47 Participants
|
40 Participants
|
40 Participants
|
37 Participants
|
34 Participants
|
|
Number of Participants With Abnormal Hematology Values
Hemoglobin, high, n=391,390,392,391,391,397
|
14 Participants
|
13 Participants
|
8 Participants
|
17 Participants
|
10 Participants
|
13 Participants
|
|
Number of Participants With Abnormal Hematology Values
Leukocytes, low, n=391,390,391,389,391,396
|
9 Participants
|
12 Participants
|
14 Participants
|
9 Participants
|
12 Participants
|
8 Participants
|
|
Number of Participants With Abnormal Hematology Values
Leukocytes, high, n=391,390,391,389,391,396
|
38 Participants
|
29 Participants
|
20 Participants
|
31 Participants
|
26 Participants
|
40 Participants
|
|
Number of Participants With Abnormal Hematology Values
Platelets, low, n=391,388,389,391,388,396
|
4 Participants
|
2 Participants
|
3 Participants
|
4 Participants
|
5 Participants
|
4 Participants
|
|
Number of Participants With Abnormal Hematology Values
Platelets, high, n=391,388,389,391,388,396
|
17 Participants
|
16 Participants
|
19 Participants
|
21 Participants
|
19 Participants
|
21 Participants
|
|
Number of Participants With Abnormal Hematology Values
MCH, low, n=391,390,392,391,391,397
|
40 Participants
|
47 Participants
|
24 Participants
|
34 Participants
|
41 Participants
|
25 Participants
|
|
Number of Participants With Abnormal Hematology Values
MCH, high, n=391,390,392,391,391,397
|
18 Participants
|
32 Participants
|
22 Participants
|
17 Participants
|
25 Participants
|
32 Participants
|
|
Number of Participants With Abnormal Hematology Values
MCV, low, n=391,390,392,391,391,397
|
20 Participants
|
22 Participants
|
10 Participants
|
15 Participants
|
19 Participants
|
14 Participants
|
|
Number of Participants With Abnormal Hematology Values
MCV, high, n=391,390,392,391,391,397
|
29 Participants
|
41 Participants
|
25 Participants
|
29 Participants
|
26 Participants
|
37 Participants
|
Adverse Events
FF/VI 100/25 mcg
Serious events: 25 serious events
Other events: 136 other events
Deaths: 0 deaths
FF/UMEC/VI 100/ 31.25/25 mcg
Serious events: 18 serious events
Other events: 150 other events
Deaths: 2 deaths
FF/UMEC/VI 100/62.5/25 mcg
Serious events: 23 serious events
Other events: 135 other events
Deaths: 0 deaths
FF/VI 200/25 mcg
Serious events: 21 serious events
Other events: 122 other events
Deaths: 1 deaths
FF/UMEC/VI 200/ 31.25/25 mcg
Serious events: 23 serious events
Other events: 127 other events
Deaths: 0 deaths
FF/UMEC/VI 200/62.5/25 mcg
Serious events: 21 serious events
Other events: 122 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
FF/VI 100/25 mcg
n=407 participants at risk
Participants received Fluticasone Furoate/ Vilanterol (FF/VI) 100/25 micrograms (mcg) inhalation powder via dry powder inhaler (DPI), once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
FF/UMEC/VI 100/ 31.25/25 mcg
n=405 participants at risk
Participants received Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) 100/31.25/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
FF/UMEC/VI 100/62.5/25 mcg
n=406 participants at risk
Participants received FF/UMEC/VI 100/62.5/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
FF/VI 200/25 mcg
n=406 participants at risk
Participants received FF/VI 200/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
FF/UMEC/VI 200/ 31.25/25 mcg
n=404 participants at risk
Participants received FF/UMEC/VI 200/31.25/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
FF/UMEC/VI 200/62.5/25 mcg
n=408 participants at risk
Participants received FF/UMEC/VI 200/62.5/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.7%
7/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
1.7%
7/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
1.7%
7/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
1.5%
6/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
1.2%
5/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.98%
4/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.00%
0/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.49%
2/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.25%
1/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.25%
1/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.49%
2/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic rhinosinusitis with nasal polyps
|
0.25%
1/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Respiratory, thoracic and mediastinal disorders
Status asthmaticus
|
0.00%
0/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.25%
1/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Infections and infestations
Pneumonia
|
0.49%
2/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.74%
3/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.74%
3/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.99%
4/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.25%
1/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.25%
1/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.25%
1/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.25%
1/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.25%
1/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.25%
1/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.25%
1/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.25%
1/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Infections and infestations
Diverticulitis
|
0.25%
1/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Infections and infestations
Metapneumovirus infection
|
0.00%
0/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.25%
1/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Infections and infestations
Periodontitis
|
0.00%
0/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.25%
1/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Infections and infestations
Pneumonia influenzal
|
0.00%
0/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.25%
1/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.25%
1/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Infections and infestations
Sepsis
|
0.00%
0/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.25%
1/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.25%
1/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.25%
1/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Infections and infestations
Wound sepsis
|
0.25%
1/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.25%
1/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.25%
1/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.25%
1/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.00%
0/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.25%
1/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.25%
1/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.25%
1/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Gastrointestinal disorders
Gastrointestinal ulcer haemorrhage
|
0.00%
0/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.25%
1/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.25%
1/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.00%
0/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.25%
1/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.25%
1/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.25%
1/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.25%
1/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.25%
1/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.25%
1/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.25%
1/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.00%
0/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.25%
1/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.25%
1/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.25%
1/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.00%
0/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.25%
1/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intestinal adenocarcinoma
|
0.00%
0/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.25%
1/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip and/or oral cavity cancer
|
0.00%
0/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.25%
1/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.25%
1/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.25%
1/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.00%
0/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.25%
1/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.25%
1/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Cardiac disorders
Angina unstable
|
0.49%
2/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.25%
1/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.25%
1/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.49%
2/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.25%
1/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.25%
1/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Cardiac disorders
Angina pectoris
|
0.25%
1/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.25%
1/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.25%
1/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.25%
1/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.25%
1/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.25%
1/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.25%
1/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.25%
1/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.25%
1/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.25%
1/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.00%
0/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.25%
1/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.25%
1/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.25%
1/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Injury, poisoning and procedural complications
Musculoskeletal foreign body
|
0.00%
0/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.25%
1/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Injury, poisoning and procedural complications
Pulmonary contusion
|
0.00%
0/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.25%
1/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.25%
1/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.25%
1/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.00%
0/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.25%
1/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.25%
1/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.00%
0/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.25%
1/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Musculoskeletal and connective tissue disorders
Spinal disorder
|
0.00%
0/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.25%
1/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.00%
0/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.25%
1/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Nervous system disorders
Cerebrovascular disorder
|
0.00%
0/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.25%
1/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.25%
1/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.25%
1/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Nervous system disorders
Hypertensive encephalopathy
|
0.00%
0/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.25%
1/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.25%
1/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.25%
1/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Renal and urinary disorders
Nephropathy toxic
|
0.00%
0/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.25%
1/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.00%
0/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.25%
1/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.25%
1/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.25%
1/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.25%
1/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.25%
1/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.25%
1/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.25%
1/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.00%
0/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.25%
1/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.25%
1/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.25%
1/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.25%
1/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Congenital, familial and genetic disorders
Hypertrophic cardiomyopathy
|
0.00%
0/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.25%
1/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.25%
1/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Investigations
Hepatic enzyme increased
|
0.25%
1/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.25%
1/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
0.00%
0/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
Other adverse events
| Measure |
FF/VI 100/25 mcg
n=407 participants at risk
Participants received Fluticasone Furoate/ Vilanterol (FF/VI) 100/25 micrograms (mcg) inhalation powder via dry powder inhaler (DPI), once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
FF/UMEC/VI 100/ 31.25/25 mcg
n=405 participants at risk
Participants received Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) 100/31.25/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
FF/UMEC/VI 100/62.5/25 mcg
n=406 participants at risk
Participants received FF/UMEC/VI 100/62.5/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
FF/VI 200/25 mcg
n=406 participants at risk
Participants received FF/VI 200/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
FF/UMEC/VI 200/ 31.25/25 mcg
n=404 participants at risk
Participants received FF/UMEC/VI 200/31.25/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
FF/UMEC/VI 200/62.5/25 mcg
n=408 participants at risk
Participants received FF/UMEC/VI 200/62.5/25 mcg inhalation powder via DPI, once daily in the morning up to 52 weeks. Participants were allowed to take albuterol/salbutamol as a rescue medication when needed during the treatment period.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
15.5%
63/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
13.8%
56/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
14.8%
60/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
13.1%
53/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
12.6%
51/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
12.5%
51/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.2%
21/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
5.9%
24/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
3.7%
15/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
3.2%
13/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
3.7%
15/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
4.7%
19/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Infections and infestations
Bronchitis
|
3.4%
14/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
4.4%
18/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
3.7%
15/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
4.7%
19/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
4.0%
16/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
5.4%
22/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Infections and infestations
Respiratory tract infection viral
|
2.7%
11/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
4.2%
17/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
2.5%
10/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
1.7%
7/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
3.0%
12/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
2.2%
9/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Infections and infestations
Influenza
|
3.2%
13/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
3.0%
12/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
3.7%
15/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
2.2%
9/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
2.0%
8/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
1.5%
6/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Infections and infestations
Pharyngitis
|
2.0%
8/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
2.5%
10/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
2.2%
9/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
3.4%
14/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
2.7%
11/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
2.2%
9/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Nervous system disorders
Headache
|
7.4%
30/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
7.7%
31/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
8.9%
36/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
5.7%
23/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
6.7%
27/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
4.7%
19/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.9%
16/407 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
3.0%
12/405 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
3.2%
13/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
1.5%
6/406 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
3.5%
14/404 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
2.2%
9/408 • Non-serious AEs and serious AEs were collected from start of study treatment (Week 0) up to Week 52
Non-serious AEs and serious AEs were collected for ITT Population.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER