Trial Outcomes & Findings for Asthma Control Test Guided Treatment in Chinese Subjects (NCT NCT02868281)
NCT ID: NCT02868281
Last Updated: 2021-07-08
Results Overview
ACT is a self-administered questionnaire comprising five items that were assessed on a five point categorical scale (1 to 5) and the scores are summed to give a total score ranging from 5 to 25, with a score of \>=20 denoting 'well-controlled asthma', a score of 16-19 denoting 'not well-controlled asthma', and a score of \<=15 denoting 'very poorly controlled asthma'. The total score was calculated as the sum of the scores from all 5 questions. Higher scores indicates improved asthma control. The recall period of the questionnaire was four weeks.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
530 participants
Primary outcome timeframe
Up to Week 24
Results posted on
2021-07-08
Participant Flow
Participants were enrolled from 12 centers in China.
Total 583 participants were screened and 530 participants were enrolled into the study (53 participants were screen failures).
Participant milestones
| Measure |
ACT Guided Treatment Group
Participants who were recruited in this Asthma Control Test (ACT) guided treatment group, were treated based on the ACT score. If ACT score =25 for \>=3 months, then step-down treatment. If ACT score \>=20 or \<25 or ACT =25 for \<3 months, then no change in treatment. If ACT score \<=19, then step-up the treatment. ACT was completed prior to any other assessments were conducted.
|
Usual Care Group
Participants who were recruited in this usual care group (control group), were treated based on physician's subjective judgement. Participants completed the ACT after investigator making the treatment decision, to ensure the investigator made treatment decision based on clinical judgement, not based on ACT score.
|
|---|---|---|
|
Overall Study
STARTED
|
252
|
278
|
|
Overall Study
COMPLETED
|
209
|
234
|
|
Overall Study
NOT COMPLETED
|
43
|
44
|
Reasons for withdrawal
| Measure |
ACT Guided Treatment Group
Participants who were recruited in this Asthma Control Test (ACT) guided treatment group, were treated based on the ACT score. If ACT score =25 for \>=3 months, then step-down treatment. If ACT score \>=20 or \<25 or ACT =25 for \<3 months, then no change in treatment. If ACT score \<=19, then step-up the treatment. ACT was completed prior to any other assessments were conducted.
|
Usual Care Group
Participants who were recruited in this usual care group (control group), were treated based on physician's subjective judgement. Participants completed the ACT after investigator making the treatment decision, to ensure the investigator made treatment decision based on clinical judgement, not based on ACT score.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
2
|
|
Overall Study
Protocol Violation
|
13
|
10
|
|
Overall Study
Lost to Follow-up
|
3
|
6
|
|
Overall Study
Withdrawal by Subject
|
11
|
15
|
|
Overall Study
Physician Decision
|
2
|
0
|
|
Overall Study
Had protocol-defined asthma exacerbation
|
8
|
8
|
|
Overall Study
Inclusion/exclusion criteria violation
|
3
|
2
|
|
Overall Study
Long journey/moving away
|
1
|
1
|
Baseline Characteristics
Asthma Control Test Guided Treatment in Chinese Subjects
Baseline characteristics by cohort
| Measure |
ACT Guided Treatment Group
n=252 Participants
Participants who were recruited in this Asthma Control Test (ACT) guided treatment group, were treated based on the ACT score. If ACT score =25 for \>=3 months, then step-down treatment. If ACT score \>=20 or \<25 or ACT =25 for \<3 months, then no change in treatment. If ACT score \<=19, then step-up the treatment. ACT was completed prior to any other assessments were conducted.
|
Usual Care Group
n=278 Participants
Participants who were recruited in this usual care group (control group), were treated based on physician's subjective judgement. Participants completed the ACT after investigator making the treatment decision, to ensure the investigator made treatment decision based on clinical judgement, not based on ACT score.
|
Total
n=530 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.9 Years
STANDARD_DEVIATION 12.74 • n=39 Participants
|
48.1 Years
STANDARD_DEVIATION 13.39 • n=41 Participants
|
48.0 Years
STANDARD_DEVIATION 13.07 • n=35 Participants
|
|
Sex: Female, Male
Female
|
122 Participants
n=39 Participants
|
141 Participants
n=41 Participants
|
263 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
130 Participants
n=39 Participants
|
137 Participants
n=41 Participants
|
267 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Race · Asian-East Asian Heritage
|
252 Participants
n=39 Participants
|
278 Participants
n=41 Participants
|
530 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Up to Week 24Population: Intent-To-Treat (ITT) Population consisted of all participants who signed informed consent form, were randomized and who had at least one post-Baseline assessment. Only those participants with data available at the specified data point were analyzed.
ACT is a self-administered questionnaire comprising five items that were assessed on a five point categorical scale (1 to 5) and the scores are summed to give a total score ranging from 5 to 25, with a score of \>=20 denoting 'well-controlled asthma', a score of 16-19 denoting 'not well-controlled asthma', and a score of \<=15 denoting 'very poorly controlled asthma'. The total score was calculated as the sum of the scores from all 5 questions. Higher scores indicates improved asthma control. The recall period of the questionnaire was four weeks.
Outcome measures
| Measure |
ACT Guided Treatment Group
n=240 Participants
Participants who were recruited in this Asthma Control Test (ACT) guided treatment group, were treated based on the ACT score. If ACT score =25 for \>=3 months, then step-down treatment. If ACT score \>=20 or \<25 or ACT =25 for \<3 months, then no change in treatment. If ACT score \<=19, then step-up the treatment. ACT was completed prior to any other assessments were conducted.
|
Usual Care Group
n=262 Participants
Participants who were recruited in this usual care group (control group), were treated based on physician's subjective judgement. Participants completed the ACT after investigator making the treatment decision, to ensure the investigator made treatment decision based on clinical judgement, not based on ACT score.
|
|---|---|---|
|
Percentage of Participants Who Had an ACT Total Score >=20 or an Improvement of More Than 3 Points in ACT During the 24-week Treatment Period
|
99.2 Percentage of participants
|
94.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 1-4, Weeks 5-8, Weeks 9-12, Weeks 13-16, Weeks 17-20 and Weeks 21-24Population: ITT Population. Only those participants with data available at the specified data point were analyzed (represented by n=x in the category titles).
Participants recorded daytime asthma symptom scores in the daily record card (DRC). Any asthma-related symptoms, such as wheeze, shortness of breath, cough or chest tightness experienced during the previous 12 hours were rated as: 0= no symptoms during the day, 1= symptoms for one short period during the day, 2= symptoms for two or more short periods during the day, 3= symptoms for most of the day which did not affect daily activities, 4= symptoms for most of the day which did affect normal daily activities, 5= symptoms so severe that participant could not go to work or perform normal daily activities. Daytime symptom score was calculated by taking average of scores for all questions. The mean daytime asthma symptom score was calculated for each participant during the 4-weekly interval (Weeks 1-4, Weeks 5-8, Weeks 9-12, Weeks 13-16, Weeks 17-20 and Weeks 21-24) by taking average of 4 weeks. Score ranged from 0-5, higher scores indicates severe symptoms.
Outcome measures
| Measure |
ACT Guided Treatment Group
n=236 Participants
Participants who were recruited in this Asthma Control Test (ACT) guided treatment group, were treated based on the ACT score. If ACT score =25 for \>=3 months, then step-down treatment. If ACT score \>=20 or \<25 or ACT =25 for \<3 months, then no change in treatment. If ACT score \<=19, then step-up the treatment. ACT was completed prior to any other assessments were conducted.
|
Usual Care Group
n=259 Participants
Participants who were recruited in this usual care group (control group), were treated based on physician's subjective judgement. Participants completed the ACT after investigator making the treatment decision, to ensure the investigator made treatment decision based on clinical judgement, not based on ACT score.
|
|---|---|---|
|
Mean Daytime Symptom Score Over the 24-week Treatment Period
Weeks 1-4, n=236, 259
|
0.3 Scores on a scale
Standard Error 0.05
|
0.4 Scores on a scale
Standard Error 0.05
|
|
Mean Daytime Symptom Score Over the 24-week Treatment Period
Weeks 5-8, n=227, 249
|
0.2 Scores on a scale
Standard Error 0.05
|
0.3 Scores on a scale
Standard Error 0.05
|
|
Mean Daytime Symptom Score Over the 24-week Treatment Period
Weeks 13-16, n=210, 238
|
0.1 Scores on a scale
Standard Error 0.05
|
0.2 Scores on a scale
Standard Error 0.05
|
|
Mean Daytime Symptom Score Over the 24-week Treatment Period
Weeks 9-12, n=217, 240
|
0.2 Scores on a scale
Standard Error 0.05
|
0.2 Scores on a scale
Standard Error 0.05
|
|
Mean Daytime Symptom Score Over the 24-week Treatment Period
Weeks 17-20, n=207, 233
|
0.1 Scores on a scale
Standard Error 0.05
|
0.2 Scores on a scale
Standard Error 0.05
|
|
Mean Daytime Symptom Score Over the 24-week Treatment Period
Weeks 21-24, n=205, 227
|
0.1 Scores on a scale
Standard Error 0.05
|
0.2 Scores on a scale
Standard Error 0.05
|
SECONDARY outcome
Timeframe: Weeks 1-4, Weeks 5-8, Weeks 9-12, Weeks 13-16, Weeks 17-20 and Weeks 21-24Population: ITT Population. Only those participants with data available at the specified data point were analyzed (represented by n=x in the category titles).
Participants recorded night-time asthma symptom scores in the DRC. Any asthma-related symptoms, such as wheeze, shortness of breath, cough or chest tightness experienced during the previous 12 hours were rated as: 0= no symptoms during the night, 1= symptoms causing to wake once or wake early, 2= symptoms causing to wake twice or more (including waking early), 3= symptoms causing to be awake for most of the night, 4= symptoms so severe that participant did not sleep at all. Night-time symptom score was calculated by taking average of scores for all questions. The mean nighttime asthma symptom score was calculated for each participant during the 4 weekly interval (Weeks 1-4; Weeks 5-8, Weeks 9-12, Weeks 13-16, Weeks 17-20 and Weeks 21-24) by taking average of 4 weeks. Score ranged from 0-5, higher scores indicates severe symptoms.
Outcome measures
| Measure |
ACT Guided Treatment Group
n=236 Participants
Participants who were recruited in this Asthma Control Test (ACT) guided treatment group, were treated based on the ACT score. If ACT score =25 for \>=3 months, then step-down treatment. If ACT score \>=20 or \<25 or ACT =25 for \<3 months, then no change in treatment. If ACT score \<=19, then step-up the treatment. ACT was completed prior to any other assessments were conducted.
|
Usual Care Group
n=258 Participants
Participants who were recruited in this usual care group (control group), were treated based on physician's subjective judgement. Participants completed the ACT after investigator making the treatment decision, to ensure the investigator made treatment decision based on clinical judgement, not based on ACT score.
|
|---|---|---|
|
Mean Night-time Symptom Score Over the 24-week Treatment Period
Weeks 13-16, n=209, 238
|
0.2 Scores on a scale
Standard Error 0.06
|
0.3 Scores on a scale
Standard Error 0.06
|
|
Mean Night-time Symptom Score Over the 24-week Treatment Period
Weeks 1-4, n=236, 258
|
0.4 Scores on a scale
Standard Error 0.07
|
0.5 Scores on a scale
Standard Error 0.06
|
|
Mean Night-time Symptom Score Over the 24-week Treatment Period
Weeks 5-8, n=226, 249
|
0.3 Scores on a scale
Standard Error 0.06
|
0.3 Scores on a scale
Standard Error 0.06
|
|
Mean Night-time Symptom Score Over the 24-week Treatment Period
Weeks 9-12, n=217, 240
|
0.2 Scores on a scale
Standard Error 0.06
|
0.3 Scores on a scale
Standard Error 0.06
|
|
Mean Night-time Symptom Score Over the 24-week Treatment Period
Weeks 17-20, n=207, 233
|
0.2 Scores on a scale
Standard Error 0.06
|
0.2 Scores on a scale
Standard Error 0.06
|
|
Mean Night-time Symptom Score Over the 24-week Treatment Period
Weeks 21-24, n=205, 227
|
0.2 Scores on a scale
Standard Error 0.06
|
0.2 Scores on a scale
Standard Error 0.06
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and at Week 24Population: ITT Population. Only those participants with data available at the specified data point were analyzed.
FEV1 is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured by spirometry. Baseline was defined as value at Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
ACT Guided Treatment Group
n=208 Participants
Participants who were recruited in this Asthma Control Test (ACT) guided treatment group, were treated based on the ACT score. If ACT score =25 for \>=3 months, then step-down treatment. If ACT score \>=20 or \<25 or ACT =25 for \<3 months, then no change in treatment. If ACT score \<=19, then step-up the treatment. ACT was completed prior to any other assessments were conducted.
|
Usual Care Group
n=227 Participants
Participants who were recruited in this usual care group (control group), were treated based on physician's subjective judgement. Participants completed the ACT after investigator making the treatment decision, to ensure the investigator made treatment decision based on clinical judgement, not based on ACT score.
|
|---|---|---|
|
Mean Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Week 24
|
0.159 Liters
Standard Error 0.0573
|
0.098 Liters
Standard Error 0.0559
|
SECONDARY outcome
Timeframe: Weeks 1-4, Weeks 5-8, Weeks 9-12, Weeks 13-16, Weeks 17-20 and Weeks 21-24Population: ITT Population. Only those participants with data available at the specified data point were analyzed (represented by n=x in the category titles).
PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Participants were provided with a Mini-Wright Peak Flow Meter and were taught how to measure and record their PEF. Participants recorded on DRC the best of three PEF measurements, using a Mini-Wright peak flow meter in the morning (7:00 to 10:00 AM) before taking any asthma drug. Mean AM PEF was calculated for each participant during the 4-weekly interval (Weeks 1-4; Weeks 5-8, Weeks 9-12, Weeks 13-16, Weeks 17-20 and Weeks 21-24) by taking average of 4 weeks.
Outcome measures
| Measure |
ACT Guided Treatment Group
n=239 Participants
Participants who were recruited in this Asthma Control Test (ACT) guided treatment group, were treated based on the ACT score. If ACT score =25 for \>=3 months, then step-down treatment. If ACT score \>=20 or \<25 or ACT =25 for \<3 months, then no change in treatment. If ACT score \<=19, then step-up the treatment. ACT was completed prior to any other assessments were conducted.
|
Usual Care Group
n=261 Participants
Participants who were recruited in this usual care group (control group), were treated based on physician's subjective judgement. Participants completed the ACT after investigator making the treatment decision, to ensure the investigator made treatment decision based on clinical judgement, not based on ACT score.
|
|---|---|---|
|
Mean Morning (Ante Meridiem [AM]) Peak Expiratory Flow (PEF) Over the 24-week Treatment Period
Weeks 1-4, n=239, 261
|
340.4 Liters per minute
Standard Error 13.37
|
352.4 Liters per minute
Standard Error 13.03
|
|
Mean Morning (Ante Meridiem [AM]) Peak Expiratory Flow (PEF) Over the 24-week Treatment Period
Weeks 5-8, n=228, 251
|
355.5 Liters per minute
Standard Error 13.39
|
362.7 Liters per minute
Standard Error 13.05
|
|
Mean Morning (Ante Meridiem [AM]) Peak Expiratory Flow (PEF) Over the 24-week Treatment Period
Weeks 9-12, n=220, 241
|
362.2 Liters per minute
Standard Error 13.42
|
366.9 Liters per minute
Standard Error 13.08
|
|
Mean Morning (Ante Meridiem [AM]) Peak Expiratory Flow (PEF) Over the 24-week Treatment Period
Weeks 13-16, n=211, 239
|
364.6 Liters per minute
Standard Error 13.40
|
367.9 Liters per minute
Standard Error 13.06
|
|
Mean Morning (Ante Meridiem [AM]) Peak Expiratory Flow (PEF) Over the 24-week Treatment Period
Weeks 17-20, n=207, 235
|
366.0 Liters per minute
Standard Error 13.38
|
371.0 Liters per minute
Standard Error 13.04
|
|
Mean Morning (Ante Meridiem [AM]) Peak Expiratory Flow (PEF) Over the 24-week Treatment Period
Weeks 21-24, n=206, 229
|
367.0 Liters per minute
Standard Error 13.43
|
371.0 Liters per minute
Standard Error 13.08
|
SECONDARY outcome
Timeframe: Weeks 1-4, Weeks 5-8, Weeks 9-12, Weeks 13-16, Weeks 17-20 and Weeks 21-24Population: ITT Population. Only those participants with data available at the specified data point were analyzed (represented by n=x in the category titles).
PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Participants were provided with a Mini-Wright Peak Flow Meter and were taught how to measure and record their PEF. Participants recorded on DRC the best of three PEF measurements, using a Mini-Wright peak flow meter in the evening (6:00 to 9:00 PM) before taking any asthma drug. Mean PM PEF was calculated for each participant during the 4-weekly interval (Weeks 1-4; Weeks 5-8, Weeks 9-12, Weeks 13-16, Weeks 17-20 and Weeks 21-24) by taking average of 4 weeks.
Outcome measures
| Measure |
ACT Guided Treatment Group
n=239 Participants
Participants who were recruited in this Asthma Control Test (ACT) guided treatment group, were treated based on the ACT score. If ACT score =25 for \>=3 months, then step-down treatment. If ACT score \>=20 or \<25 or ACT =25 for \<3 months, then no change in treatment. If ACT score \<=19, then step-up the treatment. ACT was completed prior to any other assessments were conducted.
|
Usual Care Group
n=261 Participants
Participants who were recruited in this usual care group (control group), were treated based on physician's subjective judgement. Participants completed the ACT after investigator making the treatment decision, to ensure the investigator made treatment decision based on clinical judgement, not based on ACT score.
|
|---|---|---|
|
Mean Evening (Post Meridiem [PM]) PEF Over the 24-week Treatment Period
Weeks 1-4, n=239, 261
|
342.2 Liters per minute
Standard Error 13.55
|
354.9 Liters per minute
Standard Error 13.22
|
|
Mean Evening (Post Meridiem [PM]) PEF Over the 24-week Treatment Period
Weeks 5-8, n=228, 251
|
356.2 Liters per minute
Standard Error 13.60
|
364.6 Liters per minute
Standard Error 13.27
|
|
Mean Evening (Post Meridiem [PM]) PEF Over the 24-week Treatment Period
Weeks 9-12, n=220, 241
|
362.7 Liters per minute
Standard Error 13.63
|
367.7 Liters per minute
Standard Error 13.29
|
|
Mean Evening (Post Meridiem [PM]) PEF Over the 24-week Treatment Period
Weeks 13-16, n=211, 239
|
365.8 Liters per minute
Standard Error 13.61
|
368.9 Liters per minute
Standard Error 13.27
|
|
Mean Evening (Post Meridiem [PM]) PEF Over the 24-week Treatment Period
Weeks 17-20, n=207, 235
|
366.9 Liters per minute
Standard Error 13.60
|
370.9 Liters per minute
Standard Error 13.26
|
|
Mean Evening (Post Meridiem [PM]) PEF Over the 24-week Treatment Period
Weeks 21-24, n=206, 229
|
368.1 Liters per minute
Standard Error 13.67
|
372.0 Liters per minute
Standard Error 13.33
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and at Week 24Population: ITT Population. Only those participants with data available at the specified data point were analyzed.
The AQLQ(S) contains 32 items in four domains: activity limitation (11 items), symptoms (12 items), emotional function (5 items) and environmental stimuli (4 items). Participant's response to each question was rated on a seven-point scale (1 to 7) where a value of 1 indicates "total impairment" and a value of 7 indicates "no impairment". The total AQLQ(S) score is calculated as the mean of all 32 items in the questionnaire. Hence, the total AQLQ(S) score ranged from 1 to 7 with higher scores indicating a higher quality of life. A change in score of greater than 0.5 can be considered clinically important. Baseline was defined as value at Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
ACT Guided Treatment Group
n=202 Participants
Participants who were recruited in this Asthma Control Test (ACT) guided treatment group, were treated based on the ACT score. If ACT score =25 for \>=3 months, then step-down treatment. If ACT score \>=20 or \<25 or ACT =25 for \<3 months, then no change in treatment. If ACT score \<=19, then step-up the treatment. ACT was completed prior to any other assessments were conducted.
|
Usual Care Group
n=231 Participants
Participants who were recruited in this usual care group (control group), were treated based on physician's subjective judgement. Participants completed the ACT after investigator making the treatment decision, to ensure the investigator made treatment decision based on clinical judgement, not based on ACT score.
|
|---|---|---|
|
Mean Change From Baseline in Standardized Asthma Quality of Life Questionnaire (AQLQ[S]) Total Score at Week 24
|
1.5 Scores on a scale
Standard Error 0.13
|
1.2 Scores on a scale
Standard Error 0.13
|
SECONDARY outcome
Timeframe: Up to Week 24Population: ITT Population. Only those participants with data available at the specified data point were analyzed.
ACT is a self-administered questionnaire comprising five items that were assessed on a five point categorical scale (1 to 5) and the scores are summed to give a total score ranging from 5 to 25, with a score of \>=20 denoting 'well-controlled asthma', a score of 16-19 denoting 'not well-controlled asthma', and a score of \<=15 denoting 'very poorly controlled asthma'. Higher scores indicates improved asthma control. The recall period of the questionnaire was four weeks. Median and inter-quartile range (first and third quartiles) are presented for time to first ACT score \>=20 or improvement of more than 3 points in ACT over the 24-week treatment period.
Outcome measures
| Measure |
ACT Guided Treatment Group
n=229 Participants
Participants who were recruited in this Asthma Control Test (ACT) guided treatment group, were treated based on the ACT score. If ACT score =25 for \>=3 months, then step-down treatment. If ACT score \>=20 or \<25 or ACT =25 for \<3 months, then no change in treatment. If ACT score \<=19, then step-up the treatment. ACT was completed prior to any other assessments were conducted.
|
Usual Care Group
n=224 Participants
Participants who were recruited in this usual care group (control group), were treated based on physician's subjective judgement. Participants completed the ACT after investigator making the treatment decision, to ensure the investigator made treatment decision based on clinical judgement, not based on ACT score.
|
|---|---|---|
|
Time to First ACT Score >=20 or Improvement of More Than 3 Points in ACT Over the 24-week Treatment Period
|
33.0 Days
Interval 29.0 to 57.0
|
55.0 Days
Interval 29.0 to 98.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to Week 24Population: ITT Population. Only those participants with data available at the specified data point were analyzed.
Exacerbations were assessed by the physician at each scheduled visit by reviewing the DRC, as well as specific questioning on adverse events. A moderate asthma exacerbation was defined as a deterioration in asthma requiring treatment with an oral corticosteroid. Individual courses of oral corticosteroids were classified as separate exacerbations only if they were administered more than 1 week apart. Any course started within one week of finishing the previous course was considered part of the previous exacerbation. A severe asthma exacerbation was defined as a deterioration in asthma which requires hospital admission. Annualized Rate of moderate to severe asthma exacerbation during 24-week treatment period is presented.
Outcome measures
| Measure |
ACT Guided Treatment Group
n=241 Participants
Participants who were recruited in this Asthma Control Test (ACT) guided treatment group, were treated based on the ACT score. If ACT score =25 for \>=3 months, then step-down treatment. If ACT score \>=20 or \<25 or ACT =25 for \<3 months, then no change in treatment. If ACT score \<=19, then step-up the treatment. ACT was completed prior to any other assessments were conducted.
|
Usual Care Group
n=263 Participants
Participants who were recruited in this usual care group (control group), were treated based on physician's subjective judgement. Participants completed the ACT after investigator making the treatment decision, to ensure the investigator made treatment decision based on clinical judgement, not based on ACT score.
|
|---|---|---|
|
Annualized Rate of Moderate to Severe Asthma Exacerbation During 24-week Treatment Period
|
0.10 Exacerbations per year
Interval 0.04 to 0.25
|
0.09 Exacerbations per year
Interval 0.04 to 0.22
|
Adverse Events
ACT Guided Treatment Group
Serious events: 9 serious events
Other events: 82 other events
Deaths: 1 deaths
Usual Care Group
Serious events: 14 serious events
Other events: 123 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ACT Guided Treatment Group
n=252 participants at risk
Participants who were recruited in this Asthma Control Test (ACT) guided treatment group, were treated based on the ACT score. If ACT score =25 for \>=3 months, then step-down treatment. If ACT score \>=20 or \<25 or ACT =25 for \<3 months, then no change in treatment. If ACT score \<=19, then step-up the treatment. ACT was completed prior to any other assessments were conducted.
|
Usual Care Group
n=278 participants at risk
Participants who were recruited in this usual care group (control group), were treated based on physician's subjective judgement. Participants completed the ACT after investigator making the treatment decision, to ensure the investigator made treatment decision based on clinical judgement, not based on ACT score.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.79%
2/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.72%
2/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.40%
1/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.00%
0/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Infections and infestations
Chronic sinusitis
|
0.40%
1/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.00%
0/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Infections and infestations
Otitis media chronic
|
0.40%
1/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.00%
0/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Infections and infestations
Salpingitis
|
0.40%
1/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.00%
0/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.36%
1/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.79%
2/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.00%
0/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.36%
1/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.36%
1/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Reproductive system and breast disorders
Pelvic adhesions
|
0.40%
1/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.00%
0/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.40%
1/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.00%
0/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Cardiac disorders
Arrhythmia
|
0.40%
1/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.36%
1/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.40%
1/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.00%
0/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.36%
1/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.72%
2/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.40%
1/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.00%
0/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.40%
1/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.00%
0/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.36%
1/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.36%
1/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Gastrointestinal disorders
Hypertrophic anal papilla
|
0.00%
0/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.36%
1/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.40%
1/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.00%
0/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.36%
1/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.40%
1/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.00%
0/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.00%
0/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.36%
1/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.72%
2/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.36%
1/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Nervous system disorders
Epilepsy
|
0.40%
1/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.00%
0/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Vascular disorders
Varicose vein
|
0.40%
1/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.00%
0/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Vascular disorders
Subclavian artery occlusion
|
0.00%
0/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.36%
1/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Congenital, familial and genetic disorders
Branchial cleft sinus
|
0.00%
0/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.36%
1/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Eye disorders
Macular oedema
|
0.00%
0/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.36%
1/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
General disorders
Chest pain
|
0.00%
0/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.36%
1/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.36%
1/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.36%
1/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
Other adverse events
| Measure |
ACT Guided Treatment Group
n=252 participants at risk
Participants who were recruited in this Asthma Control Test (ACT) guided treatment group, were treated based on the ACT score. If ACT score =25 for \>=3 months, then step-down treatment. If ACT score \>=20 or \<25 or ACT =25 for \<3 months, then no change in treatment. If ACT score \<=19, then step-up the treatment. ACT was completed prior to any other assessments were conducted.
|
Usual Care Group
n=278 participants at risk
Participants who were recruited in this usual care group (control group), were treated based on physician's subjective judgement. Participants completed the ACT after investigator making the treatment decision, to ensure the investigator made treatment decision based on clinical judgement, not based on ACT score.
|
|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
7.1%
18/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
16.9%
47/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Infections and infestations
Rhinitis
|
2.4%
6/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
1.1%
3/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Infections and infestations
Nasopharyngitis
|
1.6%
4/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
1.4%
4/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Infections and infestations
Bronchitis
|
1.2%
3/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
5.8%
16/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Infections and infestations
Conjunctivitis
|
1.2%
3/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
1.1%
3/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Infections and infestations
Respiratory tract infection
|
1.2%
3/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
2.2%
6/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Infections and infestations
Urinary tract infection
|
1.2%
3/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.00%
0/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Infections and infestations
Gastroenteritis
|
0.79%
2/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.00%
0/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Infections and infestations
Otitis media
|
0.79%
2/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.36%
1/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Infections and infestations
Pelvic inflammatory disease
|
0.79%
2/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.00%
0/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Infections and infestations
Vaginal infection
|
0.79%
2/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.00%
0/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Infections and infestations
Herpes zoster
|
0.40%
1/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.36%
1/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Infections and infestations
Pharyngitis
|
0.40%
1/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.36%
1/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Infections and infestations
Pulpitis dental
|
0.40%
1/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.36%
1/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Infections and infestations
Sinusitis
|
0.40%
1/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.00%
0/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Infections and infestations
Tinea cruris
|
0.40%
1/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.00%
0/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Infections and infestations
Tinea pedis
|
0.40%
1/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.00%
0/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Infections and infestations
Conjunctivitis viral
|
0.00%
0/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.36%
1/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Infections and infestations
Lung infection
|
0.00%
0/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.36%
1/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.36%
1/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Infections and infestations
Periodontitis
|
0.00%
0/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.72%
2/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.36%
1/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.36%
1/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Infections and infestations
Urethritis
|
0.00%
0/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.36%
1/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.0%
10/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
2.9%
8/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.4%
6/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
3.2%
9/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
2.0%
5/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.36%
1/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
1.2%
3/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
1.1%
3/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
1.2%
3/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.00%
0/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal obstruction
|
0.79%
2/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.00%
0/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.79%
2/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.36%
1/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.40%
1/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.72%
2/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.40%
1/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.00%
0/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.40%
1/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.36%
1/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
0.40%
1/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.00%
0/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal oedema
|
0.40%
1/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.00%
0/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.40%
1/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
1.4%
4/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.40%
1/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.00%
0/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.00%
0/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.36%
1/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.36%
1/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal pain
|
0.00%
0/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.36%
1/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.36%
1/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum increased
|
0.00%
0/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.36%
1/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.2%
3/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.00%
0/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.2%
3/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.00%
0/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.79%
2/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.00%
0/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Gastrointestinal disorders
Gastritis
|
0.79%
2/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.00%
0/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.79%
2/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.00%
0/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.40%
1/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.00%
0/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Gastrointestinal disorders
Dysbacteriosis
|
0.40%
1/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.00%
0/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Gastrointestinal disorders
Enteritis
|
0.40%
1/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.36%
1/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Gastrointestinal disorders
Gastrointestinal hypomotility
|
0.40%
1/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.00%
0/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Gastrointestinal disorders
Gingival pain
|
0.40%
1/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.00%
0/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Gastrointestinal disorders
Gingival swelling
|
0.40%
1/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.00%
0/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.40%
1/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.00%
0/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Gastrointestinal disorders
Toothache
|
0.40%
1/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.72%
2/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Gastrointestinal disorders
Vomiting
|
0.40%
1/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.00%
0/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.36%
1/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Gastrointestinal disorders
Breath odour
|
0.00%
0/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.36%
1/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.72%
2/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.36%
1/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.36%
1/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.36%
1/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.36%
1/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Gastrointestinal disorders
Tooth impacted
|
0.00%
0/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.36%
1/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
General disorders
Pyrexia
|
2.0%
5/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
1.4%
4/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
General disorders
Chest discomfort
|
1.6%
4/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.36%
1/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
General disorders
Chest pain
|
0.79%
2/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.72%
2/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
General disorders
Discomfort
|
0.00%
0/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.36%
1/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
General disorders
Fatigue
|
0.00%
0/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.36%
1/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.40%
1/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.00%
0/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.40%
1/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.36%
1/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.40%
1/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.36%
1/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.40%
1/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.00%
0/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.40%
1/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.36%
1/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.40%
1/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
1.1%
3/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.36%
1/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
1.4%
4/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.40%
1/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.00%
0/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Injury, poisoning and procedural complications
Injury
|
0.40%
1/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.00%
0/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.40%
1/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.00%
0/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.36%
1/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.36%
1/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Injury, poisoning and procedural complications
Muscle injury
|
0.00%
0/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.36%
1/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Injury, poisoning and procedural complications
Skin injury
|
0.00%
0/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.36%
1/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.36%
1/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Injury, poisoning and procedural complications
Tooth injury
|
0.00%
0/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.36%
1/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Reproductive system and breast disorders
Balanoposthitis
|
0.40%
1/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.00%
0/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.40%
1/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.00%
0/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Reproductive system and breast disorders
Endometrial thickening
|
0.40%
1/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.00%
0/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Reproductive system and breast disorders
Menstrual disorder
|
0.40%
1/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.00%
0/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Reproductive system and breast disorders
Pelvic fluid collection
|
0.40%
1/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.00%
0/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Reproductive system and breast disorders
Breast hyperplasia
|
0.00%
0/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.72%
2/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Cardiac disorders
Palpitations
|
0.40%
1/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.72%
2/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.40%
1/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.00%
0/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.36%
1/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Endocrine disorders
Adrenal mass
|
0.40%
1/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.00%
0/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Endocrine disorders
Thyroid mass
|
0.40%
1/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.00%
0/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.36%
1/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Eye disorders
Ocular hyperaemia
|
0.40%
1/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.00%
0/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Eye disorders
Scleritis
|
0.40%
1/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.00%
0/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.36%
1/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Eye disorders
Vitreous opacities
|
0.00%
0/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.36%
1/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.40%
1/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.36%
1/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.40%
1/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.00%
0/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.36%
1/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Musculoskeletal and connective tissue disorders
Myofascitis
|
0.00%
0/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.36%
1/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.36%
1/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.36%
1/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Musculoskeletal and connective tissue disorders
Soft tissue disorder
|
0.00%
0/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.36%
1/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.72%
2/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Nervous system disorders
Headache
|
0.79%
2/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
1.4%
4/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Nervous system disorders
Dizziness
|
0.40%
1/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.72%
2/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Nervous system disorders
Cerebral arteriosclerosis
|
0.00%
0/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.36%
1/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Nervous system disorders
Poor quality sleep
|
0.00%
0/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.36%
1/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Nervous system disorders
Vascular headache
|
0.00%
0/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.36%
1/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.40%
1/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.00%
0/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Renal and urinary disorders
Urate nephropathy
|
0.40%
1/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.00%
0/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Renal and urinary disorders
Glomerulonephritis chronic
|
0.00%
0/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.36%
1/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.36%
1/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.40%
1/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.72%
2/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Ear and labyrinth disorders
Deafness neurosensory
|
0.40%
1/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.00%
0/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.36%
1/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.36%
1/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.40%
1/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.36%
1/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Immune system disorders
Hypersensitivity
|
0.40%
1/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
1.1%
3/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Metabolism and nutrition disorders
Vitamin B1 deficiency
|
0.40%
1/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.00%
0/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.36%
1/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.36%
1/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Surgical and medical procedures
Tooth extraction
|
0.40%
1/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.36%
1/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.36%
1/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.36%
1/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.36%
1/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
|
Vascular disorders
Hypertension
|
0.00%
0/252 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
0.36%
1/278 • Non-serious adverse events (AEs) and serious AEs were collected from start of study treatment (Day 1) up to Week 24
Non-serious AEs and serious AEs were collected for Safety Population which consisted of all participants who were enrolled into the study and who had at least one DRC assessment.
|
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