Trial Outcomes & Findings for A Multicenter Randomized 52 Week Treatment Double-blind, Triple Dummy Parallel Group Study to Assess the Efficacy and Safety of QMF149 Compared to Mometasone Furoate in Participants With Asthma (NCT NCT02554786)
NCT ID: NCT02554786
Last Updated: 2020-03-05
Results Overview
Trough FEV1 was assessed by performing spirometric assessment. It is defined as average of the two FEV1 measurements taken 23 hr 15 min and 23 hr 45 min post-evening dose. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
2216 participants
Primary outcome timeframe
26 weeks
Results posted on
2020-03-05
Participant Flow
Participants took part in 316 investigative sites in 24 countries from 29 Dec 2015 to 28 Jun 2019.
3890 participants were screened of which 2216 were randomized to 1 of the 5 treatment groups with a randomization ratio of 1:1:1:1:1.
Participant milestones
| Measure |
QMF149 150/320 μg
QMF149 (Indacaterol acetate/Mometasone furoate) 150/320 μg was delivered once daily (o.d.) via Concept1 inhaler in the evening.
|
QMF149 150/160 μg
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 μg was delivered o.d. via Concept1 inhaler in the evening.
|
MF 800 μg
Mometasone furoate (MF) 800 μg of total daily dose (400 μg twice daily, in the morning and in the evening) was delivered via Twisthaler®.
|
MF 400 μg
MF 400 μg was delivered o.d. via Twisthaler® in the evening.
|
Salmeterol/Fluticasone 50/500 μg
Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
445
|
439
|
442
|
444
|
446
|
|
Overall Study
COMPLETED
|
410
|
413
|
412
|
403
|
416
|
|
Overall Study
NOT COMPLETED
|
35
|
26
|
30
|
41
|
30
|
Reasons for withdrawal
| Measure |
QMF149 150/320 μg
QMF149 (Indacaterol acetate/Mometasone furoate) 150/320 μg was delivered once daily (o.d.) via Concept1 inhaler in the evening.
|
QMF149 150/160 μg
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 μg was delivered o.d. via Concept1 inhaler in the evening.
|
MF 800 μg
Mometasone furoate (MF) 800 μg of total daily dose (400 μg twice daily, in the morning and in the evening) was delivered via Twisthaler®.
|
MF 400 μg
MF 400 μg was delivered o.d. via Twisthaler® in the evening.
|
Salmeterol/Fluticasone 50/500 μg
Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®.
|
|---|---|---|---|---|---|
|
Overall Study
Subject/guardian decision
|
29
|
17
|
18
|
30
|
20
|
|
Overall Study
Lost to Follow-up
|
4
|
3
|
4
|
2
|
2
|
|
Overall Study
Protocol deviation
|
1
|
3
|
3
|
4
|
2
|
|
Overall Study
Technical problems
|
1
|
1
|
0
|
2
|
1
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
2
|
|
Overall Study
Death
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Non-compliance with study treatment
|
0
|
1
|
1
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
1
|
4
|
1
|
1
|
|
Overall Study
Pregnancy
|
0
|
0
|
0
|
1
|
1
|
Baseline Characteristics
A Multicenter Randomized 52 Week Treatment Double-blind, Triple Dummy Parallel Group Study to Assess the Efficacy and Safety of QMF149 Compared to Mometasone Furoate in Participants With Asthma
Baseline characteristics by cohort
| Measure |
QMF149 150/320 μg
n=445 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/320 μg was delivered o.d. via Concept1 inhaler in the evening.
|
QMF149 150/160 μg
n=439 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 μg was delivered o.d. via Concept1 inhaler in the evening.
|
MF 800 μg
n=442 Participants
MF 800 μg of total daily dose (400 μg twice daily, in the morning and in the evening) was delivered via Twisthaler®.
|
MF 400 μg
n=444 Participants
MF 400 μg was delivered o.d. via Twisthaler® in the evening.
|
Salmeterol/Fluticasone 50/500 μg
n=446 Participants
Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®.
|
Total
n=2216 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
47.1 years
STANDARD_DEVIATION 14.56 • n=5 Participants
|
47.4 years
STANDARD_DEVIATION 14.76 • n=7 Participants
|
47.5 years
STANDARD_DEVIATION 14.99 • n=5 Participants
|
48.7 years
STANDARD_DEVIATION 14.98 • n=4 Participants
|
48.9 years
STANDARD_DEVIATION 14.59 • n=21 Participants
|
47.9 years
STANDARD_DEVIATION 14.78 • n=8 Participants
|
|
Sex: Female, Male
Female
|
262 Participants
n=5 Participants
|
253 Participants
n=7 Participants
|
250 Participants
n=5 Participants
|
272 Participants
n=4 Participants
|
256 Participants
n=21 Participants
|
1293 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
183 Participants
n=5 Participants
|
186 Participants
n=7 Participants
|
192 Participants
n=5 Participants
|
172 Participants
n=4 Participants
|
190 Participants
n=21 Participants
|
923 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Race · Caucasian
|
313 Participants
n=5 Participants
|
311 Participants
n=7 Participants
|
318 Participants
n=5 Participants
|
312 Participants
n=4 Participants
|
305 Participants
n=21 Participants
|
1559 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
23 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
97 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
98 Participants
n=4 Participants
|
102 Participants
n=21 Participants
|
493 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Race · Native American
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
68 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Race · Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
72 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic Or Latino
|
21 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
89 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · East Asian
|
52 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
53 Participants
n=21 Participants
|
259 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Southeast Asian
|
38 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
200 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · South Asian
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
14 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Russian
|
79 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
62 Participants
n=4 Participants
|
65 Participants
n=21 Participants
|
349 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Mixed ethnicity
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
49 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not reported
|
12 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
42 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Unknown
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
63 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Other
|
218 Participants
n=5 Participants
|
225 Participants
n=7 Participants
|
242 Participants
n=5 Participants
|
239 Participants
n=4 Participants
|
227 Participants
n=21 Participants
|
1151 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 26 weeksPopulation: Full Analysis Set (FAS) consisted of all participants in the RAN set who received at least one dose of study medication.
Trough FEV1 was assessed by performing spirometric assessment. It is defined as average of the two FEV1 measurements taken 23 hr 15 min and 23 hr 45 min post-evening dose. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing.
Outcome measures
| Measure |
QMF149 150/320 μg
n=395 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/320 μg was delivered o.d. via Concept1 inhaler in the evening.
|
QMF149 150/160 μg
n=389 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 μg was delivered o.d. via Concept1 inhaler in the evening.
|
MF 800 μg
n=372 Participants
MF 800 μg of total daily dose (400 μg twice daily, in the morning and in the evening) was delivered via Twisthaler®.
|
MF 400 μg
n=376 Participants
MF 400 μg was delivered o.d. via Twisthaler® in the evening.
|
Salmeterol/Fluticasone 50/500 μg
n=391 Participants
Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®.
|
|---|---|---|---|---|---|
|
Trough Forced Expiratory Volume in One Second (Trough FEV1) at Week 26
|
2.383 litre (L)
Standard Error 0.0159
|
2.387 litre (L)
Standard Error 0.0160
|
2.250 litre (L)
Standard Error 0.0162
|
2.176 litre (L)
Standard Error 0.0162
|
2.346 litre (L)
Standard Error 0.0160
|
SECONDARY outcome
Timeframe: Weeks 4, 12, 26 and 52Population: FAS consisted of all participants in the RAN set who received at least one dose of study medication. n represents the number of participants with data at respective visit
The ACQ-7 measured asthma symptom control and consists of 7 items: 5 on symptom assessment, 1 on rescue bronchodilator use and 1 on airway calibre (FEV1 % predicted). All 7 questions of the ACQ-7 were equally weighted. Items 1-5 were scored along a 7-point response scale, where 0 = totally controlled and 6 = severely uncontrolled. Item 6 is scored between 0 = no rescue medication and 6 = More than 16 puffs/inhalations most days. The 7th item was scored by the investigator based on the FEV1 % predicted from the masterscope at the site (i.e., Score = 0 means \> 95% of predicted FEV1, 1 = 90 - 95%, 2 = 80 - 89%, 3 = 70 - 79%, 4 = 60 - 69%, 5 = 50 - 59%, and Score = 6 means \< 50% of predicted FEV1). The total score was calculated as the mean of all questions.
Outcome measures
| Measure |
QMF149 150/320 μg
n=429 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/320 μg was delivered o.d. via Concept1 inhaler in the evening.
|
QMF149 150/160 μg
n=427 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 μg was delivered o.d. via Concept1 inhaler in the evening.
|
MF 800 μg
n=431 Participants
MF 800 μg of total daily dose (400 μg twice daily, in the morning and in the evening) was delivered via Twisthaler®.
|
MF 400 μg
n=428 Participants
MF 400 μg was delivered o.d. via Twisthaler® in the evening.
|
Salmeterol/Fluticasone 50/500 μg
n=439 Participants
Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®.
|
|---|---|---|---|---|---|
|
Asthma Control Questionnaire (ACQ-7) at Weeks 4, 12, 26 and 52
Week 26
|
1.267 score on a scale
Standard Error 0.0350
|
1.261 score on a scale
Standard Error 0.0350
|
1.439 score on a scale
Standard Error 0.0352
|
1.509 score on a scale
Standard Error 0.0354
|
1.322 score on a scale
Standard Error 0.0349
|
|
Asthma Control Questionnaire (ACQ-7) at Weeks 4, 12, 26 and 52
Week 4
|
1.486 score on a scale
Standard Error 0.0337
|
1.533 score on a scale
Standard Error 0.0338
|
1.659 score on a scale
Standard Error 0.0338
|
1.730 score on a scale
Standard Error 0.0337
|
1.541 score on a scale
Standard Error 0.0335
|
|
Asthma Control Questionnaire (ACQ-7) at Weeks 4, 12, 26 and 52
Week 12
|
1.394 score on a scale
Standard Error 0.0347
|
1.377 score on a scale
Standard Error 0.0348
|
1.523 score on a scale
Standard Error 0.0348
|
1.625 score on a scale
Standard Error 0.0350
|
1.445 score on a scale
Standard Error 0.0345
|
|
Asthma Control Questionnaire (ACQ-7) at Weeks 4, 12, 26 and 52
Week 52
|
1.231 score on a scale
Standard Error 0.0358
|
1.183 score on a scale
Standard Error 0.0356
|
1.373 score on a scale
Standard Error 0.0359
|
1.449 score on a scale
Standard Error 0.0361
|
1.221 score on a scale
Standard Error 0.0354
|
SECONDARY outcome
Timeframe: Week 52Population: FAS consisted of all participants in the RAN set who received at least one dose of study medication.
Trough FEV1 was assessed by performing spirometric assessment. It is defined as average of the two FEV1 measurements taken 23 hr 15 min and 23 hr 45 min post-evening dose. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing.
Outcome measures
| Measure |
QMF149 150/320 μg
n=372 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/320 μg was delivered o.d. via Concept1 inhaler in the evening.
|
QMF149 150/160 μg
n=383 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 μg was delivered o.d. via Concept1 inhaler in the evening.
|
MF 800 μg
n=364 Participants
MF 800 μg of total daily dose (400 μg twice daily, in the morning and in the evening) was delivered via Twisthaler®.
|
MF 400 μg
n=369 Participants
MF 400 μg was delivered o.d. via Twisthaler® in the evening.
|
Salmeterol/Fluticasone 50/500 μg
n=382 Participants
Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®.
|
|---|---|---|---|---|---|
|
Trough FEV1 at Week 52
|
2.386 L
Standard Error 0.0168
|
2.357 L
Standard Error 0.0167
|
2.249 L
Standard Error 0.0170
|
2.148 L
Standard Error 0.0170
|
2.338 L
Standard Error 0.0167
|
SECONDARY outcome
Timeframe: Weeks 4 (Day 30) and 12 (Day 86)Population: FAS consisted of all participants in the RAN set who received at least one dose of study medication. n represents the number of participants with data at respective visit.
Pre-dose trough FEV1 is defined as average of the two FEV1 measurements taken 45 min and 15 min pre evening dose. It was assessed by performing spirometric assessment. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing.
Outcome measures
| Measure |
QMF149 150/320 μg
n=430 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/320 μg was delivered o.d. via Concept1 inhaler in the evening.
|
QMF149 150/160 μg
n=427 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 μg was delivered o.d. via Concept1 inhaler in the evening.
|
MF 800 μg
n=430 Participants
MF 800 μg of total daily dose (400 μg twice daily, in the morning and in the evening) was delivered via Twisthaler®.
|
MF 400 μg
n=427 Participants
MF 400 μg was delivered o.d. via Twisthaler® in the evening.
|
Salmeterol/Fluticasone 50/500 μg
n=439 Participants
Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®.
|
|---|---|---|---|---|---|
|
Pre-dose FEV1 at Weeks 4 and 12
Day 30
|
2.369 L
Standard Deviation 0.0141
|
2.367 L
Standard Deviation 0.0142
|
2.237 L
Standard Deviation 0.0143
|
2.171 L
Standard Deviation 0.0143
|
0.2333 L
Standard Deviation 0.0141
|
|
Pre-dose FEV1 at Weeks 4 and 12
Day 86
|
2.368 L
Standard Deviation 0.0148
|
2.361 L
Standard Deviation 0.0148
|
2.245 L
Standard Deviation 0.0148
|
2.177 L
Standard Deviation 0.0149
|
2.330 L
Standard Deviation 0.0146
|
SECONDARY outcome
Timeframe: Up to Week 52 (Day 364)Population: FAS consisted of all participants in the RAN set who received at least one dose of study medication. n represents the number of participants with data at respective time point.
Post-dose FEV1 measurements were analyzed at 5 minutes, 15 minutes, 30 minutes and 1 hour. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing.
Outcome measures
| Measure |
QMF149 150/320 μg
n=441 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/320 μg was delivered o.d. via Concept1 inhaler in the evening.
|
QMF149 150/160 μg
n=434 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 μg was delivered o.d. via Concept1 inhaler in the evening.
|
MF 800 μg
n=438 Participants
MF 800 μg of total daily dose (400 μg twice daily, in the morning and in the evening) was delivered via Twisthaler®.
|
MF 400 μg
n=438 Participants
MF 400 μg was delivered o.d. via Twisthaler® in the evening.
|
Salmeterol/Fluticasone 50/500 μg
n=442 Participants
Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®.
|
|---|---|---|---|---|---|
|
Post Dose FEV1 (5 Minutes-1 Hour)
Day 1: 5 minutes
|
2.279 L
Standard Error 0.0084
|
2.270 L
Standard Error 0.0085
|
2.138 L
Standard Error 0.0085
|
2.118 L
Standard Error 0.0084
|
2.224 L
Standard Error 0.0084
|
|
Post Dose FEV1 (5 Minutes-1 Hour)
Day 1: 15 minutes
|
2.321 L
Standard Error 0.0088
|
2.312 L
Standard Error 0.0089
|
2.159 L
Standard Error 0.0089
|
2.137 L
Standard Error 0.0089
|
2.278 L
Standard Error 0.0088
|
|
Post Dose FEV1 (5 Minutes-1 Hour)
Day 1: 30 minutes
|
2.338 L
Standard Error 0.0095
|
2.326 L
Standard Error 0.0096
|
2.162 L
Standard Error 0.0096
|
2.141 L
Standard Error 0.0095
|
2.310 L
Standard Error 0.0095
|
|
Post Dose FEV1 (5 Minutes-1 Hour)
Day 1: 1 hour
|
2.343 L
Standard Error 0.0100
|
2.347 L
Standard Error 0.0101
|
2.166 L
Standard Error 0.0101
|
2.142 L
Standard Error 0.0100
|
2.337 L
Standard Error 0.0100
|
|
Post Dose FEV1 (5 Minutes-1 Hour)
Day 30: 5 minutes
|
2.413 L
Standard Error 0.0142
|
2.406 L
Standard Error 0.0144
|
2.224 L
Standard Error 0.0145
|
2.174 L
Standard Error 0.0145
|
2.360 L
Standard Error 0.0142
|
|
Post Dose FEV1 (5 Minutes-1 Hour)
Day 30: 30 minutes
|
2.432 L
Standard Error 0.0143
|
2.426 L
Standard Error 0.0145
|
2.238 L
Standard Error 0.0146
|
2.174 L
Standard Error 0.0146
|
2.389 L
Standard Error 0.0143
|
|
Post Dose FEV1 (5 Minutes-1 Hour)
Day 30: 1 hour
|
2.448 L
Standard Error 0.0145
|
2.440 L
Standard Error 0.0146
|
2.257 L
Standard Error 0.0147
|
2.183 L
Standard Error 0.0148
|
2.411 L
Standard Error 0.0144
|
|
Post Dose FEV1 (5 Minutes-1 Hour)
Day 86:5 minutes
|
2.411 L
Standard Error 0.0150
|
2.409 L
Standard Error 0.0150
|
2.248 L
Standard Error 0.0150
|
2.178 L
Standard Error 0.0153
|
2.356 L
Standard Error 0.0148
|
|
Post Dose FEV1 (5 Minutes-1 Hour)
Day 86: 30 minutes
|
2.436 L
Standard Error 0.0149
|
2.431 L
Standard Error 0.0149
|
2.257 L
Standard Error 0.0149
|
2.179 L
Standard Error 0.0152
|
2.398 L
Standard Error 0.0147
|
|
Post Dose FEV1 (5 Minutes-1 Hour)
Day 86:1 hour
|
2.456 L
Standard Error 0.0151
|
2.436 L
Standard Error 0.0151
|
2.269 L
Standard Error 0.0151
|
2.188 L
Standard Error 0.0154
|
2.413 L
Standard Error 0.0149
|
|
Post Dose FEV1 (5 Minutes-1 Hour)
Day 183: 5 minutes
|
2.403 L
Standard Error 0.0160
|
2.406 L
Standard Error 0.0161
|
2.240 L
Standard Error 0.0162
|
2.163 L
Standard Error 0.0164
|
2.359 L
Standard Error 0.0160
|
|
Post Dose FEV1 (5 Minutes-1 Hour)
Day 183: 30 minutes
|
2.426 L
Standard Error 0.0163
|
2.427 L
Standard Error 0.0164
|
2.250 L
Standard Error 0.0165
|
2.168 L
Standard Error 0.0167
|
2.386 L
Standard Error 0.0163
|
|
Post Dose FEV1 (5 Minutes-1 Hour)
Day 183: 1 hour
|
2.432 L
Standard Error 0.0161
|
2.423 L
Standard Error 0.0162
|
2.253 L
Standard Error 0.0163
|
2.165 L
Standard Error 0.0165
|
2.393 L
Standard Error 0.0161
|
|
Post Dose FEV1 (5 Minutes-1 Hour)
Day 364: 5 minutes
|
2.384 L
Standard Error 0.0172
|
2.379 L
Standard Error 0.0169
|
2.245 L
Standard Error 0.0172
|
2.130 L
Standard Error 0.0173
|
2.358 L
Standard Error 0.0168
|
|
Post Dose FEV1 (5 Minutes-1 Hour)
Day 364: 30 minutes
|
2.408 L
Standard Error 0.0171
|
2.399 L
Standard Error 0.0169
|
2.253 L
Standard Error 0.0172
|
2.135 L
Standard Error 0.0172
|
2.377 L
Standard Error 0.0167
|
|
Post Dose FEV1 (5 Minutes-1 Hour)
Day 364:1 hour
|
2.414 L
Standard Error 0.0175
|
2.390 L
Standard Error 0.0172
|
2.251 L
Standard Error 0.0175
|
2.128 L
Standard Error 0.0176
|
2.383 L
Standard Error 0.0171
|
SECONDARY outcome
Timeframe: Up to Week 52 (Day 365)Population: FAS consisted of all participants in the RAN set who received at least one dose of study medication. n represents the number of participants with data at respective visit.
FVC is the total amount of air exhaled during the FEV test. Trough FVC is defined as average of the two FVC measurements taken 23 hr 15 min and 23 hr 45 min post-evening dose. It was assessed by performing spirometric assessment.
Outcome measures
| Measure |
QMF149 150/320 μg
n=439 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/320 μg was delivered o.d. via Concept1 inhaler in the evening.
|
QMF149 150/160 μg
n=433 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 μg was delivered o.d. via Concept1 inhaler in the evening.
|
MF 800 μg
n=436 Participants
MF 800 μg of total daily dose (400 μg twice daily, in the morning and in the evening) was delivered via Twisthaler®.
|
MF 400 μg
n=441 Participants
MF 400 μg was delivered o.d. via Twisthaler® in the evening.
|
Salmeterol/Fluticasone 50/500 μg
n=441 Participants
Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®.
|
|---|---|---|---|---|---|
|
Trough Forced Vital Capacity (FVC)
Day 2
|
3.342 L
Standard Error 0.0173
|
3.342 L
Standard Error 0.0174
|
3.256 L
Standard Error 0.0177
|
3.203 L
Standard Error 0.0173
|
3.344 L
Standard Error 0.0176
|
|
Trough Forced Vital Capacity (FVC)
Day 184
|
3.372 L
Standard Error 0.0179
|
3.387 L
Standard Error 0.0180
|
3.322 L
Standard Error 0.0183
|
3.246 L
Standard Error 0.0182
|
3.355 L
Standard Error 0.0180
|
|
Trough Forced Vital Capacity (FVC)
Day 365
|
3.394 L
Standard Error 0.0182
|
3.364 L
Standard Error 0.0181
|
3.319 L
Standard Error 0.0184
|
3.218 L
Standard Error 0.0183
|
3.358 L
Standard Error 0.0182
|
SECONDARY outcome
Timeframe: Up to Week 52 (Day 365)Population: FAS consisted of all participants in the RAN set who received at least one dose of study medication. n represents the number of participants with data at respective visit.
FEF is the flow (or speed) of air coming out of the lung during the middle portion of a forced expiration. Trough FEF25-75% is defined as average of the two FEF25-75% measurements taken 23 hr 15 min and 23 hr 45 min post-evening dose. It was assessed by performing spirometric assessment.
Outcome measures
| Measure |
QMF149 150/320 μg
n=439 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/320 μg was delivered o.d. via Concept1 inhaler in the evening.
|
QMF149 150/160 μg
n=433 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 μg was delivered o.d. via Concept1 inhaler in the evening.
|
MF 800 μg
n=436 Participants
MF 800 μg of total daily dose (400 μg twice daily, in the morning and in the evening) was delivered via Twisthaler®.
|
MF 400 μg
n=441 Participants
MF 400 μg was delivered o.d. via Twisthaler® in the evening.
|
Salmeterol/Fluticasone 50/500 μg
n=441 Participants
Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®.
|
|---|---|---|---|---|---|
|
Trough Forced Expiratory Flow (FEF)Between 25% and 75% of FVC (FEF25-75)
Day 2
|
1.644 Litres/second (L/s)
Standard Error 0.0186
|
1.617 Litres/second (L/s)
Standard Error 0.0187
|
1.455 Litres/second (L/s)
Standard Error 0.0191
|
1.406 Litres/second (L/s)
Standard Error 0.0186
|
1.662 Litres/second (L/s)
Standard Error 0.0189
|
|
Trough Forced Expiratory Flow (FEF)Between 25% and 75% of FVC (FEF25-75)
Day 184
|
1.775 Litres/second (L/s)
Standard Error 0.0249
|
1.738 Litres/second (L/s)
Standard Error 0.0250
|
1.546 Litres/second (L/s)
Standard Error 0.0253
|
1.473 Litres/second (L/s)
Standard Error 0.0254
|
1.692 Litres/second (L/s)
Standard Error 0.0250
|
|
Trough Forced Expiratory Flow (FEF)Between 25% and 75% of FVC (FEF25-75)
Day 365
|
1.745 Litres/second (L/s)
Standard Error 0.0259
|
1.686 Litres/second (L/s)
Standard Error 0.0257
|
1.530 Litres/second (L/s)
Standard Error 0.0261
|
1.440 Litres/second (L/s)
Standard Error 0.0261
|
1.692 Litres/second (L/s)
Standard Error 0.0258
|
SECONDARY outcome
Timeframe: Up to Weeks 26 and 52Population: Full Analysis Set (FAS) consisted of all patients in the RAN set who received at least one dose of study medication. n represents tthe number of participants with data at respective visit.
PEF is a person's maximum speed of expiration. All the participants were instructed to record PEF twice daily using a mini Peak Flow Meter device, once in the morning (before taking the morning dose) and once approximately 12 h later in the evening (before taking the evening dose). At each timepoint, the participant was instructed to perform 3 consecutive manoeuvres within 10 minutes. These PEF values were captured in the e-PEF/diary. The best of 3 values were used.
Outcome measures
| Measure |
QMF149 150/320 μg
n=443 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/320 μg was delivered o.d. via Concept1 inhaler in the evening.
|
QMF149 150/160 μg
n=437 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 μg was delivered o.d. via Concept1 inhaler in the evening.
|
MF 800 μg
n=440 Participants
MF 800 μg of total daily dose (400 μg twice daily, in the morning and in the evening) was delivered via Twisthaler®.
|
MF 400 μg
n=443 Participants
MF 400 μg was delivered o.d. via Twisthaler® in the evening.
|
Salmeterol/Fluticasone 50/500 μg
n=444 Participants
Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®.
|
|---|---|---|---|---|---|
|
Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEF) Over 26 and 52 Weeks of Treatment
Week 26: Mean morning PEF
|
42.4 L/min
Standard Error 2.15
|
38.1 L/min
Standard Error 2.15
|
12.8 L/min
Standard Error 2.13
|
5.9 L/min
Standard Error 2.14
|
29.1 L/min
Standard Error 2.14
|
|
Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEF) Over 26 and 52 Weeks of Treatment
Week 26:Mean evening PEF
|
32.5 L/min
Standard Error 2.05
|
30.4 L/min
Standard Error 2.04
|
7.7 L/min
Standard Error 2.04
|
0.0 L/min
Standard Error 2.05
|
23.9 L/min
Standard Error 2.04
|
|
Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEF) Over 26 and 52 Weeks of Treatment
Week 52:Mean morning PEF
|
42.1 L/min
Standard Error 2.24
|
36.9 L/min
Standard Error 2.22
|
13.4 L/min
Standard Error 2.21
|
6.7 L/min
Standard Error 2.22
|
28.3 L/min
Standard Error 2.22
|
|
Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEF) Over 26 and 52 Weeks of Treatment
Week 52:Mean evening PEF
|
31.2 L/min
Standard Error 2.14
|
28.7 L/min
Standard Error 2.13
|
7.4 L/min
Standard Error 2.13
|
-0.3 L/min
Standard Error 2.14
|
22.1 L/min
Standard Error 2.13
|
SECONDARY outcome
Timeframe: Weeks 26 (Day 183) and 52 (Day 364)Population: FAS consisted of all participants in the RAN set who received at least one dose of study medication. n represents number of participants with data at the respective visit.
Change from baseline in ACQ-7 scores of ≤ 0.5 was defined as minimal clinically important difference and were considered clinically meaningful. The ACQ-7 measured asthma symptom control and consists of 7 items: 5 on symptom assessment, 1 on rescue bronchodilator use and 1 on airway calibre (FEV1 % predicted). All 7 questions of the ACQ-7 were equally weighted. Items 1-5 were scored along a 7-point response scale, where 0 = totally controlled and 6 = severely uncontrolled. Item 6 is scored between 0 = no rescue medication and 6 = More than 16 puffs/inhalations most days. The 7th item was scored by the investigator based on the FEV1 % predicted from the masterscope at the site (i.e., Score = 0 means \> 95% of predicted FEV1, 1 = 90 - 95%, 2 = 80 - 89%, 3 = 70 - 79%, 4 = 60 - 69%, 5 = 50 - 59%, and Score = 6 means \< 50% of predicted FEV1). The total score was calculated as the mean of all questions
Outcome measures
| Measure |
QMF149 150/320 μg
n=442 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/320 μg was delivered o.d. via Concept1 inhaler in the evening.
|
QMF149 150/160 μg
n=437 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 μg was delivered o.d. via Concept1 inhaler in the evening.
|
MF 800 μg
n=440 Participants
MF 800 μg of total daily dose (400 μg twice daily, in the morning and in the evening) was delivered via Twisthaler®.
|
MF 400 μg
n=443 Participants
MF 400 μg was delivered o.d. via Twisthaler® in the evening.
|
Salmeterol/Fluticasone 50/500 μg
n=444 Participants
Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving the Minimal Important Difference (MID) ACQ ≥ 0.5 at Weeks 26 and 52
Day 183
|
76.4 percentage of participants
|
76.2 percentage of participants
|
72.3 percentage of participants
|
66.9 percentage of participants
|
75.9 percentage of participants
|
|
Percentage of Participants Achieving the Minimal Important Difference (MID) ACQ ≥ 0.5 at Weeks 26 and 52
Day 364
|
77.7 percentage of participants
|
82.1 percentage of participants
|
73.6 percentage of participants
|
69.2 percentage of participants
|
77.3 percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 52Population: FAS consisted of all participants in the RAN set who received at least one dose of study medication.
All participants were provided with an electronic diary (e-Diary) to record clinical symptoms. They were instructed to routinely complete the e-Diary twice daily at the same time each morning and again approximately 12 hours later in the evening. The e-Diary was reviewed at each visit until study completion. Asthma symptoms free days are days with no daytime symptoms, no night-time awakenings and no symptoms on awakening. The daytime asthma symptom score was based on the daily e-diary recordings by participants with respect to shortness of breath, wheeze, cough, chest tightness, and impact on usual daily activities due to symptoms.
Outcome measures
| Measure |
QMF149 150/320 μg
n=401 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/320 μg was delivered o.d. via Concept1 inhaler in the evening.
|
QMF149 150/160 μg
n=402 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 μg was delivered o.d. via Concept1 inhaler in the evening.
|
MF 800 μg
n=408 Participants
MF 800 μg of total daily dose (400 μg twice daily, in the morning and in the evening) was delivered via Twisthaler®.
|
MF 400 μg
n=404 Participants
MF 400 μg was delivered o.d. via Twisthaler® in the evening.
|
Salmeterol/Fluticasone 50/500 μg
n=405 Participants
Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®.
|
|---|---|---|---|---|---|
|
Change From Baseline in Percentage of Asthma Symptoms Free Days
|
28.3 percentage of days
Standard Error 1.72
|
28.4 percentage of days
Standard Error 1.72
|
22.5 percentage of days
Standard Error 1.72
|
19.3 percentage of days
Standard Error 1.72
|
24.9 percentage of days
Standard Error 1.72
|
SECONDARY outcome
Timeframe: Up to Week 52Population: FAS consisted of all participants in the RAN set who received at least one dose of study medication.
All participants were provided with an electronic diary (e-Diary) to record clinical symptoms. They were instructed to routinely complete the e-Diary twice daily at the same time each morning and again approximately 12 hours later in the evening. The e-Diary was reviewed at each visit until study completion. For days with no daytime symptoms, all 5 evening questions must have a score = 0 with respect to shortness of breath, wheeze, cough, chest tightness and impact on usual daily activities due to symptoms, each with scores from 0 (no problems) to 4 (very severe problems).
Outcome measures
| Measure |
QMF149 150/320 μg
n=416 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/320 μg was delivered o.d. via Concept1 inhaler in the evening.
|
QMF149 150/160 μg
n=420 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 μg was delivered o.d. via Concept1 inhaler in the evening.
|
MF 800 μg
n=425 Participants
MF 800 μg of total daily dose (400 μg twice daily, in the morning and in the evening) was delivered via Twisthaler®.
|
MF 400 μg
n=419 Participants
MF 400 μg was delivered o.d. via Twisthaler® in the evening.
|
Salmeterol/Fluticasone 50/500 μg
n=423 Participants
Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®.
|
|---|---|---|---|---|---|
|
Change Form Baseline in Percentage of Days With no Daytime Symptoms
|
28.0 percentage of days
Standard Error 1.69
|
28.0 percentage of days
Standard Error 1.69
|
23.0 percentage of days
Standard Error 1.68
|
20.0 percentage of days
Standard Error 1.69
|
24.8 percentage of days
Standard Error 1.68
|
SECONDARY outcome
Timeframe: Up to Week 52Population: FAS consisted of all participants in the RAN set who received at least one dose of study medication.
All participants were provided with an electronic diary (e-Diary) to record clinical symptoms. They were instructed to routinely complete the e-Diary twice daily at the same time each morning and again approximately 12 hours later in the evening. The e-Diary was reviewed at each visit until study completion. The question asked for nights with no night-time awakenings was "How did you sleep last night?" had to be answered with "I did not wake up because of any breathing problems" with scores from 0 (no problem)-4 (very severe problems).
Outcome measures
| Measure |
QMF149 150/320 μg
n=415 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/320 μg was delivered o.d. via Concept1 inhaler in the evening.
|
QMF149 150/160 μg
n=420 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 μg was delivered o.d. via Concept1 inhaler in the evening.
|
MF 800 μg
n=428 Participants
MF 800 μg of total daily dose (400 μg twice daily, in the morning and in the evening) was delivered via Twisthaler®.
|
MF 400 μg
n=422 Participants
MF 400 μg was delivered o.d. via Twisthaler® in the evening.
|
Salmeterol/Fluticasone 50/500 μg
n=424 Participants
Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®.
|
|---|---|---|---|---|---|
|
Change From Baseline in Percentage of Nights With no Night-time Awakenings
|
17.0 percentage of nights
Standard Error 1.28
|
16.4 percentage of nights
Standard Error 1.27
|
14.2 percentage of nights
Standard Error 1.27
|
12.5 percentage of nights
Standard Error 1.27
|
16.1 percentage of nights
Standard Error 1.27
|
SECONDARY outcome
Timeframe: Up to Week 52Population: FAS consisted of all participants in the RAN set who received at least one dose of study medication.
All participants were provided with an electronic diary (e-Diary) to record clinical symptoms. They were instructed to routinely complete the e-Diary twice daily at the same time each morning and again approximately 12 hours later in the evening. The e-Diary was reviewed at each visit until study completion. The question asked for mornings with no symptoms on awakening was "Did you have asthma symptoms upon awakening in the morning?" to be answered with "None" with scores from 0 (no problem)-4 (very severe problems).
Outcome measures
| Measure |
QMF149 150/320 μg
n=415 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/320 μg was delivered o.d. via Concept1 inhaler in the evening.
|
QMF149 150/160 μg
n=420 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 μg was delivered o.d. via Concept1 inhaler in the evening.
|
MF 800 μg
n=428 Participants
MF 800 μg of total daily dose (400 μg twice daily, in the morning and in the evening) was delivered via Twisthaler®.
|
MF 400 μg
n=422 Participants
MF 400 μg was delivered o.d. via Twisthaler® in the evening.
|
Salmeterol/Fluticasone 50/500 μg
n=424 Participants
Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®.
|
|---|---|---|---|---|---|
|
Change Form Baseline in Percentage of Mornings With no Symptoms on Awakening
|
25.5 percentage of mornings
Standard Error 1.66
|
22.9 percentage of mornings
Standard Error 1.65
|
19.1 percentage of mornings
Standard Error 1.65
|
14.1 percentage of mornings
Standard Error 1.65
|
20.7 percentage of mornings
Standard Error 1.65
|
SECONDARY outcome
Timeframe: Up to Weeks 26 and 52Population: FAS consisted of all participants in the RAN set who received at least one dose of study medication. n represents number of participants included in the analysis.
All participants were given salbutamol/albuterol to use as rescue medication throughout the study along with e-Diary to record rescue medication use. The number of puffs of rescue medication during the past 12 hours is recorded twice (morning/evening) by the participant prior to taking study medication. The mean daily number of puffs of rescue medication use will be calculated for each participant, done separately for morning (night-time), evening (daytime), and daily (night-time plus daytime) rescue medication use
Outcome measures
| Measure |
QMF149 150/320 μg
n=443 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/320 μg was delivered o.d. via Concept1 inhaler in the evening.
|
QMF149 150/160 μg
n=437 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 μg was delivered o.d. via Concept1 inhaler in the evening.
|
MF 800 μg
n=440 Participants
MF 800 μg of total daily dose (400 μg twice daily, in the morning and in the evening) was delivered via Twisthaler®.
|
MF 400 μg
n=443 Participants
MF 400 μg was delivered o.d. via Twisthaler® in the evening.
|
Salmeterol/Fluticasone 50/500 μg
n=444 Participants
Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®.
|
|---|---|---|---|---|---|
|
Rescue Medication Usage
Week 1-52 Mean daytime number of puffs
|
-0.60 number of puffs
Standard Error 0.035
|
-0.51 number of puffs
Standard Error 0.035
|
-0.43 number of puffs
Standard Error 0.035
|
-0.36 number of puffs
Standard Error 0.035
|
-0.55 number of puffs
Standard Error 0.035
|
|
Rescue Medication Usage
Week 1-52 Mean daily number of puffs
|
-1.00 number of puffs
Standard Error 0.060
|
-0.80 number of puffs
Standard Error 0.060
|
-0.72 number of puffs
Standard Error 0.060
|
-0.56 number of puffs
Standard Error 0.060
|
-0.91 number of puffs
Standard Error 0.060
|
|
Rescue Medication Usage
Week1-26 Mean night-time number of puffs
|
-0.38 number of puffs
Standard Error 0.028
|
-0.27 number of puffs
Standard Error 0.028
|
-0.26 number of puffs
Standard Error 0.028
|
-0.19 number of puffs
Standard Error 0.028
|
-0.34 number of puffs
Standard Error 0.028
|
|
Rescue Medication Usage
Week1-26 Mean daytime number of puffs
|
-0.57 number of puffs
Standard Error 0.035
|
-0.46 number of puffs
Standard Error 0.035
|
-0.38 number of puffs
Standard Error 0.035
|
-0.34 number of puffs
Standard Error 0.035
|
-0.53 number of puffs
Standard Error 0.035
|
|
Rescue Medication Usage
Week1-26 Mean daily number of puffs
|
-0.96 number of puffs
Standard Error 0.059
|
-0.73 number of puffs
Standard Error 0.059
|
-0.65 number of puffs
Standard Error 0.059
|
-0.53 number of puffs
Standard Error 0.059
|
-0.87 number of puffs
Standard Error 0.059
|
|
Rescue Medication Usage
Week1-52 Mean night-time number of puffs
|
-0.40 number of puffs
Standard Error 0.029
|
-0.30 number of puffs
Standard Error 0.029
|
-0.29 number of puffs
Standard Error 0.028
|
-0.20 number of puffs
Standard Error 0.029
|
-0.35 number of puffs
Standard Error 0.029
|
SECONDARY outcome
Timeframe: Up to Week 52Population: FAS consisted of all participants in the RAN set who received at least one dose of study medication.
The exacerbation categories were: All (mild, moderate and severe) and combination of moderate or severe and severe.
Outcome measures
| Measure |
QMF149 150/320 μg
n=443 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/320 μg was delivered o.d. via Concept1 inhaler in the evening.
|
QMF149 150/160 μg
n=437 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 μg was delivered o.d. via Concept1 inhaler in the evening.
|
MF 800 μg
n=440 Participants
MF 800 μg of total daily dose (400 μg twice daily, in the morning and in the evening) was delivered via Twisthaler®.
|
MF 400 μg
n=443 Participants
MF 400 μg was delivered o.d. via Twisthaler® in the evening.
|
Salmeterol/Fluticasone 50/500 μg
n=444 Participants
Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®.
|
|---|---|---|---|---|---|
|
Time to First Asthma Exacerbation by Exacerbation Category
Moderate or severe asthma exacerbation
|
366.0 days
Interval 2.0 to 389.0
|
366.0 days
Interval 1.0 to 429.0
|
366.0 days
Interval 2.0 to 390.0
|
364.0 days
Interval 2.0 to 402.0
|
366.0 days
Interval 2.0 to 395.0
|
|
Time to First Asthma Exacerbation by Exacerbation Category
Severe asthma exacerbation
|
367 days
Interval 2.0 to 389.0
|
366 days
Interval 1.0 to 429.0
|
366 days
Interval 2.0 to 390.0
|
366 days
Interval 2.0 to 402.0
|
366 days
Interval 3.0 to 395.0
|
|
Time to First Asthma Exacerbation by Exacerbation Category
All (mild, moderate or severe) asthma exacerbation
|
366.0 days
Interval 2.0 to 389.0
|
366.0 days
Interval 1.0 to 429.0
|
364.5 days
Interval 2.0 to 390.0
|
306.0 days
Interval 2.0 to 402.0
|
365.0 days
Interval 2.0 to 394.0
|
SECONDARY outcome
Timeframe: Up to Week 52Population: FAS consisted of all participants in the RAN set who received at least one dose of study medication.
The exacerbation categories were: All (mild, moderate and severe) and combination of moderate or severe and severe.
Outcome measures
| Measure |
QMF149 150/320 μg
n=443 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/320 μg was delivered o.d. via Concept1 inhaler in the evening.
|
QMF149 150/160 μg
n=437 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 μg was delivered o.d. via Concept1 inhaler in the evening.
|
MF 800 μg
n=440 Participants
MF 800 μg of total daily dose (400 μg twice daily, in the morning and in the evening) was delivered via Twisthaler®.
|
MF 400 μg
n=443 Participants
MF 400 μg was delivered o.d. via Twisthaler® in the evening.
|
Salmeterol/Fluticasone 50/500 μg
n=444 Participants
Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®.
|
|---|---|---|---|---|---|
|
Time to First Hospitalization for Asthma Exacerbation
|
367.0 days
Interval 2.0 to 389.0
|
367.0 days
Interval 1.0 to 429.0
|
367.0 days
Interval 2.0 to 390.0
|
366.0 days
Interval 2.0 to 402.0
|
367.0 days
Interval 3.0 to 395.0
|
SECONDARY outcome
Timeframe: Up to Week 52Population: FAS consisted of all participants in the RAN set who received at least one dose of study medication.
The exacerbation categories were: All (mild, moderate and severe) and combination of moderate or severe and severe.
Outcome measures
| Measure |
QMF149 150/320 μg
n=443 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/320 μg was delivered o.d. via Concept1 inhaler in the evening.
|
QMF149 150/160 μg
n=437 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 μg was delivered o.d. via Concept1 inhaler in the evening.
|
MF 800 μg
n=440 Participants
MF 800 μg of total daily dose (400 μg twice daily, in the morning and in the evening) was delivered via Twisthaler®.
|
MF 400 μg
n=443 Participants
MF 400 μg was delivered o.d. via Twisthaler® in the evening.
|
Salmeterol/Fluticasone 50/500 μg
n=444 Participants
Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®.
|
|---|---|---|---|---|---|
|
Annual Rate of Asthma Exacerbations by Exacerbation Category
Moderate or severe asthma exacerbation
|
0.25 exacerbations per year
Interval 0.2 to 0.32
|
0.27 exacerbations per year
Interval 0.21 to 0.34
|
0.39 exacerbations per year
Interval 0.32 to 0.48
|
0.56 exacerbations per year
Interval 0.46 to 0.68
|
0.27 exacerbations per year
Interval 0.22 to 0.34
|
|
Annual Rate of Asthma Exacerbations by Exacerbation Category
Severe asthma exacerbation
|
0.13 exacerbations per year
Interval 0.09 to 0.17
|
0.13 exacerbations per year
Interval 0.1 to 0.18
|
0.18 exacerbations per year
Interval 0.13 to 0.23
|
0.29 exacerbations per year
Interval 0.23 to 0.38
|
0.14 exacerbations per year
Interval 0.1 to 0.19
|
|
Annual Rate of Asthma Exacerbations by Exacerbation Category
All (mild, moderate, severe) asthma exacerbation
|
0.49 exacerbations per year
Interval 0.41 to 0.6
|
0.48 exacerbations per year
Interval 0.4 to 0.59
|
0.74 exacerbations per year
Interval 0.62 to 0.88
|
1.05 exacerbations per year
Interval 0.89 to 1.24
|
0.52 exacerbations per year
Interval 0.43 to 0.63
|
SECONDARY outcome
Timeframe: Up to Week 52Population: FAS consisted of all participant in the RAN set who received at least one dose of study medication.
The exacerbation categories were: All (mild, moderate and severe) and combination of moderate or severe and severe.
Outcome measures
| Measure |
QMF149 150/320 μg
n=443 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/320 μg was delivered o.d. via Concept1 inhaler in the evening.
|
QMF149 150/160 μg
n=437 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 μg was delivered o.d. via Concept1 inhaler in the evening.
|
MF 800 μg
n=440 Participants
MF 800 μg of total daily dose (400 μg twice daily, in the morning and in the evening) was delivered via Twisthaler®.
|
MF 400 μg
n=443 Participants
MF 400 μg was delivered o.d. via Twisthaler® in the evening.
|
Salmeterol/Fluticasone 50/500 μg
n=444 Participants
Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®.
|
|---|---|---|---|---|---|
|
Duration in Days of Asthma Exacerbations by Exacerbation Category
Moderate or severe asthma exacerbation
|
2.6 days
Standard Deviation 10.60
|
3.0 days
Standard Deviation 12.53
|
3.7 days
Standard Deviation 11.40
|
5.8 days
Standard Deviation 13.98
|
3.1 days
Standard Deviation 9.68
|
|
Duration in Days of Asthma Exacerbations by Exacerbation Category
Severe asthma exacerbation
|
1.3 days
Standard Deviation 6.02
|
1.7 days
Standard Deviation 8.48
|
1.7 days
Standard Deviation 6.07
|
3.2 days
Standard Deviation 9.16
|
1.9 days
Standard Deviation 7.76
|
|
Duration in Days of Asthma Exacerbations by Exacerbation Category
All(mild, moderate,severe) asthma exacerbation
|
5.4 days
Standard Deviation 18.81
|
5.0 days
Standard Deviation 17.55
|
6.9 days
Standard Deviation 22.96
|
10.1 days
Standard Deviation 25.15
|
5.1 days
Standard Deviation 14.48
|
SECONDARY outcome
Timeframe: Up to Week 52Population: FAS consisted of all patients in the RAN set who received at least one dose of study medication.
The exacerbation categories were: All (mild, moderate and severe) and combination of moderate or severe and severe.
Outcome measures
| Measure |
QMF149 150/320 μg
n=443 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/320 μg was delivered o.d. via Concept1 inhaler in the evening.
|
QMF149 150/160 μg
n=437 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 μg was delivered o.d. via Concept1 inhaler in the evening.
|
MF 800 μg
n=440 Participants
MF 800 μg of total daily dose (400 μg twice daily, in the morning and in the evening) was delivered via Twisthaler®.
|
MF 400 μg
n=443 Participants
MF 400 μg was delivered o.d. via Twisthaler® in the evening.
|
Salmeterol/Fluticasone 50/500 μg
n=444 Participants
Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®.
|
|---|---|---|---|---|---|
|
Percentage of Participants With at Least One Asthma Exacerbation by Exacerbation Category
Moderate or severe asthma exacerbation
|
14.9 percentage of participants
|
16.9 percentage of participants
|
26.1 percentage of participants
|
32.5 percentage of participants
|
19.1 percentage of participants
|
|
Percentage of Participants With at Least One Asthma Exacerbation by Exacerbation Category
Severe asthma exacerbation
|
8.1 percentage of participants
|
9.8 percentage of participants
|
14.5 percentage of participants
|
20.1 percentage of participants
|
11.9 percentage of participants
|
|
Percentage of Participants With at Least One Asthma Exacerbation by Exacerbation Category
Moderate asthma exacerbation
|
7.7 percentage of participants
|
8.2 percentage of participants
|
14.3 percentage of participants
|
16.5 percentage of participants
|
9.2 percentage of participants
|
|
Percentage of Participants With at Least One Asthma Exacerbation by Exacerbation Category
Mild asthma exacerbation
|
13.3 percentage of participants
|
12.1 percentage of participants
|
17.5 percentage of participants
|
19.6 percentage of participants
|
15.1 percentage of participants
|
|
Percentage of Participants With at Least One Asthma Exacerbation by Exacerbation Category
All (mild, moderate, severe) asthma exacerbation
|
25.5 percentage of participants
|
25.6 percentage of participants
|
36.1 percentage of participants
|
44.5 percentage of participants
|
30.6 percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 52Population: FAS consisted of all participants in the RAN set who received at least one dose of study medication.
The exacerbation categories were: All (mild, moderate and severe) and combination of moderate or severe and severe.
Outcome measures
| Measure |
QMF149 150/320 μg
n=443 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/320 μg was delivered o.d. via Concept1 inhaler in the evening.
|
QMF149 150/160 μg
n=437 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 μg was delivered o.d. via Concept1 inhaler in the evening.
|
MF 800 μg
n=440 Participants
MF 800 μg of total daily dose (400 μg twice daily, in the morning and in the evening) was delivered via Twisthaler®.
|
MF 400 μg
n=443 Participants
MF 400 μg was delivered o.d. via Twisthaler® in the evening.
|
Salmeterol/Fluticasone 50/500 μg
n=444 Participants
Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®.
|
|---|---|---|---|---|---|
|
Time in Days to Permanent Discontinuation of Study Medication Due to Asthma Exacerbations
|
367.0 days
Interval 2.0 to 389.0
|
367.0 days
Interval 1.0 to 429.0
|
367.0 days
Interval 2.0 to 390.0
|
366.0 days
Interval 2.0 to 402.0
|
367.0 days
Interval 3.0 to 395.0
|
SECONDARY outcome
Timeframe: Up to Week 52Population: FAS consisted of all participants in the RAN set who received at least one dose of study medication.
Outcome measures
| Measure |
QMF149 150/320 μg
n=443 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/320 μg was delivered o.d. via Concept1 inhaler in the evening.
|
QMF149 150/160 μg
n=437 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 μg was delivered o.d. via Concept1 inhaler in the evening.
|
MF 800 μg
n=440 Participants
MF 800 μg of total daily dose (400 μg twice daily, in the morning and in the evening) was delivered via Twisthaler®.
|
MF 400 μg
n=443 Participants
MF 400 μg was delivered o.d. via Twisthaler® in the evening.
|
Salmeterol/Fluticasone 50/500 μg
n=444 Participants
Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Permanently Discontinued Study Medication Due to Asthma Exacerbations
|
0.2 percentage of participants
|
0 percentage of participants
|
0.9 percentage of participants
|
1.6 percentage of participants
|
0.5 percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 52Population: FAS consisted of all participants in the RAN set who received at least one dose of study medication.
The treatment of asthma exacerbations including the initiation of systemic corticosteroids were done according to investigator's or treating physician's medical judgement and in line with national and international recommendations. If systemic corticosteroids were required, a participant could return to the study after successfully completing a taper of approximately 7-10 days.
Outcome measures
| Measure |
QMF149 150/320 μg
n=443 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/320 μg was delivered o.d. via Concept1 inhaler in the evening.
|
QMF149 150/160 μg
n=437 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 μg was delivered o.d. via Concept1 inhaler in the evening.
|
MF 800 μg
n=440 Participants
MF 800 μg of total daily dose (400 μg twice daily, in the morning and in the evening) was delivered via Twisthaler®.
|
MF 400 μg
n=443 Participants
MF 400 μg was delivered o.d. via Twisthaler® in the evening.
|
Salmeterol/Fluticasone 50/500 μg
n=444 Participants
Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®.
|
|---|---|---|---|---|---|
|
Total Amounts of Systemic Corticosteroids (in Doses) Used to Treat Asthma Exacerbations
|
26.0 milligrams
Standard Deviation 136.92
|
29.9 milligrams
Standard Deviation 124.98
|
28.0 milligrams
Standard Deviation 95.18
|
47.8 milligrams
Standard Deviation 139.98
|
26.9 milligrams
Standard Deviation 114.36
|
SECONDARY outcome
Timeframe: Up to Weeks 26 and 52Population: FAS consisted of all participants in the RAN set who received at least one dose of study medication. n represents number of participants with data at respective visit.
All participants were given salbutamol/albuterol to use as rescue medication throughout the study along with e-Diary to record rescue medication use. Rescue medication free days is defined as any day where the participant did not use any puffs of rescue medication during daytime and night-time.
Outcome measures
| Measure |
QMF149 150/320 μg
n=443 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/320 μg was delivered o.d. via Concept1 inhaler in the evening.
|
QMF149 150/160 μg
n=437 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 μg was delivered o.d. via Concept1 inhaler in the evening.
|
MF 800 μg
n=440 Participants
MF 800 μg of total daily dose (400 μg twice daily, in the morning and in the evening) was delivered via Twisthaler®.
|
MF 400 μg
n=443 Participants
MF 400 μg was delivered o.d. via Twisthaler® in the evening.
|
Salmeterol/Fluticasone 50/500 μg
n=444 Participants
Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®.
|
|---|---|---|---|---|---|
|
Change From Baseline in Percentage of Rescue Medication Free Days
Weeks 1-26
|
31.5 percentage of days
Standard Error 1.53
|
27.4 percentage of days
Standard Error 1.53
|
21.4 percentage of days
Standard Error 1.52
|
19.1 percentage of days
Standard Error 1.53
|
27.4 percentage of days
Standard Error 1.52
|
|
Change From Baseline in Percentage of Rescue Medication Free Days
Weeks 1-52
|
33.1 percentage of days
Standard Error 1.55
|
29.4 percentage of days
Standard Error 1.54
|
23.5 percentage of days
Standard Error 1.54
|
20.8 percentage of days
Standard Error 1.54
|
28.8 percentage of days
Standard Error 1.54
|
SECONDARY outcome
Timeframe: Up to Week 52 (Day 364)Population: FAS consisted of all participants in the RAN set who received at least one dose of study medication.
AQLQ is a 32-item disease specific questionnaire designed to measure functional impairments that are most important to patients with asthma, with a recall time of two weeks and each question to be answered on a 7-point scale (1-totally limited/problems all the time, 7-not at all limited/no problems). It consists of 4 domains: * Symptoms = Mean of Items 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 29, 30 (12 items) * Activity limitation = Mean of Items 1, 2, 3, 4, 5, 11, 19, 25, 28, 31, 32 (11 items) * Emotional function = Mean of Items 7, 13, 15, 21, 27 (5 items) * Environmental stimuli = Mean of Items 9, 17, 23, 26 (4 items) * Overall Score = Mean of Items 1 to 32 (32 items)
Outcome measures
| Measure |
QMF149 150/320 μg
n=428 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/320 μg was delivered o.d. via Concept1 inhaler in the evening.
|
QMF149 150/160 μg
n=426 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 μg was delivered o.d. via Concept1 inhaler in the evening.
|
MF 800 μg
n=431 Participants
MF 800 μg of total daily dose (400 μg twice daily, in the morning and in the evening) was delivered via Twisthaler®.
|
MF 400 μg
n=428 Participants
MF 400 μg was delivered o.d. via Twisthaler® in the evening.
|
Salmeterol/Fluticasone 50/500 μg
n=438 Participants
Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®.
|
|---|---|---|---|---|---|
|
Asthma Quality of Life Questionnaire (AQLQ)
Day 86
|
5.618 score on a scale
Standard Error 0.0356
|
5.629 score on a scale
Standard Error 0.0357
|
5.564 score on a scale
Standard Error 0.0355
|
5.510 score on a scale
Standard Error 0.0359
|
5.592 score on a scale
Standard Error 0.0352
|
|
Asthma Quality of Life Questionnaire (AQLQ)
Day 30
|
5.560 score on a scale
Standard Error 0.0327
|
5.498 score on a scale
Standard Error 0.0328
|
5.413 score on a scale
Standard Error 0.0326
|
5.374 score on a scale
Standard Error 0.0327
|
5.515 score on a scale
Standard Error 0.0324
|
|
Asthma Quality of Life Questionnaire (AQLQ)
Day 183
|
5.724 score on a scale
Standard Error 0.0372
|
5.738 score on a scale
Standard Error 0.0372
|
5.598 score on a scale
Standard Error 0.0372
|
5.581 score on a scale
Standard Error 0.0376
|
5.639 score on a scale
Standard Error 0.0369
|
|
Asthma Quality of Life Questionnaire (AQLQ)
Day 254
|
5.761 score on a scale
Standard Error 0.0383
|
5.781 score on a scale
Standard Error 0.0382
|
5.689 score on a scale
Standard Error 0.0383
|
5.614 score on a scale
Standard Error 0.0386
|
5.700 score on a scale
Standard Error 0.0378
|
|
Asthma Quality of Life Questionnaire (AQLQ)
Day 364
|
5.783 score on a scale
Standard Error 0.0391
|
5.832 score on a scale
Standard Error 0.0388
|
5.705 score on a scale
Standard Error 0.0389
|
5.641 score on a scale
Standard Error 0.0394
|
5.742 score on a scale
Standard Error 0.0384
|
SECONDARY outcome
Timeframe: Week 26Population: FAS consisted of all participants in the RAN set who received at least one dose of study medication.
Trough FEV1 was assessed by performing spirometric assessment. It is defined as average of the two FEV1 measurements taken 23 hr 15 min and 23 hr 45 min post-evening dose. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing.
Outcome measures
| Measure |
QMF149 150/320 μg
n=395 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/320 μg was delivered o.d. via Concept1 inhaler in the evening.
|
QMF149 150/160 μg
n=389 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 μg was delivered o.d. via Concept1 inhaler in the evening.
|
MF 800 μg
n=372 Participants
MF 800 μg of total daily dose (400 μg twice daily, in the morning and in the evening) was delivered via Twisthaler®.
|
MF 400 μg
n=376 Participants
MF 400 μg was delivered o.d. via Twisthaler® in the evening.
|
Salmeterol/Fluticasone 50/500 μg
n=391 Participants
Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®.
|
|---|---|---|---|---|---|
|
Trough FEV1 Measured After 26 Weeks of Treatment
|
2.383 L
Standard Error 0.0159
|
2.387 L
Standard Error 0.0160
|
2.250 L
Standard Error 0.0162
|
2.176 L
Standard Error 0.0162
|
2.346 L
Standard Error 0.0160
|
SECONDARY outcome
Timeframe: Up to Week 52Population: Safety Set consisted of all participants who received at least one dose of study medication.
A composite endpoint of serious asthma outcomes is defined as asthma-related hospitalization, asthma-related intubation, or asthma-related death and was reviewed by the Adjudication Committee.
Outcome measures
| Measure |
QMF149 150/320 μg
n=443 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/320 μg was delivered o.d. via Concept1 inhaler in the evening.
|
QMF149 150/160 μg
n=437 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 μg was delivered o.d. via Concept1 inhaler in the evening.
|
MF 800 μg
n=440 Participants
MF 800 μg of total daily dose (400 μg twice daily, in the morning and in the evening) was delivered via Twisthaler®.
|
MF 400 μg
n=443 Participants
MF 400 μg was delivered o.d. via Twisthaler® in the evening.
|
Salmeterol/Fluticasone 50/500 μg
n=444 Participants
Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Composite Endpoint of Serious Asthma Outcomes
|
0.7 percentage of participants
|
0.5 percentage of participants
|
1.6 percentage of participants
|
1.8 percentage of participants
|
0.5 percentage of participants
|
SECONDARY outcome
Timeframe: Approximately up to 56 weeksPopulation: Safety Set consisted of all participants who received at least one dose of study medication.
An AE is any untoward medical occurrence (i.e., any unfavorable and unintended sign including abnormal laboratory findings, symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. An SAE is defined as any adverse event (appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s) or medical conditions(s) which meets any one of the following criteria: is fatal or life-threatening, results in persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect, requires inpatient hospitalization or prolongation of existing hospitalization or is medically significant, i.e. defined as an event that jeopardizes the participants or may require medical or surgical intervention.
Outcome measures
| Measure |
QMF149 150/320 μg
n=443 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/320 μg was delivered o.d. via Concept1 inhaler in the evening.
|
QMF149 150/160 μg
n=437 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 μg was delivered o.d. via Concept1 inhaler in the evening.
|
MF 800 μg
n=440 Participants
MF 800 μg of total daily dose (400 μg twice daily, in the morning and in the evening) was delivered via Twisthaler®.
|
MF 400 μg
n=443 Participants
MF 400 μg was delivered o.d. via Twisthaler® in the evening.
|
Salmeterol/Fluticasone 50/500 μg
n=444 Participants
Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
Adverse Events(AEs)
|
64.6 percentage of participants
|
66.8 percentage of participants
|
70.0 percentage of participants
|
72.2 percentage of participants
|
65.3 percentage of participants
|
|
Percentage of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
Serious Adverse Events(SAEs)
|
4.7 percentage of participants
|
4.6 percentage of participants
|
4.8 percentage of participants
|
7.0 percentage of participants
|
4.7 percentage of participants
|
Adverse Events
QMF 150/320
Serious events: 21 serious events
Other events: 228 other events
Deaths: 0 deaths
QMF 150/160
Serious events: 20 serious events
Other events: 233 other events
Deaths: 0 deaths
MF 800
Serious events: 21 serious events
Other events: 263 other events
Deaths: 0 deaths
MF 400
Serious events: 31 serious events
Other events: 290 other events
Deaths: 1 deaths
S/F 50/500
Serious events: 21 serious events
Other events: 239 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
QMF 150/320
n=443 participants at risk
QMF149 (Indacaterol acetate/Mometasone furoate) 150/320 μg was delivered o.d. via Concept1 inhaler in the evening.
|
QMF 150/160
n=437 participants at risk
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 μg was delivered o.d. via Concept1 inhaler in the evening.
|
MF 800
n=440 participants at risk
MF 800 μg of total daily dose (400 μg twice daily, in the morning and in the evening) was delivered via Twisthaler®.
|
MF 400
n=443 participants at risk
MF 400 μg was delivered o.d. via Twisthaler® in the evening.
|
S/F 50/500
n=444 participants at risk
Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.45%
2/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Cardiac disorders
Coronary artery disease
|
0.23%
1/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Endocrine disorders
Goitre
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Eye disorders
Corneal deposits
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Eye disorders
Optic ischaemic neuropathy
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Eye disorders
Retinal detachment
|
0.23%
1/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.23%
1/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.23%
1/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Gastric polyps
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.23%
1/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.23%
1/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Appendicitis
|
0.23%
1/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Complicated appendicitis
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Dengue fever
|
0.23%
1/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Diverticulitis
|
0.23%
1/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Otitis media
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.68%
3/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Pneumonia
|
0.23%
1/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.69%
3/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
1.1%
5/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.45%
2/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.23%
1/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Respiratory tract infection bacterial
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Sepsis
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Sialoadenitis
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Upper respiratory tract infection bacterial
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Accidental device ingestion
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.23%
1/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.23%
1/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.23%
1/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.45%
2/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.23%
1/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.23%
1/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.23%
1/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.23%
1/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.23%
1/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Cerebellar haematoma
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Cerebral infarction
|
0.23%
1/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Headache
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Intracranial aneurysm
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Migraine with aura
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Vertebral artery aneurysm
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Psychiatric disorders
Depression
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Renal and urinary disorders
Calculus urethral
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.23%
1/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Renal and urinary disorders
Hydroureter
|
0.23%
1/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Renal and urinary disorders
Ureteric stenosis
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.23%
1/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Renal and urinary disorders
Urethral stenosis
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Reproductive system and breast disorders
Cervix enlargement
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Reproductive system and breast disorders
Endometriosis
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Reproductive system and breast disorders
Vaginal prolapse
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Asphyxia
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.68%
3/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.46%
2/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
1.4%
6/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
1.8%
8/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.45%
2/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic rhinosinusitis with nasal polyps
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Vascular disorders
Aortic dissection
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Vascular disorders
Hypertensive crisis
|
0.23%
1/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.23%
1/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.00%
0/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
Other adverse events
| Measure |
QMF 150/320
n=443 participants at risk
QMF149 (Indacaterol acetate/Mometasone furoate) 150/320 μg was delivered o.d. via Concept1 inhaler in the evening.
|
QMF 150/160
n=437 participants at risk
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 μg was delivered o.d. via Concept1 inhaler in the evening.
|
MF 800
n=440 participants at risk
MF 800 μg of total daily dose (400 μg twice daily, in the morning and in the evening) was delivered via Twisthaler®.
|
MF 400
n=443 participants at risk
MF 400 μg was delivered o.d. via Twisthaler® in the evening.
|
S/F 50/500
n=444 participants at risk
Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.68%
3/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
2.1%
9/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
1.1%
5/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.90%
4/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
2.0%
9/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Bronchitis
|
4.5%
20/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
5.0%
22/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
5.0%
22/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
4.7%
21/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
3.8%
17/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Gastroenteritis
|
0.90%
4/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
2.1%
9/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
0.91%
4/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
1.4%
6/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
1.8%
8/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Influenza
|
2.7%
12/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
3.0%
13/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
4.3%
19/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
2.3%
10/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
3.4%
15/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Nasopharyngitis
|
11.3%
50/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
13.3%
58/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
17.7%
78/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
18.5%
82/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
10.6%
47/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Pharyngitis
|
2.3%
10/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
2.5%
11/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
2.7%
12/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
2.7%
12/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
3.2%
14/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Respiratory tract infection viral
|
2.3%
10/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
3.7%
16/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
3.2%
14/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
2.7%
12/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
2.9%
13/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Rhinitis
|
2.3%
10/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
2.3%
10/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
2.0%
9/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
1.1%
5/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
1.8%
8/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.0%
22/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
6.2%
27/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
9.1%
40/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
8.4%
37/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
8.6%
38/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Upper respiratory tract infection bacterial
|
1.1%
5/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
1.6%
7/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
1.4%
6/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
3.2%
14/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
1.8%
8/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Viral infection
|
1.6%
7/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
1.8%
8/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
2.5%
11/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
1.6%
7/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
1.4%
6/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
1.6%
7/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
2.5%
11/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
4.8%
21/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
4.5%
20/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
4.7%
21/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.0%
9/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
3.9%
17/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
2.0%
9/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
1.1%
5/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
1.8%
8/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Headache
|
5.9%
26/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
4.8%
21/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
5.5%
24/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
5.2%
23/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
5.0%
22/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
25.3%
112/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
25.9%
113/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
35.7%
157/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
43.8%
194/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
30.9%
137/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.8%
8/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
2.1%
9/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
2.7%
12/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
3.4%
15/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
1.8%
8/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.5%
11/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
1.4%
6/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
1.8%
8/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
2.0%
9/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
1.8%
8/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
1.1%
5/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
2.5%
11/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
1.6%
7/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
2.5%
11/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
1.6%
7/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
|
Vascular disorders
Hypertension
|
2.3%
10/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
3.2%
14/437 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
3.0%
13/440 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
2.5%
11/443 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
1.4%
6/444 • Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks)
The Safety Set consisted of all participants who received at least one dose of study medication.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER