Trial Outcomes & Findings for Study to Compare the Efficacy and Safety of QVM149 With QMF149 in Patients With Asthma (NCT NCT02571777)
NCT ID: NCT02571777
Last Updated: 2020-07-22
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. The primary endpoint considered the following 2 comparison groups: * QVM149 150/50/80 μg o.d. compared with QMF149 150/160 μg o.d. both delivered via Concept1 * QVM149 150/50/160 μg o.d. compared with QMF149 150/320 μg o.d. both delivered via Concept1.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
3092 participants
Primary outcome timeframe
26 weeks
Results posted on
2020-07-22
Participant Flow
Participants took part in 415 investigative sites in 41 countries
4851 participants were screened of which 3092 participants were randomized to 1 of the 5 treatment groups with a randomization ratio of 1:1:1:1:1.
Participant milestones
| Measure |
QVM149 150/50/160 µg o.d.
QVM149 150/50/160 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QVM149 150/50/80 µg o.d.
QVM149 150/50/80 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QMF149 150/320 µg o.d.
QMF149 150/320 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QMF149 150/160 µg o.d.
QMF149 150/160 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
Salmeterol/Fluticasone 50/500 μg b.i.d.
Salmeterol xinafoate /fluticasone propionate 50/500 μg twice daily (b.i.d.) delivered via Accuhaler®
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
619
|
620
|
618
|
617
|
618
|
|
Overall Study
Full Analysis Set (FAS)
|
615
|
616
|
611
|
607
|
612
|
|
Overall Study
Safety Set (SAF)
|
616
|
617
|
613
|
608
|
618
|
|
Overall Study
COMPLETED
|
580
|
582
|
577
|
580
|
582
|
|
Overall Study
NOT COMPLETED
|
39
|
38
|
41
|
37
|
36
|
Reasons for withdrawal
| Measure |
QVM149 150/50/160 µg o.d.
QVM149 150/50/160 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QVM149 150/50/80 µg o.d.
QVM149 150/50/80 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QMF149 150/320 µg o.d.
QMF149 150/320 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QMF149 150/160 µg o.d.
QMF149 150/160 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
Salmeterol/Fluticasone 50/500 μg b.i.d.
Salmeterol xinafoate /fluticasone propionate 50/500 μg twice daily (b.i.d.) delivered via Accuhaler®
|
|---|---|---|---|---|---|
|
Overall Study
Subject/guardian decision
|
34
|
26
|
26
|
25
|
27
|
|
Overall Study
Protocol Deviation
|
2
|
3
|
4
|
8
|
4
|
|
Overall Study
Death
|
1
|
1
|
4
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
2
|
0
|
1
|
|
Overall Study
Physician Decision
|
1
|
7
|
5
|
2
|
4
|
|
Overall Study
Pregnancy
|
0
|
0
|
0
|
2
|
0
|
Baseline Characteristics
Study to Compare the Efficacy and Safety of QVM149 With QMF149 in Patients With Asthma
Baseline characteristics by cohort
| Measure |
QVM149 150/50/160 µg o.d.
n=619 Participants
QVM149 150/50/160 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QVM149 150/50/80 µg o.d.
n=620 Participants
QVM149 150/50/80 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QMF149 150/320 µg o.d.
n=618 Participants
QMF149 150/320 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QMF149 150/160 µg o.d.
n=617 Participants
QMF149 150/160 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
Salmeterol/Fluticasone 50/500 μg b.i.d.
n=618 Participants
Salmeterol xinafoate /fluticasone propionate 50/500 μg twice daily (b.i.d.) delivered via Accuhaler®
|
Total
n=3092 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
52.1 years
STANDARD_DEVIATION 12.91 • n=5 Participants
|
52.4 years
STANDARD_DEVIATION 12.71 • n=7 Participants
|
52.0 years
STANDARD_DEVIATION 12.81 • n=5 Participants
|
51.8 years
STANDARD_DEVIATION 12.86 • n=4 Participants
|
52.9 years
STANDARD_DEVIATION 12.23 • n=21 Participants
|
52.2 years
STANDARD_DEVIATION 12.70 • n=8 Participants
|
|
Sex: Female, Male
Female
|
381 Participants
n=5 Participants
|
362 Participants
n=7 Participants
|
380 Participants
n=5 Participants
|
378 Participants
n=4 Participants
|
417 Participants
n=21 Participants
|
1918 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
238 Participants
n=5 Participants
|
258 Participants
n=7 Participants
|
238 Participants
n=5 Participants
|
239 Participants
n=4 Participants
|
201 Participants
n=21 Participants
|
1174 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
456 Participants
n=5 Participants
|
458 Participants
n=7 Participants
|
453 Participants
n=5 Participants
|
452 Participants
n=4 Participants
|
468 Participants
n=21 Participants
|
2287 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Black
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
17 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian
|
139 Participants
n=5 Participants
|
133 Participants
n=7 Participants
|
133 Participants
n=5 Participants
|
135 Participants
n=4 Participants
|
131 Participants
n=21 Participants
|
671 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Native American
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
32 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Other
|
13 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
84 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 26 weeksPopulation: FAS including patients with a valid measurement for the outcome measure.
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. The primary endpoint considered the following 2 comparison groups: * QVM149 150/50/80 μg o.d. compared with QMF149 150/160 μg o.d. both delivered via Concept1 * QVM149 150/50/160 μg o.d. compared with QMF149 150/320 μg o.d. both delivered via Concept1.
Outcome measures
| Measure |
QVM149 150/50/160 µg o.d.
n=614 Participants
QVM149 150/50/160 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QVM149 150/50/80 µg o.d.
n=614 Participants
QVM149 150/50/80 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QMF149 150/320 µg o.d.
n=606 Participants
QMF149 150/320 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QMF149 150/160 µg o.d.
n=602 Participants
QMF149 150/160 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
Salmeterol/Fluticasone 50/500 μg b.i.d.
n=607 Participants
Salmeterol xinafoate /fluticasone propionate 50/500 μg twice daily (b.i.d.) delivered via Accuhaler®
|
|---|---|---|---|---|---|
|
Trough Forced Expiratory Volume in 1 Second (Trough FEV1) of QVM149 Versus QMF149 at Week 26
|
2.050 litre (L)
Standard Error 0.0128
|
2.029 litre (L)
Standard Error 0.0129
|
1.984 litre (L)
Standard Error 0.0129
|
1.953 litre (L)
Standard Error 0.0130
|
1.930 litre (L)
Standard Error 0.0131
|
SECONDARY outcome
Timeframe: 26 weeks, 52 weeksPopulation: FAS including patients with a valid measurement for the outcome measure.
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 ACQ-7 total score reported below was calculated as the mean of scores of all 7 items and ranged between 0 and 6, with higher scores indicating worse asthma symptom control.
Outcome measures
| Measure |
QVM149 150/50/160 µg o.d.
n=607 Participants
QVM149 150/50/160 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QVM149 150/50/80 µg o.d.
n=595 Participants
QVM149 150/50/80 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QMF149 150/320 µg o.d.
n=596 Participants
QMF149 150/320 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QMF149 150/160 µg o.d.
n=598 Participants
QMF149 150/160 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
Salmeterol/Fluticasone 50/500 μg b.i.d.
n=599 Participants
Salmeterol xinafoate /fluticasone propionate 50/500 μg twice daily (b.i.d.) delivered via Accuhaler®
|
|---|---|---|---|---|---|
|
Asthma Control Questionnaire (ACQ-7) at Week 26 and Week 52
Week 26
|
1.542 Score on a scale
Standard Error 0.0329
|
1.543 Score on a scale
Standard Error 0.0330
|
1.528 Score on a scale
Standard Error 0.0329
|
1.614 Score on a scale
Standard Error 0.0331
|
1.628 Score on a scale
Standard Error 0.0329
|
|
Asthma Control Questionnaire (ACQ-7) at Week 26 and Week 52
Week 52
|
1.406 Score on a scale
Standard Error 0.0334
|
1.535 Score on a scale
Standard Error 0.0337
|
1.465 Score on a scale
Standard Error 0.0335
|
1.545 Score on a scale
Standard Error 0.0338
|
1.527 Score on a scale
Standard Error 0.0335
|
SECONDARY outcome
Timeframe: 26 weeksPopulation: FAS including patients with a valid measurement for the outcome measure.
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. This secondary endpoint considered the following 2 comparison groups: * QVM149 150/50/80 μg o.d. via Concept1 compared with salmeterol/fluticasone 50/500 μg b.i.d. via Accuhaler® * QVM149 150/50/160 μg o.d. via Concept 1 compared with salmeterol/fluticasone 50/500 μg b.i.d. via Accuhaler®
Outcome measures
| Measure |
QVM149 150/50/160 µg o.d.
n=614 Participants
QVM149 150/50/160 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QVM149 150/50/80 µg o.d.
n=614 Participants
QVM149 150/50/80 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QMF149 150/320 µg o.d.
n=606 Participants
QMF149 150/320 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QMF149 150/160 µg o.d.
n=602 Participants
QMF149 150/160 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
Salmeterol/Fluticasone 50/500 μg b.i.d.
n=607 Participants
Salmeterol xinafoate /fluticasone propionate 50/500 μg twice daily (b.i.d.) delivered via Accuhaler®
|
|---|---|---|---|---|---|
|
Trough Forced Expiratory Volume in 1 Second (Trough FEV1) of QVM149 Versus Salmeterol/Fluticasone at Week 26
|
2.050 litre (L)
Standard Error 0.0128
|
2.029 litre (L)
Standard Error 0.0129
|
1.984 litre (L)
Standard Error 0.0129
|
1.953 litre (L)
Standard Error 0.0130
|
1.930 litre (L)
Standard Error 0.0131
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: FAS including patients with a valid measurement for the outcome measure.
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 |
QVM149 150/50/160 µg o.d.
n=614 Participants
QVM149 150/50/160 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QVM149 150/50/80 µg o.d.
n=614 Participants
QVM149 150/50/80 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QMF149 150/320 µg o.d.
n=606 Participants
QMF149 150/320 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QMF149 150/160 µg o.d.
n=602 Participants
QMF149 150/160 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
Salmeterol/Fluticasone 50/500 μg b.i.d.
n=607 Participants
Salmeterol xinafoate /fluticasone propionate 50/500 μg twice daily (b.i.d.) delivered via Accuhaler®
|
|---|---|---|---|---|---|
|
Trough FEV1 at Week 52
|
2.050 litre (L)
Standard Error 0.0129
|
1.992 litre (L)
Standard Error 0.0130
|
1.965 litre (L)
Standard Error 0.0130
|
1.930 litre (L)
Standard Error 0.0130
|
1.905 litre (L)
Standard Error 0.0132
|
SECONDARY outcome
Timeframe: 4 weeks, 12 weeksPopulation: FAS including patients with a valid measurement for the outcome measure.
Pre-dose FVC is defined as average of the two FVC measurements taken 45 min and 15 min pre evening dose. It was assessed by performing spirometric assessment. FVC is the total amount of air exhaled during the FEV test.
Outcome measures
| Measure |
QVM149 150/50/160 µg o.d.
n=606 Participants
QVM149 150/50/160 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QVM149 150/50/80 µg o.d.
n=594 Participants
QVM149 150/50/80 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QMF149 150/320 µg o.d.
n=592 Participants
QMF149 150/320 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QMF149 150/160 µg o.d.
n=596 Participants
QMF149 150/160 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
Salmeterol/Fluticasone 50/500 μg b.i.d.
n=598 Participants
Salmeterol xinafoate /fluticasone propionate 50/500 μg twice daily (b.i.d.) delivered via Accuhaler®
|
|---|---|---|---|---|---|
|
Pre-dose Forced Vital Capacity (FVC) at Week 4 and Week 12
Week 4
|
3.091 litre (L)
Standard Error 0.0161
|
3.059 litre (L)
Standard Error 0.0163
|
3.018 litre (L)
Standard Error 0.0163
|
3.020 litre (L)
Standard Error 0.0163
|
2.952 litre (L)
Standard Error 0.0163
|
|
Pre-dose Forced Vital Capacity (FVC) at Week 4 and Week 12
Week 12
|
3.067 litre (L)
Standard Error 0.0162
|
3.065 litre (L)
Standard Error 0.0164
|
3.011 litre (L)
Standard Error 0.0163
|
3.014 litre (L)
Standard Error 0.0164
|
2.965 litre (L)
Standard Error 0.0163
|
SECONDARY outcome
Timeframe: Up to Week 52Population: FAS including patients with a valid measurement for the outcome measure.
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 |
QVM149 150/50/160 µg o.d.
n=614 Participants
QVM149 150/50/160 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QVM149 150/50/80 µg o.d.
n=614 Participants
QVM149 150/50/80 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QMF149 150/320 µg o.d.
n=606 Participants
QMF149 150/320 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QMF149 150/160 µg o.d.
n=602 Participants
QMF149 150/160 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
Salmeterol/Fluticasone 50/500 μg b.i.d.
n=607 Participants
Salmeterol xinafoate /fluticasone propionate 50/500 μg twice daily (b.i.d.) delivered via Accuhaler®
|
|---|---|---|---|---|---|
|
Trough Forced Expiratory Flow (FEF) Between 25% and 75% of FVC (FEF25-75) at 52 Weeks
|
1.354 L/s
Standard Error 0.0190
|
1.263 L/s
Standard Error 0.0192
|
1.260 L/s
Standard Error 0.0191
|
1.214 L/s
Standard Error 0.0192
|
1.207 L/s
Standard Error 0.0194
|
SECONDARY outcome
Timeframe: Baseline, 26 weeks, 52 weeksPopulation: FAS including patients with a valid measurement for the outcome measure.
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 home. 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 |
QVM149 150/50/160 µg o.d.
n=596 Participants
QVM149 150/50/160 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QVM149 150/50/80 µg o.d.
n=584 Participants
QVM149 150/50/80 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QMF149 150/320 µg o.d.
n=581 Participants
QMF149 150/320 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QMF149 150/160 µg o.d.
n=584 Participants
QMF149 150/160 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
Salmeterol/Fluticasone 50/500 μg b.i.d.
n=586 Participants
Salmeterol xinafoate /fluticasone propionate 50/500 μg twice daily (b.i.d.) delivered 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
|
47.7 L/min
Standard Error 1.93
|
40.5 L/min
Standard Error 1.95
|
29.5 L/min
Standard Error 1.95
|
25.6 L/min
Standard Error 1.95
|
12.5 L/min
Standard Error 1.95
|
|
Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEF) Over 26 and 52 Weeks of Treatment
Week 26 - Mean evening PEF
|
39.6 L/min
Standard Error 1.87
|
34.7 L/min
Standard Error 1.88
|
22.8 L/min
Standard Error 1.88
|
20.6 L/min
Standard Error 1.89
|
10.4 L/min
Standard Error 1.89
|
|
Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEF) Over 26 and 52 Weeks of Treatment
Week 52 - Mean morning PEF
|
47.5 L/min
Standard Error 2.03
|
41.2 L/min
Standard Error 2.05
|
28.8 L/min
Standard Error 2.05
|
25.6 L/min
Standard Error 2.06
|
12.7 L/min
Standard Error 2.05
|
|
Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEF) Over 26 and 52 Weeks of Treatment
Week 52 - Mean evening PEF
|
38.7 L/min
Standard Error 1.97
|
35.0 L/min
Standard Error 1.99
|
21.2 L/min
Standard Error 1.99
|
20.1 L/min
Standard Error 2.00
|
9.2 L/min
Standard Error 1.99
|
SECONDARY outcome
Timeframe: Baseline, 52 weeksPopulation: FAS including patients with a valid measurement for the outcome measure.
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 |
QVM149 150/50/160 µg o.d.
n=566 Participants
QVM149 150/50/160 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QVM149 150/50/80 µg o.d.
n=552 Participants
QVM149 150/50/80 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QMF149 150/320 µg o.d.
n=559 Participants
QMF149 150/320 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QMF149 150/160 µg o.d.
n=554 Participants
QMF149 150/160 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
Salmeterol/Fluticasone 50/500 μg b.i.d.
n=558 Participants
Salmeterol xinafoate /fluticasone propionate 50/500 μg twice daily (b.i.d.) delivered via Accuhaler®
|
|---|---|---|---|---|---|
|
Change From Baseline in Percentage of Asthma Symptom-free Days Over 52 Weeks
|
22.4 Percentage of days
Standard Error 1.35
|
18.0 Percentage of days
Standard Error 1.36
|
22.2 Percentage of days
Standard Error 1.36
|
18.0 Percentage of days
Standard Error 1.37
|
18.9 Percentage of days
Standard Error 1.36
|
SECONDARY outcome
Timeframe: Baseline, 52 weeksPopulation: FAS including patients with a valid measurement for the outcome measure.
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 |
QVM149 150/50/160 µg o.d.
n=594 Participants
QVM149 150/50/160 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QVM149 150/50/80 µg o.d.
n=577 Participants
QVM149 150/50/80 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QMF149 150/320 µg o.d.
n=579 Participants
QMF149 150/320 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QMF149 150/160 µg o.d.
n=579 Participants
QMF149 150/160 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
Salmeterol/Fluticasone 50/500 μg b.i.d.
n=578 Participants
Salmeterol xinafoate /fluticasone propionate 50/500 μg twice daily (b.i.d.) delivered via Accuhaler®
|
|---|---|---|---|---|---|
|
Change From Baseline in Percentage of Days With no Daytime Symptoms Over 52 Weeks
|
22.5 Percentage of days
Standard Error 1.32
|
17.9 Percentage of days
Standard Error 1.34
|
21.8 Percentage of days
Standard Error 1.33
|
18.0 Percentage of days
Standard Error 1.34
|
18.8 Percentage of days
Standard Error 1.34
|
SECONDARY outcome
Timeframe: Baseline, 52 weeksPopulation: FAS including patients with a valid measurement for the outcome measure.
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 |
QVM149 150/50/160 µg o.d.
n=599 Participants
QVM149 150/50/160 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QVM149 150/50/80 µg o.d.
n=584 Participants
QVM149 150/50/80 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QMF149 150/320 µg o.d.
n=582 Participants
QMF149 150/320 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QMF149 150/160 µg o.d.
n=584 Participants
QMF149 150/160 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
Salmeterol/Fluticasone 50/500 μg b.i.d.
n=586 Participants
Salmeterol xinafoate /fluticasone propionate 50/500 μg twice daily (b.i.d.) delivered via Accuhaler®
|
|---|---|---|---|---|---|
|
Change From Baseline in Percentage of Nights With no Night-time Awakenings Over 52 Weeks
|
18.0 Percentage of days
Standard Error 1.11
|
17.6 Percentage of days
Standard Error 1.12
|
18.4 Percentage of days
Standard Error 1.13
|
16.1 Percentage of days
Standard Error 1.13
|
16.9 Percentage of days
Standard Error 1.12
|
SECONDARY outcome
Timeframe: Baseline, 52 weeksPopulation: FAS including patients with a valid measurement for the outcome measure.
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 |
QVM149 150/50/160 µg o.d.
n=599 Participants
QVM149 150/50/160 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QVM149 150/50/80 µg o.d.
n=584 Participants
QVM149 150/50/80 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QMF149 150/320 µg o.d.
n=582 Participants
QMF149 150/320 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QMF149 150/160 µg o.d.
n=584 Participants
QMF149 150/160 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
Salmeterol/Fluticasone 50/500 μg b.i.d.
n=586 Participants
Salmeterol xinafoate /fluticasone propionate 50/500 μg twice daily (b.i.d.) delivered via Accuhaler®
|
|---|---|---|---|---|---|
|
Change From Baseline in Percentage of Mornings With no Symptoms on Rising Over 52 Weeks
|
19.5 Percentage of days
Standard Error 1.33
|
18.5 Percentage of days
Standard Error 1.35
|
19.9 Percentage of days
Standard Error 1.35
|
15.5 Percentage of days
Standard Error 1.35
|
15.6 Percentage of days
Standard Error 1.34
|
SECONDARY outcome
Timeframe: Baseline, 26 weeks, 52 weeksPopulation: FAS including patients with a valid measurement for the outcome measure.
Percentage of days without rescue medication usage (100 μg salbutamol/90 μg albuterol via metered-dose inhaler) as recorded by e-diary over 26 and 52 weeks of treatment.
Outcome measures
| Measure |
QVM149 150/50/160 µg o.d.
n=590 Participants
QVM149 150/50/160 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QVM149 150/50/80 µg o.d.
n=577 Participants
QVM149 150/50/80 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QMF149 150/320 µg o.d.
n=578 Participants
QMF149 150/320 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QMF149 150/160 µg o.d.
n=580 Participants
QMF149 150/160 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
Salmeterol/Fluticasone 50/500 μg b.i.d.
n=579 Participants
Salmeterol xinafoate /fluticasone propionate 50/500 μg twice daily (b.i.d.) delivered via Accuhaler®
|
|---|---|---|---|---|---|
|
Change From Baseline in Percentage of Days Without Rescue Medication Use Over 26 and 52 Weeks
Week 52
|
25.0 Percentage of days
Standard Error 1.36
|
21.9 Percentage of days
Standard Error 1.36
|
24.9 Percentage of days
Standard Error 1.36
|
20.8 Percentage of days
Standard Error 1.37
|
21.8 Percentage of days
Standard Error 1.36
|
|
Change From Baseline in Percentage of Days Without Rescue Medication Use Over 26 and 52 Weeks
Week 26
|
22.5 Percentage of days
Standard Error 1.32
|
19.5 Percentage of days
Standard Error 1.33
|
23.3 Percentage of days
Standard Error 1.33
|
18.2 Percentage of days
Standard Error 1.33
|
19.6 Percentage of days
Standard Error 1.33
|
SECONDARY outcome
Timeframe: 26 weeks, 52 weeksPopulation: FAS
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 |
QVM149 150/50/160 µg o.d.
n=615 Participants
QVM149 150/50/160 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QVM149 150/50/80 µg o.d.
n=616 Participants
QVM149 150/50/80 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QMF149 150/320 µg o.d.
n=611 Participants
QMF149 150/320 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QMF149 150/160 µg o.d.
n=607 Participants
QMF149 150/160 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
Salmeterol/Fluticasone 50/500 μg b.i.d.
n=612 Participants
Salmeterol xinafoate /fluticasone propionate 50/500 μg twice daily (b.i.d.) delivered via Accuhaler®
|
|---|---|---|---|---|---|
|
Percentage of Patients Achieving the Minimal Clinically Important Difference (MCID) ACQ ≥ 0.5 at Week 26 and Week 52
Week 26
|
71.2 Percentage of participants
|
71.7 Percentage of participants
|
74.2 Percentage of participants
|
70.7 Percentage of participants
|
67.4 Percentage of participants
|
|
Percentage of Patients Achieving the Minimal Clinically Important Difference (MCID) ACQ ≥ 0.5 at Week 26 and Week 52
Week 52
|
78.8 Percentage of participants
|
72.8 Percentage of participants
|
77.9 Percentage of participants
|
73.1 Percentage of participants
|
72.8 Percentage of participants
|
SECONDARY outcome
Timeframe: 52 weeks on average, up to 416 daysPopulation: FAS
Time from start of treatment until the first event (hospitalization for asthma exacerbation) or censoring. Patients without the event were considered as censored at the date of last treatment + 1 day. For patients having the event, the start date of the hospitalization was considered to calculate the time to event (i.e., the number of days from start of treatment up to the event start date).
Outcome measures
| Measure |
QVM149 150/50/160 µg o.d.
n=615 Participants
QVM149 150/50/160 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QVM149 150/50/80 µg o.d.
n=616 Participants
QVM149 150/50/80 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QMF149 150/320 µg o.d.
n=611 Participants
QMF149 150/320 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QMF149 150/160 µg o.d.
n=607 Participants
QMF149 150/160 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
Salmeterol/Fluticasone 50/500 μg b.i.d.
n=612 Participants
Salmeterol xinafoate /fluticasone propionate 50/500 μg twice daily (b.i.d.) delivered via Accuhaler®
|
|---|---|---|---|---|---|
|
Time to First Hospitalization for Asthma Exacerbation
|
367.0 days
Interval 2.0 to 416.0
|
367.0 days
Interval 2.0 to 396.0
|
367.0 days
Interval 1.0 to 411.0
|
367.0 days
Interval 1.0 to 408.0
|
367.0 days
Interval 1.0 to 416.0
|
SECONDARY outcome
Timeframe: 52 weeks on average, up to 416 daysPopulation: FAS
Time from start of treatment until the first event (asthma exacerbation) or censoring. Patients without the event were considered as censored at the date of last treatment + 1 day. For patients having the event, the start date of the exacerbation was considered to calculate the time to event (i.e., the number of days from start of treatment up to the event start date). The exacerbation categories were: All (mild, moderate and severe), combination of moderate or severe and severe.
Outcome measures
| Measure |
QVM149 150/50/160 µg o.d.
n=615 Participants
QVM149 150/50/160 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QVM149 150/50/80 µg o.d.
n=616 Participants
QVM149 150/50/80 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QMF149 150/320 µg o.d.
n=611 Participants
QMF149 150/320 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QMF149 150/160 µg o.d.
n=607 Participants
QMF149 150/160 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
Salmeterol/Fluticasone 50/500 μg b.i.d.
n=612 Participants
Salmeterol xinafoate /fluticasone propionate 50/500 μg twice daily (b.i.d.) delivered via Accuhaler®
|
|---|---|---|---|---|---|
|
Time to First Asthma Exacerbation by Exacerbation Category
Moderate or severe asthma exacerbation
|
366.0 days
Interval 2.0 to 416.0
|
366.0 days
Interval 2.0 to 396.0
|
366.0 days
Interval 1.0 to 411.0
|
365.0 days
Interval 1.0 to 387.0
|
365.0 days
Interval 1.0 to 416.0
|
|
Time to First Asthma Exacerbation by Exacerbation Category
Severe asthma exacerbation
|
366.0 days
Interval 2.0 to 416.0
|
366.0 days
Interval 2.0 to 396.0
|
366.0 days
Interval 1.0 to 411.0
|
366.0 days
Interval 1.0 to 389.0
|
366.0 days
Interval 1.0 to 416.0
|
|
Time to First Asthma Exacerbation by Exacerbation Category
All (mild, moderate or severe) asthma exacerbation
|
363.0 days
Interval 2.0 to 416.0
|
364.0 days
Interval 2.0 to 396.0
|
361.0 days
Interval 1.0 to 411.0
|
360.0 days
Interval 1.0 to 384.0
|
278.0 days
Interval 1.0 to 416.0
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: FAS
The exacerbation categories were: All (mild, moderate and severe) and combination of moderate or severe and severe.
Outcome measures
| Measure |
QVM149 150/50/160 µg o.d.
n=615 Participants
QVM149 150/50/160 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QVM149 150/50/80 µg o.d.
n=616 Participants
QVM149 150/50/80 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QMF149 150/320 µg o.d.
n=611 Participants
QMF149 150/320 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QMF149 150/160 µg o.d.
n=607 Participants
QMF149 150/160 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
Salmeterol/Fluticasone 50/500 μg b.i.d.
n=612 Participants
Salmeterol xinafoate /fluticasone propionate 50/500 μg twice daily (b.i.d.) delivered via Accuhaler®
|
|---|---|---|---|---|---|
|
Annual Rate of Asthma Exacerbations by Exacerbation Category
Moderate or severe asthma exacerbation
|
0.46 Exacerbations per year
Interval 0.39 to 0.54
|
0.58 Exacerbations per year
Interval 0.5 to 0.67
|
0.54 Exacerbations per year
Interval 0.47 to 0.63
|
0.67 Exacerbations per year
Interval 0.58 to 0.77
|
0.72 Exacerbations per year
Interval 0.63 to 0.82
|
|
Annual Rate of Asthma Exacerbations by Exacerbation Category
Severe asthma exacerbation
|
0.26 Exacerbations per year
Interval 0.22 to 0.31
|
0.38 Exacerbations per year
Interval 0.32 to 0.45
|
0.33 Exacerbations per year
Interval 0.28 to 0.39
|
0.41 Exacerbations per year
Interval 0.35 to 0.48
|
0.45 Exacerbations per year
Interval 0.39 to 0.53
|
|
Annual Rate of Asthma Exacerbations by Exacerbation Category
All (mild, moderate, severe) asthma exacerbation
|
0.74 Exacerbations per year
Interval 0.64 to 0.85
|
0.86 Exacerbations per year
Interval 0.75 to 0.98
|
0.93 Exacerbations per year
Interval 0.82 to 1.06
|
0.98 Exacerbations per year
Interval 0.86 to 1.11
|
1.23 Exacerbations per year
Interval 1.08 to 1.39
|
SECONDARY outcome
Timeframe: Up to Week 52Population: FAS
The exacerbation categories were: All (mild, moderate and severe) and combination of moderate or severe and severe.
Outcome measures
| Measure |
QVM149 150/50/160 µg o.d.
n=615 Participants
QVM149 150/50/160 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QVM149 150/50/80 µg o.d.
n=616 Participants
QVM149 150/50/80 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QMF149 150/320 µg o.d.
n=611 Participants
QMF149 150/320 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QMF149 150/160 µg o.d.
n=607 Participants
QMF149 150/160 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
Salmeterol/Fluticasone 50/500 μg b.i.d.
n=612 Participants
Salmeterol xinafoate /fluticasone propionate 50/500 μg twice daily (b.i.d.) delivered via Accuhaler®
|
|---|---|---|---|---|---|
|
Duration in Days of Asthma Exacerbations by Exacerbation Category
Moderate or severe asthma exacerbation
|
4.5 days
Standard Deviation 10.73
|
5.6 days
Standard Deviation 12.87
|
6.7 days
Standard Deviation 20.52
|
7.1 days
Standard Deviation 17.17
|
8.1 days
Standard Deviation 20.63
|
|
Duration in Days of Asthma Exacerbations by Exacerbation Category
Severe asthma exacerbation
|
2.8 days
Standard Deviation 7.31
|
4.1 days
Standard Deviation 11.18
|
4.9 days
Standard Deviation 19.07
|
4.5 days
Standard Deviation 10.54
|
5.8 days
Standard Deviation 18.24
|
|
Duration in Days of Asthma Exacerbations by Exacerbation Category
All (mild, moderate, severe) asthma exacerbation
|
7.0 days
Standard Deviation 16.02
|
8.1 days
Standard Deviation 20.51
|
10.7 days
Standard Deviation 28.70
|
9.6 days
Standard Deviation 21.76
|
12.8 days
Standard Deviation 29.21
|
SECONDARY outcome
Timeframe: Up to Week 52Population: FAS
The exacerbation categories were: All (mild, moderate and severe) and combination of moderate or severe and severe.
Outcome measures
| Measure |
QVM149 150/50/160 µg o.d.
n=615 Participants
QVM149 150/50/160 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QVM149 150/50/80 µg o.d.
n=616 Participants
QVM149 150/50/80 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QMF149 150/320 µg o.d.
n=611 Participants
QMF149 150/320 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QMF149 150/160 µg o.d.
n=607 Participants
QMF149 150/160 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
Salmeterol/Fluticasone 50/500 μg b.i.d.
n=612 Participants
Salmeterol xinafoate /fluticasone propionate 50/500 μg twice daily (b.i.d.) delivered via Accuhaler®
|
|---|---|---|---|---|---|
|
Percentage of Participants With at Least One Asthma Exacerbation by Exacerbation Category
Moderate or severe asthma exacerbation
|
30.2 percentage of participants
|
32.5 percentage of participants
|
31.8 percentage of participants
|
35.9 percentage of participants
|
39.7 percentage of participants
|
|
Percentage of Participants With at Least One Asthma Exacerbation by Exacerbation Category
Severe asthma exacerbation
|
21.8 percentage of participants
|
24.6 percentage of participants
|
23.2 percentage of participants
|
27.3 percentage of participants
|
29.7 percentage of participants
|
|
Percentage of Participants With at Least One Asthma Exacerbation by Exacerbation Category
All (mild, moderate, severe) asthma exacerbation
|
40.2 percentage of participants
|
40.2 percentage of participants
|
41.9 percentage of participants
|
44.0 percentage of participants
|
50.5 percentage of participants
|
SECONDARY outcome
Timeframe: 52 weeks on average, up to 416 daysPopulation: FAS
Time from start of treatment until the first event (permanent discontinuation of study medication due to asthma exacerbation) or censoring. Patients without the event were considered as censored at the date of last treatment + 1 day. For patients having the event, the date of the discontinuation of study medication was considered to calculate the time to event.
Outcome measures
| Measure |
QVM149 150/50/160 µg o.d.
n=615 Participants
QVM149 150/50/160 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QVM149 150/50/80 µg o.d.
n=616 Participants
QVM149 150/50/80 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QMF149 150/320 µg o.d.
n=611 Participants
QMF149 150/320 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QMF149 150/160 µg o.d.
n=607 Participants
QMF149 150/160 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
Salmeterol/Fluticasone 50/500 μg b.i.d.
n=612 Participants
Salmeterol xinafoate /fluticasone propionate 50/500 μg twice daily (b.i.d.) delivered via Accuhaler®
|
|---|---|---|---|---|---|
|
Time in Days to Permanent Discontinuation of Study Medication Due to Asthma Exacerbation
|
367.0 days
Interval 11.0 to 416.0
|
367.0 days
Interval 2.0 to 399.0
|
367.0 days
Interval 3.0 to 411.0
|
367.0 days
Interval 2.0 to 408.0
|
367.0 days
Interval 2.0 to 416.0
|
SECONDARY outcome
Timeframe: Up to Week 52Population: FAS
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 |
QVM149 150/50/160 µg o.d.
n=615 Participants
QVM149 150/50/160 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QVM149 150/50/80 µg o.d.
n=616 Participants
QVM149 150/50/80 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QMF149 150/320 µg o.d.
n=611 Participants
QMF149 150/320 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QMF149 150/160 µg o.d.
n=607 Participants
QMF149 150/160 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
Salmeterol/Fluticasone 50/500 μg b.i.d.
n=612 Participants
Salmeterol xinafoate /fluticasone propionate 50/500 μg twice daily (b.i.d.) delivered via Accuhaler®
|
|---|---|---|---|---|---|
|
Total Amount of Oral Corticosteroid Used (in Prednisone-equivalent mg Doses) to Treat Asthma Exacerbations
|
53.4 prednisone-equivalent milligram
Standard Deviation 169.76
|
72.0 prednisone-equivalent milligram
Standard Deviation 211.41
|
73.2 prednisone-equivalent milligram
Standard Deviation 235.90
|
82.5 prednisone-equivalent milligram
Standard Deviation 208.36
|
86.0 prednisone-equivalent milligram
Standard Deviation 199.79
|
SECONDARY outcome
Timeframe: Baseline, 26 weeks, 52 weeksPopulation: FAS including patients with a valid measurement for the outcome measure.
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 |
QVM149 150/50/160 µg o.d.
n=590 Participants
QVM149 150/50/160 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QVM149 150/50/80 µg o.d.
n=577 Participants
QVM149 150/50/80 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QMF149 150/320 µg o.d.
n=578 Participants
QMF149 150/320 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QMF149 150/160 µg o.d.
n=580 Participants
QMF149 150/160 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
Salmeterol/Fluticasone 50/500 μg b.i.d.
n=579 Participants
Salmeterol xinafoate /fluticasone propionate 50/500 μg twice daily (b.i.d.) delivered via Accuhaler®
|
|---|---|---|---|---|---|
|
Change From Baseline in Percentage of Rescue Medication Free Days Over 26 and 52 Weeks
Week 52
|
25.0 Percentage of days
Standard Error 1.36
|
21.9 Percentage of days
Standard Error 1.36
|
24.9 Percentage of days
Standard Error 1.36
|
20.8 Percentage of days
Standard Error 1.37
|
21.8 Percentage of days
Standard Error 1.36
|
|
Change From Baseline in Percentage of Rescue Medication Free Days Over 26 and 52 Weeks
Week 26
|
22.5 Percentage of days
Standard Error 1.32
|
19.5 Percentage of days
Standard Error 1.33
|
23.3 Percentage of days
Standard Error 1.33
|
18.2 Percentage of days
Standard Error 1.33
|
19.6 Percentage of days
Standard Error 1.33
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: FAS including patients with a valid measurement for the outcome measure.
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) The overall AQLQ score reported below is the mean of all 32 responses and ranges from 1 to 7, where higher scores indicate better quality of life.
Outcome measures
| Measure |
QVM149 150/50/160 µg o.d.
n=606 Participants
QVM149 150/50/160 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QVM149 150/50/80 µg o.d.
n=593 Participants
QVM149 150/50/80 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QMF149 150/320 µg o.d.
n=595 Participants
QMF149 150/320 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QMF149 150/160 µg o.d.
n=599 Participants
QMF149 150/160 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
Salmeterol/Fluticasone 50/500 μg b.i.d.
n=594 Participants
Salmeterol xinafoate /fluticasone propionate 50/500 μg twice daily (b.i.d.) delivered via Accuhaler®
|
|---|---|---|---|---|---|
|
Asthma Quality of Life Questionnaire (AQLQ) at Week 52
|
5.555 Score on a scale
Standard Error 0.0354
|
5.445 Score on a scale
Standard Error 0.0358
|
5.535 Score on a scale
Standard Error 0.0356
|
5.499 Score on a scale
Standard Error 0.0358
|
5.495 Score on a scale
Standard Error 0.0357
|
SECONDARY outcome
Timeframe: 4 weeks, 12 weeksPopulation: FAS including patients with a valid measurement for the outcome measure.
Pre-dose 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 |
QVM149 150/50/160 µg o.d.
n=606 Participants
QVM149 150/50/160 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QVM149 150/50/80 µg o.d.
n=594 Participants
QVM149 150/50/80 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QMF149 150/320 µg o.d.
n=592 Participants
QMF149 150/320 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QMF149 150/160 µg o.d.
n=596 Participants
QMF149 150/160 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
Salmeterol/Fluticasone 50/500 μg b.i.d.
n=598 Participants
Salmeterol xinafoate /fluticasone propionate 50/500 μg twice daily (b.i.d.) delivered via Accuhaler®
|
|---|---|---|---|---|---|
|
Pre-dose FEV1 at Weeks 4 and 12
Week 4
|
2.032 litres
Standard Deviation 0.0122
|
1.983 litres
Standard Deviation 0.0123
|
1.963 litres
Standard Deviation 0.0124
|
1.950 litres
Standard Deviation 0.0123
|
1.887 litres
Standard Deviation 0.0123
|
|
Pre-dose FEV1 at Weeks 4 and 12
Week 12
|
2.024 litres
Standard Deviation 0.0134
|
1.994 litres
Standard Deviation 0.0135
|
1.966 litres
Standard Deviation 0.0135
|
1.944 litres
Standard Deviation 0.0136
|
1.907 litres
Standard Deviation 0.0135
|
SECONDARY outcome
Timeframe: Up to Week 52Population: SAF
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 |
QVM149 150/50/160 µg o.d.
n=616 Participants
QVM149 150/50/160 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QVM149 150/50/80 µg o.d.
n=617 Participants
QVM149 150/50/80 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QMF149 150/320 µg o.d.
n=613 Participants
QMF149 150/320 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QMF149 150/160 µg o.d.
n=608 Participants
QMF149 150/160 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
Salmeterol/Fluticasone 50/500 μg b.i.d.
n=618 Participants
Salmeterol xinafoate /fluticasone propionate 50/500 μg twice daily (b.i.d.) delivered via Accuhaler®
|
|---|---|---|---|---|---|
|
Percentage of Participants With Composite Endpoint of Serious Asthma Outcomes
|
1.4 Percentage of participants
|
2.5 Percentage of participants
|
1.9 Percentage of participants
|
1.6 Percentage of participants
|
1.2 Percentage of participants
|
Adverse Events
QVM149 150/50/160 μg o.d.
Serious events: 46 serious events
Other events: 367 other events
Deaths: 2 deaths
QVM149 150/50/80 μg o.d.
Serious events: 49 serious events
Other events: 387 other events
Deaths: 1 deaths
QMF149 150/320 μg o.d.
Serious events: 52 serious events
Other events: 377 other events
Deaths: 4 deaths
QMF149 150/160 μg o.d.
Serious events: 38 serious events
Other events: 392 other events
Deaths: 0 deaths
Salmeterol/Fluticasone 50/500 μg b.i.d.
Serious events: 39 serious events
Other events: 419 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
QVM149 150/50/160 μg o.d.
n=616 participants at risk
QVM149 150/50/160 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QVM149 150/50/80 μg o.d.
n=617 participants at risk
QVM149 150/50/80 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QMF149 150/320 μg o.d.
n=613 participants at risk
QMF149 150/320 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QMF149 150/160 μg o.d.
n=608 participants at risk
QMF149 150/160 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
Salmeterol/Fluticasone 50/500 μg b.i.d.
n=618 participants at risk
Salmeterol xinafoate /fluticasone propionate 50/500 μg twice daily (b.i.d.) delivered via Accuhaler®
|
|---|---|---|---|---|---|
|
Immune system disorders
Drug hypersensitivity
|
0.16%
1/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Immune system disorders
Sarcoidosis
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Appendicitis
|
0.16%
1/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.32%
2/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Bursitis infective
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.32%
2/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Cholecystitis infective
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Chronic sinusitis
|
0.16%
1/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.33%
2/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Dengue fever
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Infections and infestations
HIV infection
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Hepatitis C
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.16%
1/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Blood and lymphatic system disorders
Immune thrombocytopenic purpura
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Cardiac disorders
Acute cardiac event
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.16%
1/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Cardiac disorders
Cardiac tamponade
|
0.16%
1/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Cardiac disorders
Extrasystoles
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Cardiac disorders
Myocardial infarction
|
0.16%
1/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.33%
2/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Cardiac disorders
Palpitations
|
0.16%
1/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Ear and labyrinth disorders
Middle ear effusion
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Ear and labyrinth disorders
Otorrhoea
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Eye disorders
Cataract
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.33%
2/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Eye disorders
Optic ischaemic neuropathy
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Gastrointestinal disorders
Ascites
|
0.16%
1/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.33%
2/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Gastrointestinal disorders
Gastrointestinal angiodysplasia
|
0.16%
1/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.16%
1/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Gastrointestinal disorders
Intra-abdominal fluid collection
|
0.16%
1/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.16%
1/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Gastrointestinal disorders
Peritoneal adhesions
|
0.16%
1/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Gastrointestinal disorders
Proctitis
|
0.16%
1/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.16%
1/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Gastrointestinal disorders
Rectal polyp
|
0.16%
1/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.33%
2/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
General disorders
Fatigue
|
0.16%
1/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
General disorders
Non-cardiac chest pain
|
0.32%
2/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
General disorders
Pyrexia
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
General disorders
Sudden cardiac death
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.49%
3/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Hepatobiliary disorders
Liver injury
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Hepatobiliary disorders
Primary biliary cholangitis
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Hepatobiliary disorders
Steatohepatitis
|
0.16%
1/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Infectious pleural effusion
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Influenza
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.16%
1/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.49%
3/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.32%
2/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Mastoiditis
|
0.16%
1/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Otitis media chronic
|
0.16%
1/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Pneumonia
|
0.49%
3/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.32%
2/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.49%
3/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.81%
5/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Salpingitis
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Upper respiratory tract infection bacterial
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.32%
2/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Urosepsis
|
0.16%
1/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.32%
2/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.33%
2/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Post procedural discomfort
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.33%
2/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Investigations
Transaminases increased
|
0.16%
1/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.16%
1/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Jaw disorder
|
0.16%
1/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.33%
2/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.16%
1/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Spinal deformity
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute leukaemia
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Central nervous system lymphoma
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.16%
1/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Liposarcoma
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian adenoma
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary gland adenoma
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Soft tissue sarcoma
|
0.16%
1/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Nervous system disorders
Alcoholic seizure
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Nervous system disorders
Cerebrovascular disorder
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Nervous system disorders
Hypertensive encephalopathy
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Nervous system disorders
Ischaemic neuropathy
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Nervous system disorders
Seizure
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Nervous system disorders
Syncope
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Nervous system disorders
Transient global amnesia
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.32%
2/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Psychiatric disorders
Depression
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Psychiatric disorders
Suicide attempt
|
0.16%
1/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Renal and urinary disorders
Calculus urethral
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Renal and urinary disorders
Nephritis
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Reproductive system and breast disorders
Cystocele
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Reproductive system and breast disorders
Endometriosis
|
0.16%
1/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.16%
1/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.16%
1/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.5%
9/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
2.4%
15/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
2.0%
12/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
1.3%
8/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
1.5%
9/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.32%
2/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.16%
1/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.16%
1/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.49%
3/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus polyp
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.32%
2/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Vascular disorders
Angiopathy
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Vascular disorders
Aortic dissection
|
0.16%
1/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Vascular disorders
Aortic dissection rupture
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Vascular disorders
Deep vein thrombosis
|
0.32%
2/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Vascular disorders
Haemorrhagic vasculitis
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.16%
1/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Vascular disorders
Hypertension
|
0.00%
0/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.32%
2/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Vascular disorders
Hypertensive crisis
|
0.16%
1/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Vascular disorders
Thrombophlebitis
|
0.16%
1/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Vascular disorders
Varicose vein
|
0.32%
2/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
Other adverse events
| Measure |
QVM149 150/50/160 μg o.d.
n=616 participants at risk
QVM149 150/50/160 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QVM149 150/50/80 μg o.d.
n=617 participants at risk
QVM149 150/50/80 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QMF149 150/320 μg o.d.
n=613 participants at risk
QMF149 150/320 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
QMF149 150/160 μg o.d.
n=608 participants at risk
QMF149 150/160 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
|
Salmeterol/Fluticasone 50/500 μg b.i.d.
n=618 participants at risk
Salmeterol xinafoate /fluticasone propionate 50/500 μg twice daily (b.i.d.) delivered via Accuhaler®
|
|---|---|---|---|---|---|
|
Infections and infestations
Rhinitis
|
1.9%
12/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
3.2%
20/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
2.8%
17/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
3.3%
20/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
1.8%
11/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Sinusitis
|
2.3%
14/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
2.9%
18/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
1.5%
9/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
2.8%
17/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
2.3%
14/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.4%
33/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
7.3%
45/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
8.5%
52/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
7.9%
48/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
8.4%
52/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
General disorders
Pyrexia
|
2.8%
17/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
1.8%
11/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
1.6%
10/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
1.6%
10/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
2.4%
15/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Bronchitis
|
8.0%
49/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
7.8%
48/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
7.5%
46/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
7.2%
44/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
8.9%
55/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Influenza
|
3.1%
19/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
3.4%
21/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
3.8%
23/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
4.3%
26/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
4.0%
25/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Lower respiratory tract infection
|
2.1%
13/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
1.9%
12/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
2.0%
12/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
2.8%
17/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
3.6%
22/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Nasopharyngitis
|
10.4%
64/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
12.3%
76/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
11.9%
73/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
10.5%
64/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
13.4%
83/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Pharyngitis
|
3.6%
22/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
3.4%
21/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
3.3%
20/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
3.1%
19/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
3.2%
20/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Respiratory tract infection viral
|
2.9%
18/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
2.8%
17/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
1.8%
11/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
4.8%
29/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
3.6%
22/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Upper respiratory tract infection bacterial
|
2.8%
17/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
3.6%
22/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
4.4%
27/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
4.6%
28/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
4.7%
29/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Urinary tract infection
|
1.3%
8/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.81%
5/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
1.6%
10/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
1.5%
9/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
2.1%
13/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
3.4%
21/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
5.0%
31/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
6.2%
38/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
4.3%
26/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
7.6%
47/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.32%
2/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
2.3%
14/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.82%
5/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
2.0%
12/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
1.6%
10/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.9%
12/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
2.9%
18/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
2.9%
18/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
2.6%
16/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
2.3%
14/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Nervous system disorders
Headache
|
3.7%
23/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
4.9%
30/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
3.9%
24/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
5.6%
34/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
4.0%
25/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
39.4%
243/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
39.2%
242/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
40.6%
249/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
43.6%
265/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
49.5%
306/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.9%
24/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
2.9%
18/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
1.8%
11/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
2.3%
14/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
2.4%
15/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
3.9%
24/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
2.1%
13/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
1.6%
10/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
1.5%
9/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
1.9%
12/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
3.1%
19/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
2.8%
17/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
1.5%
9/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
2.5%
15/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
3.2%
20/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Vascular disorders
Hypertension
|
2.6%
16/616 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
3.1%
19/617 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
2.3%
14/613 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
2.8%
17/608 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
3.7%
23/618 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (52 weeks on average, up to 416 days).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. Novartis does not prohibit any investigator from publishing. Any publications from a single site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER