Trial Outcomes & Findings for Dose-range Finding Efficacy and Safety Study for QBW251 in COPD Patients (NCT NCT04072887)
NCT ID: NCT04072887
Last Updated: 2023-04-28
Results Overview
The primary efficacy analysis assessed the effect of QBW251 on the absolute change from baseline in trough FEV1 in liters on Week 12. Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Baseline measurement was defined as the baseline visit pre-bronchodilator spirometry assessment. Change from baseline in the FEV1 mean scores were analyzed using a Mixed Model for Repeated Measures (MMRM): treatment + baseline score + smoking status at screening + run-in FEV1 + airflow limitation severity + region + time interval + treatment\*time interval interaction + baseline score\*time interval interaction.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
974 participants
Primary outcome timeframe
Baseline and Week 12
Results posted on
2023-04-28
Participant Flow
Participants were recruited from 149 sites in 26 countries.
Participants underwent a Screening period of up to 1 week. Then, participants entered the run-in period of up to 2 weeks to establish baseline values for symptom assessments, to standardize the COPD background therapy and to complete eligibility assessments.
Participant milestones
| Measure |
QBW251 450 mg
QBW251 was orally administered 450 mg b.i.d for 24 weeks
|
QBW251 300 mg
QBW251 was orally administered 300 mg b.i.d for 24 weeks
|
QBW251 150 mg
QBW251 was orally administered 150 mg b.i.d for 24 weeks
|
QBW251 75 mg
QBW251 was orally administered 75 mg b.i.d for 24 weeks
|
QBW251 25 mg
QBW251 was orally administered 25 mg b.i.d for 24 weeks
|
Placebo
Placebo was orally administered b.i.d for 24 weeks
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
99
|
250
|
124
|
126
|
124
|
251
|
|
Overall Study
Pharmacokinetic (PK) Set
|
99
|
250
|
123
|
126
|
124
|
0
|
|
Overall Study
Serial Pharmacokinetic (PK) Set
|
14
|
21
|
14
|
13
|
14
|
0
|
|
Overall Study
COMPLETED
|
91
|
233
|
122
|
117
|
118
|
236
|
|
Overall Study
NOT COMPLETED
|
8
|
17
|
2
|
9
|
6
|
15
|
Reasons for withdrawal
| Measure |
QBW251 450 mg
QBW251 was orally administered 450 mg b.i.d for 24 weeks
|
QBW251 300 mg
QBW251 was orally administered 300 mg b.i.d for 24 weeks
|
QBW251 150 mg
QBW251 was orally administered 150 mg b.i.d for 24 weeks
|
QBW251 75 mg
QBW251 was orally administered 75 mg b.i.d for 24 weeks
|
QBW251 25 mg
QBW251 was orally administered 25 mg b.i.d for 24 weeks
|
Placebo
Placebo was orally administered b.i.d for 24 weeks
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
8
|
1
|
3
|
3
|
13
|
|
Overall Study
Adverse Event
|
2
|
4
|
1
|
4
|
0
|
1
|
|
Overall Study
Physician Decision
|
2
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
0
|
0
|
0
|
0
|
|
Overall Study
Death
|
0
|
2
|
0
|
2
|
3
|
0
|
Baseline Characteristics
Dose-range Finding Efficacy and Safety Study for QBW251 in COPD Patients
Baseline characteristics by cohort
| Measure |
QBW251 450 mg
n=99 Participants
QBW251 was orally administered 450 mg b.i.d for 24 weeks
|
QBW251 300 mg
n=250 Participants
QBW251 was orally administered 300 mg b.i.d for 24 weeks
|
QBW251 150 mg
n=124 Participants
QBW251 was orally administered 150 mg b.i.d for 24 weeks
|
QBW251 75 mg
n=126 Participants
QBW251 was orally administered 75 mg b.i.d for 24 weeks
|
QBW251 25 mg
n=124 Participants
QBW251 was orally administered 25 mg b.i.d for 24 weeks
|
Placebo
n=251 Participants
Placebo was orally administered b.i.d for 24 weeks
|
Total
n=974 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
66.5 Years
STANDARD_DEVIATION 7.28 • n=5 Participants
|
66.6 Years
STANDARD_DEVIATION 7.56 • n=7 Participants
|
66.7 Years
STANDARD_DEVIATION 6.58 • n=5 Participants
|
65.7 Years
STANDARD_DEVIATION 8.30 • n=4 Participants
|
67.0 Years
STANDARD_DEVIATION 7.83 • n=21 Participants
|
66.7 Years
STANDARD_DEVIATION 7.59 • n=8 Participants
|
66.6 Years
STANDARD_DEVIATION 7.55 • n=8 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
99 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
49 Participants
n=21 Participants
|
92 Participants
n=8 Participants
|
373 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
63 Participants
n=5 Participants
|
151 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
76 Participants
n=4 Participants
|
75 Participants
n=21 Participants
|
159 Participants
n=8 Participants
|
601 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
26 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
43 Participants
n=8 Participants
|
166 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
21 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
87 Participants
n=5 Participants
|
193 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
96 Participants
n=4 Participants
|
93 Participants
n=21 Participants
|
198 Participants
n=8 Participants
|
761 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: The overall number of participants analyzed includes all randomized participants with a value at both baseline and week 12. Results for the QBW251 450 mg arm need to be interpreted with caution as the arm was discontinued early based on a pre-defined pharmacokinetic exposure stopping rule.
The primary efficacy analysis assessed the effect of QBW251 on the absolute change from baseline in trough FEV1 in liters on Week 12. Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Baseline measurement was defined as the baseline visit pre-bronchodilator spirometry assessment. Change from baseline in the FEV1 mean scores were analyzed using a Mixed Model for Repeated Measures (MMRM): treatment + baseline score + smoking status at screening + run-in FEV1 + airflow limitation severity + region + time interval + treatment\*time interval interaction + baseline score\*time interval interaction.
Outcome measures
| Measure |
QBW251 450 mg
n=42 Participants
QBW251 was orally administered 450 mg b.i.d for 24 weeks
|
QBW251 300 mg
n=209 Participants
QBW251 was orally administered 300 mg b.i.d for 24 weeks
|
QBW251 150 mg
n=111 Participants
QBW251 was orally administered 150 mg b.i.d for 24 weeks
|
QBW251 75 mg
n=112 Participants
QBW251 was orally administered 75 mg b.i.d for 24 weeks
|
QBW251 25 mg
n=105 Participants
QBW251 was orally administered 25 mg b.i.d for 24 weeks
|
Placebo
n=219 Participants
Placebo was orally administered b.i.d for 24 weeks
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Week 12
|
0.013 Liter
Standard Error 0.021
|
0.013 Liter
Standard Error 0.0103
|
0.014 Liter
Standard Error 0.0142
|
0.021 Liter
Standard Error 0.0141
|
0.006 Liter
Standard Error 0.0144
|
0.001 Liter
Standard Error 0.0101
|
SECONDARY outcome
Timeframe: Baseline, weeks 4, 8, 16, 20 and 24Population: The overall number of participants analyzed includes all randomized participants. The number analyzed per row represents participants with evaluable data at each time point. Results for the QBW251 450 mg arm need to be interpreted with caution as the arm was discontinued early based on a pre-defined pharmacokinetic exposure stopping rule.
The primary efficacy analysis assessed the effect of QBW251 on the absolute change from baseline in trough FEV1 in liters compared to placebo on Weeks 4, 8, 16, 20 and 24. Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Baseline measurement was defined as the baseline visit pre-bronchodilator spirometry assessment. A positive trend for change from baseline in FEV1 across the dose range is considered a favorable outcome.
Outcome measures
| Measure |
QBW251 450 mg
n=80 Participants
QBW251 was orally administered 450 mg b.i.d for 24 weeks
|
QBW251 300 mg
n=224 Participants
QBW251 was orally administered 300 mg b.i.d for 24 weeks
|
QBW251 150 mg
n=115 Participants
QBW251 was orally administered 150 mg b.i.d for 24 weeks
|
QBW251 75 mg
n=117 Participants
QBW251 was orally administered 75 mg b.i.d for 24 weeks
|
QBW251 25 mg
n=114 Participants
QBW251 was orally administered 25 mg b.i.d for 24 weeks
|
Placebo
n=221 Participants
Placebo was orally administered b.i.d for 24 weeks
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
Week 4
|
0.007 Liter
Standard Deviation 0.14
|
0.007 Liter
Standard Deviation 0.15
|
0.009 Liter
Standard Deviation 0.13
|
0.000 Liter
Standard Deviation 0.14
|
0.009 Liter
Standard Deviation 0.14
|
0.005 Liter
Standard Deviation 0.13
|
|
Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
Week 8
|
0.028 Liter
Standard Deviation 0.14
|
0.013 Liter
Standard Deviation 0.16
|
-0.002 Liter
Standard Deviation 0.13
|
0.002 Liter
Standard Deviation 0.15
|
0.016 Liter
Standard Deviation 0.16
|
0.009 Liter
Standard Deviation 0.15
|
|
Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
Week 16
|
0.013 Liter
Standard Deviation 0.18
|
0.003 Liter
Standard Deviation 0.16
|
0.005 Liter
Standard Deviation 0.14
|
0.011 Liter
Standard Deviation 0.15
|
0.007 Liter
Standard Deviation 0.17
|
-0.011 Liter
Standard Deviation 0.14
|
|
Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
Week 20
|
-0.031 Liter
Standard Deviation 0.20
|
0.005 Liter
Standard Deviation 0.18
|
0.012 Liter
Standard Deviation 0.13
|
0.001 Liter
Standard Deviation 0.16
|
0.003 Liter
Standard Deviation 0.16
|
-0.007 Liter
Standard Deviation 0.15
|
|
Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
Week 24
|
0.033 Liter
Standard Deviation 0.13
|
0.023 Liter
Standard Deviation 0.19
|
0.004 Liter
Standard Deviation 0.16
|
0.003 Liter
Standard Deviation 0.19
|
0.003 Liter
Standard Deviation 0.17
|
-0.013 Liter
Standard Deviation 0.16
|
SECONDARY outcome
Timeframe: Baseline, weeks 12 and 24Population: The overall number of participants analyzed includes all randomized participants. The number analyzed per row represents participants with evaluable data at each time point. QBW251 450 mg arm was excluded from the analysis as it was discontinued early based on a pre-defined pharmacokinetic exposure stopping rule.
The E-RS assesses overall daily respiratory COPD symptoms (Total score) and it is derived as the sum of 11 severity items; a higher scores indicate more severe symptoms. E-RS total score has a range of 0 to 40. Change from baseline in the E-RS Total weekly mean scores were analyzed using a Mixed Model for Repeated Measures (MMRM): treatment + baseline score + smoking status at screening + run-in E-RS + airflow limitation severity + region + time interval + treatment\*time interval interaction + baseline score\*time interval interaction. The mean baseline E-RS Total score was the average of the corresponding daily scores from the run-in period. A negative change from baseline corresponds to improvement in symptoms severity.
Outcome measures
| Measure |
QBW251 450 mg
n=196 Participants
QBW251 was orally administered 450 mg b.i.d for 24 weeks
|
QBW251 300 mg
n=106 Participants
QBW251 was orally administered 300 mg b.i.d for 24 weeks
|
QBW251 150 mg
n=112 Participants
QBW251 was orally administered 150 mg b.i.d for 24 weeks
|
QBW251 75 mg
n=105 Participants
QBW251 was orally administered 75 mg b.i.d for 24 weeks
|
QBW251 25 mg
n=214 Participants
QBW251 was orally administered 25 mg b.i.d for 24 weeks
|
Placebo
Placebo was orally administered b.i.d for 24 weeks
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Evaluating Respiratory Symptoms (E-RS); Total Score
Week 12
|
-1.75 Score on a scale
Standard Error 0.234
|
-1.26 Score on a scale
Standard Error 0.323
|
-1.66 Score on a scale
Standard Error 0.317
|
-1.30 Score on a scale
Standard Error 0.324
|
-1.41 Score on a scale
Standard Error 0.228
|
—
|
|
Change From Baseline in Evaluating Respiratory Symptoms (E-RS); Total Score
Week 24
|
-2.16 Score on a scale
Standard Error 0.239
|
-1.37 Score on a scale
Standard Error 0.327
|
-1.36 Score on a scale
Standard Error 0.325
|
-1.36 Score on a scale
Standard Error 0.333
|
-1.31 Score on a scale
Standard Error 0.232
|
—
|
SECONDARY outcome
Timeframe: Baseline, weeks 12 and 24Population: The overall number of participants analyzed includes all randomized participants. The number analyzed per row represents participants with evaluable data at each time point. QBW251 450 mg arm was excluded from the analysis as it was discontinued early based on a pre-defined pharmacokinetic exposure stopping rule.
The E-RS assesses both overall daily respiratory COPD symptoms (Total score) and specific respiratory symptoms using 3 subscales (Breathlessness, Cough \& Sputum, and Chest Symptoms). The E-RS comprises 11 severity items and higher scores indicate more severe symptoms. The Cough and Sputum subscale score has a range of 0 to 11 and was derived as the sum of items 2 - 4. Change from baseline in the E-RS Cough and Sputum weekly mean scores were analyzed using a Mixed Model for Repeated Measures (MMRM): treatment + baseline score + smoking status at screening + run-in E-RS + airflow limitation severity + region + time interval + treatment\*time interval interaction + baseline score\*time interval interaction. The mean baseline E-RS Cough \& Sputum subscale score was the average of the corresponding daily scores from the run-in period. Lower scores in the change from baseline correspond to lower symptom severity.
Outcome measures
| Measure |
QBW251 450 mg
n=196 Participants
QBW251 was orally administered 450 mg b.i.d for 24 weeks
|
QBW251 300 mg
n=106 Participants
QBW251 was orally administered 300 mg b.i.d for 24 weeks
|
QBW251 150 mg
n=112 Participants
QBW251 was orally administered 150 mg b.i.d for 24 weeks
|
QBW251 75 mg
n=105 Participants
QBW251 was orally administered 75 mg b.i.d for 24 weeks
|
QBW251 25 mg
n=214 Participants
QBW251 was orally administered 25 mg b.i.d for 24 weeks
|
Placebo
Placebo was orally administered b.i.d for 24 weeks
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Evaluating Respiratory Symptoms (E-RS); Cough and Sputum Score
Week 12
|
-0.78 Score on a scale
Standard Error 0.077
|
-0.63 Score on a scale
Standard Error 0.105
|
-0.52 Score on a scale
Standard Error 0.104
|
-0.22 Score on a scale
Standard Error 0.106
|
-0.44 Score on a scale
Standard Error 0.074
|
—
|
|
Change From Baseline in Evaluating Respiratory Symptoms (E-RS); Cough and Sputum Score
Week 24
|
-0.90 Score on a scale
Standard Error 0.078
|
-0.68 Score on a scale
Standard Error 0.107
|
-0.51 Score on a scale
Standard Error 0.106
|
-0.26 Score on a scale
Standard Error 0.109
|
-0.50 Score on a scale
Standard Error 0.076
|
—
|
SECONDARY outcome
Timeframe: Baseline, weeks 12 and 24Population: The overall number of participants analyzed includes all randomized participants. The number analyzed per row represents participants with evaluable data at each time point. QBW251 450 mg arm was excluded from the analysis as it was discontinued early based on a pre-defined pharmacokinetic exposure stopping rule.
The PGI-S questionnaire is a patient-reported outcomes score that rates the severity of the respiratory symptoms and of cough and mucus. The change in severity scores (Better, No change and Worse) from baseline were reported at weeks 12 and 24. Thus, the number of participants with a Better change in the severity score are reported in the table below.
Outcome measures
| Measure |
QBW251 450 mg
n=218 Participants
QBW251 was orally administered 450 mg b.i.d for 24 weeks
|
QBW251 300 mg
n=116 Participants
QBW251 was orally administered 300 mg b.i.d for 24 weeks
|
QBW251 150 mg
n=114 Participants
QBW251 was orally administered 150 mg b.i.d for 24 weeks
|
QBW251 75 mg
n=108 Participants
QBW251 was orally administered 75 mg b.i.d for 24 weeks
|
QBW251 25 mg
n=218 Participants
QBW251 was orally administered 25 mg b.i.d for 24 weeks
|
Placebo
Placebo was orally administered b.i.d for 24 weeks
|
|---|---|---|---|---|---|---|
|
Number of Participants With a "Better" Change in the Patient Global Impression of Severity (PGI-S) From Baseline
Week 12 - Respiratory Symptoms
|
66 Participants
|
27 Participants
|
35 Participants
|
33 Participants
|
64 Participants
|
—
|
|
Number of Participants With a "Better" Change in the Patient Global Impression of Severity (PGI-S) From Baseline
Week 24 - Respiratory Symptoms
|
72 Participants
|
28 Participants
|
40 Participants
|
31 Participants
|
79 Participants
|
—
|
|
Number of Participants With a "Better" Change in the Patient Global Impression of Severity (PGI-S) From Baseline
Week 12 - Cough and mucus
|
85 Participants
|
55 Participants
|
54 Participants
|
41 Participants
|
78 Participants
|
—
|
|
Number of Participants With a "Better" Change in the Patient Global Impression of Severity (PGI-S) From Baseline
Week 24 - Cough and mucus
|
104 Participants
|
57 Participants
|
50 Participants
|
37 Participants
|
96 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline, weeks 12 and 24Population: The overall number of participants analyzed includes all randomized participants. The number analyzed per row represents participants with evaluable data at each time point. QBW251 450 mg arm was excluded from the analysis as it was discontinued early based on a pre-defined pharmacokinetic exposure stopping rule.
The CASA-Q is a validated questionnaire instrument used to measure cough and sputum production, and their impact in patients COPD and/or chronic bronchitis. It contains a total of 20 items on a 5-step scale distributed in 4 domains: Cough symptoms, Cough impact, Sputum symptoms and Sputum impact. All items are rescored from 1-5 to 0-4 and then reverse scored such that better responses have higher scores. The four domains are ranged from 0-100 where higher scores associated with fewer symptoms/less impact due to cough or sputum. Change from baseline in the CASA-Q cough and symptoms scores were analyzed using a Mixed Model for Repeated Measures (MMRM): treatment + baseline score + smoking status at screening + run-in E-RS + airflow limitation severity + region + time interval + treatment\*time interval interaction + baseline score\*time interval interaction.
Outcome measures
| Measure |
QBW251 450 mg
n=217 Participants
QBW251 was orally administered 450 mg b.i.d for 24 weeks
|
QBW251 300 mg
n=115 Participants
QBW251 was orally administered 300 mg b.i.d for 24 weeks
|
QBW251 150 mg
n=114 Participants
QBW251 was orally administered 150 mg b.i.d for 24 weeks
|
QBW251 75 mg
n=108 Participants
QBW251 was orally administered 75 mg b.i.d for 24 weeks
|
QBW251 25 mg
n=218 Participants
QBW251 was orally administered 25 mg b.i.d for 24 weeks
|
Placebo
Placebo was orally administered b.i.d for 24 weeks
|
|---|---|---|---|---|---|---|
|
Change From Baseline in the Cough and Sputum Assessment Questionnaire (CASA-Q)
Cough symptoms score, week 12
|
6.06 Score on a scale
Standard Error 1.082
|
8.82 Score on a scale
Standard Error 1.488
|
6.68 Score on a scale
Standard Error 1.498
|
6.73 Score on a scale
Standard Error 1.535
|
6.06 Score on a scale
Standard Error 1.077
|
—
|
|
Change From Baseline in the Cough and Sputum Assessment Questionnaire (CASA-Q)
Cough symptoms score, week 24
|
10.49 Score on a scale
Standard Error 1.148
|
10.59 Score on a scale
Standard Error 1.556
|
8.04 Score on a scale
Standard Error 1.575
|
5.84 Score on a scale
Standard Error 1.623
|
7.25 Score on a scale
Standard Error 1.118
|
—
|
|
Change From Baseline in the Cough and Sputum Assessment Questionnaire (CASA-Q)
Cough impact score, week 12
|
4.97 Score on a scale
Standard Error 0.983
|
5.94 Score on a scale
Standard Error 1.352
|
5.89 Score on a scale
Standard Error 1.359
|
5.03 Score on a scale
Standard Error 1.394
|
5.26 Score on a scale
Standard Error 0.978
|
—
|
|
Change From Baseline in the Cough and Sputum Assessment Questionnaire (CASA-Q)
Cough impact score, week 24
|
7.08 Score on a scale
Standard Error 0.983
|
8.29 Score on a scale
Standard Error 1.334
|
7.51 Score on a scale
Standard Error 1.349
|
4.02 Score on a scale
Standard Error 1.391
|
7.12 Score on a scale
Standard Error 0.958
|
—
|
|
Change From Baseline in the Cough and Sputum Assessment Questionnaire (CASA-Q)
Sputum symptoms score, week 12
|
7.74 Score on a scale
Standard Error 1.142
|
8.51 Score on a scale
Standard Error 1.571
|
7.01 Score on a scale
Standard Error 1.580
|
5.74 Score on a scale
Standard Error 1.620
|
6.96 Score on a scale
Standard Error 1.136
|
—
|
|
Change From Baseline in the Cough and Sputum Assessment Questionnaire (CASA-Q)
Sputum symptoms score, week 24
|
10.52 Score on a scale
Standard Error 1.242
|
11.34 Score on a scale
Standard Error 1.685
|
5.81 Score on a scale
Standard Error 1.704
|
4.64 Score on a scale
Standard Error 1.756
|
9.05 Score on a scale
Standard Error 1.211
|
—
|
|
Change From Baseline in the Cough and Sputum Assessment Questionnaire (CASA-Q)
Sputum impact score, week 12
|
5.88 Score on a scale
Standard Error 1.011
|
6.58 Score on a scale
Standard Error 1.391
|
6.98 Score on a scale
Standard Error 1.398
|
4.35 Score on a scale
Standard Error 1.433
|
4.72 Score on a scale
Standard Error 1.005
|
—
|
|
Change From Baseline in the Cough and Sputum Assessment Questionnaire (CASA-Q)
Sputum impact score, week 24
|
7.14 Score on a scale
Standard Error 1.032
|
7.66 Score on a scale
Standard Error 1.401
|
7.75 Score on a scale
Standard Error 1.417
|
4.40 Score on a scale
Standard Error 1.460
|
7.04 Score on a scale
Standard Error 1.007
|
—
|
SECONDARY outcome
Timeframe: Baseline, weeks 12 and 24Population: The overall number of participants analyzed includes all randomized participants. The number analyzed per row represents participants with evaluable data at each time point. Results for the QBW251 450 mg arm need to be interpreted with caution as the arm was discontinued early based on a pre-defined pharmacokinetic exposure stopping rule.
SGRQ measures health impairment and contains 50 items divided into three components: Symptoms, Activity and Impacts. A score was calculated for each component and a "Total" score was also calculated. In each case the lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of quality of life. Change from baseline in the SGRQ scores were analyzed using a Mixed Model for Repeated Measures (MMRM): treatment + baseline score + smoking status at screening + baseline SGRQ score + airflow limitation severity + region + time interval + treatment\*time interval interaction + baseline score\*time interval interaction.
Outcome measures
| Measure |
QBW251 450 mg
n=48 Participants
QBW251 was orally administered 450 mg b.i.d for 24 weeks
|
QBW251 300 mg
n=222 Participants
QBW251 was orally administered 300 mg b.i.d for 24 weeks
|
QBW251 150 mg
n=117 Participants
QBW251 was orally administered 150 mg b.i.d for 24 weeks
|
QBW251 75 mg
n=116 Participants
QBW251 was orally administered 75 mg b.i.d for 24 weeks
|
QBW251 25 mg
n=111 Participants
QBW251 was orally administered 25 mg b.i.d for 24 weeks
|
Placebo
n=221 Participants
Placebo was orally administered b.i.d for 24 weeks
|
|---|---|---|---|---|---|---|
|
Change From Baseline in St. George's Respiratory Questionnaire (SGRQ)
Week 12 - Total score
|
-0.34 Score on a scale
Standard Error 11.17
|
-5.84 Score on a scale
Standard Error 14.82
|
-3.14 Score on a scale
Standard Error 12.67
|
-6.78 Score on a scale
Standard Error 14.64
|
-3.85 Score on a scale
Standard Error 10.82
|
-3.36 Score on a scale
Standard Error 13.27
|
|
Change From Baseline in St. George's Respiratory Questionnaire (SGRQ)
Week 24 - Total score
|
-2.93 Score on a scale
Standard Error 10.58
|
-6.48 Score on a scale
Standard Error 15.35
|
-3.69 Score on a scale
Standard Error 12.39
|
-6.06 Score on a scale
Standard Error 14.88
|
-1.70 Score on a scale
Standard Error 10.97
|
-4.37 Score on a scale
Standard Error 13.00
|
|
Change From Baseline in St. George's Respiratory Questionnaire (SGRQ)
Week 12 - Symptoms score
|
-5.24 Score on a scale
Standard Error 21.16
|
-8.23 Score on a scale
Standard Error 18.73
|
-5.70 Score on a scale
Standard Error 18.39
|
-6.93 Score on a scale
Standard Error 19.29
|
-5.59 Score on a scale
Standard Error 16.52
|
-6.07 Score on a scale
Standard Error 17.14
|
|
Change From Baseline in St. George's Respiratory Questionnaire (SGRQ)
Week 24 - Symptoms score
|
-7.90 Score on a scale
Standard Error 22.47
|
-10.59 Score on a scale
Standard Error 21.06
|
-7.09 Score on a scale
Standard Error 17.02
|
-8.42 Score on a scale
Standard Error 18.21
|
-5.16 Score on a scale
Standard Error 15.61
|
-6.97 Score on a scale
Standard Error 17.39
|
|
Change From Baseline in St. George's Respiratory Questionnaire (SGRQ)
Week 12 - Activity score
|
-2.00 Score on a scale
Standard Error 10.83
|
-4.80 Score on a scale
Standard Error 17.67
|
-4.72 Score on a scale
Standard Error 17.35
|
-7.27 Score on a scale
Standard Error 17.48
|
-4.06 Score on a scale
Standard Error 14.68
|
-2.40 Score on a scale
Standard Error 15.21
|
|
Change From Baseline in St. George's Respiratory Questionnaire (SGRQ)
Week 24 - Activity score
|
-1.25 Score on a scale
Standard Error 12.50
|
-5.12 Score on a scale
Standard Error 17.36
|
-3.69 Score on a scale
Standard Error 16.37
|
-5.80 Score on a scale
Standard Error 20.47
|
-1.20 Score on a scale
Standard Error 14.36
|
-4.27 Score on a scale
Standard Error 16.07
|
|
Change From Baseline in St. George's Respiratory Questionnaire (SGRQ)
Week 12 - Impacts score
|
2.03 Score on a scale
Standard Error 14.28
|
-5.69 Score on a scale
Standard Error 17.06
|
-1.49 Score on a scale
Standard Error 13.88
|
-6.42 Score on a scale
Standard Error 16.63
|
-3.13 Score on a scale
Standard Error 13.11
|
-3.11 Score on a scale
Standard Error 15.90
|
|
Change From Baseline in St. George's Respiratory Questionnaire (SGRQ)
Week 24 - Impacts score
|
-2.21 Score on a scale
Standard Error 8.24
|
-6.04 Score on a scale
Standard Error 17.455
|
-2.63 Score on a scale
Standard Error 14.18
|
-5.44 Score on a scale
Standard Error 16.05
|
-1.04 Score on a scale
Standard Error 13.95
|
-3.68 Score on a scale
Standard Error 14.95
|
SECONDARY outcome
Timeframe: Pre-dose on Days 15, 29, 57, 85, 113, 141 and 169Population: The overall number of participants analyzed includes the PK analysis set. The number analyzed per row represents participants with evaluable data at each time point. Results for the QBW251 450 mg arm need to be interpreted with caution as the arm was discontinued early based on a pre-defined pharmacokinetic exposure stopping rule.
Venous whole blood samples were collected for pharmacokinetics characterization. Cmin was measured pre dose at all visits and was summarized using descriptive statistics. All concentrations below the lower limit of quantification (LLOQ) were treated as zero.
Outcome measures
| Measure |
QBW251 450 mg
n=75 Participants
QBW251 was orally administered 450 mg b.i.d for 24 weeks
|
QBW251 300 mg
n=180 Participants
QBW251 was orally administered 300 mg b.i.d for 24 weeks
|
QBW251 150 mg
n=101 Participants
QBW251 was orally administered 150 mg b.i.d for 24 weeks
|
QBW251 75 mg
n=100 Participants
QBW251 was orally administered 75 mg b.i.d for 24 weeks
|
QBW251 25 mg
n=96 Participants
QBW251 was orally administered 25 mg b.i.d for 24 weeks
|
Placebo
Placebo was orally administered b.i.d for 24 weeks
|
|---|---|---|---|---|---|---|
|
Minimum Plasma Concentration (Cmin) for QBW251
Day 169
|
637 ng/mL
Standard Deviation 349
|
465 ng/mL
Standard Deviation 618
|
128 ng/mL
Standard Deviation 147
|
44.9 ng/mL
Standard Deviation 61.1
|
8.97 ng/mL
Standard Deviation 8.08
|
—
|
|
Minimum Plasma Concentration (Cmin) for QBW251
Day 15
|
1280 ng/mL
Standard Deviation 1700
|
619 ng/mL
Standard Deviation 1230
|
143 ng/mL
Standard Deviation 158
|
44.0 ng/mL
Standard Deviation 49.0
|
12.7 ng/mL
Standard Deviation 15.5
|
—
|
|
Minimum Plasma Concentration (Cmin) for QBW251
Day 29
|
951 ng/mL
Standard Deviation 1050
|
571 ng/mL
Standard Deviation 923
|
125 ng/mL
Standard Deviation 123
|
47.8 ng/mL
Standard Deviation 47.3
|
10.1 ng/mL
Standard Deviation 10.1
|
—
|
|
Minimum Plasma Concentration (Cmin) for QBW251
Day 57
|
1040 ng/mL
Standard Deviation 1330
|
572 ng/mL
Standard Deviation 833
|
116 ng/mL
Standard Deviation 103
|
47.7 ng/mL
Standard Deviation 62.2
|
14.2 ng/mL
Standard Deviation 25.5
|
—
|
|
Minimum Plasma Concentration (Cmin) for QBW251
Day 85
|
1080 ng/mL
Standard Deviation 1360
|
587 ng/mL
Standard Deviation 951
|
119 ng/mL
Standard Deviation 147
|
49.7 ng/mL
Standard Deviation 71.2
|
9.93 ng/mL
Standard Deviation 10.3
|
—
|
|
Minimum Plasma Concentration (Cmin) for QBW251
Day 113
|
859 ng/mL
Standard Deviation 1150
|
593 ng/mL
Standard Deviation 1000
|
120 ng/mL
Standard Deviation 130
|
52.7 ng/mL
Standard Deviation 73.9
|
9.89 ng/mL
Standard Deviation 9.20
|
—
|
|
Minimum Plasma Concentration (Cmin) for QBW251
Day 141
|
1150 ng/mL
Standard Deviation 1150
|
552 ng/mL
Standard Deviation 923
|
118 ng/mL
Standard Deviation 103
|
66.8 ng/mL
Standard Deviation 226
|
15.9 ng/mL
Standard Deviation 45.7
|
—
|
SECONDARY outcome
Timeframe: Days 1, 15 and 169Population: The overall number of participants analyzed includes the PK analysis set. The number analyzed per row represents participants with evaluable data at each time point. Results for the QBW251 450 mg arm need to be interpreted with caution as the arm was discontinued early based on a pre-defined pharmacokinetic exposure stopping rule.
Venous whole blood samples were collected for pharmacokinetics characterization. Cmax was calculated from plasma concentration data using non-compartmental methods and summarized using descriptive statistics. Cmax was measured in the samples taken at 3 hours post-dose with the exception of the participants included in the Serial PK set on Days 1 and 15 for whom all samples (1, 2, 4, 6, and 8 hours post-dose) were taken into consideration for the measurement of Cmax. All concentrations below the lower limit of quantification (LLOQ) were treated as zero.
Outcome measures
| Measure |
QBW251 450 mg
n=93 Participants
QBW251 was orally administered 450 mg b.i.d for 24 weeks
|
QBW251 300 mg
n=222 Participants
QBW251 was orally administered 300 mg b.i.d for 24 weeks
|
QBW251 150 mg
n=110 Participants
QBW251 was orally administered 150 mg b.i.d for 24 weeks
|
QBW251 75 mg
n=115 Participants
QBW251 was orally administered 75 mg b.i.d for 24 weeks
|
QBW251 25 mg
n=124 Participants
QBW251 was orally administered 25 mg b.i.d for 24 weeks
|
Placebo
Placebo was orally administered b.i.d for 24 weeks
|
|---|---|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) for QBW251
Day 1
|
1280 ng/mL
Standard Deviation 847
|
751 ng/mL
Standard Deviation 598
|
251 ng/mL
Standard Deviation 238
|
68.9 ng/mL
Standard Deviation 64.5
|
14.4 ng/mL
Standard Deviation 15.2
|
—
|
|
Maximum Plasma Concentration (Cmax) for QBW251
Day 15
|
2500 ng/mL
Standard Deviation 1710
|
1320 ng/mL
Standard Deviation 1030
|
411 ng/mL
Standard Deviation 368
|
114 ng/mL
Standard Deviation 101
|
26.1 ng/mL
Standard Deviation 20.6
|
—
|
|
Maximum Plasma Concentration (Cmax) for QBW251
Day 169
|
2370 ng/mL
Standard Deviation 1160
|
1210 ng/mL
Standard Deviation 797
|
361 ng/mL
Standard Deviation 303
|
104 ng/mL
Standard Deviation 86.6
|
22.5 ng/mL
Standard Deviation 16.4
|
—
|
SECONDARY outcome
Timeframe: 1, 2, 4, 6, and 8 hours post-dose on Days 1 and 15Population: The overall number of participants analyzed includes the Serial PK analysis set. The number analyzed per row represents participants with evaluable data at each time point.
Venous whole blood samples were collected for pharmacokinetics characterization. Cmax was calculated from plasma concentration data using non-compartmental methods and summarized using descriptive statistics. All concentrations below the lower limit of quantification (LLOQ) were treated as zero.
Outcome measures
| Measure |
QBW251 450 mg
n=14 Participants
QBW251 was orally administered 450 mg b.i.d for 24 weeks
|
QBW251 300 mg
n=16 Participants
QBW251 was orally administered 300 mg b.i.d for 24 weeks
|
QBW251 150 mg
n=13 Participants
QBW251 was orally administered 150 mg b.i.d for 24 weeks
|
QBW251 75 mg
n=13 Participants
QBW251 was orally administered 75 mg b.i.d for 24 weeks
|
QBW251 25 mg
n=13 Participants
QBW251 was orally administered 25 mg b.i.d for 24 weeks
|
Placebo
Placebo was orally administered b.i.d for 24 weeks
|
|---|---|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) for QBW251 in Serial PK Set
Day 1
|
1510 ng/mL
Standard Deviation 928
|
1280 ng/mL
Standard Deviation 622
|
478 ng/mL
Standard Deviation 241
|
96.6 ng/mL
Standard Deviation 72.7
|
25.3 ng/mL
Standard Deviation 29.7
|
—
|
|
Maximum Plasma Concentration (Cmax) for QBW251 in Serial PK Set
Day 15
|
2700 ng/mL
Standard Deviation 1170
|
1870 ng/mL
Standard Deviation 844
|
542 ng/mL
Standard Deviation 523
|
175 ng/mL
Standard Deviation 127
|
39.4 ng/mL
Standard Deviation 27.0
|
—
|
SECONDARY outcome
Timeframe: 1, 2, 4, 6, and 8 hours post-dose on Days 1 and 15Population: The overall number of participants analyzed includes the Serial PK analysis set. The number analyzed per row represents participants with evaluable data at each time point.
Venous whole blood samples were collected for pharmacokinetics characterization. AUC0-24h was calculated from plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics. All concentrations below the lower limit of quantification (LLOQ) were treated as zero.
Outcome measures
| Measure |
QBW251 450 mg
n=11 Participants
QBW251 was orally administered 450 mg b.i.d for 24 weeks
|
QBW251 300 mg
n=14 Participants
QBW251 was orally administered 300 mg b.i.d for 24 weeks
|
QBW251 150 mg
n=11 Participants
QBW251 was orally administered 150 mg b.i.d for 24 weeks
|
QBW251 75 mg
n=12 Participants
QBW251 was orally administered 75 mg b.i.d for 24 weeks
|
QBW251 25 mg
n=12 Participants
QBW251 was orally administered 25 mg b.i.d for 24 weeks
|
Placebo
Placebo was orally administered b.i.d for 24 weeks
|
|---|---|---|---|---|---|---|
|
Area Under the Curve From Time 0 to 24 Hours (AUC0-24h) of QBW251 in Serial PK Set
Day 15
|
30000 ng*h/mL
Standard Deviation 22600
|
16500 ng*h/mL
Standard Deviation 8380
|
4740 ng*h/mL
Standard Deviation 2390
|
1390 ng*h/mL
Standard Deviation 679
|
333 ng*h/mL
Standard Deviation 209
|
—
|
|
Area Under the Curve From Time 0 to 24 Hours (AUC0-24h) of QBW251 in Serial PK Set
Day 1
|
10900 ng*h/mL
Standard Deviation 3740
|
8480 ng*h/mL
Standard Deviation 3660
|
2920 ng*h/mL
Standard Deviation 1140
|
769 ng*h/mL
Standard Deviation 330
|
185 ng*h/mL
Standard Deviation 107
|
—
|
Adverse Events
QBW251 450 mg
Serious events: 10 serious events
Other events: 48 other events
Deaths: 0 deaths
QBW251 300 mg
Serious events: 33 serious events
Other events: 117 other events
Deaths: 2 deaths
QBW251 150 mg
Serious events: 6 serious events
Other events: 59 other events
Deaths: 0 deaths
QBW251 75 mg
Serious events: 14 serious events
Other events: 55 other events
Deaths: 2 deaths
QBW251 25 mg
Serious events: 12 serious events
Other events: 60 other events
Deaths: 3 deaths
Placebo
Serious events: 15 serious events
Other events: 107 other events
Deaths: 0 deaths
Total
Serious events: 90 serious events
Other events: 446 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
QBW251 450 mg
n=99 participants at risk
QBW251 was orally administered 450 mg b.i.d for 24 weeks
|
QBW251 300 mg
n=250 participants at risk
QBW251 was orally administered 300 mg b.i.d for 24 weeks
|
QBW251 150 mg
n=124 participants at risk
QBW251 was orally administered 150 mg b.i.d for 24 weeks
|
QBW251 75 mg
n=126 participants at risk
QBW251 was orally administered 75 mg b.i.d for 24 weeks
|
QBW251 25 mg
n=124 participants at risk
QBW251 was orally administered 25 mg b.i.d for 24 weeks
|
Placebo
n=251 participants at risk
Placebo was orally administered b.i.d for 24 weeks
|
Total
n=974 participants at risk
Total
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.40%
1/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.10%
1/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.79%
1/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.10%
1/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
0/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.40%
1/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.10%
1/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.40%
1/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.10%
1/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Cardiac disorders
Bundle branch block left
|
0.00%
0/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.40%
1/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.10%
1/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.40%
1/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.10%
1/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.79%
1/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.10%
1/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Cardiac disorders
Cor pulmonale
|
0.00%
0/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.81%
1/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.10%
1/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.79%
1/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.10%
1/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.40%
1/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.10%
1/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Cardiac disorders
Supraventricular tachycardia
|
1.0%
1/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.10%
1/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.79%
1/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.10%
1/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Eye disorders
Cataract
|
0.00%
0/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.40%
1/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.10%
1/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Eye disorders
Retinal detachment
|
0.00%
0/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.40%
1/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.10%
1/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.40%
1/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.10%
1/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.79%
1/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.40%
1/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.21%
2/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.40%
1/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.10%
1/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Acute abdomen
|
0.00%
0/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.81%
1/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.10%
1/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.40%
1/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.10%
1/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.79%
1/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.10%
1/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Erosive oesophagitis
|
0.00%
0/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.79%
1/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.10%
1/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.81%
1/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.10%
1/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.81%
1/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.10%
1/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.40%
1/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.10%
1/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.40%
1/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.10%
1/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.40%
1/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.81%
1/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.21%
2/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
General disorders
Chest pain
|
0.00%
0/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.79%
1/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.10%
1/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
General disorders
Pyrexia
|
0.00%
0/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.40%
1/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.10%
1/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
General disorders
Vascular stent thrombosis
|
0.00%
0/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.40%
1/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.10%
1/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.79%
1/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.10%
1/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
COVID-19
|
0.00%
0/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.2%
3/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.79%
1/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.6%
2/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.62%
6/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.40%
1/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.81%
1/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.21%
2/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.79%
1/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.10%
1/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Endocarditis bacterial
|
0.00%
0/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.79%
1/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.10%
1/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Erysipelas
|
0.00%
0/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.40%
1/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.10%
1/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.79%
1/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.10%
1/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Peritoneal abscess
|
0.00%
0/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.40%
1/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.10%
1/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Pneumonia
|
1.0%
1/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.4%
6/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.4%
3/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.6%
2/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.2%
3/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.5%
15/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.81%
1/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.10%
1/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.40%
1/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.10%
1/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Injury, poisoning and procedural complications
Bone graft lysis
|
0.00%
0/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.40%
1/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.10%
1/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.40%
1/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.10%
1/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.40%
1/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.10%
1/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.79%
1/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.10%
1/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Injury, poisoning and procedural complications
Procedural intestinal perforation
|
0.00%
0/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.40%
1/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.10%
1/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.40%
1/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.10%
1/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.40%
1/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.10%
1/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Blood potassium increased
|
0.00%
0/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.40%
1/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.10%
1/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.00%
0/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.81%
1/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.10%
1/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.40%
1/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.10%
1/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
1.0%
1/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.10%
1/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Abdominal neoplasm
|
0.00%
0/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.79%
1/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.10%
1/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
1.0%
1/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.81%
1/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.21%
2/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
1.0%
1/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.10%
1/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder adenocarcinoma
|
0.00%
0/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.79%
1/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.10%
1/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.00%
0/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.79%
1/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.10%
1/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.00%
0/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.79%
1/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.10%
1/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
1.0%
1/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.2%
3/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.41%
4/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes
|
0.00%
0/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.40%
1/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.10%
1/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to peritoneum
|
0.00%
0/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.79%
1/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.10%
1/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer stage IIIA
|
0.00%
0/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.40%
1/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.10%
1/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma
|
0.00%
0/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.81%
1/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.10%
1/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.40%
1/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.10%
1/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.00%
0/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.81%
1/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.10%
1/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
1.0%
1/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.10%
1/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.40%
1/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.10%
1/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
Aphasia
|
0.00%
0/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.81%
1/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.10%
1/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
Embolic stroke
|
0.00%
0/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.81%
1/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.10%
1/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
Hypoaesthesia
|
1.0%
1/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.10%
1/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.79%
1/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.10%
1/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.40%
1/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.10%
1/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.40%
1/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.79%
1/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.21%
2/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.40%
1/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.10%
1/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
5.1%
5/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.6%
9/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.81%
1/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
4.0%
5/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.6%
2/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.0%
5/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
27/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.81%
1/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.10%
1/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Lung consolidation
|
0.00%
0/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.40%
1/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.10%
1/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.40%
1/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.10%
1/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.81%
1/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.10%
1/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.40%
1/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.10%
1/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Vascular disorders
Hypertensive emergency
|
0.00%
0/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.81%
1/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.10%
1/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Vascular disorders
Hypotension
|
0.00%
0/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.79%
1/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.10%
1/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
1.0%
1/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.10%
1/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
Other adverse events
| Measure |
QBW251 450 mg
n=99 participants at risk
QBW251 was orally administered 450 mg b.i.d for 24 weeks
|
QBW251 300 mg
n=250 participants at risk
QBW251 was orally administered 300 mg b.i.d for 24 weeks
|
QBW251 150 mg
n=124 participants at risk
QBW251 was orally administered 150 mg b.i.d for 24 weeks
|
QBW251 75 mg
n=126 participants at risk
QBW251 was orally administered 75 mg b.i.d for 24 weeks
|
QBW251 25 mg
n=124 participants at risk
QBW251 was orally administered 25 mg b.i.d for 24 weeks
|
Placebo
n=251 participants at risk
Placebo was orally administered b.i.d for 24 weeks
|
Total
n=974 participants at risk
Total
|
|---|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.0%
2/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
7/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.4%
3/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.4%
3/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.6%
2/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
7/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.5%
24/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.0%
1/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.40%
1/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.2%
4/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.79%
1/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.2%
3/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.0%
10/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
Dizziness
|
4.0%
4/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.0%
5/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.79%
1/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.81%
1/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.40%
1/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.2%
12/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
Headache
|
4.0%
4/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
4.4%
11/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.2%
4/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.2%
4/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.2%
4/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.4%
6/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.4%
33/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.0%
1/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.6%
4/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.79%
1/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.81%
1/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.4%
6/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.3%
13/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
16.2%
16/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
20.4%
51/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
25.8%
32/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
19.0%
24/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
27.4%
34/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
22.3%
56/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
21.9%
213/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
2.0%
2/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.40%
1/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.31%
3/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Cardiac disorders
Atrial fibrillation
|
2.0%
2/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.40%
1/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.6%
2/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.81%
1/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.2%
3/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.92%
9/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Diarrhoea
|
6.1%
6/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
7/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.81%
1/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.6%
2/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.4%
3/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.4%
6/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.6%
25/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Nausea
|
5.1%
5/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.6%
4/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.6%
2/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.4%
3/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.81%
1/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.0%
5/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.1%
20/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Vomiting
|
1.0%
1/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.80%
2/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.4%
3/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.81%
1/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.6%
4/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.1%
11/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
General disorders
Chest pain
|
0.00%
0/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.80%
2/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.4%
3/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.81%
1/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.40%
1/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.72%
7/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
General disorders
Fatigue
|
2.0%
2/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.2%
3/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.6%
2/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.79%
1/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.2%
3/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.1%
11/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Bronchitis
|
4.0%
4/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.4%
6/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.6%
2/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.4%
3/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.80%
2/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.7%
17/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
COVID-19
|
0.00%
0/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.6%
4/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.81%
1/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.79%
1/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
4.8%
6/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.0%
5/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.7%
17/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Cystitis
|
0.00%
0/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.80%
2/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.6%
2/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.4%
3/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.81%
1/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.40%
1/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.92%
9/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Gastroenteritis
|
4.0%
4/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.80%
2/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.79%
1/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.81%
1/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.40%
1/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.92%
9/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Influenza
|
2.0%
2/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.6%
4/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.79%
1/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.81%
1/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.80%
2/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.0%
10/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Lower respiratory tract infection
|
3.0%
3/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.2%
3/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.4%
3/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.6%
2/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.2%
4/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.0%
5/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.1%
20/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Nasopharyngitis
|
4.0%
4/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
4.8%
12/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
4.0%
5/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
7.9%
10/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
4.8%
6/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
4.0%
10/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
4.8%
47/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Pharyngitis
|
2.0%
2/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.81%
1/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.6%
2/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.2%
3/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.82%
8/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Pneumonia
|
3.0%
3/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.0%
5/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.81%
1/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.79%
1/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.6%
2/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.80%
2/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
14/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Sinusitis
|
0.00%
0/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.40%
1/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.4%
3/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.79%
1/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.80%
2/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.72%
7/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Upper respiratory tract infection
|
3.0%
3/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.6%
4/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
4.0%
5/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.0%
5/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.7%
17/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Upper respiratory tract infection bacterial
|
3.0%
3/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
4.8%
12/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.2%
4/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.2%
4/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.2%
4/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.6%
9/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.7%
36/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Urinary tract infection
|
3.0%
3/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.2%
8/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.4%
3/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
4.0%
5/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.6%
2/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.0%
5/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.7%
26/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Viral upper respiratory tract infection
|
3.0%
3/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.2%
8/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.4%
3/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.4%
3/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.4%
3/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
7/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
27/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.80%
2/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.4%
3/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.40%
1/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.62%
6/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
C-reactive protein increased
|
1.0%
1/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.2%
8/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.2%
4/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.80%
2/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.5%
15/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Gamma-glutamyltransferase increased
|
4.0%
4/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.4%
6/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.2%
4/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.6%
2/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.2%
3/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.0%
19/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Haemoglobin decreased
|
2.0%
2/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.40%
1/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.31%
3/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Hepatic enzyme increased
|
2.0%
2/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.80%
2/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.80%
2/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.62%
6/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.0%
2/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.40%
1/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.81%
1/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.40%
1/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.51%
5/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.0%
2/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.80%
2/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.6%
2/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.79%
1/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.4%
3/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.4%
6/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.6%
16/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
2.0%
2/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.81%
1/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.31%
3/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.0%
3/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.80%
2/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.6%
2/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.72%
7/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Vascular disorders
Hypertension
|
4.0%
4/99 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.2%
8/250 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.4%
3/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.4%
3/126 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.4%
3/124 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.6%
4/251 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.6%
25/974 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 199 days.
Any sign or symptom that occurs during the 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. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER