Trial Outcomes & Findings for An Effectiveness Study Comparing Fluticasone Furoate (FF, GW685698)/Vilanterol (VI, GW642444) With Standard Treatment in Asthma (NCT NCT01706198)
NCT ID: NCT01706198
Last Updated: 2019-01-24
Results Overview
The ACT is a validated self-administered questionnaire utilizing 5 questions to assess asthma control during the past 4 weeks on a 5-point categorical scale (1 to 5). By answering all 5 questions, participants with asthma obtained an ACT score ranging between 5 and 25. Higher scores indicated better control of asthma. An ACT score of \<=15 showed poorly controlled asthma; 16 to 19 showed partly controlled asthma and \>=20 showed well controlled asthma. The total score was calculated as the sum of the scores from all 5 questions. The primary efficacy analysis (PEA) Population is defined as all Intent-to-Treat (ITT) participants (that is, all participants who were randomized and received at least one prescription of study medication) who have an ACT total score of \<20 at Baseline (Day 0). The percentage of responders that is participants with an ACT total score \>=20 or an increase from Baseline of \>=3 has been presented
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
4233 participants
Primary outcome timeframe
Baseline (Day 0) and Week 24
Results posted on
2019-01-24
Participant Flow
This was a multi-center, randomized, open label study to evaluate the effectiveness of fluticasone furoate (FF)/vilanterol (VI) Inhalation Powder (FF 100 micrograms \[mcg\]/VI 25 mcg or FF 200 mcg/VI 25 mcg) compared with usual asthma maintenance therapy in participants with asthma in a localized geographical region of United Kingdom.
A total of 4725 participants were screened of which 4233 participants were randomized to either initiate with FF/VI or continue their usual asthma maintenance therapy in a ratio of 1:1. The total duration of study was approximately 12 months (52 weeks).
Participant milestones
| Measure |
Usual Care
Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).
|
FF/VI
Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.
|
|---|---|---|
|
Overall Study
STARTED
|
2119
|
2114
|
|
Overall Study
COMPLETED
|
1946
|
1920
|
|
Overall Study
NOT COMPLETED
|
173
|
194
|
Reasons for withdrawal
| Measure |
Usual Care
Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).
|
FF/VI
Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.
|
|---|---|---|
|
Overall Study
Adverse Event
|
12
|
15
|
|
Overall Study
Protocol Violation
|
7
|
5
|
|
Overall Study
Other: Subject reached stopping criteria
|
11
|
13
|
|
Overall Study
Lost to Follow-up
|
97
|
93
|
|
Overall Study
Physician Decision
|
23
|
37
|
|
Overall Study
Withdrawal by Subject
|
23
|
31
|
Baseline Characteristics
An Effectiveness Study Comparing Fluticasone Furoate (FF, GW685698)/Vilanterol (VI, GW642444) With Standard Treatment in Asthma
Baseline characteristics by cohort
| Measure |
Usual Care
n=2119 Participants
Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).
|
FF/VI
n=2114 Participants
Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.
|
Total
n=4233 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.7 Years
STANDARD_DEVIATION 16.69 • n=5 Participants
|
49.9 Years
STANDARD_DEVIATION 16.05 • n=7 Participants
|
49.8 Years
STANDARD_DEVIATION 16.37 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1241 Participants
n=5 Participants
|
1257 Participants
n=7 Participants
|
2498 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
878 Participants
n=5 Participants
|
857 Participants
n=7 Participants
|
1735 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage
|
25 Count of Participants
n=5 Participants
|
40 Count of Participants
n=7 Participants
|
65 Count of Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - Central/South Asian Heritage
|
35 Count of Participants
n=5 Participants
|
46 Count of Participants
n=7 Participants
|
81 Count of Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - East Asian Heritage
|
4 Count of Participants
n=5 Participants
|
9 Count of Participants
n=7 Participants
|
13 Count of Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - Japanese Heritage
|
2 Count of Participants
n=5 Participants
|
0 Count of Participants
n=7 Participants
|
2 Count of Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - South East Asian Heritage
|
9 Count of Participants
n=5 Participants
|
18 Count of Participants
n=7 Participants
|
27 Count of Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 Count of Participants
n=5 Participants
|
1 Count of Participants
n=7 Participants
|
2 Count of Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White - Arabic/North African Heritage
|
6 Count of Participants
n=5 Participants
|
5 Count of Participants
n=7 Participants
|
11 Count of Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White - White/Caucasian/European Heritage
|
2002 Count of Participants
n=5 Participants
|
1971 Count of Participants
n=7 Participants
|
3973 Count of Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mixed race
|
33 Count of Participants
n=5 Participants
|
23 Count of Participants
n=7 Participants
|
56 Count of Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
2 Count of Participants
n=5 Participants
|
1 Count of Participants
n=7 Participants
|
3 Count of Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 0) and Week 24Population: PEA Population. Only participants with non-missing ACT score were analyzed.
The ACT is a validated self-administered questionnaire utilizing 5 questions to assess asthma control during the past 4 weeks on a 5-point categorical scale (1 to 5). By answering all 5 questions, participants with asthma obtained an ACT score ranging between 5 and 25. Higher scores indicated better control of asthma. An ACT score of \<=15 showed poorly controlled asthma; 16 to 19 showed partly controlled asthma and \>=20 showed well controlled asthma. The total score was calculated as the sum of the scores from all 5 questions. The primary efficacy analysis (PEA) Population is defined as all Intent-to-Treat (ITT) participants (that is, all participants who were randomized and received at least one prescription of study medication) who have an ACT total score of \<20 at Baseline (Day 0). The percentage of responders that is participants with an ACT total score \>=20 or an increase from Baseline of \>=3 has been presented
Outcome measures
| Measure |
FF/VI
n=1373 Participants
Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.
|
Usual Care
n=1399 Participants
Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).
|
|---|---|---|
|
Percentage of Participants Who Have Either an Asthma Control Test (ACT) Total Score of >=20 or an Increase From Baseline of >=3 in ACT Total Score at Week 24.
|
71 Percentage of participants
|
56 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and Weeks 12, 40 and 52Population: ITT Population
The ACT is a validated self-administered questionnaire utilizing 5 questions to assess asthma control during the past 4 weeks on a 5-point categorical scale (1 to 5). By answering all 5 questions, participants with asthma obtained an ACT score ranging between 5 and 25. Higher scores indicated better control of asthma. An ACT score of \<=15 showed poorly controlled asthma; 16 to 19 showed partly controlled asthma and \>=20 showed well controlled asthma. The total score was calculated as the sum of the scores from all 5 questions. ITT Population comprised of all participants who were randomized and received at least one prescription of study medication. The percentage of responders that is participants with an ACT total score \>=20 or an increase from Baseline of \>=3 has been presented. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
Outcome measures
| Measure |
FF/VI
n=2114 Participants
Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.
|
Usual Care
n=2119 Participants
Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).
|
|---|---|---|
|
Percentage of Participants Who Have Either an ACT Total Score of >=20 or an Increase From Baseline of >=3 in ACT Total Score at Weeks 12, 40 and 52.
Week 12, n=2032, 2009
|
75 Percentage of participants
|
62 Percentage of participants
|
|
Percentage of Participants Who Have Either an ACT Total Score of >=20 or an Increase From Baseline of >=3 in ACT Total Score at Weeks 12, 40 and 52.
Week 40, n=1938, 1904
|
71 Percentage of participants
|
60 Percentage of participants
|
|
Percentage of Participants Who Have Either an ACT Total Score of >=20 or an Increase From Baseline of >=3 in ACT Total Score at Weeks 12, 40 and 52.
Week 52, n=1922, 1896
|
70 Percentage of participants
|
58 Percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 12, 24, 40 and 52Population: ITT Population
The ACT is a validated self-administered questionnaire utilizing 5 questions to assess asthma control during the past 4 weeks on a 5-point categorical scale (1 to 5). By answering all 5 questions, participants with asthma obtained an ACT score ranging between 5 and 25. Higher scores indicated better control of asthma. An ACT score of \<=15 showed poorly controlled asthma; 16 to 19 showed partly controlled asthma and \>=20 showed well controlled asthma. The total score was calculated as the sum of the scores from all 5 questions. The percentage of participants with an ACT total score \>=20 has been presented. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
Outcome measures
| Measure |
FF/VI
n=2114 Participants
Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.
|
Usual Care
n=2119 Participants
Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).
|
|---|---|---|
|
Percentage of Participants With Asthma Control (ACT Total Score >=20) at Weeks 12, 24, 40 and 52.
Week 12, n=2032, 2009
|
61 Percentage of participants
|
46 Percentage of participants
|
|
Percentage of Participants With Asthma Control (ACT Total Score >=20) at Weeks 12, 24, 40 and 52.
Week 24, n=1957, 1936
|
60 Percentage of participants
|
46 Percentage of participants
|
|
Percentage of Participants With Asthma Control (ACT Total Score >=20) at Weeks 12, 24, 40 and 52.
Week 40, n=1938, 1904
|
58 Percentage of participants
|
45 Percentage of participants
|
|
Percentage of Participants With Asthma Control (ACT Total Score >=20) at Weeks 12, 24, 40 and 52.
Week 52, n=1922, 1896
|
58 Percentage of participants
|
44 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and Weeks 12, 24, 40 and 52Population: ITT Population
The ACT is a validated self-administered questionnaire utilizing 5 questions to assess asthma control during the past 4 weeks on a 5-point categorical scale (1 to 5). By answering all 5 questions, participants with asthma obtained an ACT score ranging between 5 and 25. Higher scores indicated better control of asthma. An ACT score of \<=15 showed poorly controlled asthma; 16 to 19 showed partly controlled asthma and \>=20 showed well controlled asthma. The total score was calculated as the sum of the scores from all 5 questions. The percentage of participants with an increase in ACT total score \>=3 from Baseline has been presented. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
Outcome measures
| Measure |
FF/VI
n=2114 Participants
Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.
|
Usual Care
n=2119 Participants
Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).
|
|---|---|---|
|
Percentage of Participants Who Have an Increase From Baseline of >=3 in ACT Total Score at Weeks 12, 24, 40 and 52.
Week 12, n=2032, 2009
|
55 Percentage of participants
|
39 Percentage of participants
|
|
Percentage of Participants Who Have an Increase From Baseline of >=3 in ACT Total Score at Weeks 12, 24, 40 and 52.
Week 24, n=1957, 1936
|
54 Percentage of participants
|
40 Percentage of participants
|
|
Percentage of Participants Who Have an Increase From Baseline of >=3 in ACT Total Score at Weeks 12, 24, 40 and 52.
Week 40, n=1938, 1904
|
53 Percentage of participants
|
42 Percentage of participants
|
|
Percentage of Participants Who Have an Increase From Baseline of >=3 in ACT Total Score at Weeks 12, 24, 40 and 52.
Week 52, n=1922, 1896
|
50 Percentage of participants
|
37 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and Weeks 12, 24, 40 and 52Population: ITT Population
The ACT is a validated self-administered questionnaire utilizing 5 questions to assess asthma control during the past 4 weeks on a 5-point categorical scale (1 to 5). By answering all 5 questions, participants with asthma obtained an ACT score ranging between 5 and 25. Higher scores indicated better control of asthma. An ACT score of \<=15 showed poorly controlled asthma; 16 to 19 showed partly controlled asthma and \>=20 showed well controlled asthma. The total score was calculated as the sum of the scores from all 5 questions. Baseline value is the value at Visit 2 (Day 0) assessment. Change from Baseline is the value at post-dose visit minus Baseline. The least square mean change in ACT scores has been presented. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
Outcome measures
| Measure |
FF/VI
n=2114 Participants
Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.
|
Usual Care
n=2119 Participants
Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).
|
|---|---|---|
|
Mean Change From Baseline in ACT Total Score at Weeks 12, 24, 40 and 52.
Week 12, n=2032, 2009
|
3.31 Scores on ACT scale
Standard Error 0.087
|
1.77 Scores on ACT scale
Standard Error 0.087
|
|
Mean Change From Baseline in ACT Total Score at Weeks 12, 24, 40 and 52.
Week 24, n=1957, 1936
|
3.20 Scores on ACT scale
Standard Error 0.094
|
1.70 Scores on ACT scale
Standard Error 0.093
|
|
Mean Change From Baseline in ACT Total Score at Weeks 12, 24, 40 and 52.
Week 40, n=1938, 1904
|
3.00 Scores on ACT scale
Standard Error 0.097
|
1.63 Scores on ACT scale
Standard Error 0.096
|
|
Mean Change From Baseline in ACT Total Score at Weeks 12, 24, 40 and 52.
Week 52, n=1922, 1896
|
2.99 Scores on ACT scale
Standard Error 0.095
|
1.49 Scores on ACT scale
Standard Error 0.094
|
SECONDARY outcome
Timeframe: Weeks 12, 24, 40 and 52Population: ITT Population
The ACT is a validated self-administered questionnaire utilizing 5 questions to assess asthma control during the past 4 weeks on a 5-point categorical scale (1 to 5). By answering all 5 questions, participants with asthma obtained an ACT score ranging between 5 and 25. Higher scores indicated better control of asthma. An ACT score of \<=15 showed poorly controlled asthma; 16 to 19 showed partly controlled asthma and \>=20 showed well controlled asthma. The total score was calculated as the sum of the scores from all 5 questions. The percentage of participants under each ACT total score category that is \>=20, 16 to 19 and \<=15 has been presented. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
Outcome measures
| Measure |
FF/VI
n=2114 Participants
Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.
|
Usual Care
n=2119 Participants
Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).
|
|---|---|---|
|
Percentage of Participants in Each ACT Total Score Category (>=20, 16 to 19, <=15) at Weeks 12, 24, 40 and 52.
>=20, Week 12, n=2032, 2009
|
61 Percentage of participants
|
46 Percentage of participants
|
|
Percentage of Participants in Each ACT Total Score Category (>=20, 16 to 19, <=15) at Weeks 12, 24, 40 and 52.
16 to 19, Week 12, n=2032, 2009
|
20 Percentage of participants
|
26 Percentage of participants
|
|
Percentage of Participants in Each ACT Total Score Category (>=20, 16 to 19, <=15) at Weeks 12, 24, 40 and 52.
<=15, Week 12, n=2032, 2009
|
18 Percentage of participants
|
28 Percentage of participants
|
|
Percentage of Participants in Each ACT Total Score Category (>=20, 16 to 19, <=15) at Weeks 12, 24, 40 and 52.
>=20, Week 24, n=1957, 1936
|
60 Percentage of participants
|
46 Percentage of participants
|
|
Percentage of Participants in Each ACT Total Score Category (>=20, 16 to 19, <=15) at Weeks 12, 24, 40 and 52.
16 to 19, Week 24, n=1957, 1936
|
20 Percentage of participants
|
25 Percentage of participants
|
|
Percentage of Participants in Each ACT Total Score Category (>=20, 16 to 19, <=15) at Weeks 12, 24, 40 and 52.
<=15, Week 24, n=1957, 1936
|
20 Percentage of participants
|
29 Percentage of participants
|
|
Percentage of Participants in Each ACT Total Score Category (>=20, 16 to 19, <=15) at Weeks 12, 24, 40 and 52.
>=20, Week 40, n=1938, 1904
|
58 Percentage of participants
|
45 Percentage of participants
|
|
Percentage of Participants in Each ACT Total Score Category (>=20, 16 to 19, <=15) at Weeks 12, 24, 40 and 52.
16 to 19, Week 40, n=1938, 1904
|
21 Percentage of participants
|
24 Percentage of participants
|
|
Percentage of Participants in Each ACT Total Score Category (>=20, 16 to 19, <=15) at Weeks 12, 24, 40 and 52.
<=15, Week 40, n=1938, 1904
|
21 Percentage of participants
|
31 Percentage of participants
|
|
Percentage of Participants in Each ACT Total Score Category (>=20, 16 to 19, <=15) at Weeks 12, 24, 40 and 52.
>=20, Week 52, n=1922, 1896
|
58 Percentage of participants
|
44 Percentage of participants
|
|
Percentage of Participants in Each ACT Total Score Category (>=20, 16 to 19, <=15) at Weeks 12, 24, 40 and 52.
16 to 19, Week 52, n=1922, 1896
|
20 Percentage of participants
|
26 Percentage of participants
|
|
Percentage of Participants in Each ACT Total Score Category (>=20, 16 to 19, <=15) at Weeks 12, 24, 40 and 52.
<=15, Week 52, n=1922, 1896
|
21 Percentage of participants
|
30 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 52Population: ITT Population
All contacts are defined as any encounter the participant may have with a doctor, nurse or other healthcare professionals working as part of the National Health Service (NHS) as identified in the electronic medical records (EMR). Contacts were defined to be asthma-related if the most prominent signs and symptoms that the participant presented were a direct result of the participant's asthma. An asthma-related secondary care contact is defined as an inpatient admission or a specialist outpatient visit or an accident and emergency (A\&E) contact. A participant with an A\&E contact and subsequent inpatient admission was considered to have had two healthcare contacts. The least square mean annual rate of all asthma-related secondary care contacts along with 95% confidence interval has been presented.
Outcome measures
| Measure |
FF/VI
n=2114 Participants
Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.
|
Usual Care
n=2119 Participants
Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).
|
|---|---|---|
|
Annual Rate of Asthma-related Secondary Care Contacts
|
0.30 Contacts per participant per year
Interval 0.26 to 0.36
|
0.30 Contacts per participant per year
Interval 0.25 to 0.34
|
SECONDARY outcome
Timeframe: Up to Week 52Population: ITT Population
All contacts are defined as any encounter the participant may have with a doctor, nurse or other healthcare professionals working as part of the NHS as identified in the EMR. Contacts were defined to be asthma-related if the most prominent signs and symptoms that the participant presented were a direct result of the participant's asthma. Asthma-related primary care contacts is defined as the sum of primary care contacts on a given calendar date with either a nurse, General Practitioner or other healthcare professional that can be considered as asthma-related as per Read codes. The least square mean annual rate of all asthma-related primary care contacts along with 95% confidence interval has been presented.
Outcome measures
| Measure |
FF/VI
n=2114 Participants
Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.
|
Usual Care
n=2119 Participants
Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).
|
|---|---|---|
|
Annual Rate of Asthma-related Primary Care Contacts
|
1.45 Contacts per participant per year
Interval 1.39 to 1.51
|
1.42 Contacts per participant per year
Interval 1.36 to 1.47
|
SECONDARY outcome
Timeframe: Up to Week 52Population: ITT Population
Asthma-related primary care contact is defined as the sum of primary care contacts on a given calendar date with either a nurse, General Practitioner or other healthcare professional that can be considered as asthma-related as per Read codes. Time to first asthma-related primary care contact was measured from the date of randomization (that is, study treatment start date) to the date of first asthma-related primary care contact, or study treatment stop date for participants who completed the study without any asthma-related primary care contacts (censored). Analyses of time to first asthma-related primary care contact was censored at Day 364. The number of participants at risk at Weeks 0, 13, 26, 39 and 52 has been presented. Kaplan Meier method of analysis was used. Study related primary care contacts (that is, contacts scheduled solely due to the participant taking part in clinical trial) were excluded from this analysis.
Outcome measures
| Measure |
FF/VI
n=2114 Participants
Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.
|
Usual Care
n=2119 Participants
Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).
|
|---|---|---|
|
Number of Participants With Time to First Asthma-related Primary Care Contact
Week 0
|
2114 Participants
|
2119 Participants
|
|
Number of Participants With Time to First Asthma-related Primary Care Contact
Week 13
|
1599 Participants
|
1621 Participants
|
|
Number of Participants With Time to First Asthma-related Primary Care Contact
Week 26
|
1214 Participants
|
1208 Participants
|
|
Number of Participants With Time to First Asthma-related Primary Care Contact
Week 39
|
932 Participants
|
907 Participants
|
|
Number of Participants With Time to First Asthma-related Primary Care Contact
Week 52
|
488 Participants
|
479 Participants
|
SECONDARY outcome
Timeframe: Up to Week 52Population: ITT Population
A secondary care contact is defined as an inpatient admission or a specialist outpatient visit or an A\&E contact. A participant with an A\&E contact and subsequent inpatient admission was considered to have had two healthcare contacts. The inpatient admissions recorded at two hospitals on the same day, were counted as a single (inpatient admission) secondary care contact. In the situation where inpatient admission periods overlapped (example, a new inpatient admission was recorded within the dates of an existing inpatient admission period), it was counted as a single (inpatient admission) healthcare contact with start date defined as the earliest inpatient admission date for either of the overlapping admissions and end date defined as the latest discharge date for either of the overlapping admissions. The least square mean annual rate of all on-treatment secondary care contacts along with 95% confidence interval has been summarized.
Outcome measures
| Measure |
FF/VI
n=2114 Participants
Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.
|
Usual Care
n=2119 Participants
Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).
|
|---|---|---|
|
Annual Rate of All On-treatment Secondary Care Contacts
|
5.17 Contacts per participant per year
Interval 4.86 to 5.51
|
5.23 Contacts per participant per year
Interval 4.91 to 5.57
|
SECONDARY outcome
Timeframe: Up to Week 52Population: ITT Population
All contacts are defined as any encounter the participant may have with a doctor, nurse or other healthcare professionals working as part of the NHS as identified in the EMR. Total primary care contacts is defined as the sum of primary care contacts on a given calendar date with either a nurse, General Practitioner or other healthcare professional. The least square mean annual rate of all on-treatment primary care contacts along with 95% confidence interval has been presented.
Outcome measures
| Measure |
FF/VI
n=2114 Participants
Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.
|
Usual Care
n=2119 Participants
Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).
|
|---|---|---|
|
Annual Rate of All On-treatment Primary Care Contacts
|
11.64 Contacts per participant per year
Interval 11.25 to 12.04
|
10.61 Contacts per participant per year
Interval 10.26 to 10.98
|
SECONDARY outcome
Timeframe: Up to Week 52Population: ITT Population
Time to first primary care contact is measured from the date of randomization (that is, study treatment start date) to the date of first primary care contact, or study treatment stop date for participants who completed the study without any primary care contacts (censored). Analyses of time to first primary care contact will be censored at Day 364. The number of participants at risk at Weeks 0, 13, 26, 39 and 52 has been presented. Kaplan Meier method of analysis was used. Study related primary care contacts (that is, contacts scheduled solely due to the participant taking part in clinical trial) were excluded from this analysis.
Outcome measures
| Measure |
FF/VI
n=2114 Participants
Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.
|
Usual Care
n=2119 Participants
Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).
|
|---|---|---|
|
Number of Participants With Time to First Primary Care Contact
Week 0
|
2114 Participants
|
2119 Participants
|
|
Number of Participants With Time to First Primary Care Contact
Week 13
|
483 Participants
|
513 Participants
|
|
Number of Participants With Time to First Primary Care Contact
Week 26
|
242 Participants
|
245 Participants
|
|
Number of Participants With Time to First Primary Care Contact
Week 39
|
178 Participants
|
160 Participants
|
|
Number of Participants With Time to First Primary Care Contact
Week 52
|
96 Participants
|
79 Participants
|
SECONDARY outcome
Timeframe: Up to Week 52Population: ITT Population
A severe asthma exacerbation is defined as deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) or antibiotics, and inpatient hospitalization, or emergency department visit due to asthma that required systemic corticosteroids or antibiotics. Least square mean for annual rate of severe asthma exacerbation along with 95% confidence interval has been presented.
Outcome measures
| Measure |
FF/VI
n=2114 Participants
Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.
|
Usual Care
n=2119 Participants
Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).
|
|---|---|---|
|
Mean Annual Rate of Severe Asthma Exacerbations
|
0.40 Exacerbations per participant per year
Interval 0.37 to 0.43
|
0.41 Exacerbations per participant per year
Interval 0.38 to 0.44
|
SECONDARY outcome
Timeframe: Up to Week 52Population: ITT Population
A severe asthma exacerbation is defined as deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) or antibiotics, and inpatient hospitalization, or emergency department visit due to asthma that required systemic corticosteroids or antibiotics. The date of a severe asthma exacerbation was defined as the exacerbation onset date. Participants who completed the study without a severe asthma exacerbation were censored. Time to first severe asthma exacerbation was measured from the date of randomization (that is, study treatment start date) to the onset date of first severe asthma exacerbation, or study treatment stop date for participants who completed the study without any severe asthma exacerbations (censored). Analyses of time to first severe asthma exacerbation was censored at Day 364. The number of participants with severe asthma exacerbation has been presented.
Outcome measures
| Measure |
FF/VI
n=2114 Participants
Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.
|
Usual Care
n=2119 Participants
Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).
|
|---|---|---|
|
Time to First Severe Asthma Exacerbation.
|
634 Participants
|
654 Participants
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: ITT Population
Salbutamol was prescribed as a rescue medication to be used as and when necessary throughout the study. The number of salbutamol inhalers used by each participant during the study was calculated based on the total number of inhalers (adjusted to an equivalence of 200 metered actuations) prescribed. Number of salbutamol inhalers prescribed during the study was derived taking the participants time on study medication into account so it corresponds to 12 months on treatment. The least square mean number of salbutamol inhalers prescribed per participant during the study has been presented. Only participants exposed to study drug for at least 30 days were included in the analysis.
Outcome measures
| Measure |
FF/VI
n=2108 Participants
Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.
|
Usual Care
n=2116 Participants
Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).
|
|---|---|---|
|
Mean Number of Salbutamol Inhalers Prescribed for Each Participant Over the 12 Month Treatment Period.
|
7.2 Mean number of inhalers per participant
Standard Error 0.11
|
8.0 Mean number of inhalers per participant
Standard Error 0.11
|
SECONDARY outcome
Timeframe: Up to Week 52Population: ITT Population
Initial therapy is defined as the treatment that the participant was prescribed at randomization. Modification of initial therapy included any change in brand, dose or frequency of inhaler, that is, stepping up in class, dose or frequency, stepping down in class, dose or frequency, switching to another brand of inhaler, switching treatment arm or withdrawal from the study. Time to modification of initial therapy was measured from the date of randomization (that is, exposure start date) to the date of modification of initial therapy or date of treatment termination for participants who completed the study without modifiying initial therapy (censored). The number of participants with modification of initial therapy has been presented.
Outcome measures
| Measure |
FF/VI
n=2114 Participants
Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.
|
Usual Care
n=2119 Participants
Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).
|
|---|---|---|
|
Time to Modification of Initial Therapy
|
563 Participants
|
488 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and Week 52Population: ITT Population
The AQLQ(S) contained 32 items under the following four domains: activity limitation (11 items), symptoms (12 items), emotional function (5 items) and environmental stimuli (4 items). The response format consisted of a seven-point scale where a value of 1 indicated "total impairment" and a value of 7 indicated "no impairment". The total AQLQ(S) score is the mean of all 32 items in the questionnaire and each individual domain score was calculated as the mean of the items within that domain. Hence, the total and domain scores were each defined on a range from 1 to 7 with higher scores indicating a higher quality of life. Baseline value is the value at Day 0 assessment. Change from Baseline is post dose visit value minus Baseline. The percentage of responders that is, participants with an increase from Baseline of \>=0.5 in AQLQ(S) total score has been presented. Only those participants available at the specified time point was analyzed.
Outcome measures
| Measure |
FF/VI
n=1896 Participants
Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.
|
Usual Care
n=1922 Participants
Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).
|
|---|---|---|
|
Percentage of Participants Who Have an Increase From Baseline of >=0.5 in Standardized Asthma Quality of Life Questionnaire [AQLQ(S)] Total Score at Week 52.
|
55 Percentage of participants
|
43 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and Week 52Population: ITT Population
The AQLQ(S) contained 32 items under the following four domains: activity limitation (11 items), symptoms (12 items), emotional function (5 items) and environmental stimuli (4 items). The response format consisted of a seven-point scale where a value of 1 indicated "total impairment" and a value of 7 indicated "no impairment". The total environmental stimuli domain score was calculated as the mean of the items within the environmental stimuli domain. Hence, the environmental stimuli domain scores were each defined on a range from 1 to 7 with higher scores indicating a higher quality of life. Baseline value is the value at Day 0 assessment. Change from Baseline is post dose visit value minus Baseline. The percentage of responders that is, participants with an increase from Baseline of \>=0.5 in AQLQ(S) environmental stimuli domain score has been presented. Only those participants available at the specified time point was analyzed.
Outcome measures
| Measure |
FF/VI
n=1896 Participants
Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.
|
Usual Care
n=1922 Participants
Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).
|
|---|---|---|
|
Percentage of Participants Who Have an Increase From Baseline of >=0.5 in AQLQ(S) Environmental Stimuli Domain Score at Week 52.
|
59 Percentage of participants
|
50 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 52Population: ITT Population
A serious advent event (SAE) of pneumonia was defined as any SAE in the adverse event special interest (AESI) group of "pneumonia". The incidence of the SAEs of pneumonia for each treatment group is defined as the percentage of participants in that group who have experienced at least one SAE of pneumonia from start date of study treatment to the stop date of exposure + 28 days or date of study discontinuation, whichever is earliest. The percentage of participants with SAE of pneumonia has been presented.
Outcome measures
| Measure |
FF/VI
n=2114 Participants
Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.
|
Usual Care
n=2119 Participants
Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).
|
|---|---|---|
|
Percentage of Participants With Serious Adverse Event (SAE) of Pneumonia
|
1 Percentage of participants
|
1 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 52Population: ITT Population
An SAE of pneumonia was defined as any SAE in the AESI group of "pneumonia". The date of an event for an SAE of pneumonia was the AE onset date. Participants who do not have an SAE of pneumonia during the first 364 days of the treatment period (start date of exposure to min \[end date of exposure + 28 days, date of study discontinuation, start date of exposure + 363\]) were censored. Time to first SAE of pneumonia was measured from the date of randomization (that is, study treatment start date) to the onset date of first SAE of pneumonia. The number of participants with first on-treatment SAE of pneumonia has been presented.
Outcome measures
| Measure |
FF/VI
n=2114 Participants
Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.
|
Usual Care
n=2119 Participants
Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).
|
|---|---|---|
|
Time to First SAE of Pneumonia
|
23 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: Up to Week 52Population: ITT Population
All SAEs included in the AESI group of "pneumonia" were considered as an SAE of pneumonia. Fatal SAEs of pneumonia are SAEs that led to death of participants. The number of participants with fatal SAEs of pneumonia has been presented.
Outcome measures
| Measure |
FF/VI
n=2114 Participants
Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.
|
Usual Care
n=2119 Participants
Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).
|
|---|---|---|
|
Number of Participants With Fatal SAEs of Pneumonia
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to Week 52Population: ITT Population
An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; important medical events which may require medical or surgical intervention for example, invasive or malignant cancers; all events of possible drug-induced liver injury with hyperbilirubinemia. The number of participants with on-treatment SAEs has been summarized.
Outcome measures
| Measure |
FF/VI
n=2114 Participants
Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.
|
Usual Care
n=2119 Participants
Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).
|
|---|---|---|
|
Number of Participants With SAEs
|
284 Participants
|
284 Participants
|
SECONDARY outcome
Timeframe: Up to Week 52Population: ITT Population
An ADR is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, for which there is a reasonable possibility that the untoward occurrence is causally related to the medicinal product. ADRs are a subset of AEs for a given medicinal product.
Outcome measures
| Measure |
FF/VI
n=2114 Participants
Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.
|
Usual Care
n=2119 Participants
Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).
|
|---|---|---|
|
Number of Participants With Adverse Drug Reactions (ADRs)
|
326 Participants
|
109 Participants
|
Adverse Events
Usual Care
Serious events: 284 serious events
Other events: 0 other events
Deaths: 27 deaths
FF/VI
Serious events: 284 serious events
Other events: 0 other events
Deaths: 15 deaths
Serious adverse events
| Measure |
Usual Care
n=2119 participants at risk
Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).
|
FF/VI
n=2114 participants at risk
Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.14%
3/2119 • Number of events 3 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.14%
3/2114 • Number of events 3 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Blood and lymphatic system disorders
Anaemia of chronic disease
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Blood and lymphatic system disorders
Lymphadenopathy mediastinal
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Cardiac disorders
Acute coronary syndrome
|
0.05%
1/2119 • Number of events 2 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Cardiac disorders
Acute myocardial infarction
|
0.09%
2/2119 • Number of events 2 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.19%
4/2114 • Number of events 4 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Cardiac disorders
Angina pectoris
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.24%
5/2114 • Number of events 5 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Cardiac disorders
Angina unstable
|
0.09%
2/2119 • Number of events 2 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Cardiac disorders
Arrhythmia
|
0.14%
3/2119 • Number of events 3 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.09%
2/2114 • Number of events 2 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Cardiac disorders
Atrial fibrillation
|
0.66%
14/2119 • Number of events 16 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.33%
7/2114 • Number of events 7 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Cardiac disorders
Cardiac arrest
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.09%
2/2114 • Number of events 2 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Cardiac disorders
Cardiac failure congestive
|
0.09%
2/2119 • Number of events 2 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Cardiac disorders
Cardiac ventricular thrombosis
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Cardiac disorders
Coronary artery disease
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Cardiac disorders
Coronary artery thrombosis
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Cardiac disorders
Diastolic dysfunction
|
0.09%
2/2119 • Number of events 2 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Cardiac disorders
Hypertensive heart disease
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.14%
3/2114 • Number of events 3 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Cardiac disorders
Left ventricular hypertrophy
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Cardiac disorders
Myocardial infarction
|
0.09%
2/2119 • Number of events 2 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.09%
2/2114 • Number of events 2 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Cardiac disorders
Myocardial ischaemia
|
0.09%
2/2119 • Number of events 2 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.24%
5/2114 • Number of events 5 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.09%
2/2114 • Number of events 2 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Cardiac disorders
Palpitations
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Cardiac disorders
Sinus node dysfunction
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Cardiac disorders
Ventricular tachycardia
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Congenital, familial and genetic disorders
Branchial cyst
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Congenital, familial and genetic disorders
Endocardial fibroelastosis
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Ear and labyrinth disorders
Tinnitus
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Endocrine disorders
Adrenal insufficiency
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Endocrine disorders
Hyperparathyroidism
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Endocrine disorders
Hyperthyroidism
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Endocrine disorders
Hypothyroidism
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Endocrine disorders
Secondary hypogonadism
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Eye disorders
Angle closure glaucoma
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Eye disorders
Cataract
|
0.19%
4/2119 • Number of events 4 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.28%
6/2114 • Number of events 6 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Eye disorders
Diabetic retinopathy
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Eye disorders
Glaucoma
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.19%
4/2114 • Number of events 4 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Eye disorders
Retinal detachment
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Gastrointestinal disorders
Abdominal pain
|
0.19%
4/2119 • Number of events 4 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.24%
5/2114 • Number of events 5 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Gastrointestinal disorders
Abdominal wall haematoma
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 2 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Gastrointestinal disorders
Constipation
|
0.24%
5/2119 • Number of events 5 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.19%
4/2114 • Number of events 4 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.09%
2/2114 • Number of events 2 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Gastrointestinal disorders
Gastritis
|
0.24%
5/2119 • Number of events 5 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.09%
2/2119 • Number of events 2 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.14%
3/2114 • Number of events 3 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Gastrointestinal disorders
Haematemesis
|
0.09%
2/2119 • Number of events 2 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Gastrointestinal disorders
Incarcerated umbilical hernia
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Gastrointestinal disorders
Melaena
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Gastrointestinal disorders
Oesophagitis
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Gastrointestinal disorders
Pancreatitis
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.14%
3/2114 • Number of events 3 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Gastrointestinal disorders
Proctalgia
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Gastrointestinal disorders
Umbilical hernia, obstructive
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Gastrointestinal disorders
Vomiting
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.09%
2/2114 • Number of events 2 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
General disorders
Chest pain
|
0.19%
4/2119 • Number of events 4 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
General disorders
Generalised oedema
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
General disorders
Non-cardiac chest pain
|
0.14%
3/2119 • Number of events 3 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
General disorders
Peripheral swelling
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
General disorders
Surgical failure
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Hepatobiliary disorders
Cholecystitis
|
0.14%
3/2119 • Number of events 3 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 2 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.14%
3/2114 • Number of events 3 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.09%
2/2119 • Number of events 2 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Hepatobiliary disorders
Hepatic failure
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Immune system disorders
Anaphylactic reaction
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Immune system disorders
Hypersensitivity
|
0.09%
2/2119 • Number of events 2 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Immune system disorders
Mycotic allergy
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Infections and infestations
Abdominal abscess
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Infections and infestations
Abdominal wall abscess
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Infections and infestations
Abscess
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Infections and infestations
Anal abscess
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Infections and infestations
Appendicitis
|
0.09%
2/2119 • Number of events 2 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Infections and infestations
Atypical pneumonia
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Infections and infestations
Biliary sepsis
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Infections and infestations
Candida infection
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Infections and infestations
Cellulitis
|
0.52%
11/2119 • Number of events 13 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.33%
7/2114 • Number of events 8 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Infections and infestations
Chronic hepatitis C
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Infections and infestations
Diverticulitis
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.14%
3/2114 • Number of events 3 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Infections and infestations
Empyema
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Infections and infestations
Encephalitis
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.09%
2/2114 • Number of events 2 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Infections and infestations
Genital herpes
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Infections and infestations
Genital infection
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Infections and infestations
Infected dermal cyst
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Infections and infestations
Infected skin ulcer
|
0.14%
3/2119 • Number of events 3 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.09%
2/2114 • Number of events 2 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Infections and infestations
Kidney infection
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Infections and infestations
Liver abscess
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Infections and infestations
Localised infection
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Infections and infestations
Lower respiratory tract infection
|
0.33%
7/2119 • Number of events 7 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.24%
5/2114 • Number of events 5 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Infections and infestations
Necrotising fasciitis
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Infections and infestations
Neutropenic sepsis
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.09%
2/2114 • Number of events 2 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Infections and infestations
Ophthalmic herpes simplex
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Infections and infestations
Pelvic inflammatory disease
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Infections and infestations
Periorbital cellulitis
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Infections and infestations
Peritonsillar abscess
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Infections and infestations
Pilonidal cyst
|
0.09%
2/2119 • Number of events 3 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Infections and infestations
Pneumonia
|
0.61%
13/2119 • Number of events 14 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
1.1%
23/2114 • Number of events 24 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Infections and infestations
Pneumonia mycoplasmal
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Infections and infestations
Post procedural sepsis
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Infections and infestations
Postoperative wound infection
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.09%
2/2114 • Number of events 2 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Infections and infestations
Pseudomonas infection
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Infections and infestations
Pyelonephritis
|
0.14%
3/2119 • Number of events 3 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.14%
3/2114 • Number of events 3 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Infections and infestations
Sepsis
|
0.33%
7/2119 • Number of events 7 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.14%
3/2114 • Number of events 3 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Infections and infestations
Sialoadenitis
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Infections and infestations
Staphylococcal infection
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Infections and infestations
Subcutaneous abscess
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Infections and infestations
Tonsillitis
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Infections and infestations
Upper respiratory tract infection
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Infections and infestations
Urinary tract infection
|
0.19%
4/2119 • Number of events 4 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.57%
12/2114 • Number of events 13 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Infections and infestations
Urosepsis
|
0.09%
2/2119 • Number of events 2 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Infections and infestations
Viral infection
|
0.09%
2/2119 • Number of events 2 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Infections and infestations
Viral labyrinthitis
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Infections and infestations
Vulval abscess
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Infections and infestations
Wound infection
|
0.09%
2/2119 • Number of events 2 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.14%
3/2119 • Number of events 3 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.09%
2/2114 • Number of events 2 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.09%
2/2119 • Number of events 2 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.38%
8/2114 • Number of events 8 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Injury, poisoning and procedural complications
Burns third degree
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Injury, poisoning and procedural complications
Comminuted fracture
|
0.09%
2/2119 • Number of events 2 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Injury, poisoning and procedural complications
Fall
|
0.24%
5/2119 • Number of events 5 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.28%
6/2114 • Number of events 6 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.09%
2/2119 • Number of events 2 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.09%
2/2114 • Number of events 2 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.09%
2/2119 • Number of events 2 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.14%
3/2119 • Number of events 3 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.14%
3/2114 • Number of events 3 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Injury, poisoning and procedural complications
Foreign body
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Injury, poisoning and procedural complications
Fracture
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.19%
4/2119 • Number of events 5 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Injury, poisoning and procedural complications
Head injury
|
0.14%
3/2119 • Number of events 3 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.24%
5/2119 • Number of events 5 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.09%
2/2114 • Number of events 2 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.24%
5/2119 • Number of events 5 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.24%
5/2114 • Number of events 5 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Injury, poisoning and procedural complications
Intentional product misuse
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.09%
2/2119 • Number of events 2 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 2 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Injury, poisoning and procedural complications
Limb crushing injury
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Injury, poisoning and procedural complications
Overdose
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.09%
2/2114 • Number of events 2 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.09%
2/2119 • Number of events 2 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.09%
2/2114 • Number of events 2 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Injury, poisoning and procedural complications
Pubis fracture
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.42%
9/2119 • Number of events 10 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.19%
4/2114 • Number of events 4 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.09%
2/2114 • Number of events 2 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Injury, poisoning and procedural complications
Skull fractured base
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.09%
2/2114 • Number of events 2 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Injury, poisoning and procedural complications
Subarachnoid haemorrhage
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.09%
2/2114 • Number of events 2 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.09%
2/2114 • Number of events 2 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Injury, poisoning and procedural complications
Wound secretion
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.14%
3/2119 • Number of events 3 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.24%
5/2114 • Number of events 5 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Investigations
Blood potassium decreased
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Investigations
Electrocardiogram QT prolonged
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Investigations
International normalised ratio abnormal
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Investigations
Liver function test abnormal
|
0.33%
7/2119 • Number of events 7 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.52%
11/2114 • Number of events 11 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Investigations
Renal function test abnormal
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Metabolism and nutrition disorders
Dehydration
|
0.09%
2/2119 • Number of events 2 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.14%
3/2119 • Number of events 3 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.14%
3/2114 • Number of events 3 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.09%
2/2119 • Number of events 2 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Metabolism and nutrition disorders
Gout
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.19%
4/2114 • Number of events 4 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.09%
2/2119 • Number of events 2 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.09%
2/2119 • Number of events 2 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.61%
13/2119 • Number of events 13 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.57%
12/2114 • Number of events 12 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.38%
8/2119 • Number of events 9 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.14%
3/2114 • Number of events 3 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.14%
3/2119 • Number of events 3 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Musculoskeletal and connective tissue disorders
Metatarsalgia
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.09%
2/2119 • Number of events 2 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.09%
2/2114 • Number of events 2 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.24%
5/2114 • Number of events 5 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Musculoskeletal and connective tissue disorders
Palindromic rheumatism
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acinic cell carcinoma of salivary gland
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenoma benign
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma recurrent
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.09%
2/2119 • Number of events 6 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.19%
4/2114 • Number of events 4 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain cancer metastatic
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.09%
2/2119 • Number of events 2 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.09%
2/2114 • Number of events 2 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Central nervous system lymphoma
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chondrosarcoma
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer metastatic
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenocarcinoma
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal carcinoma
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal stromal tumour
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lentigo maligna
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.09%
2/2114 • Number of events 2 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.09%
2/2114 • Number of events 2 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic renal cell carcinoma
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Penile squamous cell carcinoma
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Phyllodes tumour
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Precursor B-lymphoblastic lymphoma
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.19%
4/2119 • Number of events 4 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.14%
3/2114 • Number of events 3 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.09%
2/2114 • Number of events 2 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer recurrent
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.09%
2/2114 • Number of events 2 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ureteric cancer
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Nervous system disorders
Amnesia
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Nervous system disorders
Anosmia
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.24%
5/2114 • Number of events 5 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Nervous system disorders
Cerebrovascular disorder
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Nervous system disorders
Dementia
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.09%
2/2114 • Number of events 2 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Nervous system disorders
Dizziness
|
0.09%
2/2119 • Number of events 2 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Nervous system disorders
Drug withdrawal convulsions
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Nervous system disorders
Epilepsy
|
0.09%
2/2119 • Number of events 2 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Nervous system disorders
Headache
|
0.19%
4/2119 • Number of events 4 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.09%
2/2114 • Number of events 2 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Nervous system disorders
Ischaemic stroke
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.14%
3/2114 • Number of events 3 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Nervous system disorders
Migraine
|
0.09%
2/2119 • Number of events 2 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.24%
5/2114 • Number of events 5 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Nervous system disorders
Multiple sclerosis
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Nervous system disorders
Multiple sclerosis relapse
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Nervous system disorders
Neuropathy peripheral
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Nervous system disorders
Paraesthesia
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Nervous system disorders
Parkinson's disease
|
0.09%
2/2119 • Number of events 2 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Nervous system disorders
Radiculopathy
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Nervous system disorders
Sciatica
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Nervous system disorders
Seizure
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.24%
5/2114 • Number of events 5 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Nervous system disorders
Sensory disturbance
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Nervous system disorders
Status epilepticus
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Nervous system disorders
Subdural hygroma
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Nervous system disorders
Syncope
|
0.09%
2/2119 • Number of events 2 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.14%
3/2114 • Number of events 3 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.09%
2/2114 • Number of events 2 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Nervous system disorders
VIth nerve paralysis
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Nervous system disorders
Vascular dementia
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Nervous system disorders
Vertebral artery dissection
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Nervous system disorders
Vocal cord paralysis
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Pregnancy, puerperium and perinatal conditions
Abortion missed
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.09%
2/2114 • Number of events 2 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Pregnancy, puerperium and perinatal conditions
Unintended pregnancy
|
0.14%
3/2119 • Number of events 3 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.14%
3/2114 • Number of events 3 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Pregnancy, puerperium and perinatal conditions
Unwanted pregnancy
|
0.09%
2/2119 • Number of events 2 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.09%
2/2114 • Number of events 2 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Product Issues
Device dislocation
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.09%
2/2114 • Number of events 3 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Psychiatric disorders
Alcoholism
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Psychiatric disorders
Antisocial personality disorder
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Psychiatric disorders
Bipolar disorder
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Psychiatric disorders
Confusional state
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Psychiatric disorders
Delusion
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Psychiatric disorders
Depression
|
0.09%
2/2119 • Number of events 2 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.19%
4/2114 • Number of events 4 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Psychiatric disorders
Depression suicidal
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Psychiatric disorders
Eating disorder
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Psychiatric disorders
Hypomania
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Psychiatric disorders
Persistent depressive disorder
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Psychiatric disorders
Post-traumatic stress disorder
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Psychiatric disorders
Psychotic disorder
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.09%
2/2114 • Number of events 2 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Psychiatric disorders
Schizoaffective disorder
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Psychiatric disorders
Suicidal ideation
|
0.09%
2/2119 • Number of events 2 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.14%
3/2114 • Number of events 3 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Renal and urinary disorders
Acute kidney injury
|
0.42%
9/2119 • Number of events 9 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.28%
6/2114 • Number of events 6 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.24%
5/2119 • Number of events 5 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.14%
3/2114 • Number of events 3 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Renal and urinary disorders
Haematuria
|
0.09%
2/2119 • Number of events 2 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.09%
2/2114 • Number of events 2 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Renal and urinary disorders
Loin pain haematuria syndrome
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Renal and urinary disorders
Renal colic
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.09%
2/2114 • Number of events 2 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Renal and urinary disorders
Renal impairment
|
0.14%
3/2119 • Number of events 3 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.14%
3/2114 • Number of events 3 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Renal and urinary disorders
Urinary retention
|
0.19%
4/2119 • Number of events 4 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.09%
2/2114 • Number of events 2 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Reproductive system and breast disorders
Oedema genital
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Reproductive system and breast disorders
Ovarian cyst torsion
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Reproductive system and breast disorders
Prostatitis
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.4%
30/2119 • Number of events 34 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
1.1%
24/2114 • Number of events 30 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.24%
5/2119 • Number of events 6 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.14%
3/2119 • Number of events 3 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal inflammation
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Pickwickian syndrome
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.09%
2/2119 • Number of events 2 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.09%
2/2114 • Number of events 2 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary eosinophilia
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.09%
2/2119 • Number of events 2 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Reflux laryngitis
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.09%
2/2119 • Number of events 2 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.09%
2/2114 • Number of events 2 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.09%
2/2119 • Number of events 2 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.14%
3/2114 • Number of events 3 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Skin and subcutaneous tissue disorders
Skin necrosis
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Surgical and medical procedures
Abortion induced
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Vascular disorders
Angiodysplasia
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Vascular disorders
Aortic stenosis
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Vascular disorders
Deep vein thrombosis
|
0.09%
2/2119 • Number of events 2 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.24%
5/2114 • Number of events 6 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Vascular disorders
Essential hypertension
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Vascular disorders
Haematoma
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Vascular disorders
Hypertension
|
0.09%
2/2119 • Number of events 2 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Vascular disorders
Hypotension
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Vascular disorders
Raynaud's phenomenon
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Vascular disorders
Superior vena cava occlusion
|
0.00%
0/2119 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.05%
1/2114 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Vascular disorders
Temporal arteritis
|
0.05%
1/2119 • Number of events 1 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
0.00%
0/2114 • On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
Other adverse events
Adverse event data not reported
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER