Trial Outcomes & Findings for SAS115359: A 6-month Study to Assess the Safety and Benefit of Inhaled Fluticasone Propionate/Salmeterol Combination Compared With Inhaled Fluticasone Propionate in the Treatment of Adolescents and Adults (12 Years of Age and Older) With Asthma. (NCT NCT01475721)
NCT ID: NCT01475721
Last Updated: 2018-08-06
Results Overview
Composite endpoint was defined as clinically relevant endpoint that is constructed from combinations of other clinically relevant endpoints of serious asthma outcomes (i.e., asthma-related hospitalization, asthma-related endotracheal intubation, or asthma-related death). Hospitalization was defined as an inpatient stay or a ≥24-hour stay in an observation area in an emergency department or other equivalent facility. Probability of having event was summarized with Kaplan-Meier estimates.Hazard ratio, confidence interval, and p-value are from a stratified Cox proportional hazard model, using randomization stratum as the stratification factor. The 95% CI provided in the table is actually the 95.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
11751 participants
Primary outcome timeframe
From Day 1 up to 26 weeks
Results posted on
2018-08-06
Participant Flow
Study duration was 29 weeks, comprised of a randomization visit followed by a treatment period of 26 weeks and a 1 week follow-up phone call. Participants were assessed for eligibility at screening up to 15 days prior to randomization.
Eligible adolescent and adult participants with asthma were stratified based on current asthma medication and a Asthma Control Questionnaire (ACQ-6) score and randomized 1:1 to double-blind study treatment. A total of 11751 were enrolled; however, 72 were randomized but did not receive study treatment.
Participant milestones
| Measure |
Fluticasone Propionate/Salmeterol Combination (FSC)
Participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg or FSC 500/50 µg as one inhalation twice daily (BID) via Dry powder inhaler (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
|
Fluticasone Propionate (FP)
Participants received one of following treatments: FP 100 µg or FP 250 µg or FP 500 µg as one inhalation (BID) via (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
|
|---|---|---|
|
Overall Study
STARTED
|
5834
|
5845
|
|
Overall Study
COMPLETED
|
5823
|
5831
|
|
Overall Study
NOT COMPLETED
|
11
|
14
|
Reasons for withdrawal
| Measure |
Fluticasone Propionate/Salmeterol Combination (FSC)
Participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg or FSC 500/50 µg as one inhalation twice daily (BID) via Dry powder inhaler (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
|
Fluticasone Propionate (FP)
Participants received one of following treatments: FP 100 µg or FP 250 µg or FP 500 µg as one inhalation (BID) via (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
|
|---|---|---|
|
Overall Study
Death
|
3
|
6
|
|
Overall Study
Withdrawal by Subject
|
8
|
8
|
Baseline Characteristics
SAS115359: A 6-month Study to Assess the Safety and Benefit of Inhaled Fluticasone Propionate/Salmeterol Combination Compared With Inhaled Fluticasone Propionate in the Treatment of Adolescents and Adults (12 Years of Age and Older) With Asthma.
Baseline characteristics by cohort
| Measure |
Fluticasone Propionate/Salmeterol Combination (FSC)
n=5834 Participants
Participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg or FSC 500/50 µg as one inhalation twice daily (BID) via Dry powder inhaler (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
|
Fluticasone Propionate (FP)
n=5845 Participants
Participants received one of following treatments: FP 100 µg or FP 250 µg or FP 500 µg as one inhalation (BID) via (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
|
Total
n=11679 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.4 Years
STANDARD_DEVIATION 17.45 • n=5 Participants
|
43.4 Years
STANDARD_DEVIATION 17.28 • n=7 Participants
|
43.4 Years
STANDARD_DEVIATION 17.36 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3851 Participants
n=5 Participants
|
3898 Participants
n=7 Participants
|
7749 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1983 Participants
n=5 Participants
|
1947 Participants
n=7 Participants
|
3930 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Missing
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage
|
870 Participants
n=5 Participants
|
856 Participants
n=7 Participants
|
1726 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaska native
|
109 Participants
n=5 Participants
|
116 Participants
n=7 Participants
|
225 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian-Central/South Asian Heritage
|
36 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian-East Asian Heritage
|
94 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
182 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Japanese Heritage
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian-South East Asian Heritage
|
234 Participants
n=5 Participants
|
224 Participants
n=7 Participants
|
458 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White-Arabic/North African Heritage
|
22 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White-White/Caucasian/European Heritage
|
4352 Participants
n=5 Participants
|
4388 Participants
n=7 Participants
|
8740 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
102 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
193 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From Day 1 up to 26 weeksPopulation: Intent to treat (ITT) Population comprised of all participants randomized to study drug and who took study drug.
Composite endpoint was defined as clinically relevant endpoint that is constructed from combinations of other clinically relevant endpoints of serious asthma outcomes (i.e., asthma-related hospitalization, asthma-related endotracheal intubation, or asthma-related death). Hospitalization was defined as an inpatient stay or a ≥24-hour stay in an observation area in an emergency department or other equivalent facility. Probability of having event was summarized with Kaplan-Meier estimates.Hazard ratio, confidence interval, and p-value are from a stratified Cox proportional hazard model, using randomization stratum as the stratification factor. The 95% CI provided in the table is actually the 95.
Outcome measures
| Measure |
Fluticasone Propionate/Salmeterol Combination (FSC)
n=5834 Participants
Participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg or FSC 500/50 µg as one inhalation twice daily (BID) via Dry powder inhaler (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
|
Fluticasone Propionate (FP)
n=5845 Participants
Participants received one of following treatments: FP 100 µg or FP 250 µg or FP 500 µg as one inhalation (BID) via (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
|
|---|---|---|
|
Number of Participants Experiencing an Event in the Composite Safety Endpoint of Serious Asthma Outcomes ( Asthma-related Hospitalization, Asthma-related Endotracheal Intubation, or Asthma-related Death)
|
34 Participants
|
33 Participants
|
PRIMARY outcome
Timeframe: From Day 1 up to 26 weeksPopulation: Modified intent to treat (mITT) Population comprised of participants included in the ITT population that correspond to each participant's period of exposure to study drug plus seven days after the last date of study drug treatment.
An asthma exacerbation is defined as a deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least three days or an inpatient hospitalization or emergency department visit due to asthma that required systemic corticosteroids.
Outcome measures
| Measure |
Fluticasone Propionate/Salmeterol Combination (FSC)
n=5834 Participants
Participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg or FSC 500/50 µg as one inhalation twice daily (BID) via Dry powder inhaler (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
|
Fluticasone Propionate (FP)
n=5845 Participants
Participants received one of following treatments: FP 100 µg or FP 250 µg or FP 500 µg as one inhalation (BID) via (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
|
|---|---|---|
|
Number of Participants Experiencing at Least One Asthma Exacerbation
|
480 Participants
|
597 Participants
|
SECONDARY outcome
Timeframe: From Day 1 up to 26 weeksPopulation: ITT Population
Hospitalization was defined as an inpatient stay or a ≥24-hour stay in an observation area in an emergency department or other equivalent facility.
Outcome measures
| Measure |
Fluticasone Propionate/Salmeterol Combination (FSC)
n=5834 Participants
Participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg or FSC 500/50 µg as one inhalation twice daily (BID) via Dry powder inhaler (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
|
Fluticasone Propionate (FP)
n=5845 Participants
Participants received one of following treatments: FP 100 µg or FP 250 µg or FP 500 µg as one inhalation (BID) via (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
|
|---|---|---|
|
Number of Participants Experiencing at Least One Asthma Related Hospitalization , Endotracheal Intubation and Death
Hospitalization
|
34 Participants
|
33 Participants
|
|
Number of Participants Experiencing at Least One Asthma Related Hospitalization , Endotracheal Intubation and Death
Endotracheal intubation
|
0 Participants
|
2 Participants
|
|
Number of Participants Experiencing at Least One Asthma Related Hospitalization , Endotracheal Intubation and Death
Death
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Day 1 up to 26 weeksPopulation: mITT Population
An asthma exacerbation is defined as a deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least three days or an inpatient hospitalization or emergency department visit due to asthma that required systemic corticosteroids.
Outcome measures
| Measure |
Fluticasone Propionate/Salmeterol Combination (FSC)
n=5834 Participants
Participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg or FSC 500/50 µg as one inhalation twice daily (BID) via Dry powder inhaler (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
|
Fluticasone Propionate (FP)
n=5845 Participants
Participants received one of following treatments: FP 100 µg or FP 250 µg or FP 500 µg as one inhalation (BID) via (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
|
|---|---|---|
|
Number of Participant Withdrawals From Study Treatment Due to Asthma Exacerbation
|
66 Participants
|
84 Participants
|
SECONDARY outcome
Timeframe: From Day 1 up to 26 weeksPopulation: mITT Population. Only those participants available at specified timepoint were analysed.
Rescue medication included albuterol/salbutamol used to treat acute asthma were reported as puffs per 24 hours over a period of 6 months.
Outcome measures
| Measure |
Fluticasone Propionate/Salmeterol Combination (FSC)
n=5677 Participants
Participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg or FSC 500/50 µg as one inhalation twice daily (BID) via Dry powder inhaler (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
|
Fluticasone Propionate (FP)
n=5673 Participants
Participants received one of following treatments: FP 100 µg or FP 250 µg or FP 500 µg as one inhalation (BID) via (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
|
|---|---|---|
|
Mean Rescue Medication (Albuterol/Salbutamol) Use as Puffs Per 24 Hours
|
0.90 Number of Puffs
Standard Error 0.018
|
1.09 Number of Puffs
Standard Error 0.020
|
Adverse Events
Fluticasone Propionate/Salmeterol Combination (FSC)
Serious events: 134 serious events
Other events: 46 other events
Deaths: 0 deaths
Fluticasone Propionate (FP)
Serious events: 125 serious events
Other events: 75 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fluticasone Propionate/Salmeterol Combination (FSC)
n=5834 participants at risk
Participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg or FSC 500/50 µg as one inhalation twice daily (BID) via Dry powder inhaler (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
|
Fluticasone Propionate (FP)
n=5845 participants at risk
Participants received one of following treatments: FP 100 µg or FP 250 µg or FP 500 µg as one inhalation (BID) via (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
|
|---|---|---|
|
Gastrointestinal disorders
Large intestine polyp
|
0.02%
1/5834 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.00%
0/5845 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Gastrointestinal disorders
Pancreatitis
|
0.02%
1/5834 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.00%
0/5845 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Blood and lymphatic system disorders
Anaemia
|
0.05%
3/5834 • Number of events 3 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.02%
1/5845 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Cardiac disorders
Atrial fibrillation
|
0.05%
3/5834 • Number of events 3 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.00%
0/5845 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/5834 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.03%
2/5845 • Number of events 2 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Cardiac disorders
Angina unstable
|
0.03%
2/5834 • Number of events 2 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.00%
0/5845 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Cardiac disorders
Arrhythmia
|
0.02%
1/5834 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.00%
0/5845 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Cardiac disorders
Cardiac failure congestive
|
0.02%
1/5834 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.03%
2/5845 • Number of events 2 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Cardiac disorders
Cardiomyopathy
|
0.02%
1/5834 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.00%
0/5845 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/5834 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.02%
1/5845 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Cardiac disorders
Myocardial infarction
|
0.02%
1/5834 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.00%
0/5845 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Cardiac disorders
Myocardial ischaemia
|
0.02%
1/5834 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.02%
1/5845 • Number of events 2 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/5834 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.02%
1/5845 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Cardiac disorders
Prinzmetal angina
|
0.00%
0/5834 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.02%
1/5845 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Congenital, familial and genetic disorders
Hereditary angioedema
|
0.02%
1/5834 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.00%
0/5845 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Ear and labyrinth disorders
Vertigo
|
0.02%
1/5834 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.00%
0/5845 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Endocrine disorders
Autoimmune thyroiditis
|
0.02%
1/5834 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.00%
0/5845 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Eye disorders
Retinal detachment
|
0.02%
1/5834 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.00%
0/5845 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/5834 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.03%
2/5845 • Number of events 2 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Gastrointestinal disorders
Abdominal pain
|
0.02%
1/5834 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.00%
0/5845 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/5834 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.02%
1/5845 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/5834 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.02%
1/5845 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Gastrointestinal disorders
Duodenal ulcer perforation
|
0.00%
0/5834 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.02%
1/5845 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/5834 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.02%
1/5845 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Gastrointestinal disorders
Dysphagia
|
0.02%
1/5834 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.00%
0/5845 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Gastrointestinal disorders
Enteritis
|
0.02%
1/5834 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.00%
0/5845 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Gastrointestinal disorders
Food poisoning
|
0.02%
1/5834 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.00%
0/5845 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/5834 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.02%
1/5845 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.02%
1/5834 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.00%
0/5845 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/5834 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.02%
1/5845 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/5834 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.02%
1/5845 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Gastrointestinal disorders
Vomiting
|
0.02%
1/5834 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.00%
0/5845 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.03%
2/5834 • Number of events 2 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.02%
1/5845 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
General disorders
Chest pain
|
0.03%
2/5834 • Number of events 2 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.07%
4/5845 • Number of events 5 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
General disorders
Sudden cardiac death
|
0.00%
0/5834 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.02%
1/5845 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/5834 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.02%
1/5845 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/5834 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.02%
1/5845 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/5834 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.02%
1/5845 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/5834 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.02%
1/5845 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.02%
1/5834 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.03%
2/5845 • Number of events 2 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Immune system disorders
Anaphylactic reaction
|
0.02%
1/5834 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.02%
1/5845 • Number of events 3 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Immune system disorders
Allergic granulomatous angiitis
|
0.00%
0/5834 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.02%
1/5845 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Immune system disorders
Anaphylactic shock
|
0.02%
1/5834 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.00%
0/5845 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Infections and infestations
Influenza
|
0.00%
0/5834 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.05%
3/5845 • Number of events 3 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Infections and infestations
Pyelonephritis
|
0.05%
3/5834 • Number of events 3 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.00%
0/5845 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Infections and infestations
Dengue fever
|
0.03%
2/5834 • Number of events 2 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.00%
0/5845 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Infections and infestations
Typhoid fever
|
0.03%
2/5834 • Number of events 2 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.00%
0/5845 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Infections and infestations
Abscess
|
0.02%
1/5834 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.00%
0/5845 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Infections and infestations
Abscess neck
|
0.00%
0/5834 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.02%
1/5845 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Infections and infestations
Acute tonsillitis
|
0.00%
0/5834 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.02%
1/5845 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Infections and infestations
Breast abscess
|
0.02%
1/5834 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.00%
0/5845 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Infections and infestations
Bronchopneumonia
|
0.02%
1/5834 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.00%
0/5845 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Infections and infestations
Cellulitis
|
0.02%
1/5834 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.00%
0/5845 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Infections and infestations
Diverticulitis
|
0.02%
1/5834 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.00%
0/5845 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Infections and infestations
Erysipelas
|
0.00%
0/5834 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.02%
1/5845 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Infections and infestations
Extradural abscess
|
0.02%
1/5834 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.00%
0/5845 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Infections and infestations
Gastroenteritis
|
0.02%
1/5834 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.03%
2/5845 • Number of events 2 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Infections and infestations
Helicobacter gastritis
|
0.00%
0/5834 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.02%
1/5845 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Infections and infestations
Kidney infection
|
0.02%
1/5834 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.00%
0/5845 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Infections and infestations
Lobar pneumonia
|
0.02%
1/5834 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.00%
0/5845 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Infections and infestations
Paronychia
|
0.02%
1/5834 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.00%
0/5845 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Infections and infestations
Peritonsillitis
|
0.00%
0/5834 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.02%
1/5845 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Infections and infestations
Pneumonia
|
0.14%
8/5834 • Number of events 8 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.14%
8/5845 • Number of events 9 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Infections and infestations
Salpingo-oophoritis
|
0.00%
0/5834 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.02%
1/5845 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Infections and infestations
Sepsis
|
0.00%
0/5834 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.02%
1/5845 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Infections and infestations
Sialoadenitis
|
0.02%
1/5834 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.00%
0/5845 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Infections and infestations
Skin infection
|
0.00%
0/5834 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.02%
1/5845 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Infections and infestations
Upper respiratory tract infection
|
0.02%
1/5834 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.00%
0/5845 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Infections and infestations
Viraemia
|
0.00%
0/5834 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.02%
1/5845 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Infections and infestations
Viral infection
|
0.00%
0/5834 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.02%
1/5845 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/5834 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.02%
1/5845 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Infections and infestations
Appendicitis
|
0.02%
1/5834 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.02%
1/5845 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Infections and infestations
Bronchitis
|
0.02%
1/5834 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.02%
1/5845 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.03%
2/5834 • Number of events 2 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.00%
0/5845 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.03%
2/5834 • Number of events 2 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.00%
0/5845 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/5834 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.02%
1/5845 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/5834 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.02%
1/5845 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/5834 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.02%
1/5845 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Injury, poisoning and procedural complications
Delayed recovery from anaesthesia
|
0.00%
0/5834 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.02%
1/5845 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Injury, poisoning and procedural complications
Heat exhaustion
|
0.02%
1/5834 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.00%
0/5845 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.02%
1/5834 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.00%
0/5845 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.02%
1/5834 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.00%
0/5845 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Injury, poisoning and procedural complications
Ligament injury
|
0.00%
0/5834 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.02%
1/5845 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/5834 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.02%
1/5845 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Injury, poisoning and procedural complications
Overdose
|
0.02%
1/5834 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.00%
0/5845 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.02%
1/5834 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.00%
0/5845 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.02%
1/5834 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.00%
0/5845 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.02%
1/5834 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.00%
0/5845 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.02%
1/5834 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.00%
0/5845 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.02%
1/5834 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.00%
0/5845 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Injury, poisoning and procedural complications
Traumatic liver injury
|
0.02%
1/5834 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.00%
0/5845 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.02%
1/5834 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.02%
1/5845 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Investigations
Coagulation time prolonged
|
0.00%
0/5834 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.02%
1/5845 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.05%
3/5834 • Number of events 3 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.00%
0/5845 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.03%
2/5834 • Number of events 2 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.00%
0/5845 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.02%
1/5834 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.00%
0/5845 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.03%
2/5834 • Number of events 2 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.00%
0/5845 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Musculoskeletal and connective tissue disorders
Bone cyst
|
0.00%
0/5834 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.02%
1/5845 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.02%
1/5834 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.00%
0/5845 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/5834 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.02%
1/5845 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.02%
1/5834 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.00%
0/5845 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/5834 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.02%
1/5845 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.02%
1/5834 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.00%
0/5845 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.03%
2/5834 • Number of events 2 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.02%
1/5845 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.00%
0/5834 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.02%
1/5845 • Number of events 2 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic neoplasm
|
0.00%
0/5834 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.02%
1/5845 • Number of events 2 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anaplastic astrocytoma
|
0.02%
1/5834 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.00%
0/5845 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/5834 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.02%
1/5845 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer stage II
|
0.00%
0/5834 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.02%
1/5845 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
0.00%
0/5834 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.02%
1/5845 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.02%
1/5834 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.00%
0/5845 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/5834 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.02%
1/5845 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal oncocytoma
|
0.02%
1/5834 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.00%
0/5845 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.02%
1/5834 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.02%
1/5845 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Nervous system disorders
Ischaemic stroke
|
0.02%
1/5834 • Number of events 2 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.00%
0/5845 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/5834 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.02%
1/5845 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Nervous system disorders
Cerebral infarction
|
0.02%
1/5834 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.00%
0/5845 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Nervous system disorders
Cervical cord compression
|
0.02%
1/5834 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.00%
0/5845 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/5834 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.02%
1/5845 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/5834 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.02%
1/5845 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Nervous system disorders
Migraine
|
0.00%
0/5834 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.02%
1/5845 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Nervous system disorders
Spinal subdural haematoma
|
0.02%
1/5834 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.00%
0/5845 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Nervous system disorders
Headache
|
0.02%
1/5834 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.02%
1/5845 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Nervous system disorders
Syncope
|
0.02%
1/5834 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.02%
1/5845 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Nervous system disorders
Transient ischaemic attack
|
0.03%
2/5834 • Number of events 2 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.03%
2/5845 • Number of events 2 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Nervous system disorders
Cerebrovascular accident
|
0.07%
4/5834 • Number of events 4 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.05%
3/5845 • Number of events 3 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.02%
1/5834 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.07%
4/5845 • Number of events 4 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Pregnancy, puerperium and perinatal conditions
Abortion
|
0.00%
0/5834 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.02%
1/5845 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Pregnancy, puerperium and perinatal conditions
Blighted ovum
|
0.00%
0/5834 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.02%
1/5845 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.02%
1/5834 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.00%
0/5845 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Pregnancy, puerperium and perinatal conditions
Stillbirth
|
0.00%
0/5834 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.02%
1/5845 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Psychiatric disorders
Depression
|
0.00%
0/5834 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.03%
2/5845 • Number of events 2 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Psychiatric disorders
Stress
|
0.03%
2/5834 • Number of events 2 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.00%
0/5845 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Psychiatric disorders
Anxiety
|
0.02%
1/5834 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.00%
0/5845 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Psychiatric disorders
Bulimia nervosa
|
0.00%
0/5834 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.02%
1/5845 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/5834 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.02%
1/5845 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Psychiatric disorders
Somnambulism
|
0.02%
1/5834 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.00%
0/5845 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Psychiatric disorders
Suicidal ideation
|
0.02%
1/5834 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.03%
2/5845 • Number of events 2 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.03%
2/5834 • Number of events 2 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.00%
0/5845 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/5834 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.02%
1/5845 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/5834 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.02%
1/5845 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Renal and urinary disorders
Renal cyst
|
0.02%
1/5834 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.00%
0/5845 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Reproductive system and breast disorders
Fallopian tube cyst
|
0.00%
0/5834 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.02%
1/5845 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Reproductive system and breast disorders
Uterine cervical squamous metaplasia
|
0.02%
1/5834 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.00%
0/5845 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/5834 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.02%
1/5845 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.02%
1/5834 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.02%
1/5845 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.02%
1/5834 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.09%
5/5845 • Number of events 5 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Respiratory, thoracic and mediastinal disorders
Status asthmaticus
|
0.00%
0/5834 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.03%
2/5845 • Number of events 2 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.02%
1/5834 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.00%
0/5845 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/5834 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.02%
1/5845 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/5834 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.02%
1/5845 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.00%
0/5834 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.02%
1/5845 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.02%
1/5834 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.00%
0/5845 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.00%
0/5834 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.02%
1/5845 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.51%
30/5834 • Number of events 32 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.48%
28/5845 • Number of events 30 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/5834 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.02%
1/5845 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.02%
1/5834 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.00%
0/5845 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
0.02%
1/5834 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.00%
0/5845 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Vascular disorders
Hypertension
|
0.03%
2/5834 • Number of events 2 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.00%
0/5845 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Vascular disorders
Aortic dissection
|
0.00%
0/5834 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.02%
1/5845 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Vascular disorders
Femoral artery occlusion
|
0.02%
1/5834 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.00%
0/5845 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Vascular disorders
Varicose vein
|
0.00%
0/5834 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.02%
1/5845 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
|
Nervous system disorders
Hemiparesis
|
0.02%
1/5834 • Number of events 1 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
0.00%
0/5845 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
Other adverse events
| Measure |
Fluticasone Propionate/Salmeterol Combination (FSC)
n=5834 participants at risk
Participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg or FSC 500/50 µg as one inhalation twice daily (BID) via Dry powder inhaler (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
|
Fluticasone Propionate (FP)
n=5845 participants at risk
Participants received one of following treatments: FP 100 µg or FP 250 µg or FP 500 µg as one inhalation (BID) via (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.79%
46/5834 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
1.3%
75/5845 • Serious adverse events (SAEs) and non-serious events (AEs) were collected from post-randomization, throughout the treatment period of 26 weeks up to a 1-week follow-up phone call (27 Weeks).
All SAEs are presented and Non-serious AEs were collected from the members of mITT population up until the participants' withdrawal from study treatment, only non-serious AEs that lead to withdrawal of study treatment were collected
|
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