Trial Outcomes & Findings for Effects of Co-administration of Canagliflozin 300 mg and Phentermine 15 mg With Placebo in the Treatment of Non-Diabetic Overweight and Obese Participants (NCT NCT02243202)
NCT ID: NCT02243202
Last Updated: 2016-10-06
Results Overview
The percent change from baseline in body weight at Week 26 was analysed.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
335 participants
Primary outcome timeframe
Week 26
Results posted on
2016-10-06
Participant Flow
Between screening and randomisation, eligible subjects were included in a 4-week single-blind run-in period in which all subjects were placed on a hypocaloric diet.
Participant milestones
| Measure |
Placebo
Participants received placebo tablets orally for 26 weeks.
|
Phentermine 15 mg
Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.
|
Canagliflozin 300 mg
Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.
|
Canagliflozin 300 mg/Phentermine 15 mg
Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
82
|
85
|
84
|
84
|
|
Overall Study
Treated
|
82
|
85
|
84
|
83
|
|
Overall Study
COMPLETED
|
57
|
60
|
53
|
61
|
|
Overall Study
NOT COMPLETED
|
25
|
25
|
31
|
23
|
Reasons for withdrawal
| Measure |
Placebo
Participants received placebo tablets orally for 26 weeks.
|
Phentermine 15 mg
Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.
|
Canagliflozin 300 mg
Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.
|
Canagliflozin 300 mg/Phentermine 15 mg
Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
5
|
6
|
10
|
4
|
|
Overall Study
Lost to Follow-up
|
9
|
9
|
14
|
11
|
|
Overall Study
Protocol Violation
|
3
|
1
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
7
|
6
|
4
|
4
|
|
Overall Study
Other
|
1
|
3
|
1
|
2
|
|
Overall Study
Randomized but not received treatment
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Effects of Co-administration of Canagliflozin 300 mg and Phentermine 15 mg With Placebo in the Treatment of Non-Diabetic Overweight and Obese Participants
Baseline characteristics by cohort
| Measure |
Placebo
n=82 Participants
Participants received placebo tablets orally for 26 weeks.
|
Phentermine 15 mg
n=85 Participants
Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.
|
Canagliflozin 300 mg
n=84 Participants
Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.
|
Canagliflozin 300 mg/Phentermine 15 mg
n=83 Participants
Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.
|
Total
n=334 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
44.8 years
STANDARD_DEVIATION 11.09 • n=5 Participants
|
46.4 years
STANDARD_DEVIATION 11.14 • n=7 Participants
|
45.2 years
STANDARD_DEVIATION 11.02 • n=5 Participants
|
46.3 years
STANDARD_DEVIATION 12.45 • n=4 Participants
|
45.7 years
STANDARD_DEVIATION 11.41 • n=21 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
69 Participants
n=4 Participants
|
273 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
61 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
82 participants
n=5 Participants
|
85 participants
n=7 Participants
|
84 participants
n=5 Participants
|
83 participants
n=4 Participants
|
334 participants
n=21 Participants
|
|
Baseline Weight
|
104.3 Kilogram [kg]
STANDARD_DEVIATION 18.16 • n=5 Participants
|
102.8 Kilogram [kg]
STANDARD_DEVIATION 17.89 • n=7 Participants
|
103.3 Kilogram [kg]
STANDARD_DEVIATION 19.14 • n=5 Participants
|
101.1 Kilogram [kg]
STANDARD_DEVIATION 18.07 • n=4 Participants
|
102.9 Kilogram [kg]
STANDARD_DEVIATION 18.28 • n=21 Participants
|
|
Baseline Body Mass Index (BMI)
|
38 kilogram per meter square [kg/m²]
STANDARD_DEVIATION 5.2 • n=5 Participants
|
37 kilogram per meter square [kg/m²]
STANDARD_DEVIATION 5.4 • n=7 Participants
|
37.3 kilogram per meter square [kg/m²]
STANDARD_DEVIATION 4.68 • n=5 Participants
|
36.8 kilogram per meter square [kg/m²]
STANDARD_DEVIATION 5.36 • n=4 Participants
|
37.3 kilogram per meter square [kg/m²]
STANDARD_DEVIATION 5.16 • n=21 Participants
|
|
Baseline Systolic Blood Pressure
|
122.5 millimeters of mercury [mmHg]
STANDARD_DEVIATION 13.86 • n=5 Participants
|
123.0 millimeters of mercury [mmHg]
STANDARD_DEVIATION 11.83 • n=7 Participants
|
124.5 millimeters of mercury [mmHg]
STANDARD_DEVIATION 13.01 • n=5 Participants
|
124.8 millimeters of mercury [mmHg]
STANDARD_DEVIATION 12.83 • n=4 Participants
|
123.7 millimeters of mercury [mmHg]
STANDARD_DEVIATION 12.87 • n=21 Participants
|
|
Baseline Diastolic Blood Pressure
|
78.8 millimeters of mercury [mmHg]
STANDARD_DEVIATION 8.43 • n=5 Participants
|
78.1 millimeters of mercury [mmHg]
STANDARD_DEVIATION 9.00 • n=7 Participants
|
80.2 millimeters of mercury [mmHg]
STANDARD_DEVIATION 7.88 • n=5 Participants
|
79.4 millimeters of mercury [mmHg]
STANDARD_DEVIATION 8.21 • n=4 Participants
|
79.1 millimeters of mercury [mmHg]
STANDARD_DEVIATION 8.39 • n=21 Participants
|
|
Baseline Pulse Rate
|
73.5 (BEATS/MIN)
STANDARD_DEVIATION 8.72 • n=5 Participants
|
70.7 (BEATS/MIN)
STANDARD_DEVIATION 10.09 • n=7 Participants
|
71.5 (BEATS/MIN)
STANDARD_DEVIATION 9.40 • n=5 Participants
|
72.4 (BEATS/MIN)
STANDARD_DEVIATION 9.66 • n=4 Participants
|
72.0 (BEATS/MIN)
STANDARD_DEVIATION 9.50 • n=21 Participants
|
PRIMARY outcome
Timeframe: Week 26Population: The modified intent-to-treat (mITT) analysis set included all randomized participants who received at least 1 dose of double-blind study agent. N=number of participants analysed is the total participants who were evaluable for this outcome measure.
The percent change from baseline in body weight at Week 26 was analysed.
Outcome measures
| Measure |
Placebo
n=76 Participants
Participants received placebo tablets orally for 26 weeks.
|
Phentermine 15 mg
n=76 Participants
Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.
|
Canagliflozin 300 mg
n=78 Participants
Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.
|
Canagliflozin 300 mg/Phentermine 15 mg
n=77 Participants
Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Body Weight at Week 26
|
-0.6 Percent Change
Standard Error 0.6
|
-4.1 Percent Change
Standard Error 0.6
|
-1.9 Percent Change
Standard Error 0.6
|
-7.5 Percent Change
Standard Error 0.6
|
SECONDARY outcome
Timeframe: Week 26Population: The mITT analysis set included all randomized participants who received at least 1 dose of double-blind study agent. N=number of participants analysed is the total participants who were evaluable for this outcome measure.
Percentage of participants with weight loss \>= 5 percent were analysed at week 26.
Outcome measures
| Measure |
Placebo
n=57 Participants
Participants received placebo tablets orally for 26 weeks.
|
Phentermine 15 mg
n=60 Participants
Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.
|
Canagliflozin 300 mg
n=56 Participants
Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.
|
Canagliflozin 300 mg/Phentermine 15 mg
n=63 Participants
Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants With Weight Loss More Than Equal to (>=) 5 Percent at Week 26
|
17.5 percentage of participants
|
41.7 percentage of participants
|
17.9 percentage of participants
|
66.7 percentage of participants
|
SECONDARY outcome
Timeframe: Week 26Population: The mITT analysis set included all randomized participants who received at least 1 dose of double-blind study agent. N=number of participants analysed is the total participants who were evaluable for this outcome measure.
Change from baseline in systolic blood pressure was analysed at week 26.
Outcome measures
| Measure |
Placebo
n=75 Participants
Participants received placebo tablets orally for 26 weeks.
|
Phentermine 15 mg
n=76 Participants
Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.
|
Canagliflozin 300 mg
n=78 Participants
Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.
|
Canagliflozin 300 mg/Phentermine 15 mg
n=77 Participants
Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Systolic Blood Pressure at Week 26
|
-2.7 mmHg (millimeters of mercury)
Standard Error 1.3
|
-1.4 mmHg (millimeters of mercury)
Standard Error 1.2
|
-3.1 mmHg (millimeters of mercury)
Standard Error 1.3
|
-6.9 mmHg (millimeters of mercury)
Standard Error 1.2
|
SECONDARY outcome
Timeframe: Week 26Population: The mITT analysis set included all randomized participants who received at least 1 dose of double-blind study agent. N=number of participants analysed is the total participants who were evaluable for this outcome measure.
Absolute change from baseline in body weight was analysed at week 26.
Outcome measures
| Measure |
Placebo
n=76 Participants
Participants received placebo tablets orally for 26 weeks.
|
Phentermine 15 mg
n=76 Participants
Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.
|
Canagliflozin 300 mg
n=78 Participants
Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.
|
Canagliflozin 300 mg/Phentermine 15 mg
n=77 Participants
Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.
|
|---|---|---|---|---|
|
Absolute Change From Baseline in Body Weight at Week 26
|
-0.6 Kilogram (Kg)
Standard Error 0.6
|
-4.1 Kilogram (Kg)
Standard Error 0.6
|
-1.9 Kilogram (Kg)
Standard Error 0.7
|
-7.3 Kilogram (Kg)
Standard Error 0.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 26Population: The mITT analysis set included all randomized participants who received at least 1 dose of double-blind study agent. N=number of participants analysed is the total participants who were evaluable for this outcome measure.
Change from baseline in diastolic blood pressure (DBP) at week 26.
Outcome measures
| Measure |
Placebo
n=75 Participants
Participants received placebo tablets orally for 26 weeks.
|
Phentermine 15 mg
n=76 Participants
Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.
|
Canagliflozin 300 mg
n=78 Participants
Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.
|
Canagliflozin 300 mg/Phentermine 15 mg
n=77 Participants
Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Diastolic Blood Pressure (DBP) at Week 26
|
-0.9 mmHg (millimeters of mercury)
Standard Error 0.9
|
0.1 mmHg (millimeters of mercury)
Standard Error 0.8
|
-1.5 mmHg (millimeters of mercury)
Standard Error 0.9
|
-2.5 mmHg (millimeters of mercury)
Standard Error 0.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 26Population: The modified intent-to-treat (mITT) analysis set included all randomized participants who received at least 1 dose of double-blind study agent. N=number of participants analysed is the total participants who were evaluable for this outcome measure.
Change from baseline in pulse rate at week 26
Outcome measures
| Measure |
Placebo
n=75 Participants
Participants received placebo tablets orally for 26 weeks.
|
Phentermine 15 mg
n=76 Participants
Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.
|
Canagliflozin 300 mg
n=78 Participants
Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.
|
Canagliflozin 300 mg/Phentermine 15 mg
n=77 Participants
Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Pulse Rate at Week 26
|
-0.7 Beats Per Minute (Beats/Min)
Standard Error 1.0
|
4.1 Beats Per Minute (Beats/Min)
Standard Error 1.0
|
0.7 Beats Per Minute (Beats/Min)
Standard Error 1.0
|
3.5 Beats Per Minute (Beats/Min)
Standard Error 0.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 26Population: The mITT analysis set included all randomized participants who received at least 1 dose of double-blind study agent.
Percentage of participants with weight loss \>= 10 percent at week 26.
Outcome measures
| Measure |
Placebo
n=82 Participants
Participants received placebo tablets orally for 26 weeks.
|
Phentermine 15 mg
n=85 Participants
Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.
|
Canagliflozin 300 mg
n=84 Participants
Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.
|
Canagliflozin 300 mg/Phentermine 15 mg
n=83 Participants
Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants With Weight Loss More Than Equal to (>=) 10 Percent at Week 26
|
8.8 Percentage of Participants
|
8.3 Percentage of Participants
|
5.4 Percentage of Participants
|
34.9 Percentage of Participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 41 other events
Deaths: 0 deaths
Phentermine 15 mg
Serious events: 0 serious events
Other events: 37 other events
Deaths: 0 deaths
Canagliflozin 300 mg
Serious events: 0 serious events
Other events: 42 other events
Deaths: 0 deaths
Canagliflozin 300 mg/Phentermine 15 mg
Serious events: 1 serious events
Other events: 42 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=82 participants at risk
Participants received placebo tablets orally for 26 weeks.
|
Phentermine 15 mg
n=85 participants at risk
Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.
|
Canagliflozin 300 mg
n=84 participants at risk
Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.
|
Canagliflozin 300 mg/Phentermine 15 mg
n=83 participants at risk
Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/82 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
0.00%
0/85 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
0.00%
0/84 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
1.2%
1/83 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
Other adverse events
| Measure |
Placebo
n=82 participants at risk
Participants received placebo tablets orally for 26 weeks.
|
Phentermine 15 mg
n=85 participants at risk
Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.
|
Canagliflozin 300 mg
n=84 participants at risk
Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.
|
Canagliflozin 300 mg/Phentermine 15 mg
n=83 participants at risk
Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.
|
|---|---|---|---|---|
|
Cardiac disorders
Tachycardia
|
0.00%
0/82 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
0.00%
0/85 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
0.00%
0/84 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
2.4%
2/83 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
|
Gastrointestinal disorders
Abdominal Distension
|
2.4%
2/82 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
2.4%
2/85 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
0.00%
0/84 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
3.6%
3/83 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
|
Gastrointestinal disorders
Constipation
|
3.7%
3/82 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
12.9%
11/85 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
1.2%
1/84 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
7.2%
6/83 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.2%
1/82 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
2.4%
2/85 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
0.00%
0/84 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
0.00%
0/83 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/82 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
2.4%
2/85 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
0.00%
0/84 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
6.0%
5/83 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
|
Gastrointestinal disorders
Dyspepsia
|
2.4%
2/82 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
1.2%
1/85 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
1.2%
1/84 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
2.4%
2/83 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/82 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
7.1%
6/85 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
8.3%
7/84 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
3.6%
3/83 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
0.00%
0/82 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
0.00%
0/85 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
2.4%
2/84 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
0.00%
0/83 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
|
General disorders
Fatigue
|
0.00%
0/82 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
2.4%
2/85 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
2.4%
2/84 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
0.00%
0/83 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/82 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
1.2%
1/85 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
2.4%
2/84 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
0.00%
0/83 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
|
Infections and infestations
Acute Sinusitis
|
2.4%
2/82 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
0.00%
0/85 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
2.4%
2/84 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
0.00%
0/83 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
|
Infections and infestations
Bronchitis
|
2.4%
2/82 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
5.9%
5/85 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
2.4%
2/84 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
1.2%
1/83 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/82 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
0.00%
0/85 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
2.4%
2/84 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
1.2%
1/83 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
|
Infections and infestations
Gastroenteritis
|
1.2%
1/82 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
0.00%
0/85 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
3.6%
3/84 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
3.6%
3/83 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
|
Infections and infestations
Influenza
|
1.2%
1/82 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
4.7%
4/85 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
0.00%
0/84 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
1.2%
1/83 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
|
Infections and infestations
Nasopharyngitis
|
4.9%
4/82 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
2.4%
2/85 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
2.4%
2/84 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
1.2%
1/83 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/82 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
0.00%
0/85 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
0.00%
0/84 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
2.4%
2/83 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
|
Infections and infestations
Pharyngitis Streptococcal
|
1.2%
1/82 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
1.2%
1/85 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
4.8%
4/84 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
0.00%
0/83 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
|
Infections and infestations
Sinusitis
|
3.7%
3/82 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
1.2%
1/85 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
2.4%
2/84 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
3.6%
3/83 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
|
Infections and infestations
Tooth Infection
|
4.9%
4/82 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
1.2%
1/85 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
0.00%
0/84 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
2.4%
2/83 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
18.3%
15/82 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
5.9%
5/85 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
13.1%
11/84 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
10.8%
9/83 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/82 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
1.2%
1/85 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
3.6%
3/84 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
2.4%
2/83 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
|
Infections and infestations
Viral Infection
|
0.00%
0/82 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
1.2%
1/85 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
2.4%
2/84 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
1.2%
1/83 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
|
Infections and infestations
Vulvovaginal Candidiasis
|
0.00%
0/82 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
0.00%
0/85 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
3.6%
3/84 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
0.00%
0/83 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
|
Infections and infestations
Vulvovaginal Mycotic Infection
|
0.00%
0/82 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
0.00%
0/85 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
4.8%
4/84 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
4.8%
4/83 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
|
Injury, poisoning and procedural complications
Fall
|
2.4%
2/82 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
0.00%
0/85 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
0.00%
0/84 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
0.00%
0/83 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
|
Injury, poisoning and procedural complications
Muscle Strain
|
1.2%
1/82 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
1.2%
1/85 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
2.4%
2/84 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
1.2%
1/83 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
1.2%
1/82 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
3.5%
3/85 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
1.2%
1/84 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
0.00%
0/83 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/82 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
2.4%
2/85 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
0.00%
0/84 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
1.2%
1/83 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
|
Metabolism and nutrition disorders
Polydipsia
|
0.00%
0/82 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
0.00%
0/85 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
0.00%
0/84 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
2.4%
2/83 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.2%
1/82 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
1.2%
1/85 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
1.2%
1/84 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
2.4%
2/83 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
1.2%
1/82 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
1.2%
1/85 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
3.6%
3/84 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
0.00%
0/83 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/82 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
1.2%
1/85 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
0.00%
0/84 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
2.4%
2/83 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/82 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
0.00%
0/85 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
1.2%
1/84 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
2.4%
2/83 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/82 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
0.00%
0/85 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
1.2%
1/84 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
2.4%
2/83 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
|
Nervous system disorders
Headache
|
1.2%
1/82 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
2.4%
2/85 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
3.6%
3/84 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
6.0%
5/83 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
|
Nervous system disorders
Tension Headache
|
0.00%
0/82 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
0.00%
0/85 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
0.00%
0/84 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
2.4%
2/83 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/82 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
0.00%
0/85 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
2.4%
2/84 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
0.00%
0/83 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
|
Psychiatric disorders
Insomnia
|
3.7%
3/82 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
1.2%
1/85 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
0.00%
0/84 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
2.4%
2/83 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
|
Psychiatric disorders
Sleep Disorder
|
0.00%
0/82 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
0.00%
0/85 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
0.00%
0/84 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
2.4%
2/83 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/82 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
2.4%
2/85 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
2.4%
2/84 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
0.00%
0/83 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
1.2%
1/82 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
1.2%
1/85 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
1.2%
1/84 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
2.4%
2/83 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/82 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
1.2%
1/85 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
2.4%
2/84 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
0.00%
0/83 • Up to 33 weeks
Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
- Publication restrictions are in place
Restriction type: OTHER