Trial Outcomes & Findings for A Study of the Safety and Effectiveness of Canagliflozin (JNJ-28431754) in Promoting Weight Loss in Overweight and Obese Patients Who do Not Have Diabetes (NCT NCT00650806)
NCT ID: NCT00650806
Last Updated: 2013-05-24
Results Overview
The table below shows the mean percent change in body weight from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the least-squares mean percent change.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
376 participants
Primary outcome timeframe
Day 1 (Baseline) and Week 12
Results posted on
2013-05-24
Participant Flow
This study evaluated the efficacy and safety of canagliflozin (JNJ-28431754) in nondiabetic, overweight, and obese patients. The study was conducted between 31 March 2008 and 18 September 2008 and recruited patients from 38 study centers located in the United States and Puerto Rico.
A total of 376 patients were randomly allocated to the 4 treatment arms in the study and comprised the intent-to-treat analysis set which was used for the efficacy analyses. All 376 patients received at least 1 dose of study drug and were included in the safety analysis set.
Participant milestones
| Measure |
Placebo
Each patient received matching placebo once daily for 12 weeks.
|
Canagliflozin 50 mg
Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
|
Canagliflozin 100 mg
Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
|
Canagliflozin 300 mg
Each patient received 300 mg of canaliflozin (JNJ-28431754) once daily for 12 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
89
|
98
|
93
|
96
|
|
Overall Study
COMPLETED
|
71
|
77
|
64
|
70
|
|
Overall Study
NOT COMPLETED
|
18
|
21
|
29
|
26
|
Reasons for withdrawal
| Measure |
Placebo
Each patient received matching placebo once daily for 12 weeks.
|
Canagliflozin 50 mg
Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
|
Canagliflozin 100 mg
Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
|
Canagliflozin 300 mg
Each patient received 300 mg of canaliflozin (JNJ-28431754) once daily for 12 weeks.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
5
|
3
|
4
|
|
Overall Study
Lost to Follow-up
|
7
|
6
|
11
|
10
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
1
|
|
Overall Study
Pregnancy
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
7
|
5
|
8
|
6
|
|
Overall Study
Noncompliance with study drug regimen
|
1
|
1
|
0
|
0
|
|
Overall Study
Study terminated by sponsor
|
2
|
3
|
5
|
4
|
|
Overall Study
Other
|
1
|
1
|
2
|
0
|
Baseline Characteristics
A Study of the Safety and Effectiveness of Canagliflozin (JNJ-28431754) in Promoting Weight Loss in Overweight and Obese Patients Who do Not Have Diabetes
Baseline characteristics by cohort
| Measure |
Placebo
n=89 Participants
Each patient received matching placebo once daily for 12 weeks.
|
Canagliflozin 50 mg
n=98 Participants
Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
|
Canagliflozin 100 mg
n=93 Participants
Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
|
Canagliflozin 300 mg
n=96 Participants
Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
|
Total
n=376 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
88 Participants
n=5 Participants
|
97 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
94 Participants
n=4 Participants
|
372 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Age Continuous
|
45.1 years
STANDARD_DEVIATION 11.92 • n=5 Participants
|
44.9 years
STANDARD_DEVIATION 11.8 • n=7 Participants
|
45.8 years
STANDARD_DEVIATION 10.95 • n=5 Participants
|
43.5 years
STANDARD_DEVIATION 10.99 • n=4 Participants
|
44.8 years
STANDARD_DEVIATION 11.4 • n=21 Participants
|
|
Sex: Female, Male
Female
|
75 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
86 Participants
n=4 Participants
|
323 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
53 Participants
n=21 Participants
|
|
Region Enroll
PUERTO RICO
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
4 participants
n=5 Participants
|
5 participants
n=4 Participants
|
16 participants
n=21 Participants
|
|
Region Enroll
UNITED STATES
|
86 participants
n=5 Participants
|
94 participants
n=7 Participants
|
89 participants
n=5 Participants
|
91 participants
n=4 Participants
|
360 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Day 1 (Baseline) and Week 12Population: This analysis was conducted using the intent-to-treat analysis set, which included all patients who were randomly assigned to a treatment group. The last-observation-carried-forward method was applied when the Week 12 values were missing. The table includes only patients with both baseline and post baseline values.
The table below shows the mean percent change in body weight from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the least-squares mean percent change.
Outcome measures
| Measure |
Placebo
n=86 Participants
Each patient received matching placebo once daily for 12 weeks.
|
Canagliflozin 50 mg
n=95 Participants
Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
|
Canagliflozin 100 mg
n=85 Participants
Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
|
Canaglifloziin 300 mg
n=93 Participants
Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
|
|---|---|---|---|---|
|
Percent Change in Body Weight From Baseline to Week 12
|
-1.1 Percent change
Standard Deviation 2.4
|
-2.0 Percent change
Standard Deviation 3.0
|
-2.8 Percent change
Standard Deviation 2.9
|
-2.5 Percent change
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) and Week 12Population: This analysis was conducted using the intent-to-treat analysis set, which included all patients who were randomly assigned to a treatment group. The last-observation-carried-forward method was applied when the Week 12 values were missing. The table includes only patients with both baseline and post baseline values.
The table below shows the mean absolute change in body weight from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the least-squares mean change.
Outcome measures
| Measure |
Placebo
n=86 Participants
Each patient received matching placebo once daily for 12 weeks.
|
Canagliflozin 50 mg
n=95 Participants
Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
|
Canagliflozin 100 mg
n=85 Participants
Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
|
Canaglifloziin 300 mg
n=93 Participants
Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
|
|---|---|---|---|---|
|
Absolute Change in Body Weight From Baseline to Week 12
|
-1.1 kg
Standard Deviation 2.46
|
-1.9 kg
Standard Deviation 2.90
|
-2.8 kg
Standard Deviation 2.90
|
-2.4 kg
Standard Deviation 2.90
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) and Week 12Population: This analysis was conducted using the intent-to-treat analysis set, which included all patients who were randomly assigned to a treatment group. The last-observation-carried-forward method was applied when the Week 12 values were missing. The table includes only patients with both baseline and post baseline values.
The table below shows the mean change in BMI from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the least-squares mean change.
Outcome measures
| Measure |
Placebo
n=86 Participants
Each patient received matching placebo once daily for 12 weeks.
|
Canagliflozin 50 mg
n=95 Participants
Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
|
Canagliflozin 100 mg
n=85 Participants
Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
|
Canaglifloziin 300 mg
n=93 Participants
Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
|
|---|---|---|---|---|
|
Change in Body Mass Index (BMI) From Baseline to Week 12
|
-0.4 kg/m2
Standard Deviation 0.86
|
-0.7 kg/m2
Standard Deviation 1.05
|
-1.0 kg/m2
Standard Deviation 1.05
|
-0.9 kg/m2
Standard Deviation 1.07
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) and Week 12Population: This analysis was conducted using the intent-to-treat analysis set, which included all patients who were randomly assigned to a treatment group. The last-observation-carried-forward method was applied when the Week 12 values were missing. The table includes only patients with both baseline and post baseline values.
The table below shows the percentage of patients who lost at least 5% of their initial body weight by Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo).
Outcome measures
| Measure |
Placebo
n=86 Participants
Each patient received matching placebo once daily for 12 weeks.
|
Canagliflozin 50 mg
n=95 Participants
Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
|
Canagliflozin 100 mg
n=85 Participants
Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
|
Canaglifloziin 300 mg
n=93 Participants
Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
|
|---|---|---|---|---|
|
Percentage of Patients Who Lost at Least 5% of Their Initial Body Weight by Week 12
|
8.1 Percentage of patients
|
12.6 Percentage of patients
|
18.8 Percentage of patients
|
17.2 Percentage of patients
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) and Week 12Population: This analysis was conducted using the intent-to-treat analysis set, which included all patients who were randomly assigned to a treatment group. The last-observation-carried-forward method was applied when the Week 12 values were missing. The table includes only patients with both baseline and post baseline values.
The table below shows the percentage of patients who lost at least 10% of their initial body weight by Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo).
Outcome measures
| Measure |
Placebo
n=86 Participants
Each patient received matching placebo once daily for 12 weeks.
|
Canagliflozin 50 mg
n=95 Participants
Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
|
Canagliflozin 100 mg
n=85 Participants
Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
|
Canaglifloziin 300 mg
n=93 Participants
Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
|
|---|---|---|---|---|
|
Percentage of Patients Who Lost at Least 10% of Their Initial Body Weight by Week 12
|
0.0 Percentage of patients
|
3.2 Percentage of patients
|
2.4 Percentage of patients
|
1.1 Percentage of patients
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) and Week 12Population: This analysis was conducted using the intent-to-treat analysis set, which included all patients who were randomly assigned to a treatment group. The last-observation-carried-forward method was applied when the Week 12 values were missing. The table includes only patients with both baseline and post baseline values.
The table below shows the mean change in waist circumference from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the least-squares mean change.
Outcome measures
| Measure |
Placebo
n=78 Participants
Each patient received matching placebo once daily for 12 weeks.
|
Canagliflozin 50 mg
n=87 Participants
Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
|
Canagliflozin 100 mg
n=73 Participants
Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
|
Canaglifloziin 300 mg
n=82 Participants
Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
|
|---|---|---|---|---|
|
Change in Waist Circumference From Baseline to Week 12
|
-1.2 cm
Standard Deviation 10.06
|
-1.4 cm
Standard Deviation 4.99
|
-2.9 cm
Standard Deviation 10.32
|
-2.6 cm
Standard Deviation 7.22
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) and Week 12Population: This analysis was conducted using the intent-to-treat analysis set, which included all patients who were randomly assigned to a treatment group. The last-observation-carried-forward method was applied when the Week 12 values were missing. The table includes only patients with both baseline and post baseline values.
The table below shows the mean change in hip circumference from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the least-squares mean change.
Outcome measures
| Measure |
Placebo
n=77 Participants
Each patient received matching placebo once daily for 12 weeks.
|
Canagliflozin 50 mg
n=86 Participants
Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
|
Canagliflozin 100 mg
n=72 Participants
Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
|
Canaglifloziin 300 mg
n=81 Participants
Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
|
|---|---|---|---|---|
|
Change in Hip Circumference From Baseline to Week 12
|
0.1 cm
Standard Deviation 10.38
|
-2.0 cm
Standard Deviation 3.97
|
-2.1 cm
Standard Deviation 10.62
|
-3.0 cm
Standard Deviation 7.95
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) and Week 12Population: This analysis was conducted using the intent-to-treat analysis set, which included all patients who were randomly assigned to a treatment group. The last-observation-carried-forward method was applied when the Week 12 values were missing. The table includes only patients with both baseline and post baseline values.
The table below shows the mean change in waist/hip ratio from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the least-squares mean change.
Outcome measures
| Measure |
Placebo
n=77 Participants
Each patient received matching placebo once daily for 12 weeks.
|
Canagliflozin 50 mg
n=86 Participants
Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
|
Canagliflozin 100 mg
n=72 Participants
Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
|
Canaglifloziin 300 mg
n=81 Participants
Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
|
|---|---|---|---|---|
|
Change in Waist/Hip Ratio From Baseline to Week 12
|
-0.011 ratio
Standard Deviation 0.0542
|
0.003 ratio
Standard Deviation 0.0422
|
-0.008 ratio
Standard Deviation 0.0915
|
-0.004 ratio
Standard Deviation 0.0469
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
Canagliflozin 50 mg
Serious events: 1 serious events
Other events: 41 other events
Deaths: 0 deaths
Canagliflozin 100 mg
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
Canagliflozin 300 mg
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=89 participants at risk
Each patient received matching placebo once daily for 12 weeks.
|
Canagliflozin 50 mg
n=98 participants at risk
Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
|
Canagliflozin 100 mg
n=93 participants at risk
Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
|
Canagliflozin 300 mg
n=96 participants at risk
Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/89 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.0%
1/98 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/93 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
0.00%
0/96 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
Other adverse events
| Measure |
Placebo
n=89 participants at risk
Each patient received matching placebo once daily for 12 weeks.
|
Canagliflozin 50 mg
n=98 participants at risk
Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
|
Canagliflozin 100 mg
n=93 participants at risk
Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
|
Canagliflozin 300 mg
n=96 participants at risk
Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
2.2%
2/89 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
5.1%
5/98 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
3.2%
3/93 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
2.1%
2/96 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.6%
5/89 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
5.1%
5/98 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
3.2%
3/93 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
2.1%
2/96 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Gastrointestinal disorders
Nausea
|
2.2%
2/89 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
7.1%
7/98 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
6.5%
6/93 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
3.1%
3/96 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Infections and infestations
Nasopharyngitis
|
3.4%
3/89 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
6.1%
6/98 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.1%
1/93 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.0%
1/96 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/89 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
6.1%
6/98 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
2.2%
2/93 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
1.0%
1/96 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.6%
5/89 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
6.1%
6/98 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
6.5%
6/93 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
5.2%
5/96 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Infections and infestations
Urinary tract infection
|
6.7%
6/89 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
10.2%
10/98 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
7.5%
7/93 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
8.3%
8/96 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
1.1%
1/89 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
8.2%
8/98 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
5.4%
5/93 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
14.6%
14/96 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
|
Nervous system disorders
Headache
|
7.9%
7/89 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
6.1%
6/98 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
11.8%
11/93 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
4.2%
4/96 • Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
|
Additional Information
Vice President, Franchise Medical Leader, Cardiovascular & Metabolism Franchise
Janssen Research & Development, LLC
Phone: 1 800 526 7736
Results disclosure agreements
- Principal investigator is a sponsor employee 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 in writing, such publication will be withheld for up to an additional 60 days.
- Publication restrictions are in place
Restriction type: OTHER