Trial Outcomes & Findings for Randomized, Double-blind, Active-controlled, Study of Rivoglitazone in Type 2 Diabetes Mellitus (NCT NCT00571519)
NCT ID: NCT00571519
Last Updated: 2021-05-26
Results Overview
Glycosylated hemoglobin (A1c) levels and mean changes in A1c were used to measure glycemic control. A1c categorical targets are \<7.0% and \<6.5%.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
94 participants
Primary outcome timeframe
Baseline up to week 2, week 4, week 6, week 8, week 10, week 12, week 16, and week 20 post-dose.
Results posted on
2021-05-26
Participant Flow
A total of 94 participants who met all inclusion criteria and no exclusion criteria were enrolled in the study at 73 clinic sites in the United States of America and 22 in India.
Participants with type 2 diabetes mellitus who were either untreated (ie, not receiving antihyperglycemic medication within at least 2 months prior to screening) or were treated with a single, non-thiazolidinedione agent as monotherapy without adequate glycemic control were enrolled in this study.
Participant milestones
| Measure |
Placebo
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone-matching placebo tablet or a Pioglitazone-matching placebo capsule once daily for 18 weeks.
|
Rivoglitazone 0.5mg
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 0.5mg tablet once daily for 18 weeks.
|
Rivoglitazone 1.0mg
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0mg tablet once daily for 18 weeks.
|
Rivoglitazone 1.5mg
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5mg tablet once daily for 18 weeks.
|
Pioglitazone 15 mg
Participants with type 2 diabetes mellitus who were administered a Pioglitazone 15 mg capsule once daily for 18 weeks.
|
Pioglitazone 30 mg
Participants with type 2 diabetes mellitus who were administered a Pioglitazone 30 mg capsule once daily for 18 weeks.
|
Pioglitazone 45 mg
Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg capsule once daily for 18 weeks.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
9
|
12
|
27
|
9
|
10
|
24
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
9
|
12
|
27
|
9
|
10
|
24
|
Reasons for withdrawal
| Measure |
Placebo
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone-matching placebo tablet or a Pioglitazone-matching placebo capsule once daily for 18 weeks.
|
Rivoglitazone 0.5mg
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 0.5mg tablet once daily for 18 weeks.
|
Rivoglitazone 1.0mg
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0mg tablet once daily for 18 weeks.
|
Rivoglitazone 1.5mg
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5mg tablet once daily for 18 weeks.
|
Pioglitazone 15 mg
Participants with type 2 diabetes mellitus who were administered a Pioglitazone 15 mg capsule once daily for 18 weeks.
|
Pioglitazone 30 mg
Participants with type 2 diabetes mellitus who were administered a Pioglitazone 30 mg capsule once daily for 18 weeks.
|
Pioglitazone 45 mg
Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg capsule once daily for 18 weeks.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Subject withdrew consent
|
0
|
1
|
0
|
2
|
1
|
1
|
2
|
|
Overall Study
Hyperglycemia meeting discontinuation criteria
|
1
|
0
|
1
|
1
|
0
|
0
|
0
|
|
Overall Study
Therapeutic failure/lack of efficacy
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Termination of study by Sponsor
|
2
|
7
|
10
|
24
|
8
|
9
|
22
|
|
Overall Study
Per medical monitor regarding thyroid-stimulating hormone level
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Randomized, Double-blind, Active-controlled, Study of Rivoglitazone in Type 2 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
Placebo
n=3 Participants
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone-matching placebo tablet or a Pioglitazone-matching placebo capsule once daily for 18 weeks.
|
Rivoglitazone 0.5mg
n=9 Participants
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 0.5mg tablet once daily for 18 weeks.
|
Rivoglitazone 1.0mg
n=12 Participants
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0mg tablet once daily for 18 weeks.
|
Rivoglitazone 1.5mg
n=27 Participants
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5mg tablet once daily for 18 weeks.
|
Pioglitazone 15 mg
n=9 Participants
Participants with type 2 diabetes mellitus who were administered a Pioglitazone 15 mg capsule once daily for 18 weeks.
|
Pioglitazone 30 mg
n=10 Participants
Participants with type 2 diabetes mellitus who were administered a Pioglitazone 30 mg capsule once daily for 18 weeks.
|
Pioglitazone 45 mg
n=24 Participants
Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg capsule once daily for 18 weeks.
|
Total
n=94 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
56.0 years
STANDARD_DEVIATION 11.36 • n=5 Participants
|
55.1 years
STANDARD_DEVIATION 13.03 • n=7 Participants
|
58.3 years
STANDARD_DEVIATION 10.86 • n=5 Participants
|
59.4 years
STANDARD_DEVIATION 10.46 • n=4 Participants
|
57.0 years
STANDARD_DEVIATION 9.85 • n=21 Participants
|
58.5 years
STANDARD_DEVIATION 7.71 • n=10 Participants
|
58.0 years
STANDARD_DEVIATION 11.72 • n=115 Participants
|
58.1 years
STANDARD_DEVIATION 10.57 • n=6 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
9 Participants
n=115 Participants
|
43 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
15 Participants
n=115 Participants
|
51 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
18 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
22 Participants
n=115 Participants
|
76 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
9 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
8 Participants
n=115 Participants
|
20 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
12 Participants
n=115 Participants
|
63 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Baseline up to week 2, week 4, week 6, week 8, week 10, week 12, week 16, and week 20 post-dose.Population: Change in A1c was assessed using the Full Analysis Set. There were "0" numbers analyzed reported beyond Week 6 due to early termination by the sponsor because of changes in the clinical development plan. Data was not collected for participants that did not complete the later time points prior to study termination so cannot be included in the table.
Glycosylated hemoglobin (A1c) levels and mean changes in A1c were used to measure glycemic control. A1c categorical targets are \<7.0% and \<6.5%.
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone-matching placebo tablet or a Pioglitazone-matching placebo capsule once daily for 18 weeks.
|
Rivoglitazone 0.5mg
n=9 Participants
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 0.5mg tablet once daily for 18 weeks.
|
Rivoglitazone 1.0mg
n=12 Participants
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0mg tablet once daily for 18 weeks.
|
Rivoglitazone 1.5mg
n=27 Participants
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5mg tablet once daily for 18 weeks.
|
Pioglitazone 15 mg
n=8 Participants
Participants with type 2 diabetes mellitus who were administered a Pioglitazone 15 mg capsule once daily for 18 weeks.
|
Pioglitazone 30 mg
n=10 Participants
Participants with type 2 diabetes mellitus who were administered a Pioglitazone 30 mg capsule once daily for 18 weeks.
|
Pioglitazone 45 mg
n=24 Participants
Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg capsule once daily for 18 weeks.
|
|---|---|---|---|---|---|---|---|
|
Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Change from Baseline to Week 16
|
—
|
0.7 percentage of A1c
Standard Deviation NA
Not available as data was calculated for one participant.
|
—
|
—
|
—
|
-0.4 percentage of A1c
Standard Deviation 0.35
|
-0.8 percentage of A1c
Standard Deviation 0.67
|
|
Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Baseline
|
7.8 percentage of A1c
Standard Deviation 0.55
|
7.5 percentage of A1c
Standard Deviation 0.41
|
7.7 percentage of A1c
Standard Deviation 0.67
|
7.5 percentage of A1c
Standard Deviation 0.46
|
7.7 percentage of A1c
Standard Deviation 0.56
|
7.5 percentage of A1c
Standard Deviation 0.51
|
7.6 percentage of A1c
Standard Deviation 0.50
|
|
Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Week 2
|
8.2 percentage of A1c
Standard Deviation 0.87
|
7.6 percentage of A1c
Standard Deviation 0.54
|
7.9 percentage of A1c
Standard Deviation 0.96
|
7.6 percentage of A1c
Standard Deviation 0.49
|
7.6 percentage of A1c
Standard Deviation 0.61
|
7.5 percentage of A1c
Standard Deviation 0.43
|
7.7 percentage of A1c
Standard Deviation 0.56
|
|
Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Change in Baseline to Week 2
|
0.3 percentage of A1c
Standard Deviation 0.67
|
0.1 percentage of A1c
Standard Deviation 0.23
|
0.1 percentage of A1c
Standard Deviation 0.54
|
0.1 percentage of A1c
Standard Deviation 0.30
|
-0.1 percentage of A1c
Standard Deviation 0.23
|
0.1 percentage of A1c
Standard Deviation 0.19
|
0.1 percentage of A1c
Standard Deviation 0.31
|
|
Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Week 4
|
7.8 percentage of A1c
Standard Deviation 1.06
|
7.6 percentage of A1c
Standard Deviation 0.86
|
7.4 percentage of A1c
Standard Deviation 0.42
|
7.5 percentage of A1c
Standard Deviation 0.56
|
7.6 percentage of A1c
Standard Deviation 0.68
|
7.4 percentage of A1c
Standard Deviation 0.56
|
7.6 percentage of A1c
Standard Deviation 0.62
|
|
Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Change from Baseline to Week 4
|
-0.1 percentage of A1c
Standard Deviation 0.28
|
0.2 percentage of A1c
Standard Deviation 0.49
|
-0.1 percentage of A1c
Standard Deviation 0.32
|
-0.0 percentage of A1c
Standard Deviation 0.43
|
-0.0 percentage of A1c
Standard Deviation 0.32
|
-0.1 percentage of A1c
Standard Deviation 0.27
|
-0.0 percentage of A1c
Standard Deviation 0.37
|
|
Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Week 6
|
8.6 percentage of A1c
Standard Deviation NA
Not available as data was calculated for one participant.
|
7.7 percentage of A1c
Standard Deviation 0.99
|
7.4 percentage of A1c
Standard Deviation 0.39
|
7.3 percentage of A1c
Standard Deviation 0.55
|
7.4 percentage of A1c
Standard Deviation 0.68
|
7.2 percentage of A1c
Standard Deviation 0.65
|
7.5 percentage of A1c
Standard Deviation 0.73
|
|
Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Change from Baseline to Week 6
|
0.2 percentage of A1c
Standard Deviation NA
Not available as data was calculated for one participant.
|
0.3 percentage of A1c
Standard Deviation 0.61
|
-0.2 percentage of A1c
Standard Deviation 0.25
|
-0.1 percentage of A1c
Standard Deviation 0.41
|
-0.2 percentage of A1c
Standard Deviation 0.18
|
-0.2 percentage of A1c
Standard Deviation 0.46
|
-0.2 percentage of A1c
Standard Deviation 0.44
|
|
Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Week 8
|
—
|
7.2 percentage of A1c
Standard Deviation 0.62
|
7.4 percentage of A1c
Standard Deviation 0.23
|
7.2 percentage of A1c
Standard Deviation 0.52
|
7.6 percentage of A1c
Standard Deviation 0.76
|
7.2 percentage of A1c
Standard Deviation 0.54
|
7.4 percentage of A1c
Standard Deviation 0.73
|
|
Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Change from Baseline to Week 8
|
—
|
0.0 percentage of A1c
Standard Deviation 0.48
|
-0.5 percentage of A1c
Standard Deviation 0.53
|
-0.2 percentage of A1c
Standard Deviation 0.37
|
0.0 percentage of A1c
Standard Deviation 0.78
|
-0.2 percentage of A1c
Standard Deviation 0.42
|
-0.3 percentage of A1c
Standard Deviation 0.47
|
|
Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Week 10
|
—
|
7.2 percentage of A1c
Standard Deviation 0.92
|
7.2 percentage of A1c
Standard Deviation 0.00
|
7.2 percentage of A1c
Standard Deviation 0.40
|
7.6 percentage of A1c
Standard Deviation 0.71
|
6.8 percentage of A1c
Standard Deviation 0.70
|
7.2 percentage of A1c
Standard Deviation 0.93
|
|
Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Change from Baseline to Week 10
|
—
|
0.0 percentage of A1c
Standard Deviation 1.13
|
-0.7 percentage of A1c
Standard Deviation 0.28
|
-0.3 percentage of A1c
Standard Deviation 0.37
|
-0.2 percentage of A1c
Standard Deviation 0.27
|
-0.4 percentage of A1c
Standard Deviation 0.76
|
-0.3 percentage of A1c
Standard Deviation 0.58
|
|
Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Week 12
|
—
|
7.7 percentage of A1c
Standard Deviation NA
Not available as data was calculated for one participant.
|
7.2 percentage of A1c
Standard Deviation NA
Not available as data was calculated for one participant.
|
7.0 percentage of A1c
Standard Deviation 0.54
|
7.2 percentage of A1c
Standard Deviation 0.44
|
7.0 percentage of A1c
Standard Deviation 0.39
|
7.0 percentage of A1c
Standard Deviation 0.92
|
|
Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Change from Baseline to Week 12
|
—
|
0.7 percentage of A1c
Standard Deviation NA
Not available as data was calculated for one participant.
|
-0.9 percentage of A1c
Standard Deviation NA
Not available as data was calculated for one participant.
|
-0.2 percentage of A1c
Standard Deviation 0.29
|
-0.2 percentage of A1c
Standard Deviation 0.29
|
-0.1 percentage of A1c
Standard Deviation 0.44
|
-0.8 percentage of A1c
Standard Deviation 0.50
|
|
Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Week 16
|
—
|
7.7 percentage of A1c
Standard Deviation NA
Not available as data was calculated for one participant.
|
—
|
—
|
—
|
6.9 percentage of A1c
Standard Deviation 0.00
|
7.4 percentage of A1c
Standard Deviation 0.60
|
|
Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Week 20
|
—
|
—
|
—
|
—
|
—
|
7.0 percentage of A1c
Standard Deviation NA
Not available as data was calculated for one participant.
|
7.4 percentage of A1c
Standard Deviation 0.49
|
|
Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Change from Baseline to Week 20
|
—
|
—
|
—
|
—
|
—
|
-0.6 percentage of A1c
Standard Deviation NA
Not available as data was calculated for one participant.
|
-0.6 percentage of A1c
Standard Deviation 0.42
|
SECONDARY outcome
Timeframe: Baseline up to week 2, week 4, week 6, week 8, week 12, week 16, and week 20 post-dose.Population: Fasting Plasma Glucose was assessed from the Full Analysis Set. There were "0" numbers analyzed reported beyond Week 6 due to early termination by the sponsor because of changes in the clinical development plan. Data was not collected for participants that did not complete the later time points prior to study termination so cannot be included in the table.
Normal fasting plasma glucose (FPG) -- or blood sugar -- is between 70 and 100 milligrams per deciliter (mg/dL) for people who do not have diabetes. People with Type 2 diabetes typically have FPG that is too high, so a negative change from baseline and a lower FPG means improvement.
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone-matching placebo tablet or a Pioglitazone-matching placebo capsule once daily for 18 weeks.
|
Rivoglitazone 0.5mg
n=9 Participants
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 0.5mg tablet once daily for 18 weeks.
|
Rivoglitazone 1.0mg
n=12 Participants
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0mg tablet once daily for 18 weeks.
|
Rivoglitazone 1.5mg
n=27 Participants
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5mg tablet once daily for 18 weeks.
|
Pioglitazone 15 mg
n=8 Participants
Participants with type 2 diabetes mellitus who were administered a Pioglitazone 15 mg capsule once daily for 18 weeks.
|
Pioglitazone 30 mg
n=10 Participants
Participants with type 2 diabetes mellitus who were administered a Pioglitazone 30 mg capsule once daily for 18 weeks.
|
Pioglitazone 45 mg
n=24 Participants
Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg capsule once daily for 18 weeks.
|
|---|---|---|---|---|---|---|---|
|
Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Baseline
|
218.7 mg/dL
Standard Deviation 48.09
|
164.1 mg/dL
Standard Deviation 45.09
|
160.1 mg/dL
Standard Deviation 34.34
|
162.2 mg/dL
Standard Deviation 42.37
|
173.3 mg/dL
Standard Deviation 35.77
|
138.3 mg/dL
Standard Deviation 22.89
|
158.5 mg/dL
Standard Deviation 35.45
|
|
Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Week 2
|
210.0 mg/dL
Standard Deviation 71.51
|
157.8 mg/dL
Standard Deviation 48.45
|
149.8 mg/dL
Standard Deviation 49.38
|
152.4 mg/dL
Standard Deviation 50.06
|
160.8 mg/dL
Standard Deviation 21.12
|
140.9 mg/dL
Standard Deviation 19.43
|
144.7 mg/dL
Standard Deviation 34.46
|
|
Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Change from Baseline to Week 2
|
-8.7 mg/dL
Standard Deviation 41.59
|
-1.0 mg/dL
Standard Deviation 20.06
|
-10.5 mg/dL
Standard Deviation 36.05
|
-13.6 mg/dL
Standard Deviation 33.75
|
-12.5 mg/dL
Standard Deviation 22.48
|
2.6 mg/dL
Standard Deviation 16.93
|
-13.8 mg/dL
Standard Deviation 24.11
|
|
Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Week 4
|
157.5 mg/dL
Standard Deviation 37.48
|
149.4 mg/dL
Standard Deviation 55.44
|
128.6 mg/dL
Standard Deviation 33.31
|
145.6 mg/dL
Standard Deviation 35.32
|
171.4 mg/dL
Standard Deviation 48.23
|
140.3 mg/dL
Standard Deviation 30.49
|
143.6 mg/dL
Standard Deviation 26.40
|
|
Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Change from Baseline to Week 4
|
-33.5 mg/dL
Standard Deviation 43.13
|
-8.3 mg/dL
Standard Deviation 12.50
|
-24.6 mg/dL
Standard Deviation 30.97
|
-26.2 mg/dL
Standard Deviation 27.69
|
-1.9 mg/dL
Standard Deviation 38.79
|
2.3 mg/dL
Standard Deviation 20.34
|
-20.0 mg/dL
Standard Deviation 24.20
|
|
Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Week 6
|
218.0 mg/dL
Standard Deviation NA
Not available as data was calculated for one participant.
|
158.4 mg/dL
Standard Deviation 54.77
|
126.5 mg/dL
Standard Deviation 24.14
|
126.9 mg/dL
Standard Deviation 17.76
|
174.3 mg/dL
Standard Deviation 41.80
|
134.0 mg/dL
Standard Deviation 25.00
|
146.8 mg/dL
Standard Deviation 44.22
|
|
Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Change from Baseline to Week 6
|
31.0 mg/dL
Standard Deviation NA
Not available as data was calculated for one participant.
|
-0.2 mg/dL
Standard Deviation 23.70
|
-30.8 mg/dL
Standard Deviation 22.22
|
-41.1 mg/dL
Standard Deviation 33.09
|
0.7 mg/dL
Standard Deviation 48.65
|
-4.0 mg/dL
Standard Deviation 12.51
|
-17.1 mg/dL
Standard Deviation 41.99
|
|
Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Week 8
|
—
|
153.6 mg/dL
Standard Deviation 56.44
|
129.5 mg/dL
Standard Deviation 15.35
|
125.0 mg/dL
Standard Deviation 15.70
|
149.2 mg/dL
Standard Deviation 35.72
|
145.6 mg/dL
Standard Deviation 49.47
|
148.3 mg/dL
Standard Deviation 34.55
|
|
Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Change from Baseline to Week 8
|
—
|
12.2 mg/dL
Standard Deviation 32.89
|
-41.3 mg/dL
Standard Deviation 26.29
|
-35.1 mg/dL
Standard Deviation 20.51
|
-23.2 mg/dL
Standard Deviation 57.14
|
7.6 mg/dL
Standard Deviation 41.71
|
-20.0 mg/dL
Standard Deviation 28.27
|
|
Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Week 12
|
—
|
142.0 mg/dL
Standard Deviation NA
Not available as data was calculated for one participant.
|
131.0 mg/dL
Standard Deviation NA
Not available as data was calculated for one participant.
|
120.3 mg/dL
Standard Deviation 11.79
|
131.7 mg/dL
Standard Deviation 13.43
|
122.3 mg/dL
Standard Deviation 13.23
|
126.4 mg/dL
Standard Deviation 27.77
|
|
Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Change from Baseline to Week 12
|
—
|
16.0 mg/dL
Standard Deviation NA
Not available as data was calculated for one participant.
|
-51.0 mg/dL
Standard Deviation NA
Not available as data was calculated for one participant.
|
-32.5 mg/dL
Standard Deviation 25.38
|
-25.3 mg/dL
Standard Deviation 18.58
|
-9.8 mg/dL
Standard Deviation 25.08
|
-29.4 mg/dL
Standard Deviation 20.50
|
|
Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Week 16
|
—
|
159.0 mg/dL
Standard Deviation NA
Not available as data was calculated for one participant.
|
—
|
—
|
—
|
111.0 mg/dL
Standard Deviation 2.83
|
133.7 mg/dL
Standard Deviation 22.19
|
|
Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Change from Baseline to Week 16
|
—
|
33.0 mg/dL
Standard Deviation NA
Not available as data was calculated for one participant.
|
—
|
—
|
—
|
-19.5 mg/dL
Standard Deviation 4.95
|
-39.3 mg/dL
Standard Deviation 51.78
|
|
Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Week 20
|
—
|
—
|
—
|
—
|
—
|
107.0 mg/dL
Standard Deviation NA
Not available as data was calculated for one participant.
|
124.0 mg/dL
Standard Deviation 15.56
|
|
Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Change from Baseline to Week 20
|
—
|
—
|
—
|
—
|
—
|
-25.0 mg/dL
Standard Deviation NA
Not available as data was calculated for one participant.
|
-18.0 mg/dL
Standard Deviation 1.41
|
SECONDARY outcome
Timeframe: Baseline up to week 12 post-dose.Population: Total cholesterol was assessed from the Full Analysis Set. There were "0" numbers analyzed reported beyond Week 6 due to early termination by the sponsor because of changes in the clinical development plan. Data was not collected for participants that did not complete the later time points prior to study termination so cannot be included in the table.
Total cholesterol is a measure of the total amount of cholesterol in the blood, including low-density lipoprotein cholesterol (LDL-C) - the "bad" cholesterol, high-density lipoprotein cholesterol (HDL-C) - the "good" cholesterol, and triglycerides. The equation to calculate total cholesterol is: LDL + HDL + (triglycerides/5) = total cholesterol.
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone-matching placebo tablet or a Pioglitazone-matching placebo capsule once daily for 18 weeks.
|
Rivoglitazone 0.5mg
n=9 Participants
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 0.5mg tablet once daily for 18 weeks.
|
Rivoglitazone 1.0mg
n=12 Participants
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0mg tablet once daily for 18 weeks.
|
Rivoglitazone 1.5mg
n=27 Participants
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5mg tablet once daily for 18 weeks.
|
Pioglitazone 15 mg
n=8 Participants
Participants with type 2 diabetes mellitus who were administered a Pioglitazone 15 mg capsule once daily for 18 weeks.
|
Pioglitazone 30 mg
n=10 Participants
Participants with type 2 diabetes mellitus who were administered a Pioglitazone 30 mg capsule once daily for 18 weeks.
|
Pioglitazone 45 mg
n=24 Participants
Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg capsule once daily for 18 weeks.
|
|---|---|---|---|---|---|---|---|
|
Change in Total Cholesterol From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Baseline
|
162.2 mg/dL
Standard Deviation 38.10
|
211.3 mg/dL
Standard Deviation 52.87
|
204.9 mg/dL
Standard Deviation 63.66
|
171.6 mg/dL
Standard Deviation 38.95
|
172.1 mg/dL
Standard Deviation 35.49
|
201.7 mg/dL
Standard Deviation 50.13
|
188.1 mg/dL
Standard Deviation 47.45
|
|
Change in Total Cholesterol From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Week 12
|
—
|
311.0 mg/dL
Standard Deviation NA
Not available as data was calculated for one participant.
|
193.0 mg/dL
Standard Deviation NA
Not available as data was calculated for one participant.
|
145.8 mg/dL
Standard Deviation 17.27
|
151.3 mg/dL
Standard Deviation 47.08
|
213.3 mg/dL
Standard Deviation 28.62
|
186.6 mg/dL
Standard Deviation 36.19
|
SECONDARY outcome
Timeframe: Baseline up to week 12 post-dose.Population: Total cholesterol was assessed from the Full Analysis Set. There were "0" numbers analyzed reported beyond Week 6 due to early termination by the sponsor because of changes in the clinical development plan. Data was not collected for participants that did not complete the later time points prior to study termination so cannot be included in the table.
Total cholesterol is a measure of the total amount of cholesterol in the blood, including low-density lipoprotein cholesterol (LDL-C) - the "bad" cholesterol, high-density lipoprotein cholesterol (HDL-C) - the "good" cholesterol, and triglycerides. The equation to calculate total cholesterol is: LDL + HDL + (triglycerides/5) = total cholesterol.
Outcome measures
| Measure |
Placebo
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone-matching placebo tablet or a Pioglitazone-matching placebo capsule once daily for 18 weeks.
|
Rivoglitazone 0.5mg
n=1 Participants
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 0.5mg tablet once daily for 18 weeks.
|
Rivoglitazone 1.0mg
n=1 Participants
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0mg tablet once daily for 18 weeks.
|
Rivoglitazone 1.5mg
n=4 Participants
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5mg tablet once daily for 18 weeks.
|
Pioglitazone 15 mg
n=3 Participants
Participants with type 2 diabetes mellitus who were administered a Pioglitazone 15 mg capsule once daily for 18 weeks.
|
Pioglitazone 30 mg
n=4 Participants
Participants with type 2 diabetes mellitus who were administered a Pioglitazone 30 mg capsule once daily for 18 weeks.
|
Pioglitazone 45 mg
n=5 Participants
Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg capsule once daily for 18 weeks.
|
|---|---|---|---|---|---|---|---|
|
Percent Change in Total Cholesterol From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
|
—
|
8.9 percent change
Standard Deviation NA
Not available as data was calculated for one participant.
|
-8.5 percent change
Standard Deviation NA
Not available as data was calculated for one participant.
|
-2.2 percent change
Standard Deviation 6.46
|
-1.6 percent change
Standard Deviation 9.54
|
2.7 percent change
Standard Deviation 15.73
|
7.4 percent change
Standard Deviation 15.60
|
SECONDARY outcome
Timeframe: Baseline up to week 12 post-dose.Population: Total Triglycerides were assessed from the Full Analysis Set. There were "0" numbers analyzed reported beyond Week 6 due to early termination by the sponsor because of changes in the clinical development plan. Data was not collected for participants that did not complete the later time points prior to study termination so cannot be included in the table.
Total Triglycerides (TG) is a measure of the total amount of triglycerides in the blood. The equation to calculate total triglycerides is: (total cholesterol-Low-density Lipoprotein cholesterol (LDL- C) - High-density lipoprotein cholesterol (HDL- C)) x 5 = Total Triglycerides. A negative change means improvement.
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone-matching placebo tablet or a Pioglitazone-matching placebo capsule once daily for 18 weeks.
|
Rivoglitazone 0.5mg
n=9 Participants
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 0.5mg tablet once daily for 18 weeks.
|
Rivoglitazone 1.0mg
n=12 Participants
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0mg tablet once daily for 18 weeks.
|
Rivoglitazone 1.5mg
n=27 Participants
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5mg tablet once daily for 18 weeks.
|
Pioglitazone 15 mg
n=8 Participants
Participants with type 2 diabetes mellitus who were administered a Pioglitazone 15 mg capsule once daily for 18 weeks.
|
Pioglitazone 30 mg
n=10 Participants
Participants with type 2 diabetes mellitus who were administered a Pioglitazone 30 mg capsule once daily for 18 weeks.
|
Pioglitazone 45 mg
n=24 Participants
Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg capsule once daily for 18 weeks.
|
|---|---|---|---|---|---|---|---|
|
Change in Total Triglycerides From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Baseline
|
100.8 mg/dL
Standard Deviation 15.94
|
293.2 mg/dL
Standard Deviation 300.50
|
214.8 mg/dL
Standard Deviation 145.63
|
156.5 mg/dL
Standard Deviation 85.96
|
165.7 mg/dL
Standard Deviation 118.31
|
221.0 mg/dL
Standard Deviation 188.82
|
163.0 mg/dL
Standard Deviation 72.29
|
|
Change in Total Triglycerides From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Week 12
|
—
|
179.0 mg/dL
Standard Deviation NA
Not available as data was calculated for one participant.
|
180.0 mg/dL
Standard Deviation NA
Not available as data was calculated for one participant.
|
72.0 mg/dL
Standard Deviation 6.73
|
82.3 mg/dL
Standard Deviation 44.52
|
161.3 mg/dL
Standard Deviation 100.69
|
90.8 mg/dL
Standard Deviation 41.95
|
SECONDARY outcome
Timeframe: Baseline up to week 12 post-dose.Population: Total Triglycerides were assessed from the Full Analysis Set. There were "0" numbers analyzed reported beyond Week 6 due to early termination by the sponsor because of changes in the clinical development plan. Data was not collected for participants that did not complete the later time points prior to study termination so cannot be included in the table.
Total Triglycerides (TG) is a measure of the total amount of triglycerides in the blood. The equation to calculate total triglycerides is: (total cholesterol-Low-density Lipoprotein cholesterol (LDL- C) - High-density lipoprotein cholesterol (HDL- C)) x 5 = Total Triglycerides. A negative change means improvement.
Outcome measures
| Measure |
Placebo
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone-matching placebo tablet or a Pioglitazone-matching placebo capsule once daily for 18 weeks.
|
Rivoglitazone 0.5mg
n=1 Participants
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 0.5mg tablet once daily for 18 weeks.
|
Rivoglitazone 1.0mg
n=1 Participants
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0mg tablet once daily for 18 weeks.
|
Rivoglitazone 1.5mg
n=4 Participants
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5mg tablet once daily for 18 weeks.
|
Pioglitazone 15 mg
n=3 Participants
Participants with type 2 diabetes mellitus who were administered a Pioglitazone 15 mg capsule once daily for 18 weeks.
|
Pioglitazone 30 mg
n=4 Participants
Participants with type 2 diabetes mellitus who were administered a Pioglitazone 30 mg capsule once daily for 18 weeks.
|
Pioglitazone 45 mg
n=5 Participants
Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg capsule once daily for 18 weeks.
|
|---|---|---|---|---|---|---|---|
|
Percent Change in Total Triglycerides From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
|
—
|
-15.4 percent change
Standard Deviation NA
Not available as data was calculated for one participant.
|
-34.1 percent change
Standard Deviation NA
Not available as data was calculated for one participant.
|
-16.8 percent change
Standard Deviation 16.17
|
-20.5 percent change
Standard Deviation 40.04
|
-16.1 percent change
Standard Deviation 24.80
|
-16.2 percent change
Standard Deviation 33.60
|
SECONDARY outcome
Timeframe: Baseline up to week 12 post-dose.Population: Low-Density Lipoprotein Cholesterol was assessed from the Full Analysis Set. There were "0" numbers analyzed reported beyond Week 6 due to early termination by the sponsor because of changes in the clinical development plan. Data was not collected for participants that did not complete the later time points prior to study termination so cannot be included in the table.
Low-density lipoprotein cholesterol (LDL-C) is a measure of the total amount of low-density lipoprotein cholesterol in the blood. LDL-C was measured as part of the fasting lipid panel. LDL-C is considered "bad" cholesterol, so a lower score (negative change) means improvement.
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone-matching placebo tablet or a Pioglitazone-matching placebo capsule once daily for 18 weeks.
|
Rivoglitazone 0.5mg
n=9 Participants
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 0.5mg tablet once daily for 18 weeks.
|
Rivoglitazone 1.0mg
n=12 Participants
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0mg tablet once daily for 18 weeks.
|
Rivoglitazone 1.5mg
n=27 Participants
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5mg tablet once daily for 18 weeks.
|
Pioglitazone 15 mg
n=8 Participants
Participants with type 2 diabetes mellitus who were administered a Pioglitazone 15 mg capsule once daily for 18 weeks.
|
Pioglitazone 30 mg
n=10 Participants
Participants with type 2 diabetes mellitus who were administered a Pioglitazone 30 mg capsule once daily for 18 weeks.
|
Pioglitazone 45 mg
n=24 Participants
Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg capsule once daily for 18 weeks.
|
|---|---|---|---|---|---|---|---|
|
Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Baseline
|
101.7 mg/dL
Standard Deviation 33.90
|
124.1 mg/dL
Standard Deviation 45.67
|
125.8 mg/dL
Standard Deviation 53.79
|
95.9 mg/dL
Standard Deviation 28.52
|
95.7 mg/dL
Standard Deviation 22.73
|
105.8 mg/dL
Standard Deviation 35.12
|
108.4 mg/dL
Standard Deviation 41.93
|
|
Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Week 12
|
—
|
226.0 mg/dL
Standard Deviation NA
Not available as data was calculated for one participant.
|
112.0 mg/dL
Standard Deviation NA
Not available as data was calculated for one participant.
|
78.5 mg/dL
Standard Deviation 20.70
|
82.7 mg/dL
Standard Deviation 45.54
|
129.8 mg/dL
Standard Deviation 10.56
|
111.6 mg/dL
Standard Deviation 24.67
|
SECONDARY outcome
Timeframe: Baseline up to week 12 post-dose.Population: Low-Density Lipoprotein Cholesterol was assessed from the Full Analysis Set. There were "0" numbers analyzed reported beyond Week 6 due to early termination by the sponsor because of changes in the clinical development plan. Data was not collected for participants that did not complete the later time points prior to study termination so cannot be included in the table.
Low-density lipoprotein cholesterol (LDL-C) is a measure of the total amount of low-density lipoprotein cholesterol in the blood. LDL-C was measured as part of the fasting lipid panel. LDL-C is considered "bad" cholesterol, so a lower score (negative change) means improvement.
Outcome measures
| Measure |
Placebo
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone-matching placebo tablet or a Pioglitazone-matching placebo capsule once daily for 18 weeks.
|
Rivoglitazone 0.5mg
n=1 Participants
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 0.5mg tablet once daily for 18 weeks.
|
Rivoglitazone 1.0mg
n=1 Participants
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0mg tablet once daily for 18 weeks.
|
Rivoglitazone 1.5mg
n=4 Participants
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5mg tablet once daily for 18 weeks.
|
Pioglitazone 15 mg
n=3 Participants
Participants with type 2 diabetes mellitus who were administered a Pioglitazone 15 mg capsule once daily for 18 weeks.
|
Pioglitazone 30 mg
n=3 Participants
Participants with type 2 diabetes mellitus who were administered a Pioglitazone 30 mg capsule once daily for 18 weeks.
|
Pioglitazone 45 mg
n=5 Participants
Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg capsule once daily for 18 weeks.
|
|---|---|---|---|---|---|---|---|
|
Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
|
—
|
16.8 percent change
Standard Deviation NA
Not available as data was calculated for one participant.
|
-1.8 percent change
Standard Deviation NA
Not available as data was calculated for one participant.
|
-8.6 percent change
Standard Deviation 3.25
|
-5.7 percent change
Standard Deviation 18.70
|
14.5 percent change
Standard Deviation 1.15
|
14.0 percent change
Standard Deviation 18.48
|
SECONDARY outcome
Timeframe: Baseline up to week 12 post-dose.Population: High-Density Lipoprotein Cholesterol was assessed from the Full Analysis Set. There were "0" numbers analyzed reported beyond Week 6 due to early termination by the sponsor because of changes in the clinical development plan. Data was not collected for participants that did not complete the later time points prior to study termination so cannot be included in the table.
High-density lipoprotein cholesterol (HDL-C) is a measure of the total amount of high-density lipoprotein cholesterol in the blood. HDL-C was measured as part of the fasting lipid panel. HDL-C is considered "good" cholesterol, so a higher score (positive change) means improvement.
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone-matching placebo tablet or a Pioglitazone-matching placebo capsule once daily for 18 weeks.
|
Rivoglitazone 0.5mg
n=9 Participants
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 0.5mg tablet once daily for 18 weeks.
|
Rivoglitazone 1.0mg
n=12 Participants
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0mg tablet once daily for 18 weeks.
|
Rivoglitazone 1.5mg
n=27 Participants
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5mg tablet once daily for 18 weeks.
|
Pioglitazone 15 mg
n=8 Participants
Participants with type 2 diabetes mellitus who were administered a Pioglitazone 15 mg capsule once daily for 18 weeks.
|
Pioglitazone 30 mg
n=10 Participants
Participants with type 2 diabetes mellitus who were administered a Pioglitazone 30 mg capsule once daily for 18 weeks.
|
Pioglitazone 45 mg
n=24 Participants
Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg capsule once daily for 18 weeks.
|
|---|---|---|---|---|---|---|---|
|
Change in High-Density Lipoprotein Cholesterol From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Change from Baseline Week 12
|
—
|
-1.0 mg/dL
Standard Deviation NA
Not available as data was calculated for one participant.
|
5.9 mg/dL
Standard Deviation NA
Not available as data was calculated for one participant.
|
13.1 mg/dL
Standard Deviation 14.03
|
12.9 mg/dL
Standard Deviation 12.93
|
10.8 mg/dL
Standard Deviation 10.26
|
11.1 mg/dL
Standard Deviation 10.39
|
|
Change in High-Density Lipoprotein Cholesterol From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Baseline
|
40.2 mg/dL
Standard Deviation 2.31
|
43.9 mg/dL
Standard Deviation 10.84
|
42.4 mg/dL
Standard Deviation 9.23
|
44.3 mg/dL
Standard Deviation 13.70
|
42.5 mg/dL
Standard Deviation 10.87
|
49.4 mg/dL
Standard Deviation 14.23
|
47.2 mg/dL
Standard Deviation 11.86
|
|
Change in High-Density Lipoprotein Cholesterol From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Week 12
|
—
|
49.0 mg/dL
Standard Deviation NA
Not available as data was calculated for one participant.
|
45.0 mg/dL
Standard Deviation NA
Not available as data was calculated for one participant.
|
52.8 mg/dL
Standard Deviation 11.53
|
52.3 mg/dL
Standard Deviation 21.01
|
51.3 mg/dL
Standard Deviation 10.14
|
56.6 mg/dL
Standard Deviation 14.43
|
SECONDARY outcome
Timeframe: Baseline up to week 12 post-dose.Population: High-Density Lipoprotein Cholesterol was assessed from the Full Analysis Set. There were "0" numbers analyzed reported beyond Week 6 due to early termination by the sponsor because of changes in the clinical development plan. Data was not collected for participants that did not complete the later time points prior to study termination so cannot be included in the table.
High-density lipoprotein cholesterol (HDL-C) is a measure of the total amount of high-density lipoprotein cholesterol in the blood. HDL-C was measured as part of the fasting lipid panel. HDL-C is considered "good" cholesterol, so a higher score (positive change) means improvement.
Outcome measures
| Measure |
Placebo
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone-matching placebo tablet or a Pioglitazone-matching placebo capsule once daily for 18 weeks.
|
Rivoglitazone 0.5mg
n=1 Participants
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 0.5mg tablet once daily for 18 weeks.
|
Rivoglitazone 1.0mg
n=1 Participants
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0mg tablet once daily for 18 weeks.
|
Rivoglitazone 1.5mg
n=4 Participants
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5mg tablet once daily for 18 weeks.
|
Pioglitazone 15 mg
n=3 Participants
Participants with type 2 diabetes mellitus who were administered a Pioglitazone 15 mg capsule once daily for 18 weeks.
|
Pioglitazone 30 mg
n=4 Participants
Participants with type 2 diabetes mellitus who were administered a Pioglitazone 30 mg capsule once daily for 18 weeks.
|
Pioglitazone 45 mg
n=5 Participants
Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg capsule once daily for 18 weeks.
|
|---|---|---|---|---|---|---|---|
|
Percent Change in High-Density Lipoprotein Cholesterol From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
|
—
|
-1.0 percent change
Standard Deviation NA
Not available as data was calculated for one participant.
|
5.9 percent change
Standard Deviation NA
Not available as data was calculated for one participant.
|
13.1 percent change
Standard Deviation 14.03
|
12.9 percent change
Standard Deviation 12.93
|
10.8 percent change
Standard Deviation 10.26
|
11.1 percent change
Standard Deviation 10.39
|
SECONDARY outcome
Timeframe: Baseline up to week 12 post-dose.Population: Apolipoprotein (Apo) A-I was assessed from the Full Analysis Set. There were instances of zero (0) numbers analyzed reported beyond Week 6 due to early termination by the sponsor because of changes in the clinical development plan. Data was not collected for participants that did not complete the later time points prior to study termination and were not reported in the table.
Apolipoprotein (Apo) A-I is a measure of the total amount of Apolipoprotein (Apo) A-I in the blood. Apo A-I was measured as part of the fasting lipid panel.
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone-matching placebo tablet or a Pioglitazone-matching placebo capsule once daily for 18 weeks.
|
Rivoglitazone 0.5mg
n=9 Participants
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 0.5mg tablet once daily for 18 weeks.
|
Rivoglitazone 1.0mg
n=12 Participants
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0mg tablet once daily for 18 weeks.
|
Rivoglitazone 1.5mg
n=27 Participants
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5mg tablet once daily for 18 weeks.
|
Pioglitazone 15 mg
n=8 Participants
Participants with type 2 diabetes mellitus who were administered a Pioglitazone 15 mg capsule once daily for 18 weeks.
|
Pioglitazone 30 mg
n=10 Participants
Participants with type 2 diabetes mellitus who were administered a Pioglitazone 30 mg capsule once daily for 18 weeks.
|
Pioglitazone 45 mg
n=24 Participants
Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg capsule once daily for 18 weeks.
|
|---|---|---|---|---|---|---|---|
|
Change in Apolipoprotein (Apo) A-I From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Baseline
|
134.0 mg/dL
Standard Deviation 7.57
|
146.7 mg/dL
Standard Deviation 15.68
|
139.7 mg/dL
Standard Deviation 16.20
|
142.4 mg/dL
Standard Deviation 27.72
|
133.0 mg/dL
Standard Deviation 20.34
|
158.6 mg/dL
Standard Deviation 31.57
|
149.6 mg/dL
Standard Deviation 25.89
|
|
Change in Apolipoprotein (Apo) A-I From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Week 12
|
—
|
144.0 mg/dL
Standard Deviation NA
Not available as data was calculated for one participant.
|
141.0 mg/dL
Standard Deviation NA
Not available as data was calculated for one participant.
|
149.8 mg/dL
Standard Deviation 21.08
|
145.3 mg/dL
Standard Deviation 34.27
|
153.0 mg/dL
Standard Deviation 24.14
|
158.2 mg/dL
Standard Deviation 31.44
|
SECONDARY outcome
Timeframe: Baseline up to week 12 post-dose.Population: Apolipoprotein (Apo) A-I was assessed from the Full Analysis Set. There were instances of zero (0) number analyzed reported beyond Week 6 due to early termination by the sponsor because of changes in the clinical development plan. Data were not collected for participants that did not complete the later time points prior to study termination and not available for the table.
Apolipoprotein (Apo) A-I is a measure of the total amount of Apolipoprotein (Apo) A-I in the blood. Apo A-I was measured as part of the fasting lipid panel.
Outcome measures
| Measure |
Placebo
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone-matching placebo tablet or a Pioglitazone-matching placebo capsule once daily for 18 weeks.
|
Rivoglitazone 0.5mg
n=1 Participants
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 0.5mg tablet once daily for 18 weeks.
|
Rivoglitazone 1.0mg
n=1 Participants
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0mg tablet once daily for 18 weeks.
|
Rivoglitazone 1.5mg
n=4 Participants
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5mg tablet once daily for 18 weeks.
|
Pioglitazone 15 mg
n=3 Participants
Participants with type 2 diabetes mellitus who were administered a Pioglitazone 15 mg capsule once daily for 18 weeks.
|
Pioglitazone 30 mg
n=4 Participants
Participants with type 2 diabetes mellitus who were administered a Pioglitazone 30 mg capsule once daily for 18 weeks.
|
Pioglitazone 45 mg
n=5 Participants
Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg capsule once daily for 18 weeks.
|
|---|---|---|---|---|---|---|---|
|
Percent Change in Apolipoprotein (Apo) A-I From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
|
—
|
-14.5 percent change
Standard Deviation NA
Not available as data was calculated for one participant.
|
-2.8 percent change
Standard Deviation NA
Not available as data was calculated for one participant.
|
2.8 percent change
Standard Deviation 9.18
|
3.0 percent change
Standard Deviation 6.90
|
0.3 percent change
Standard Deviation 6.81
|
1.4 percent change
Standard Deviation 10.19
|
SECONDARY outcome
Timeframe: Baseline up to week 12 post-dose.Population: Apolipoprotein (Apo) B was assessed from the Full Analysis Set. There were instances of zero (0) number analyzed reported beyond Week 6 due to early termination by the sponsor because of changes in the clinical development plan. Data were not collected for participants that did not complete the later time points prior to study termination and not available for the table.
Apolipoprotein (Apo) B is a measure of the total amount of Apolipoprotein (Apo) B in the blood. Apo B was measured as part of the fasting lipid panel.
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone-matching placebo tablet or a Pioglitazone-matching placebo capsule once daily for 18 weeks.
|
Rivoglitazone 0.5mg
n=9 Participants
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 0.5mg tablet once daily for 18 weeks.
|
Rivoglitazone 1.0mg
n=12 Participants
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0mg tablet once daily for 18 weeks.
|
Rivoglitazone 1.5mg
n=27 Participants
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5mg tablet once daily for 18 weeks.
|
Pioglitazone 15 mg
n=8 Participants
Participants with type 2 diabetes mellitus who were administered a Pioglitazone 15 mg capsule once daily for 18 weeks.
|
Pioglitazone 30 mg
n=10 Participants
Participants with type 2 diabetes mellitus who were administered a Pioglitazone 30 mg capsule once daily for 18 weeks.
|
Pioglitazone 45 mg
n=24 Participants
Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg capsule once daily for 18 weeks.
|
|---|---|---|---|---|---|---|---|
|
Change in Apolipoprotein (Apo) B From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Baseline
|
94.0 mg/dL
Standard Deviation 26.44
|
119.1 mg/dL
Standard Deviation 36.53
|
121.9 mg/dL
Standard Deviation 36.37
|
101.3 mg/dL
Standard Deviation 29.72
|
105.5 mg/dL
Standard Deviation 34.32
|
113.4 mg/dL
Standard Deviation 25.20
|
108.4 mg/dL
Standard Deviation 31.94
|
|
Change in Apolipoprotein (Apo) B From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Week 12
|
—
|
206.0 mg/dL
Standard Deviation NA
Not available as data was calculated for one participant.
|
115.0 mg/dL
Standard Deviation NA
Not available as data was calculated for one participant.
|
76.5 mg/dL
Standard Deviation 17.06
|
77.7 mg/dL
Standard Deviation 31.53
|
120.8 mg/dL
Standard Deviation 15.46
|
95.6 mg/dL
Standard Deviation 23.39
|
SECONDARY outcome
Timeframe: Baseline up to week 12 post-dose.Population: Apolipoprotein (Apo) B was assessed from the Full Analysis Set. There were instances of zero (0) number analyzed reported beyond Week 6 due to early termination by the sponsor because of changes in the clinical development plan. Data were not collected for participants that did not complete the later time points prior to study termination and not available for the table.
Apolipoprotein (Apo) B is a measure of the total amount of Apolipoprotein (Apo) B in the blood. Apo B was measured as part of the fasting lipid panel.
Outcome measures
| Measure |
Placebo
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone-matching placebo tablet or a Pioglitazone-matching placebo capsule once daily for 18 weeks.
|
Rivoglitazone 0.5mg
n=1 Participants
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 0.5mg tablet once daily for 18 weeks.
|
Rivoglitazone 1.0mg
n=1 Participants
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0mg tablet once daily for 18 weeks.
|
Rivoglitazone 1.5mg
n=4 Participants
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5mg tablet once daily for 18 weeks.
|
Pioglitazone 15 mg
n=3 Participants
Participants with type 2 diabetes mellitus who were administered a Pioglitazone 15 mg capsule once daily for 18 weeks.
|
Pioglitazone 30 mg
n=4 Participants
Participants with type 2 diabetes mellitus who were administered a Pioglitazone 30 mg capsule once daily for 18 weeks.
|
Pioglitazone 45 mg
n=5 Participants
Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg capsule once daily for 18 weeks.
|
|---|---|---|---|---|---|---|---|
|
Percent Change in Apolipoprotein (Apo) B From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
|
—
|
13.2 percent change
Standard Deviation NA
Not available as data was calculated for one participant.
|
-12.2 percent change
Standard Deviation NA
Not available as data was calculated for one participant.
|
-11.5 percent change
Standard Deviation 5.21
|
-14.8 percent change
Standard Deviation 20.97
|
0.1 percent change
Standard Deviation 6.63
|
1.7 percent change
Standard Deviation 16.20
|
SECONDARY outcome
Timeframe: Baseline up to week 26 post-dose, approximately a total of 27 weeks.Population: Treatment-emergent adverse events were assessed from the Safety Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone-matching placebo tablet or a Pioglitazone-matching placebo capsule once daily for 18 weeks.
|
Rivoglitazone 0.5mg
n=9 Participants
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 0.5mg tablet once daily for 18 weeks.
|
Rivoglitazone 1.0mg
n=12 Participants
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0mg tablet once daily for 18 weeks.
|
Rivoglitazone 1.5mg
n=27 Participants
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5mg tablet once daily for 18 weeks.
|
Pioglitazone 15 mg
n=8 Participants
Participants with type 2 diabetes mellitus who were administered a Pioglitazone 15 mg capsule once daily for 18 weeks.
|
Pioglitazone 30 mg
n=10 Participants
Participants with type 2 diabetes mellitus who were administered a Pioglitazone 30 mg capsule once daily for 18 weeks.
|
Pioglitazone 45 mg
n=24 Participants
Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg capsule once daily for 18 weeks.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Lymphadenitis
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Hypothyroidism
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Conjunctivitis
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Eye Pruritus
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Ocular Hyperaemia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Abdominal Pain
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Dry Mouth
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Flatulence
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Nausea
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Stomach Discomfort
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Malaise
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Non-cardiac chest pain
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Oedema
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Oedema peripheral
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Cholelithiasis
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Seasonal allergy
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Bronchitis
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Fungal infection
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Furuncle
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Influenza
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Nasopharyngitis
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Sinusitis
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Upper respiratory tract
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Viral upper respiratory tract infection
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Arthropod bite
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Back injury
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Blood creatine phosphokinase increased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Haemoglobin decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Red blood cell morphology abnormal
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Back pain
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Flank pain
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Joint crepitation
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Muscle twitching
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Musculoskeletal pain
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Musculoskeletal stiffness
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Myalgia
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Pain in extremity
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Carpal tunnel syndrome
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Dizziness
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Headache
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Insomnia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Mood altered
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Pharyngolaryngeal pain
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Hyperhidrosis
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Rash
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Hypertension
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Rivoglitazone 0.5mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Rivoglitazone 1.0mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Rivoglitazone 1.5mg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Pioglitazone 15 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Pioglitazone 30 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Pioglitazone 45 mg
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=3 participants at risk
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone-matching placebo tablet or a Pioglitazone-matching placebo capsule once daily for 18 weeks.
|
Rivoglitazone 0.5mg
n=9 participants at risk
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 0.5mg tablet once daily for 18 weeks.
|
Rivoglitazone 1.0mg
n=12 participants at risk
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.0mg tablet once daily for 18 weeks.
|
Rivoglitazone 1.5mg
n=27 participants at risk
Participants with type 2 diabetes mellitus who were administered a Rivoglitazone 1.5mg tablet once daily for 18 weeks.
|
Pioglitazone 15 mg
n=8 participants at risk
Participants with type 2 diabetes mellitus who were administered a Pioglitazone 15 mg capsule once daily for 18 weeks.
|
Pioglitazone 30 mg
n=10 participants at risk
Participants with type 2 diabetes mellitus who were administered a Pioglitazone 30 mg capsule once daily for 18 weeks.
|
Pioglitazone 45 mg
n=24 participants at risk
Participants with type 2 diabetes mellitus who were administered a Pioglitazone 45 mg capsule once daily for 18 weeks.
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
3.7%
1/27 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/8 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/10 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
11.1%
1/9 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/27 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/8 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/10 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
3.7%
1/27 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/8 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/10 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/27 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/8 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/10 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
4.2%
1/24 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
|
Gastrointestinal disorders
Stomach discomfort
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/27 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/8 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
10.0%
1/10 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
|
General disorders
Malaise
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
11.1%
1/9 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/27 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/8 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/10 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
3.7%
1/27 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/8 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/10 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
|
General disorders
Edema
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/27 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/8 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/10 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
4.2%
1/24 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
|
General disorders
Edema peripheral
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
3.7%
1/27 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/8 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/10 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
8.3%
2/24 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
11.1%
1/9 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/27 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/8 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/10 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
4.2%
1/24 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/27 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/8 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/10 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
4.2%
1/24 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
|
Infections and infestations
Furuncle
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/27 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/8 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
10.0%
1/10 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
|
Infections and infestations
Influenza
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/27 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/8 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/10 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
4.2%
1/24 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
8.3%
1/12 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
3.7%
1/27 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/8 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/10 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
4.2%
1/24 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
11.1%
1/9 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/27 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/8 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/10 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
7.4%
2/27 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
12.5%
1/8 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
10.0%
1/10 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
4.2%
1/24 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
11.1%
1/9 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/27 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/8 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/10 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/27 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/8 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/10 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
8.3%
2/24 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
|
Investigations
Hemoglobin decreased
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/27 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
12.5%
1/8 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/10 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
|
Investigations
Red blood cell morphology abnormal
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/27 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/8 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/10 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
4.2%
1/24 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
3.7%
1/27 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
12.5%
1/8 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/10 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
11.1%
1/9 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/27 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/8 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/10 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
|
Musculoskeletal and connective tissue disorders
Joint crepitation
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
3.7%
1/27 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/8 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/10 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/27 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/8 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/10 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
4.2%
1/24 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
3.7%
1/27 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/8 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/10 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
4.2%
1/24 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/27 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/8 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/10 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
4.2%
1/24 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
11.1%
1/9 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/27 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/8 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/10 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
3.7%
1/27 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/8 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/10 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/27 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
12.5%
1/8 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/10 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/9 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/27 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
12.5%
1/8 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/10 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
11.1%
1/9 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/12 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/27 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/8 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
0.00%
0/10 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
4.2%
1/24 • Treatment-emergent adverse event (TEAE) data were collected from Baseline (Day 1) up to week 26 post-dose, approximately a total of 27 weeks.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place