Trial Outcomes & Findings for Long-term Safety Study of Alogliptin in Participants With Type 2 Diabetes in Japan (NCT NCT01263496)
NCT ID: NCT01263496
Last Updated: 2012-02-03
Results Overview
A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug and within 30 days after receiving the last dose of study drug. A TEAE may also be a pre-treatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug, which increases in intensity after the start of dosing. Adverse events data with onset occurring more than 30 days after last dose of study drug (AE start date - last dose date \>30) will be listed, but not included in the summary tables below.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
438 participants
Primary outcome timeframe
52 Weeks.
Results posted on
2012-02-03
Participant Flow
Participants enrolled at 53 investigative sites in Japan from 10 May 2007 to 27 September 2008.
Participants with a historical diagnosis of type 2 diabetes mellitus with uncontrolled blood glucose despite diet and exercise therapies were enrolled in one of 5, once-daily (QD) or three-times daily (TID) treatment groups. Analyses were performed by treatment dose group or by treatment dose in this study.
Participant milestones
| Measure |
Alogliptin 6.25 mg Dose Group* → Alogliptin 6.25 mg Dose Group
Alogliptin 6.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
\*for participants from the 6.5 mg dosing ARM of the SYR-322/CCT-001 (NCT01263470) dose-ranging study.
|
Alogliptin 12.5 mg Dose Group* → Alogliptin 12.5 mg Dose Group
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
\*for participants from the 12.5 mg dosing ARM of the SYR-322/CCT-001 (NCT01263470) dose-ranging study.
|
Alogliptin 25 mg Dose Group* → Alogliptin 25 mg Dose Group
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
\*for participants from the 25 mg dosing ARM of the SYR-322/CCT-001 (NCT01263470) dose-ranging study.
|
Alogliptin 50 mg Dose Group* → Alogliptin 50 mg Dose Group
Alogliptin 50 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
\*for participants from the 50 mg dosing ARM of the SYR-322/CCT-001 (NCT01263470) dose-ranging study.
|
Voglibose 0.2 mg Dose Group* → Voglibose 0.2 mg Dose Group
Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
\*for participants from the voglibose 0.2 mg dosing ARM of the SYR-322/CCT-001 (NCT01263470) dose-ranging study.
|
Placebo Dose Group* → Alogliptin 6.25 mg Dose Group
Placebo-matching tablets, orally, once or three times daily for up to 40 weeks.
\*for participants from the placebo dosing ARM of the SYR-322/CCT-001 (NCT01263470) dose-ranging study.
|
Placebo Dose Group* → Alogliptin 12.5 mg Dose Group
Placebo-matching tablets, orally, once or three times daily for up to 40 weeks.
\*for participants from the placebo dosing ARM of the SYR-322/CCT-001 (NCT01263470) dose-ranging study.
|
Placebo Dose Group* → Alogliptin 25 mg Dose Group
Placebo-matching tablets, orally, once or three times daily for up to 40 weeks.
\*for participants from the placebo dosing ARM of the SYR-322/CCT-001 (NCT01263470) dose-ranging study.
|
Placebo Dose Group* → Alogliptin 50 mg Dose Group
Placebo-matching tablets, orally, once or three times daily for up to 40 weeks.
\*for participants from the placebo dosing ARM of the SYR-322/CCT-001 (NCT01263470) dose-ranging study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Enrolled - Long-Term Extension Study
STARTED
|
72
|
75
|
72
|
75
|
74
|
17
|
17
|
18
|
18
|
|
Enrolled - Long-Term Extension Study
COMPLETED
|
71
|
75
|
72
|
74
|
72
|
17
|
17
|
18
|
18
|
|
Enrolled - Long-Term Extension Study
NOT COMPLETED
|
1
|
0
|
0
|
1
|
2
|
0
|
0
|
0
|
0
|
|
Entered - Long-Term Extension Study
STARTED
|
71
|
72
|
72
|
74
|
71
|
17
|
17
|
17
|
18
|
|
Entered - Long-Term Extension Study
COMPLETED
|
62
|
59
|
62
|
68
|
61
|
16
|
16
|
16
|
15
|
|
Entered - Long-Term Extension Study
NOT COMPLETED
|
9
|
13
|
10
|
6
|
10
|
1
|
1
|
1
|
3
|
Reasons for withdrawal
| Measure |
Alogliptin 6.25 mg Dose Group* → Alogliptin 6.25 mg Dose Group
Alogliptin 6.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
\*for participants from the 6.5 mg dosing ARM of the SYR-322/CCT-001 (NCT01263470) dose-ranging study.
|
Alogliptin 12.5 mg Dose Group* → Alogliptin 12.5 mg Dose Group
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
\*for participants from the 12.5 mg dosing ARM of the SYR-322/CCT-001 (NCT01263470) dose-ranging study.
|
Alogliptin 25 mg Dose Group* → Alogliptin 25 mg Dose Group
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
\*for participants from the 25 mg dosing ARM of the SYR-322/CCT-001 (NCT01263470) dose-ranging study.
|
Alogliptin 50 mg Dose Group* → Alogliptin 50 mg Dose Group
Alogliptin 50 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
\*for participants from the 50 mg dosing ARM of the SYR-322/CCT-001 (NCT01263470) dose-ranging study.
|
Voglibose 0.2 mg Dose Group* → Voglibose 0.2 mg Dose Group
Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
\*for participants from the voglibose 0.2 mg dosing ARM of the SYR-322/CCT-001 (NCT01263470) dose-ranging study.
|
Placebo Dose Group* → Alogliptin 6.25 mg Dose Group
Placebo-matching tablets, orally, once or three times daily for up to 40 weeks.
\*for participants from the placebo dosing ARM of the SYR-322/CCT-001 (NCT01263470) dose-ranging study.
|
Placebo Dose Group* → Alogliptin 12.5 mg Dose Group
Placebo-matching tablets, orally, once or three times daily for up to 40 weeks.
\*for participants from the placebo dosing ARM of the SYR-322/CCT-001 (NCT01263470) dose-ranging study.
|
Placebo Dose Group* → Alogliptin 25 mg Dose Group
Placebo-matching tablets, orally, once or three times daily for up to 40 weeks.
\*for participants from the placebo dosing ARM of the SYR-322/CCT-001 (NCT01263470) dose-ranging study.
|
Placebo Dose Group* → Alogliptin 50 mg Dose Group
Placebo-matching tablets, orally, once or three times daily for up to 40 weeks.
\*for participants from the placebo dosing ARM of the SYR-322/CCT-001 (NCT01263470) dose-ranging study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Enrolled - Long-Term Extension Study
Protocol Violation
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Enrolled - Long-Term Extension Study
Adverse Event
|
0
|
0
|
0
|
1
|
2
|
0
|
0
|
0
|
0
|
|
Entered - Long-Term Extension Study
Adverse Event
|
0
|
5
|
6
|
3
|
1
|
0
|
0
|
0
|
1
|
|
Entered - Long-Term Extension Study
Lost to Follow-up
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Entered - Long-Term Extension Study
Withdrawal by Subject
|
1
|
2
|
0
|
2
|
4
|
1
|
1
|
0
|
1
|
|
Entered - Long-Term Extension Study
Lack of Efficacy
|
8
|
4
|
4
|
1
|
5
|
0
|
0
|
0
|
1
|
|
Entered - Long-Term Extension Study
Participant Unavailability
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Long-term Safety Study of Alogliptin in Participants With Type 2 Diabetes in Japan
Baseline characteristics by cohort
| Measure |
Alogliptin 6.25 mg QD
n=96 Participants
Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 12.5 mg QD
n=101 Participants
Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD
n=97 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 50 mg QD
n=97 Participants
Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
|
Voglibose 0.2 mg TID
n=83 Participants
Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
Total
n=474 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Customized
≤ 64 years
|
69 participants
n=5 Participants
|
67 participants
n=7 Participants
|
64 participants
n=5 Participants
|
65 participants
n=4 Participants
|
51 participants
n=21 Participants
|
316 participants
n=8 Participants
|
|
Age, Customized
≥ 65 years
|
27 participants
n=5 Participants
|
34 participants
n=7 Participants
|
33 participants
n=5 Participants
|
32 participants
n=4 Participants
|
32 participants
n=21 Participants
|
158 participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
133 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
70 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
68 Participants
n=4 Participants
|
56 Participants
n=21 Participants
|
341 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 52 Weeks.Population: Adverse Event Profile in the Safety Analysis Set
A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug and within 30 days after receiving the last dose of study drug. A TEAE may also be a pre-treatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug, which increases in intensity after the start of dosing. Adverse events data with onset occurring more than 30 days after last dose of study drug (AE start date - last dose date \>30) will be listed, but not included in the summary tables below.
Outcome measures
| Measure |
Alogliptin 6.25 mg QD
n=96 Participants
Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 12.5 mg QD
n=101 Participants
Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD
n=97 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 50 mg QD
n=97 Participants
Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
|
Voglibose 0.2 mg TID
n=83 Participants
Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|---|---|---|
|
Number of Participants With Adverse Events.
Serious Adverse Event Related to Study Drug
|
1 participants
|
2 participants
|
2 participants
|
2 participants
|
0 participants
|
|
Number of Participants With Adverse Events.
Other Adverse Events (Incidence ≥3%)
|
78 participants
|
81 participants
|
81 participants
|
88 participants
|
74 participants
|
|
Number of Participants With Adverse Events.
Serious Adverse Event
|
1 participants
|
5 participants
|
8 participants
|
5 participants
|
4 participants
|
SECONDARY outcome
Timeframe: Baseline and Week 12.Population: Values are Summary Statistics.
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 and glycosylated hemoglobin collected at baseline.
Outcome measures
| Measure |
Alogliptin 6.25 mg QD
n=93 Participants
Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 12.5 mg QD
n=97 Participants
Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD
n=94 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 50 mg QD
n=94 Participants
Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
|
Voglibose 0.2 mg TID
n=79 Participants
Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (Week 12).
|
-0.55 percentage of Glycosylated Hemoglobin
Standard Deviation 0.703
|
-0.70 percentage of Glycosylated Hemoglobin
Standard Deviation 0.545
|
-0.74 percentage of Glycosylated Hemoglobin
Standard Deviation 0.520
|
-0.86 percentage of Glycosylated Hemoglobin
Standard Deviation 0.499
|
-0.15 percentage of Glycosylated Hemoglobin
Standard Deviation 0.735
|
SECONDARY outcome
Timeframe: Baseline and Week 16.Population: Values are Summary Statistics.
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 16 and glycosylated hemoglobin collected at baseline.
Outcome measures
| Measure |
Alogliptin 6.25 mg QD
n=88 Participants
Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 12.5 mg QD
n=89 Participants
Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD
n=89 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 50 mg QD
n=91 Participants
Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
|
Voglibose 0.2 mg TID
n=71 Participants
Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (Week 16).
|
-0.57 percentage of Glycosylated Hemoglobin
Standard Deviation 0.758
|
-0.75 percentage of Glycosylated Hemoglobin
Standard Deviation 0.586
|
-0.77 percentage of Glycosylated Hemoglobin
Standard Deviation 0.616
|
-0.90 percentage of Glycosylated Hemoglobin
Standard Deviation 0.565
|
-0.25 percentage of Glycosylated Hemoglobin
Standard Deviation 0.633
|
SECONDARY outcome
Timeframe: Baseline and Week 20.Population: Values are Summary Statistics.
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 20 and glycosylated hemoglobin collected at baseline.
Outcome measures
| Measure |
Alogliptin 6.25 mg QD
n=87 Participants
Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 12.5 mg QD
n=87 Participants
Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD
n=88 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 50 mg QD
n=90 Participants
Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
|
Voglibose 0.2 mg TID
n=69 Participants
Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (Week 20).
|
-0.56 percentage of Glycosylated Hemoglobin
Standard Deviation 0.699
|
-0.69 percentage of Glycosylated Hemoglobin
Standard Deviation 0.628
|
-0.70 percentage of Glycosylated Hemoglobin
Standard Deviation 0.672
|
-0.88 percentage of Glycosylated Hemoglobin
Standard Deviation 0.602
|
-0.30 percentage of Glycosylated Hemoglobin
Standard Deviation 0.650
|
SECONDARY outcome
Timeframe: Baseline and Week 24.Population: Values are Summary Statistics.
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 24 and glycosylated hemoglobin collected at baseline.
Outcome measures
| Measure |
Alogliptin 6.25 mg QD
n=86 Participants
Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 12.5 mg QD
n=84 Participants
Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD
n=89 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 50 mg QD
n=89 Participants
Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
|
Voglibose 0.2 mg TID
n=66 Participants
Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (Week 24).
|
-0.47 percentage of Glycosylated Hemoglobin
Standard Deviation 0.736
|
-0.61 percentage of Glycosylated Hemoglobin
Standard Deviation 0.697
|
-0.66 percentage of Glycosylated Hemoglobin
Standard Deviation 0.714
|
-0.83 percentage of Glycosylated Hemoglobin
Standard Deviation 0.647
|
-0.29 percentage of Glycosylated Hemoglobin
Standard Deviation 0.730
|
SECONDARY outcome
Timeframe: Baseline and Week 28.Population: Values are Summary Statistics.
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 28 and glycosylated hemoglobin collected at baseline.
Outcome measures
| Measure |
Alogliptin 6.25 mg QD
n=85 Participants
Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 12.5 mg QD
n=82 Participants
Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD
n=87 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 50 mg QD
n=86 Participants
Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
|
Voglibose 0.2 mg TID
n=65 Participants
Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (Week 28).
|
-0.39 percentage of Glycosylated Hemoglobin
Standard Deviation 0.804
|
-0.56 percentage of Glycosylated Hemoglobin
Standard Deviation 0.721
|
-0.67 percentage of Glycosylated Hemoglobin
Standard Deviation 0.749
|
-0.78 percentage of Glycosylated Hemoglobin
Standard Deviation 0.705
|
-0.32 percentage of Glycosylated Hemoglobin
Standard Deviation 0.676
|
SECONDARY outcome
Timeframe: Baseline and Week 32.Population: Values are Summary Statistics.
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 32 and glycosylated hemoglobin collected at baseline.
Outcome measures
| Measure |
Alogliptin 6.25 mg QD
n=84 Participants
Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 12.5 mg QD
n=81 Participants
Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD
n=87 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 50 mg QD
n=85 Participants
Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
|
Voglibose 0.2 mg TID
n=64 Participants
Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (Week 32).
|
-0.35 percentage of Glycosylated Hemoglobin
Standard Deviation 0.787
|
-0.56 percentage of Glycosylated Hemoglobin
Standard Deviation 0.811
|
-0.61 percentage of Glycosylated Hemoglobin
Standard Deviation 0.777
|
-0.76 percentage of Glycosylated Hemoglobin
Standard Deviation 0.757
|
-0.27 percentage of Glycosylated Hemoglobin
Standard Deviation 0.662
|
SECONDARY outcome
Timeframe: Baseline and Week 36.Population: Values are Summary Statistics.
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 36 and glycosylated hemoglobin collected at baseline.
Outcome measures
| Measure |
Alogliptin 6.25 mg QD
n=82 Participants
Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 12.5 mg QD
n=81 Participants
Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD
n=82 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 50 mg QD
n=84 Participants
Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
|
Voglibose 0.2 mg TID
n=64 Participants
Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (Week 36).
|
-0.33 percentage of Glycosylated Hemoglobin
Standard Deviation 0.724
|
-0.52 percentage of Glycosylated Hemoglobin
Standard Deviation 0.857
|
-0.66 percentage of Glycosylated Hemoglobin
Standard Deviation 0.722
|
-0.77 percentage of Glycosylated Hemoglobin
Standard Deviation 0.759
|
-0.28 percentage of Glycosylated Hemoglobin
Standard Deviation 0.664
|
SECONDARY outcome
Timeframe: Baseline and Week 40.Population: Values are Summary Statistics.
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 40 and glycosylated hemoglobin collected at baseline.
Outcome measures
| Measure |
Alogliptin 6.25 mg QD
n=81 Participants
Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 12.5 mg QD
n=79 Participants
Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD
n=79 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 50 mg QD
n=84 Participants
Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
|
Voglibose 0.2 mg TID
n=63 Participants
Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (Week 40).
|
-0.33 percentage of Glycosylated Hemoglobin
Standard Deviation 0.686
|
-0.48 percentage of Glycosylated Hemoglobin
Standard Deviation 0.882
|
-0.66 percentage of Glycosylated Hemoglobin
Standard Deviation 0.694
|
-0.77 percentage of Glycosylated Hemoglobin
Standard Deviation 0.765
|
-0.28 percentage of Glycosylated Hemoglobin
Standard Deviation 0.627
|
SECONDARY outcome
Timeframe: Baseline and Week 44.Population: Values are Summary Statistics.
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 44 and glycosylated hemoglobin collected at baseline.
Outcome measures
| Measure |
Alogliptin 6.25 mg QD
n=65 Participants
Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 12.5 mg QD
n=61 Participants
Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD
n=63 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 50 mg QD
n=69 Participants
Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
|
Voglibose 0.2 mg TID
n=63 Participants
Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (Week 44).
|
-0.29 percentage of Glycosylated Hemoglobin
Standard Deviation 0.649
|
-0.59 percentage of Glycosylated Hemoglobin
Standard Deviation 0.722
|
-0.71 percentage of Glycosylated Hemoglobin
Standard Deviation 0.767
|
-0.79 percentage of Glycosylated Hemoglobin
Standard Deviation 0.770
|
-0.35 percentage of Glycosylated Hemoglobin
Standard Deviation 0.632
|
SECONDARY outcome
Timeframe: Baseline and Week 48.Population: Values are Summary Statistics.
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 48 and glycosylated hemoglobin collected at baseline.
Outcome measures
| Measure |
Alogliptin 6.25 mg QD
n=63 Participants
Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 12.5 mg QD
n=60 Participants
Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD
n=62 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 50 mg QD
n=69 Participants
Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
|
Voglibose 0.2 mg TID
n=61 Participants
Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (Week 48).
|
-0.43 percentage of Glycosylated Hemoglobin
Standard Deviation 0.590
|
-0.66 percentage of Glycosylated Hemoglobin
Standard Deviation 0.716
|
-0.76 percentage of Glycosylated Hemoglobin
Standard Deviation 0.736
|
-0.83 percentage of Glycosylated Hemoglobin
Standard Deviation 0.779
|
-0.40 percentage of Glycosylated Hemoglobin
Standard Deviation 0.695
|
SECONDARY outcome
Timeframe: Baseline and Week 52.Population: Values are Summary Statistics.
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 52 and glycosylated hemoglobin collected at baseline.
Outcome measures
| Measure |
Alogliptin 6.25 mg QD
n=62 Participants
Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 12.5 mg QD
n=59 Participants
Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD
n=62 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 50 mg QD
n=68 Participants
Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
|
Voglibose 0.2 mg TID
n=61 Participants
Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (Week 52).
|
-0.49 percentage of Glycosylated Hemoglobin
Standard Deviation 0.544
|
-0.65 percentage of Glycosylated Hemoglobin
Standard Deviation 0.726
|
-0.74 percentage of Glycosylated Hemoglobin
Standard Deviation 0.754
|
-0.85 percentage of Glycosylated Hemoglobin
Standard Deviation 0.785
|
-0.37 percentage of Glycosylated Hemoglobin
Standard Deviation 0.723
|
SECONDARY outcome
Timeframe: Baseline and Final Visit (up to Week 52).Population: Values are Summary Statistics.
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 52 or final visit and glycosylated hemoglobin collected at baseline.
Outcome measures
| Measure |
Alogliptin 6.25 mg QD
n=96 Participants
Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 12.5 mg QD
n=101 Participants
Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD
n=96 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 50 mg QD
n=97 Participants
Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
|
Voglibose 0.2 mg TID
n=83 Participants
Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (Final Visit).
|
-0.40 percentage of Glycosylated Hemoglobin
Standard Deviation 0.713
|
-0.47 percentage of Glycosylated Hemoglobin
Standard Deviation 0.817
|
-0.63 percentage of Glycosylated Hemoglobin
Standard Deviation 0.788
|
-0.86 percentage of Glycosylated Hemoglobin
Standard Deviation 0.723
|
-0.22 percentage of Glycosylated Hemoglobin
Standard Deviation 0.882
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Values are Summary Statistics.
The change between the value of fasting plasma glucose collected at week 12 and fasting plasma glucose collected at baseline.
Outcome measures
| Measure |
Alogliptin 6.25 mg QD
n=93 Participants
Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 12.5 mg QD
n=97 Participants
Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD
n=94 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 50 mg QD
n=94 Participants
Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
|
Voglibose 0.2 mg TID
n=79 Participants
Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (Week 12).
|
-12.1 mg/dL
Standard Deviation 32.26
|
-15.3 mg/dL
Standard Deviation 23.57
|
-17.0 mg/dL
Standard Deviation 21.42
|
-23.0 mg/dL
Standard Deviation 23.35
|
-3.6 mg/dL
Standard Deviation 26.98
|
SECONDARY outcome
Timeframe: Baseline and Week 16.Population: Values are Summary Statistics.
The change between the value of fasting plasma glucose collected at week 16 and fasting plasma glucose collected at baseline.
Outcome measures
| Measure |
Alogliptin 6.25 mg QD
n=88 Participants
Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 12.5 mg QD
n=89 Participants
Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD
n=89 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 50 mg QD
n=97 Participants
Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
|
Voglibose 0.2 mg TID
n=71 Participants
Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (Week 16).
|
-10.8 mg/dL
Standard Deviation 24.52
|
-15.8 mg/dL
Standard Deviation 23.76
|
-17.0 mg/dL
Standard Deviation 23.34
|
-18.8 mg/dL
Standard Deviation 29.74
|
-6.4 mg/dL
Standard Deviation 28.02
|
SECONDARY outcome
Timeframe: Baseline and Week 20.Population: Values are Summary Statistics.
The change between the value of fasting plasma glucose collected at week 20 and fasting plasma glucose collected at baseline.
Outcome measures
| Measure |
Alogliptin 6.25 mg QD
n=87 Participants
Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 12.5 mg QD
n=87 Participants
Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD
n=88 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 50 mg QD
n=90 Participants
Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
|
Voglibose 0.2 mg TID
n=69 Participants
Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (Week 20).
|
-11.5 mg/dL
Standard Deviation 27.50
|
-15.3 mg/dL
Standard Deviation 24.49
|
-13.8 mg/dL
Standard Deviation 23.10
|
-20.1 mg/dL
Standard Deviation 27.94
|
-4.6 mg/dL
Standard Deviation 27.53
|
SECONDARY outcome
Timeframe: Baseline and Week 24.Population: Values are Summary Statistics.
The change between the value of fasting plasma glucose collected at week 24 and fasting plasma glucose collected at baseline.
Outcome measures
| Measure |
Alogliptin 6.25 mg QD
n=86 Participants
Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 12.5 mg QD
n=84 Participants
Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD
n=89 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 50 mg QD
n=89 Participants
Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
|
Voglibose 0.2 mg TID
n=66 Participants
Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (Week 24).
|
-10.6 mg/dL
Standard Deviation 29.15
|
-11.7 mg/dL
Standard Deviation 28.19
|
-13.8 mg/dL
Standard Deviation 23.70
|
-20.2 mg/dL
Standard Deviation 28.90
|
-8.3 mg/dL
Standard Deviation 25.58
|
SECONDARY outcome
Timeframe: Baseline and Week 28.Population: Values are Summary Statistics.
The change between the value of fasting plasma glucose collected at week 28 and fasting plasma glucose collected at baseline.
Outcome measures
| Measure |
Alogliptin 6.25 mg QD
n=85 Participants
Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 12.5 mg QD
n=82 Participants
Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD
n=87 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 50 mg QD
n=86 Participants
Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
|
Voglibose 0.2 mg TID
n=65 Participants
Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (Week 28).
|
-9.6 mg/dL
Standard Deviation 30.07
|
-13.4 mg/dL
Standard Deviation 30.06
|
-14.1 mg/dL
Standard Deviation 23.86
|
-19.9 mg/dL
Standard Deviation 32.36
|
-7.2 mg/dL
Standard Deviation 28.13
|
SECONDARY outcome
Timeframe: Baseline and Week 32.Population: Values are Summary Statistics.
The change between the value of fasting plasma glucose collected at week 32 and fasting plasma glucose collected at baseline.
Outcome measures
| Measure |
Alogliptin 6.25 mg QD
n=84 Participants
Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 12.5 mg QD
n=81 Participants
Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD
n=87 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 50 mg QD
n=85 Participants
Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
|
Voglibose 0.2 mg TID
n=64 Participants
Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (Week 32).
|
-14.5 mg/dL
Standard Deviation 21.13
|
-12.9 mg/dL
Standard Deviation 31.64
|
-14.9 mg/dL
Standard Deviation 25.86
|
-20.3 mg/dL
Standard Deviation 30.72
|
-9.1 mg/dL
Standard Deviation 26.59
|
SECONDARY outcome
Timeframe: Baseline and Week 36.Population: Values are Summary Statistics.
The change between the value of fasting plasma glucose collected at week 36 and fasting plasma glucose collected at baseline.
Outcome measures
| Measure |
Alogliptin 6.25 mg QD
n=81 Participants
Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 12.5 mg QD
n=82 Participants
Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD
n=81 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 50 mg QD
n=84 Participants
Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
|
Voglibose 0.2 mg TID
n=64 Participants
Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (Week 36).
|
-10.7 mg/dL
Standard Deviation 24.25
|
-14.3 mg/dL
Standard Deviation 32.31
|
-16.9 mg/dL
Standard Deviation 23.66
|
-20.9 mg/dL
Standard Deviation 32.48
|
-8.4 mg/dL
Standard Deviation 25.36
|
SECONDARY outcome
Timeframe: Baseline and Week 40.Population: Values are Summary Statistics.
The change between the value of fasting plasma glucose collected at week 40 and fasting plasma glucose collected at baseline.
Outcome measures
| Measure |
Alogliptin 6.25 mg QD
n=81 Participants
Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 12.5 mg QD
n=79 Participants
Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD
n=79 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 50 mg QD
n=84 Participants
Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
|
Voglibose 0.2 mg TID
n=63 Participants
Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (Week 40).
|
-13.5 mg/dL
Standard Deviation 19.32
|
-14.8 mg/dL
Standard Deviation 28.76
|
-15.7 mg/dL
Standard Deviation 21.38
|
-23.2 mg/dL
Standard Deviation 29.40
|
-13.8 mg/dL
Standard Deviation 25.82
|
SECONDARY outcome
Timeframe: Baseline and Week 44.Population: Values are Summary Statistics.
The change between the value of fasting plasma glucose collected at week 44 and fasting plasma glucose collected at baseline.
Outcome measures
| Measure |
Alogliptin 6.25 mg QD
n=65 Participants
Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 12.5 mg QD
n=61 Participants
Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD
n=63 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 50 mg QD
n=69 Participants
Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
|
Voglibose 0.2 mg TID
n=63 Participants
Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (Week 44).
|
-16.7 mg/dL
Standard Deviation 22.28
|
-18.7 mg/dL
Standard Deviation 26.79
|
-19.0 mg/dL
Standard Deviation 24.77
|
-24.7 mg/dL
Standard Deviation 29.69
|
-15.0 mg/dL
Standard Deviation 26.09
|
SECONDARY outcome
Timeframe: Baseline and Week 48.Population: Values are Summary Statistics.
The change between the value of fasting plasma glucose collected at week 48 and fasting plasma glucose collected at baseline.
Outcome measures
| Measure |
Alogliptin 6.25 mg QD
n=62 Participants
Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 12.5 mg QD
n=60 Participants
Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD
n=62 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 50 mg QD
n=69 Participants
Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
|
Voglibose 0.2 mg TID
n=61 Participants
Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (Week 48).
|
-16.0 mg/dL
Standard Deviation 21.54
|
-20.8 mg/dL
Standard Deviation 24.97
|
-22.8 mg/dL
Standard Deviation 21.89
|
-25.4 mg/dL
Standard Deviation 30.50
|
-13.5 mg/dL
Standard Deviation 26.30
|
SECONDARY outcome
Timeframe: Baseline and Week 52.Population: Values are Summary Statistics.
The change between the value of fasting plasma glucose collected at week 52 and fasting plasma glucose collected at baseline.
Outcome measures
| Measure |
Alogliptin 6.25 mg QD
n=62 Participants
Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 12.5 mg QD
n=59 Participants
Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD
n=62 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 50 mg QD
n=68 Participants
Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
|
Voglibose 0.2 mg TID
n=61 Participants
Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (Week 52).
|
-13.7 mg/dL
Standard Deviation 21.54
|
-19.5 mg/dL
Standard Deviation 25.63
|
-21.4 mg/dL
Standard Deviation 22.35
|
-26.0 mg/dL
Standard Deviation 29.05
|
-12.5 mg/dL
Standard Deviation 25.77
|
SECONDARY outcome
Timeframe: Baseline and Final Visit (up to Week 52).Population: Values are Summary Statistics.
The change between the value of fasting plasma glucose collected at week 52 or final visit and fasting plasma glucose collected at baseline.
Outcome measures
| Measure |
Alogliptin 6.25 mg QD
n=96 Participants
Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 12.5 mg QD
n=101 Participants
Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD
n=96 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 50 mg QD
n=97 Participants
Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
|
Voglibose 0.2 mg TID
n=83 Participants
Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (Final Visit).
|
-10.4 mg/dL
Standard Deviation 27.13
|
-15.5 mg/dL
Standard Deviation 31.02
|
-17.1 mg/dL
Standard Deviation 26.50
|
-27.6 mg/dL
Standard Deviation 28.13
|
-8.8 mg/dL
Standard Deviation 30.14
|
SECONDARY outcome
Timeframe: Baseline and Week 12.Population: Values are Summary Statistics.
The change between the value of fasting C-peptide collected at week 12 and fasting C-peptide collected at baseline.
Outcome measures
| Measure |
Alogliptin 6.25 mg QD
n=93 Participants
Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 12.5 mg QD
n=97 Participants
Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD
n=94 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 50 mg QD
n=94 Participants
Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
|
Voglibose 0.2 mg TID
n=79 Participants
Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Fasting C-peptide (Week 12).
|
-0.02 ng/mL
Standard Deviation 0.667
|
0.19 ng/mL
Standard Deviation 0.604
|
0.19 ng/mL
Standard Deviation 0.567
|
0.25 ng/mL
Standard Deviation 0.706
|
-0.04 ng/mL
Standard Deviation 0.900
|
SECONDARY outcome
Timeframe: Baseline and Week 16.Population: Values are Summary Statistics.
The change between the value of fasting C-peptide collected at week 16 and fasting C-peptide collected at baseline.
Outcome measures
| Measure |
Alogliptin 6.25 mg QD
n=88 Participants
Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 12.5 mg QD
n=89 Participants
Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD
n=89 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 50 mg QD
n=91 Participants
Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
|
Voglibose 0.2 mg TID
n=71 Participants
Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Fasting C-peptide (Week 16).
|
0.08 ng/mL
Standard Deviation 0.790
|
0.22 ng/mL
Standard Deviation 0.640
|
0.33 ng/mL
Standard Deviation 0.679
|
0.46 ng/mL
Standard Deviation 0.924
|
-0.01 ng/mL
Standard Deviation 0.886
|
SECONDARY outcome
Timeframe: Baseline and Week 20.Population: Values are Summary Statistics.
The change between the value of fasting C-peptide collected at week 20 and fasting C-peptide collected at baseline.
Outcome measures
| Measure |
Alogliptin 6.25 mg QD
n=86 Participants
Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 12.5 mg QD
n=86 Participants
Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD
n=88 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 50 mg QD
n=90 Participants
Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
|
Voglibose 0.2 mg TID
n=69 Participants
Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Fasting C-peptide (Week 20).
|
0.15 ng/mL
Standard Deviation 0.634
|
0.35 ng/mL
Standard Deviation 0.781
|
0.28 ng/mL
Standard Deviation 0.608
|
0.56 ng/mL
Standard Deviation 0.971
|
-0.16 ng/mL
Standard Deviation 0.953
|
SECONDARY outcome
Timeframe: Baseline and Week 24.Population: Values are Summary Statistics.
The change between the value of fasting C-peptide collected at week 24 and fasting C-peptide collected at baseline.
Outcome measures
| Measure |
Alogliptin 6.25 mg QD
n=83 Participants
Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 12.5 mg QD
n=80 Participants
Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD
n=83 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 50 mg QD
n=85 Participants
Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
|
Voglibose 0.2 mg TID
n=66 Participants
Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Fasting C-peptide (Week 24).
|
0.12 ng/mL
Standard Deviation 0.742
|
0.26 ng/mL
Standard Deviation 0.722
|
0.20 ng/mL
Standard Deviation 0.603
|
0.23 ng/mL
Standard Deviation 0.620
|
-0.10 ng/mL
Standard Deviation 0.831
|
SECONDARY outcome
Timeframe: Baseline and Week 28.Population: Values are Summary Statistics.
The change between the value of fasting C-peptide collected at week 28 and fasting C-peptide collected at baseline.
Outcome measures
| Measure |
Alogliptin 6.25 mg QD
n=80 Participants
Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 12.5 mg QD
n=73 Participants
Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD
n=77 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 50 mg QD
n=80 Participants
Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
|
Voglibose 0.2 mg TID
n=65 Participants
Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Fasting C-peptide (Week 28).
|
0.11 ng/mL
Standard Deviation 0.692
|
0.21 ng/mL
Standard Deviation 0.642
|
0.26 ng/mL
Standard Deviation 0.591
|
0.29 ng/mL
Standard Deviation 0.857
|
-0.04 ng/mL
Standard Deviation 0.951
|
SECONDARY outcome
Timeframe: Baseline and Week 32.Population: Values are Summary Statistics.
The change between the value of fasting C-peptide collected at week 32 and fasting C-peptide collected at baseline.
Outcome measures
| Measure |
Alogliptin 6.25 mg QD
n=67 Participants
Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 12.5 mg QD
n=66 Participants
Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD
n=74 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 50 mg QD
n=73 Participants
Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
|
Voglibose 0.2 mg TID
n=63 Participants
Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Fasting C-peptide (Week 32).
|
0.03 ng/mL
Standard Deviation 0.778
|
0.41 ng/mL
Standard Deviation 0.652
|
0.45 ng/mL
Standard Deviation 0.718
|
0.37 ng/mL
Standard Deviation 0.816
|
-0.01 ng/mL
Standard Deviation 0.950
|
SECONDARY outcome
Timeframe: Baseline and Week 36.Population: Values are Summary Statistics.
The change between the value of fasting C-peptide collected at week 36 and fasting C-peptide collected at baseline.
Outcome measures
| Measure |
Alogliptin 6.25 mg QD
n=55 Participants
Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 12.5 mg QD
n=46 Participants
Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD
n=50 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 50 mg QD
n=54 Participants
Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
|
Voglibose 0.2 mg TID
n=48 Participants
Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Fasting C-peptide (Week 36).
|
0.12 ng/mL
Standard Deviation 0.714
|
0.33 ng/mL
Standard Deviation 0.639
|
0.20 ng/mL
Standard Deviation 0.750
|
0.42 ng/mL
Standard Deviation 0.856
|
0.09 ng/mL
Standard Deviation 0.777
|
SECONDARY outcome
Timeframe: Baseline and Week 40.Population: Values are Summary Statistics.
The change between the value of fasting C-peptide collected at week 40 and fasting C-peptide collected at baseline.
Outcome measures
| Measure |
Alogliptin 6.25 mg QD
n=33 Participants
Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 12.5 mg QD
n=26 Participants
Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD
n=35 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 50 mg QD
n=41 Participants
Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
|
Voglibose 0.2 mg TID
n=35 Participants
Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Fasting C-peptide (Week 40).
|
-0.14 ng/mL
Standard Deviation 0.998
|
0.48 ng/mL
Standard Deviation 0.836
|
0.27 ng/mL
Standard Deviation 0.735
|
0.44 ng/mL
Standard Deviation 0.567
|
0.13 ng/mL
Standard Deviation 1.066
|
SECONDARY outcome
Timeframe: Baseline and Week 44.Population: Values are Summary Statistics.
The change between the value of fasting C-peptide collected at week 44 and fasting C-peptide collected at baseline.
Outcome measures
| Measure |
Alogliptin 6.25 mg QD
n=17 Participants
Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 12.5 mg QD
n=18 Participants
Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD
n=20 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 50 mg QD
n=20 Participants
Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
|
Voglibose 0.2 mg TID
n=21 Participants
Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Fasting C-peptide (Week 44).
|
0.22 ng/mL
Standard Deviation 0.963
|
0.52 ng/mL
Standard Deviation 0.887
|
0.59 ng/mL
Standard Deviation 0.881
|
0.20 ng/mL
Standard Deviation 0.651
|
-0.06 ng/mL
Standard Deviation 0.991
|
SECONDARY outcome
Timeframe: Baseline and Week 48.Population: Values are Summary Statistics.
The change between the value of fasting C-peptide collected at week 48 and fasting C-peptide collected at baseline.
Outcome measures
| Measure |
Alogliptin 6.25 mg QD
n=6 Participants
Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 12.5 mg QD
n=7 Participants
Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD
n=9 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 50 mg QD
n=6 Participants
Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
|
Voglibose 0.2 mg TID
n=9 Participants
Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Fasting C-peptide (Week 48).
|
-0.40 ng/mL
Standard Deviation 0.632
|
0.54 ng/mL
Standard Deviation 0.796
|
0.04 ng/mL
Standard Deviation 0.485
|
0.15 ng/mL
Standard Deviation 0.558
|
-0.10 ng/mL
Standard Deviation 0.934
|
SECONDARY outcome
Timeframe: Baseline and Week 52.Population: Values are Summary Statistics.
The change between the value of fasting C-peptide collected at week 52 and fasting C-peptide collected at baseline.
Outcome measures
| Measure |
Alogliptin 6.25 mg QD
n=2 Participants
Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 12.5 mg QD
n=3 Participants
Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD
n=3 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 50 mg QD
n=4 Participants
Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
|
Voglibose 0.2 mg TID
n=3 Participants
Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Fasting C-peptide (Week 52).
|
-0.25 ng/mL
Standard Deviation 0.212
|
0.73 ng/mL
Standard Deviation 0.874
|
0.10 ng/mL
Standard Deviation 0.781
|
0.30 ng/mL
Standard Deviation 1.095
|
0.70 ng/mL
Standard Deviation 1.473
|
SECONDARY outcome
Timeframe: Baseline and Final Visit (up to Week 52).Population: Values are Summary Statistics.
The change between the value of fasting C-peptide collected at week 52 or final visit and fasting C-peptide collected at baseline.
Outcome measures
| Measure |
Alogliptin 6.25 mg QD
n=96 Participants
Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 12.5 mg QD
n=101 Participants
Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD
n=96 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 50 mg QD
n=97 Participants
Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
|
Voglibose 0.2 mg TID
n=83 Participants
Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Fasting C-peptide (Final Visit).
|
0.34 ng/mL
Standard Deviation 1.046
|
0.44 ng/mL
Standard Deviation 0.820
|
0.32 ng/mL
Standard Deviation 0.805
|
0.48 ng/mL
Standard Deviation 0.765
|
0.18 ng/mL
Standard Deviation 0.970
|
SECONDARY outcome
Timeframe: Baseline and Week 12.Population: Values are Summary Statistics.
The change between the value of blood glucose collected at week 12 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
Outcome measures
| Measure |
Alogliptin 6.25 mg QD
n=93 Participants
Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 12.5 mg QD
n=97 Participants
Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD
n=95 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 50 mg QD
n=94 Participants
Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
|
Voglibose 0.2 mg TID
n=79 Participants
Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 12).
|
62.9 mg/dL
Standard Deviation 33.75
|
61.8 mg/dL
Standard Deviation 31.41
|
56.4 mg/dL
Standard Deviation 36.70
|
55.8 mg/dL
Standard Deviation 30.83
|
64.8 mg/dL
Standard Deviation 31.62
|
SECONDARY outcome
Timeframe: Baseline and Week 24.Population: Values are Summary Statistics.
The change between the value of blood glucose collected at week 24 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
Outcome measures
| Measure |
Alogliptin 6.25 mg QD
n=71 Participants
Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 12.5 mg QD
n=68 Participants
Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD
n=74 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 50 mg QD
n=74 Participants
Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
|
Voglibose 0.2 mg TID
n=67 Participants
Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 24).
|
64.3 mg/dL
Standard Deviation 37.80
|
55.5 mg/dL
Standard Deviation 30.63
|
55.5 mg/dL
Standard Deviation 39.78
|
55.9 mg/dL
Standard Deviation 33.60
|
56.6 mg/dL
Standard Deviation 30.02
|
SECONDARY outcome
Timeframe: Baseline and Week 52.Population: Values are Summary Statistics.
The change between the value of blood glucose collected at week 52 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
Outcome measures
| Measure |
Alogliptin 6.25 mg QD
n=80 Participants
Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 12.5 mg QD
n=76 Participants
Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD
n=78 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 50 mg QD
n=83 Participants
Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
|
Voglibose 0.2 mg TID
n=61 Participants
Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 52).
|
65.7 mg/dL
Standard Deviation 38.39
|
62.6 mg/dL
Standard Deviation 30.18
|
58.3 mg/dL
Standard Deviation 32.62
|
51.8 mg/dL
Standard Deviation 36.73
|
61.0 mg/dL
Standard Deviation 30.16
|
SECONDARY outcome
Timeframe: Baseline and Final Visit (up to Week 52).Population: Values are Summary Statistics.
The change between the value of blood glucose collected at week 52 or final visit and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
Outcome measures
| Measure |
Alogliptin 6.25 mg QD
n=93 Participants
Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 12.5 mg QD
n=97 Participants
Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD
n=95 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 50 mg QD
n=94 Participants
Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
|
Voglibose 0.2 mg TID
n=79 Participants
Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Final Visit).
|
65.0 mg/dL
Standard Deviation 37.48
|
63.8 mg/dL
Standard Deviation 32.46
|
60.4 mg/dL
Standard Deviation 35.09
|
52.6 mg/dL
Standard Deviation 37.07
|
52.6 mg/dL
Standard Deviation 32.38
|
SECONDARY outcome
Timeframe: Baseline and Week 12.Population: Values are Summary Statistics.
The change between the value of blood glucose collected at week 12 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
Outcome measures
| Measure |
Alogliptin 6.25 mg QD
n=93 Participants
Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 12.5 mg QD
n=97 Participants
Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD
n=95 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 50 mg QD
n=94 Participants
Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
|
Voglibose 0.2 mg TID
n=79 Participants
Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 12).
|
-57.0 mg·hr/dL
Standard Deviation 75.68
|
-55.4 mg·hr/dL
Standard Deviation 61.17
|
-67.8 mg·hr/dL
Standard Deviation 55.52
|
-80.5 mg·hr/dL
Standard Deviation 51.95
|
-50.0 mg·hr/dL
Standard Deviation 62.49
|
SECONDARY outcome
Timeframe: Baseline and Week 24.Population: Values are Summary Statistics.
The change between the value of blood glucose collected at week 24 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
Outcome measures
| Measure |
Alogliptin 6.25 mg QD
n=70 Participants
Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 12.5 mg QD
n=68 Participants
Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD
n=74 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 50 mg QD
n=74 Participants
Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
|
Voglibose 0.2 mg TID
n=67 Participants
Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 24).
|
-43.9 mg·hr/dL
Standard Deviation 76.23
|
-52.5 mg·hr/dL
Standard Deviation 74.32
|
-69.8 mg·hr/dL
Standard Deviation 73.23
|
-75.1 mg·hr/dL
Standard Deviation 68.57
|
-62.4 mg·hr/dL
Standard Deviation 62.68
|
SECONDARY outcome
Timeframe: Baseline and Week 52.Population: Values are Summary Statistics.
The change between the value of blood glucose collected at week 52 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
Outcome measures
| Measure |
Alogliptin 6.25 mg QD
n=80 Participants
Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 12.5 mg QD
n=76 Participants
Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD
n=78 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 50 mg QD
n=83 Participants
Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
|
Voglibose 0.2 mg TID
n=61 Participants
Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 52).
|
-59.5 mg·hr/dL
Standard Deviation 50.66
|
-62.0 mg·hr/dL
Standard Deviation 59.52
|
-69.0 mg·hr/dL
Standard Deviation 64.88
|
-88.7 mg·hr/dL
Standard Deviation 73.36
|
-65.4 mg·hr/dL
Standard Deviation 67.93
|
SECONDARY outcome
Timeframe: Baseline and Final Visit (up to Week 52).Population: Values are Summary Statistics.
The change between the value of blood glucose collected at week 52 or final visit and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
Outcome measures
| Measure |
Alogliptin 6.25 mg QD
n=93 Participants
Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 12.5 mg QD
n=97 Participants
Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD
n=95 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 50 mg QD
n=94 Participants
Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
|
Voglibose 0.2 mg TID
n=79 Participants
Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Final Visit).
|
-53.5 mg·hr/dL
Standard Deviation 70.32
|
-55.1 mg·hr/dL
Standard Deviation 76.72
|
-67.6 mg·hr/dL
Standard Deviation 69.49
|
-91.3 mg·hr/dL
Standard Deviation 71.93
|
-56.4 mg·hr/dL
Standard Deviation 73.88
|
SECONDARY outcome
Timeframe: Baseline and Week 12.Population: Values are Summary Statistics.
The change between the value of C-peptide collected at week 12 and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
Outcome measures
| Measure |
Alogliptin 6.25 mg QD
n=93 Participants
Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 12.5 mg QD
n=97 Participants
Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD
n=95 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 50 mg QD
n=94 Participants
Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
|
Voglibose 0.2 mg TID
n=79 Participants
Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 12).
|
0.56 ng·hr/mL
Standard Deviation 1.765
|
0.97 ng·hr/mL
Standard Deviation 1.975
|
0.96 ng·hr/mL
Standard Deviation 2.073
|
0.99 ng·hr/mL
Standard Deviation 1.742
|
-0.39 ng·hr/mL
Standard Deviation 2.091
|
SECONDARY outcome
Timeframe: Baseline and Week 24.Population: Values are Summary Statistics.
The change between the value of C-peptide collected at week 24 and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
Outcome measures
| Measure |
Alogliptin 6.25 mg QD
n=69 Participants
Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 12.5 mg QD
n=68 Participants
Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD
n=72 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 50 mg QD
n=74 Participants
Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
|
Voglibose 0.2 mg TID
n=67 Participants
Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 24).
|
0.93 ng·hr/mL
Standard Deviation 2.068
|
1.35 ng·hr/mL
Standard Deviation 1.928
|
1.14 ng·hr/mL
Standard Deviation 1.743
|
1.38 ng·hr/mL
Standard Deviation 1.934
|
-0.10 ng·hr/mL
Standard Deviation 1.994
|
SECONDARY outcome
Timeframe: Baseline and Week 52.Population: Values are Summary Statistics.
The change between the value of C-peptide collected at week 52 and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
Outcome measures
| Measure |
Alogliptin 6.25 mg QD
n=6 Participants
Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 12.5 mg QD
n=4 Participants
Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD
n=3 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 50 mg QD
n=5 Participants
Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
|
Voglibose 0.2 mg TID
n=3 Participants
Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 52).
|
1.91 ng·hr/mL
Standard Deviation 2.922
|
3.44 ng·hr/mL
Standard Deviation 3.320
|
2.37 ng·hr/mL
Standard Deviation 5.399
|
3.14 ng·hr/mL
Standard Deviation 2.368
|
1.86 ng·hr/mL
Standard Deviation 0.293
|
SECONDARY outcome
Timeframe: Baseline and Final Visit (up to Week 52).Population: Values are Summary Statistics.
The change between the value of C-peptide collected at week 52 or final visit and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
Outcome measures
| Measure |
Alogliptin 6.25 mg QD
n=92 Participants
Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 12.5 mg QD
n=97 Participants
Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD
n=95 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 50 mg QD
n=94 Participants
Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
|
Voglibose 0.2 mg TID
n=79 Participants
Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Final Visit).
|
0.99 ng·hr/mL
Standard Deviation 2.087
|
1.45 ng·hr/mL
Standard Deviation 2.257
|
1.14 ng·hr/mL
Standard Deviation 2.054
|
1.41 ng·hr/mL
Standard Deviation 2.028
|
0.15 ng·hr/mL
Standard Deviation 1.866
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Values are Summary Statistics.
The change between the value of insulin collected at week 12 and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
Outcome measures
| Measure |
Alogliptin 6.25 mg QD
n=86 Participants
Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 12.5 mg QD
n=94 Participants
Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD
n=85 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 50 mg QD
n=90 Participants
Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
|
Voglibose 0.2 mg TID
n=68 Participants
Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 12).
|
0.49 μU·hr/mL
Standard Deviation 18.988
|
2.63 μU·hr/mL
Standard Deviation 15.416
|
4.44 μU·hr/mL
Standard Deviation 13.637
|
-0.03 μU·hr/mL
Standard Deviation 21.572
|
-15.40 μU·hr/mL
Standard Deviation 20.416
|
SECONDARY outcome
Timeframe: Baseline and Week 24.Population: Values are Summary Statistics.
The change between the value of insulin collected at week 24 and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
Outcome measures
| Measure |
Alogliptin 6.25 mg QD
n=61 Participants
Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 12.5 mg QD
n=64 Participants
Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD
n=68 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 50 mg QD
n=71 Participants
Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
|
Voglibose 0.2 mg TID
n=59 Participants
Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 24).
|
-1.89 μU·hr/mL
Standard Deviation 21.943
|
4.50 μU·hr/mL
Standard Deviation 12.876
|
2.85 μU·hr/mL
Standard Deviation 12.309
|
-0.98 μU·hr/mL
Standard Deviation 27.457
|
-16.21 μU·hr/mL
Standard Deviation 20.927
|
SECONDARY outcome
Timeframe: Baseline and Week 52.Population: Values are Summary Statistics.
The change between the value of insulin collected at week 52 and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
Outcome measures
| Measure |
Alogliptin 6.25 mg QD
n=76 Participants
Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 12.5 mg QD
n=70 Participants
Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD
n=75 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 50 mg QD
n=80 Participants
Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
|
Voglibose 0.2 mg TID
n=56 Participants
Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 52).
|
-7.62 μU·hr/mL
Standard Deviation 19.526
|
-1.71 μU·hr/mL
Standard Deviation 15.032
|
-0.44 μU·hr/mL
Standard Deviation 14.871
|
-2.30 μU·hr/mL
Standard Deviation 22.985
|
-15.66 μU·hr/mL
Standard Deviation 20.026
|
SECONDARY outcome
Timeframe: Baseline and Final Visit (up to Week 52).Population: Values are Summary Statistics.
The change between the value of insulin collected at week 52 or final visit and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
Outcome measures
| Measure |
Alogliptin 6.25 mg QD
n=87 Participants
Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 12.5 mg QD
n=91 Participants
Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD
n=91 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 50 mg QD
n=91 Participants
Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
|
Voglibose 0.2 mg TID
n=70 Participants
Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Final Visit).
|
-6.93 μU·hr/mL
Standard Deviation 18.945
|
-1.67 μU·hr/mL
Standard Deviation 15.508
|
0.43 μU·hr/mL
Standard Deviation 14.532
|
-1.56 μU·hr/mL
Standard Deviation 21.843
|
-14.65 μU·hr/mL
Standard Deviation 19.322
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Values are Summary Statistics.
The change between the value of glucagons collected at week 12 and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
Outcome measures
| Measure |
Alogliptin 6.25 mg QD
n=92 Participants
Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 12.5 mg QD
n=96 Participants
Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD
n=95 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 50 mg QD
n=93 Participants
Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
|
Voglibose 0.2 mg TID
n=79 Participants
Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 12).
|
-9.5 pg·hr/mL
Standard Deviation 38.86
|
-4.4 pg·hr/mL
Standard Deviation 36.89
|
-6.6 pg·hr/mL
Standard Deviation 46.85
|
-15.5 pg·hr/mL
Standard Deviation 41.23
|
-16.3 pg·hr/mL
Standard Deviation 52.26
|
SECONDARY outcome
Timeframe: Baseline and Week 24.Population: Values are Summary Statistics.
The change between the value of glucagons collected at week 24 and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
Outcome measures
| Measure |
Alogliptin 6.25 mg QD
n=70 Participants
Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 12.5 mg QD
n=67 Participants
Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD
n=74 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 50 mg QD
n=74 Participants
Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
|
Voglibose 0.2 mg TID
n=67 Participants
Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 24).
|
-1.7 pg·hr/mL
Standard Deviation 37.90
|
3.0 pg·hr/mL
Standard Deviation 41.66
|
0.9 pg·hr/mL
Standard Deviation 50.56
|
-0.8 pg·hr/mL
Standard Deviation 43.71
|
-7.6 pg·hr/mL
Standard Deviation 60.64
|
SECONDARY outcome
Timeframe: Baseline and Week 52.Population: Values are Summary Statistics.
The change between the value of glucagons collected at week 52 and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
Outcome measures
| Measure |
Alogliptin 6.25 mg QD
n=80 Participants
Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 12.5 mg QD
n=75 Participants
Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD
n=78 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 50 mg QD
n=82 Participants
Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
|
Voglibose 0.2 mg TID
n=61 Participants
Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 52).
|
-10.7 pg·hr/mL
Standard Deviation 47.21
|
-11.3 pg·hr/mL
Standard Deviation 45.41
|
-14.5 pg·hr/mL
Standard Deviation 59.39
|
-12.5 pg·hr/mL
Standard Deviation 52.10
|
-13.8 pg·hr/mL
Standard Deviation 61.15
|
SECONDARY outcome
Timeframe: Baseline and Final Visit (up to Week 52).Population: Values are Summary Statistics.
The change between the value of glucagons collected at week 52 or final visit and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
Outcome measures
| Measure |
Alogliptin 6.25 mg QD
n=93 Participants
Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 12.5 mg QD
n=96 Participants
Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD
n=95 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 50 mg QD
n=93 Participants
Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
|
Voglibose 0.2 mg TID
n=79 Participants
Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Final Visit).
|
-9.8 pg·hr/mL
Standard Deviation 45.93
|
-9.0 pg·hr/mL
Standard Deviation 48.99
|
-10.3 pg·hr/mL
Standard Deviation 61.18
|
-14.6 pg·hr/mL
Standard Deviation 51.22
|
-13.9 pg·hr/mL
Standard Deviation 58.84
|
Adverse Events
Alogliptin 6.25 mg QD
Serious events: 2 serious events
Other events: 78 other events
Deaths: 0 deaths
Alogliptin 12.5 mg QD
Serious events: 8 serious events
Other events: 81 other events
Deaths: 0 deaths
Alogliptin 25 mg QD
Serious events: 8 serious events
Other events: 81 other events
Deaths: 0 deaths
Alogliptin 50 mg QD
Serious events: 5 serious events
Other events: 88 other events
Deaths: 0 deaths
Voglibose 0.2 mg TID
Serious events: 4 serious events
Other events: 74 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Alogliptin 6.25 mg QD
n=96 participants at risk
Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 12.5 mg QD
n=101 participants at risk
Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD
n=97 participants at risk
Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 50 mg QD
n=97 participants at risk
Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
|
Voglibose 0.2 mg TID
n=83 participants at risk
Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|---|---|---|
|
Infections and infestations
Pneumonia
|
0.00%
0/96 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/101 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.0%
1/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.4%
2/83 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/96 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/101 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.2%
1/83 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/96 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/101 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.0%
1/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/83 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/96 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/101 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.0%
1/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/83 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/96 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.99%
1/101 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/83 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/96 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.99%
1/101 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/83 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
1.0%
1/96 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/101 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/83 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/96 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/101 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.0%
1/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/83 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.00%
0/96 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/101 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.0%
1/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/83 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer metastatic
|
0.00%
0/96 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.99%
1/101 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/83 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer female
|
0.00%
0/96 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/101 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.2%
1/83 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large intestine carcinoma
|
0.00%
0/96 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/101 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.0%
1/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/83 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/96 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.99%
1/101 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/83 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/96 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.99%
1/101 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/83 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Cerebral infarction
|
1.0%
1/96 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/101 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.0%
1/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.0%
1/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/83 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/96 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/101 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.0%
1/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/83 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/96 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/101 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.0%
1/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/83 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Hypertension
|
0.00%
0/96 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/101 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.0%
1/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/83 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/96 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/101 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.0%
1/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/83 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/96 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.99%
1/101 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/83 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/96 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.99%
1/101 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/83 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/96 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/101 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.0%
1/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/83 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/96 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.99%
1/101 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/83 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Accident
|
0.00%
0/96 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/101 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.2%
1/83 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Other adverse events
| Measure |
Alogliptin 6.25 mg QD
n=96 participants at risk
Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 12.5 mg QD
n=101 participants at risk
Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD
n=97 participants at risk
Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 50 mg QD
n=97 participants at risk
Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
|
Voglibose 0.2 mg TID
n=83 participants at risk
Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
30.2%
29/96 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
28.7%
29/101 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.0%
32/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
35.1%
34/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.3%
21/83 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Bronchitis
|
4.2%
4/96 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.9%
6/101 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.0%
1/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
4.1%
4/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.2%
1/83 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Gastroenteritis
|
2.1%
2/96 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.0%
2/101 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
4.1%
4/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.1%
3/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.6%
3/83 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/96 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.0%
2/101 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.1%
2/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.1%
2/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.6%
3/83 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Tinea pedis
|
2.1%
2/96 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.99%
1/101 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.1%
2/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.6%
3/83 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Cystitis
|
2.1%
2/96 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/101 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.1%
3/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.4%
2/83 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Rhinitis
|
2.1%
2/96 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/101 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.1%
3/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.1%
2/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/83 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Immune system disorders
Seasonal allergy
|
7.3%
7/96 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
5/101 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.1%
3/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.0%
1/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.4%
2/83 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
2.1%
2/96 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/101 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.0%
1/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.0%
1/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.0%
5/83 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.0%
1/96 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.99%
1/101 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.0%
1/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.1%
3/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.2%
1/83 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Headache
|
6.2%
6/96 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/101 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.2%
7/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.1%
3/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.2%
1/83 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Dizziness
|
3.1%
3/96 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.99%
1/101 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.1%
2/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.2%
5/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.2%
1/83 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Hypoaesthesia
|
5.2%
5/96 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.99%
1/101 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.0%
1/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.0%
1/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
4.8%
4/83 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/96 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/101 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.1%
3/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.0%
1/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/83 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Eye disorders
Cataract
|
5.2%
5/96 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.0%
2/101 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.1%
2/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.1%
2/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.4%
2/83 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Eye disorders
Diabetic retinopathy
|
3.1%
3/96 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.0%
2/101 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.0%
1/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.1%
2/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.2%
1/83 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Eye disorders
Conjunctivitis allergic
|
3.1%
3/96 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/101 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.1%
2/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.4%
2/83 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/96 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/101 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.0%
1/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.6%
3/83 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Hypertension
|
0.00%
0/96 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.0%
2/101 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.1%
3/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.0%
1/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.4%
2/83 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
8.3%
8/96 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
5/101 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.2%
7/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.2%
7/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.6%
8/83 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
2.1%
2/96 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.99%
1/101 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.1%
3/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
4.1%
4/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.2%
1/83 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
2.1%
2/96 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/101 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.1%
3/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.0%
1/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/83 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Constipation
|
3.1%
3/96 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.0%
3/101 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
4.1%
4/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
6/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.6%
8/83 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Dental caries
|
4.2%
4/96 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
4.0%
4/101 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.1%
2/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
6/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.0%
5/83 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Flatulence
|
2.1%
2/96 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
4.0%
4/101 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.0%
1/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.1%
2/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.6%
8/83 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
2.1%
2/96 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.0%
2/101 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
4.1%
4/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.1%
2/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.2%
6/83 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.1%
3/96 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.0%
2/101 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.1%
3/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.2%
5/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.4%
2/83 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Gastritis
|
2.1%
2/96 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.0%
3/101 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.0%
1/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
4.1%
4/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.6%
3/83 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.1%
2/96 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.99%
1/101 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.1%
2/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.1%
3/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
4.8%
4/83 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Periodontal disease
|
2.1%
2/96 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.0%
2/101 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.0%
1/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.1%
3/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.2%
1/83 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Hepatobiliary disorders
Gallbladder polyp
|
1.0%
1/96 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/101 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.1%
2/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.6%
3/83 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
1.0%
1/96 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.99%
1/101 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.1%
2/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.2%
5/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
4.8%
4/83 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
1.0%
1/96 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.99%
1/101 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.1%
2/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.0%
1/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
4.8%
4/83 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/96 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.0%
2/101 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.1%
3/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.1%
2/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/83 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/96 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
5/101 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.0%
1/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/83 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.3%
7/96 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
5/101 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
4.1%
4/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.2%
7/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
4.8%
4/83 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.1%
3/96 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
4.0%
4/101 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.1%
2/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
6/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.6%
3/83 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.0%
1/96 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.0%
3/101 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.0%
1/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.0%
1/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.4%
2/83 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
3.1%
3/96 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.99%
1/101 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.1%
3/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.0%
1/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/83 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/96 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/101 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.1%
3/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.1%
2/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.6%
3/83 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/96 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.99%
1/101 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
4.1%
4/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.1%
2/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.2%
1/83 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/96 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.0%
3/101 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.1%
2/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.4%
2/83 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
4.2%
4/96 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/101 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.1%
2/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.2%
1/83 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
1.0%
1/96 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/101 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.1%
3/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.1%
3/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/83 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
3.1%
3/96 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.99%
1/101 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.0%
1/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/83 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Malaise
|
0.00%
0/96 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.99%
1/101 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
4.1%
4/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.2%
1/83 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood creatine phosphokinase increased
|
2.1%
2/96 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
4.0%
4/101 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.1%
3/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
8.2%
8/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.2%
6/83 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/96 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
4.0%
4/101 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.1%
3/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.1%
3/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.4%
2/83 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.0%
1/96 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
4.0%
4/101 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
4.1%
4/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.4%
2/83 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/96 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.0%
2/101 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.0%
1/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.1%
3/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.4%
2/83 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
3.1%
3/96 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.0%
3/101 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.0%
1/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.1%
2/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.4%
2/83 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/96 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.0%
2/101 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
4.1%
4/97 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.6%
3/83 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Additional Information
General Manager
Japan Development Center, Pharmaceutical Development Division
Phone: +81-6-6204-5257
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The clinical trial contract states that information should never be disclosed without prior consent of the sponsor, although it does not specify the number of days during which disclosure of information is limited.
- Publication restrictions are in place
Restriction type: OTHER