Trial Outcomes & Findings for Long-term Safety Study of Alogliptin Used in Combination With Sulfonylurea or Metformin in Participants With Type 2 Diabetes in Japan (NCT NCT01318135)
NCT ID: NCT01318135
Last Updated: 2012-08-16
Results Overview
Treatment-emergent adverse events (TEAE) are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug. A TEAE may also be a pretreatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug that increases in severity after the start of dosing.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
576 participants
Primary outcome timeframe
52 Weeks.
Results posted on
2012-08-16
Participant Flow
Participants enrolled at 58 investigative sites in Japan from 06 January 2009 to 23 January 2010.
Participants who had completed a core phase 2/3 glimepiride (SYR-322/CCT-005; NCT01318083) or metformin (SYR-322/CCT-006; NCT01318109) add-on study were enrolled in one of four, once daily (QD) or twice-daily (BID) treatment groups. Five participants completed OCT-005 study without receiving the study drug.
Participant milestones
| Measure |
CCT/005 - 12.5 mg Dose Group* → 12.5 mg Combination Group
Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
\*for participants from the 12.5 mg combination dosing ARM of the SYR-322/CCT-005 (NCT01318083) core phase 2/3 glimepiride add-on study.
|
CCT/005 - 25 mg Dose Group* → 25 mg Combination Dose Group
Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
\*for participants from the 25 mg combination dosing ARM of the SYR-322/CCT-005 (NCT01318083) core phase 2/3 glimepiride add-on study.
|
Glimepiride Monotherapy Group* → 12.5 mg Combination Group
Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
\*for participants from the glimepiride 1, 2, 3 or 4 mg dosing ARM of the SYR-322/CCT-005 (NCT01318083) core phase 2/3 glimepiride add-on study.
|
Glimepiride Monotherapy Group* → 25 mg Combination Group
Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
\*for participants from the glimepiride 1, 2, 3 or 4 mg dosing ARM of the SYR-322/CCT-005 (NCT01318083) core phase 2/3 glimepiride add-on study.
|
CCT/006 - 12.5 mg Dose Group* → 12.5 mg Combination Group
Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
\*for participants from the 12.5 mg combination dosing ARM of the SYR-322/CCT-006 (NCT01318109) core phase 2/3 metformin add-on study.
|
CCT/006 - 25 mg Dose Group* → 25 mg Combination Group
Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
\*for participants from the 25 mg combination dosing ARM of the SYR-322/CCT-006 (NCT01318109) core phase 2/3 metformin add-on study.
|
Metformin Monotherapy Group* → 12.5 mg Combination Group
Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
\*for participants from the metformin 500 mg or 750 mg dosing ARM of the SYR-322/CCT-006 (NCT01318109) core phase 2/3 metformin add-on study.
|
Metformin Monotherapy Group* → 25 mg Combination Group
Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
\*for participants from the metformin 500 mg or 750 mg dosing ARM of the SYR-322/CCT-006 (NCT01318109) core phase 2/3 metformin add-on study.
|
|---|---|---|---|---|---|---|---|---|
|
Enrolled - Long-Term Extension Study
STARTED
|
99
|
102
|
46
|
49
|
91
|
90
|
50
|
49
|
|
Enrolled - Long-Term Extension Study
COMPLETED
|
97
|
102
|
46
|
49
|
91
|
90
|
50
|
49
|
|
Enrolled - Long-Term Extension Study
NOT COMPLETED
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Entered - Long-Term Extension Study
STARTED
|
97
|
102
|
46
|
49
|
90
|
87
|
50
|
49
|
|
Entered - Long-Term Extension Study
COMPLETED
|
80
|
89
|
38
|
42
|
81
|
83
|
49
|
46
|
|
Entered - Long-Term Extension Study
NOT COMPLETED
|
17
|
13
|
8
|
7
|
9
|
4
|
1
|
3
|
Reasons for withdrawal
| Measure |
CCT/005 - 12.5 mg Dose Group* → 12.5 mg Combination Group
Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
\*for participants from the 12.5 mg combination dosing ARM of the SYR-322/CCT-005 (NCT01318083) core phase 2/3 glimepiride add-on study.
|
CCT/005 - 25 mg Dose Group* → 25 mg Combination Dose Group
Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
\*for participants from the 25 mg combination dosing ARM of the SYR-322/CCT-005 (NCT01318083) core phase 2/3 glimepiride add-on study.
|
Glimepiride Monotherapy Group* → 12.5 mg Combination Group
Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
\*for participants from the glimepiride 1, 2, 3 or 4 mg dosing ARM of the SYR-322/CCT-005 (NCT01318083) core phase 2/3 glimepiride add-on study.
|
Glimepiride Monotherapy Group* → 25 mg Combination Group
Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
\*for participants from the glimepiride 1, 2, 3 or 4 mg dosing ARM of the SYR-322/CCT-005 (NCT01318083) core phase 2/3 glimepiride add-on study.
|
CCT/006 - 12.5 mg Dose Group* → 12.5 mg Combination Group
Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
\*for participants from the 12.5 mg combination dosing ARM of the SYR-322/CCT-006 (NCT01318109) core phase 2/3 metformin add-on study.
|
CCT/006 - 25 mg Dose Group* → 25 mg Combination Group
Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
\*for participants from the 25 mg combination dosing ARM of the SYR-322/CCT-006 (NCT01318109) core phase 2/3 metformin add-on study.
|
Metformin Monotherapy Group* → 12.5 mg Combination Group
Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
\*for participants from the metformin 500 mg or 750 mg dosing ARM of the SYR-322/CCT-006 (NCT01318109) core phase 2/3 metformin add-on study.
|
Metformin Monotherapy Group* → 25 mg Combination Group
Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
\*for participants from the metformin 500 mg or 750 mg dosing ARM of the SYR-322/CCT-006 (NCT01318109) core phase 2/3 metformin add-on study.
|
|---|---|---|---|---|---|---|---|---|
|
Enrolled - Long-Term Extension Study
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Enrolled - Long-Term Extension Study
Treatment Complications
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Entered - Long-Term Extension Study
Adverse Event
|
9
|
3
|
4
|
3
|
4
|
2
|
0
|
0
|
|
Entered - Long-Term Extension Study
Protocol Violation
|
1
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Entered - Long-Term Extension Study
Withdrawal by Subject
|
2
|
2
|
2
|
1
|
2
|
0
|
0
|
1
|
|
Entered - Long-Term Extension Study
Lack of Efficacy
|
5
|
7
|
2
|
3
|
2
|
2
|
1
|
1
|
|
Entered - Long-Term Extension Study
Use of Excluded Medications
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Long-term Safety Study of Alogliptin Used in Combination With Sulfonylurea or Metformin in Participants With Type 2 Diabetes in Japan
Baseline characteristics by cohort
| Measure |
Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID
n=150 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
|
Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID
n=152 Participants
Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
|
Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID
n=142 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
|
Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID
n=145 Participants
Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
|
Total
n=589 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
≤ 64 years
|
93 participants
9.50 • n=5 Participants
|
105 participants
8.92 • n=7 Participants
|
142 participants
8.12 • n=5 Participants
|
145 participants
8.41 • n=4 Participants
|
485 participants
n=21 Participants
|
|
Age, Customized
≥ 65 years
|
57 participants
n=5 Participants
|
47 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
104 participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
195 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
97 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
101 Participants
n=4 Participants
|
394 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 52 Weeks.Population: Full Analysis Set was defined as the population of participants randomized in the core phase 2/3 SYR-322/CCT-005 (NCT01318083) or SYR-322/CCT-006 (NCT01318109) add-on studies and received at least 1 dose of the investigational products (SYR-322DB in combination with glimepiride or metformin) for the treatment period were identified for analysis.
Treatment-emergent adverse events (TEAE) are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug. A TEAE may also be a pretreatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug that increases in severity after the start of dosing.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID
n=150 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
|
Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID
n=152 Participants
Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
|
Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID
n=142 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
|
Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID
n=145 Participants
Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events.
Serious Adverse Event
|
16 participants
|
3 participants
|
7 participants
|
5 participants
|
|
Number of Participants With Adverse Events.
Other Adverse Event (≥3% Frequency Threshold)
|
116 participants
|
134 participants
|
108 participants
|
113 participants
|
SECONDARY outcome
Timeframe: Baseline and Week 8.Population: Values are from the Full Analysis Set.
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 8 and glycosylated hemoglobin collected at baseline.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID
n=147 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
|
Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID
n=150 Participants
Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
|
Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID
n=141 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
|
Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID
n=143 Participants
Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (Week 8).
|
-0.53 percentage of Glycosylated Hemoglobin
Standard Deviation 0.506
|
-0.65 percentage of Glycosylated Hemoglobin
Standard Deviation 0.515
|
-0.53 percentage of Glycosylated Hemoglobin
Standard Deviation 0.486
|
-0.59 percentage of Glycosylated Hemoglobin
Standard Deviation 0.394
|
SECONDARY outcome
Timeframe: Baseline and Week 12.Population: Values are from the Full Analysis Set.
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 12.5 mg QD and Glimepiride 1- 6 mg QD or BID
n=145 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
|
Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID
n=148 Participants
Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
|
Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID
n=140 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
|
Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID
n=142 Participants
Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (Week 12).
|
-0.63 percentage of Glycosylated Hemoglobin
Standard Deviation 0.626
|
-0.72 percentage of Glycosylated Hemoglobin
Standard Deviation 0.589
|
-0.61 percentage of Glycosylated Hemoglobin
Standard Deviation 0.576
|
-0.71 percentage of Glycosylated Hemoglobin
Standard Deviation 0.489
|
SECONDARY outcome
Timeframe: Baseline and Week 16.Population: Values are from the Full Analysis Set.
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 12.5 mg QD and Glimepiride 1- 6 mg QD or BID
n=141 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
|
Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID
n=147 Participants
Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
|
Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID
n=138 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
|
Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID
n=135 Participants
Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (Week 16).
|
-0.66 percentage of Glycosylated Hemoglobin
Standard Deviation 0.685
|
-0.76 percentage of Glycosylated Hemoglobin
Standard Deviation 0.660
|
-0.69 percentage of Glycosylated Hemoglobin
Standard Deviation 0.614
|
-0.78 percentage of Glycosylated Hemoglobin
Standard Deviation 0.495
|
SECONDARY outcome
Timeframe: Baseline and Week 20.Population: Values are from the Full Analysis Set.
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 12.5 mg QD and Glimepiride 1- 6 mg QD or BID
n=139 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
|
Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID
n=146 Participants
Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
|
Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID
n=136 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
|
Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID
n=134 Participants
Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (Week 20).
|
-0.63 percentage of Glycosylated Hemoglobin
Standard Deviation 0.754
|
-0.70 percentage of Glycosylated Hemoglobin
Standard Deviation 0.689
|
-0.67 percentage of Glycosylated Hemoglobin
Standard Deviation 0.648
|
-0.78 percentage of Glycosylated Hemoglobin
Standard Deviation 0.553
|
SECONDARY outcome
Timeframe: Baseline and Week 24.Population: Values are from the Full Analysis Set.
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 12.5 mg QD and Glimepiride 1- 6 mg QD or BID
n=137 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
|
Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID
n=145 Participants
Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
|
Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID
n=135 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
|
Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID
n=134 Participants
Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (Week 24).
|
-0.59 percentage of Glycosylated Hemoglobin
Standard Deviation 0.823
|
-0.70 percentage of Glycosylated Hemoglobin
Standard Deviation 0.740
|
-0.68 percentage of Glycosylated Hemoglobin
Standard Deviation 0.668
|
-0.78 percentage of Glycosylated Hemoglobin
Standard Deviation 0.623
|
SECONDARY outcome
Timeframe: Baseline and Week 28.Population: Values are from the Full Analysis Set.
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 12.5 mg QD and Glimepiride 1- 6 mg QD or BID
n=132 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
|
Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID
n=144 Participants
Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
|
Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID
n=135 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
|
Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID
n=132 Participants
Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (Week 28).
|
-0.62 percentage of Glycosylated Hemoglobin
Standard Deviation 0.841
|
-0.76 percentage of Glycosylated Hemoglobin
Standard Deviation 0.721
|
-0.70 percentage of Glycosylated Hemoglobin
Standard Deviation 0.659
|
-0.84 percentage of Glycosylated Hemoglobin
Standard Deviation 0.596
|
SECONDARY outcome
Timeframe: Baseline and Week 32.Population: Values are from the Full Analysis Set.
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 12.5 mg QD and Glimepiride 1- 6 mg QD or BID
n=132 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
|
Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID
n=140 Participants
Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
|
Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID
n=135 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
|
Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID
n=129 Participants
Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (Week 32).
|
-0.63 percentage of Glycosylated Hemoglobin
Standard Deviation 0.868
|
-0.77 percentage of Glycosylated Hemoglobin
Standard Deviation 0.736
|
-0.67 percentage of Glycosylated Hemoglobin
Standard Deviation 0.644
|
-0.81 percentage of Glycosylated Hemoglobin
Standard Deviation 0.634
|
SECONDARY outcome
Timeframe: Baseline and Week 36.Population: Values are from the Full Analysis Set.
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 12.5 mg QD and Glimepiride 1- 6 mg QD or BID
n=128 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
|
Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID
n=137 Participants
Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
|
Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID
n=134 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
|
Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID
n=129 Participants
Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (Week 36).
|
-0.64 percentage of Glycosylated Hemoglobin
Standard Deviation 0.881
|
-0.77 percentage of Glycosylated Hemoglobin
Standard Deviation 0.745
|
-0.67 percentage of Glycosylated Hemoglobin
Standard Deviation 0.659
|
-0.79 percentage of Glycosylated Hemoglobin
Standard Deviation 0.653
|
SECONDARY outcome
Timeframe: Baseline and Week 40.Population: Values are from the Full Analysis Set.
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 12.5 mg QD and Glimepiride 1- 6 mg QD or BID
n=124 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
|
Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID
n=135 Participants
Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
|
Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID
n=132 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
|
Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID
n=129 Participants
Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (Week 40).
|
-0.66 percentage of Glycosylated Hemoglobin
Standard Deviation 0.799
|
-0.74 percentage of Glycosylated Hemoglobin
Standard Deviation 0.779
|
-0.63 percentage of Glycosylated Hemoglobin
Standard Deviation 0.676
|
-0.74 percentage of Glycosylated Hemoglobin
Standard Deviation 0.698
|
SECONDARY outcome
Timeframe: Baseline and Week 44.Population: Values are from the Full Analysis Set.
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 12.5 mg QD and Glimepiride 1- 6 mg QD or BID
n=84 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
|
Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID
n=90 Participants
Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
|
Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID
n=81 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
|
Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID
n=83 Participants
Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (Week 44).
|
-0.48 percentage of Glycosylated Hemoglobin
Standard Deviation 0.726
|
-0.71 percentage of Glycosylated Hemoglobin
Standard Deviation 0.666
|
-0.47 percentage of Glycosylated Hemoglobin
Standard Deviation 0.787
|
-0.70 percentage of Glycosylated Hemoglobin
Standard Deviation 0.688
|
SECONDARY outcome
Timeframe: Baseline and Week 48.Population: Values are from the Full Analysis Set.
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 12.5 mg QD and Glimepiride 1- 6 mg QD or BID
n=82 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
|
Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID
n=90 Participants
Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
|
Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID
n=81 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
|
Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID
n=83 Participants
Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (Week 48).
|
-0.40 percentage of Glycosylated Hemoglobin
Standard Deviation 0.706
|
-0.61 percentage of Glycosylated Hemoglobin
Standard Deviation 0.660
|
-0.36 percentage of Glycosylated Hemoglobin
Standard Deviation 0.762
|
-0.62 percentage of Glycosylated Hemoglobin
Standard Deviation 0.707
|
SECONDARY outcome
Timeframe: Baseline and Week 52.Population: Values are from the Full Analysis Set.
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 12.5 mg QD and Glimepiride 1- 6 mg QD or BID
n=80 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
|
Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID
n=89 Participants
Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
|
Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID
n=81 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
|
Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID
n=83 Participants
Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (Week 52).
|
-0.33 percentage of Glycosylated Hemoglobin
Standard Deviation 0.652
|
-0.53 percentage of Glycosylated Hemoglobin
Standard Deviation 0.643
|
-0.29 percentage of Glycosylated Hemoglobin
Standard Deviation 0.744
|
-0.53 percentage of Glycosylated Hemoglobin
Standard Deviation 0.790
|
SECONDARY outcome
Timeframe: Baseline and Final Visit (up to 52).Population: Values are from the Full Analysis Set.
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 final visit and glycosylated hemoglobin collected at baseline.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID
n=149 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
|
Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID
n=152 Participants
Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
|
Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID
n=142 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
|
Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID
n=145 Participants
Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (Final Visit).
|
-0.42 percentage of Glycosylated Hemoglobin
Standard Deviation 0.838
|
-0.58 percentage of Glycosylated Hemoglobin
Standard Deviation 0.791
|
-0.44 percentage of Glycosylated Hemoglobin
Standard Deviation 0.720
|
-0.58 percentage of Glycosylated Hemoglobin
Standard Deviation 0.781
|
SECONDARY outcome
Timeframe: Baseline and Week 8.Population: Values are from the Full Analysis Set.
The change between the value of fasting blood glucose collected at week 8 and baseline.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID
n=147 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
|
Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID
n=150 Participants
Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
|
Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID
n=141 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
|
Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID
n=143 Participants
Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Fasting Blood Glucose (Week 8).
|
-20.7 mg/dL
Standard Deviation 26.50
|
-19.6 mg/dL
Standard Deviation 30.53
|
-22.0 mg/dL
Standard Deviation 22.76
|
-23.4 mg/dL
Standard Deviation 26.75
|
SECONDARY outcome
Timeframe: Baseline and Week 12.Population: Values are from the Full Analysis Set.
The change between the value of fasting blood glucose collected at week 12 and baseline.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID
n=145 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
|
Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID
n=148 Participants
Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
|
Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID
n=140 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
|
Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID
n=142 Participants
Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Fasting Blood Glucose (Week 12).
|
-22.0 mg/dL
Standard Deviation 32.19
|
-18.1 mg/dL
Standard Deviation 29.05
|
-22.9 mg/dL
Standard Deviation 24.04
|
-24.2 mg/dL
Standard Deviation 27.30
|
SECONDARY outcome
Timeframe: Baseline and Week 16.Population: Values are from the Full Analysis Set.
The change between the value of fasting blood glucose collected at week 6 and baseline.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID
n=141 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
|
Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID
n=147 Participants
Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
|
Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID
n=138 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
|
Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID
n=135 Participants
Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Fasting Blood Glucose (Week 16).
|
-22.3 mg/dL
Standard Deviation 34.37
|
-17.8 mg/dL
Standard Deviation 32.22
|
-21.8 mg/dL
Standard Deviation 26.86
|
-26.1 mg/dL
Standard Deviation 26.93
|
SECONDARY outcome
Timeframe: Baseline and Week 20.Population: Values are from the Full Analysis Set.
The change between the value of fasting blood glucose collected at week 20 and baseline.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID
n=139 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
|
Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID
n=146 Participants
Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
|
Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID
n=136 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
|
Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID
n=134 Participants
Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Fasting Blood Glucose (Week 20).
|
-22.4 mg/dL
Standard Deviation 31.75
|
-22.3 mg/dL
Standard Deviation 30.93
|
-23.4 mg/dL
Standard Deviation 27.88
|
-26.1 mg/dL
Standard Deviation 26.19
|
SECONDARY outcome
Timeframe: Baseline and Week 24.Population: Values are from the Full Analysis Set.
The change between the value of fasting blood glucose collected at week 24 and baseline.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID
n=137 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
|
Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID
n=145 Participants
Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
|
Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID
n=135 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
|
Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID
n=133 Participants
Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Fasting Blood Glucose (Week 24).
|
-24.0 mg/dL
Standard Deviation 31.69
|
-25.0 mg/dL
Standard Deviation 32.68
|
-25.6 mg/dL
Standard Deviation 24.22
|
-26.3 mg/dL
Standard Deviation 28.09
|
SECONDARY outcome
Timeframe: Baseline and Week 28.Population: Values are from the Full Analysis Set.
The change between the value of fasting blood glucose collected at week 28 and baseline.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID
n=132 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
|
Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID
n=144 Participants
Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
|
Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID
n=135 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
|
Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID
n=131 Participants
Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Fasting Blood Glucose (Week 28).
|
-19.9 mg/dL
Standard Deviation 36.87
|
-25.9 mg/dL
Standard Deviation 33.67
|
-25.8 mg/dL
Standard Deviation 26.16
|
-28.2 mg/dL
Standard Deviation 29.49
|
SECONDARY outcome
Timeframe: Baseline and Week 32.Population: Values are from the Full Analysis Set.
The change between the value of fasting blood glucose collected at week 32 and baseline.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID
n=132 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
|
Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID
n=139 Participants
Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
|
Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID
n=135 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
|
Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID
n=129 Participants
Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Fasting Blood Glucose (Week 32).
|
-22.4 mg/dL
Standard Deviation 37.47
|
-26.1 mg/dL
Standard Deviation 30.69
|
-23.2 mg/dL
Standard Deviation 25.71
|
-28.2 mg/dL
Standard Deviation 29.31
|
SECONDARY outcome
Timeframe: Baseline and Week 36.Population: Values are from the Full Analysis Set.
The change between the value of fasting blood glucose collected at week 36 and baseline.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID
n=128 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
|
Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID
n=136 Participants
Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
|
Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID
n=134 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
|
Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID
n=129 Participants
Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Fasting Blood Glucose (Week 36).
|
-25.5 mg/dL
Standard Deviation 34.16
|
-26.7 mg/dL
Standard Deviation 33.12
|
-23.4 mg/dL
Standard Deviation 24.00
|
-26.0 mg/dL
Standard Deviation 31.26
|
SECONDARY outcome
Timeframe: Baseline and Week 40.Population: Values are from the Full Analysis Set.
The change between the value of fasting blood glucose collected at week 40 and baseline.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID
n=124 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
|
Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID
n=135 Participants
Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
|
Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID
n=132 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
|
Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID
n=129 Participants
Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Fasting Blood Glucose (Week 40).
|
-21.3 mg/dL
Standard Deviation 33.44
|
-22.7 mg/dL
Standard Deviation 30.19
|
-19.8 mg/dL
Standard Deviation 24.81
|
-23.2 mg/dL
Standard Deviation 31.13
|
SECONDARY outcome
Timeframe: Baseline and Week 44.Population: Values are from the Full Analysis Set.
The change between the value of fasting blood glucose collected at week 44 and baseline.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID
n=83 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
|
Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID
n=90 Participants
Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
|
Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID
n=81 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
|
Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID
n=83 Participants
Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Fasting Blood Glucose (Week 44).
|
-15.4 mg/dL
Standard Deviation 31.69
|
-21.9 mg/dL
Standard Deviation 29.33
|
-16.3 mg/dL
Standard Deviation 26.22
|
-24.0 mg/dL
Standard Deviation 31.49
|
SECONDARY outcome
Timeframe: Baseline and Week 48.Population: Values are from the Full Analysis Set.
The change between the value of fasting blood glucose collected at week 48 and baseline.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID
n=82 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
|
Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID
n=90 Participants
Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
|
Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID
n=81 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
|
Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID
n=83 Participants
Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Fasting Blood Glucose (Week 48).
|
-13.6 mg/dL
Standard Deviation 28.29
|
-16.6 mg/dL
Standard Deviation 30.68
|
-14.3 mg/dL
Standard Deviation 24.22
|
-23.3 mg/dL
Standard Deviation 29.73
|
SECONDARY outcome
Timeframe: Baseline and Week 52.Population: Values are from the Full Analysis Set.
The change between the value of fasting blood glucose collected at week 52 and baseline.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID
n=80 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
|
Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID
n=89 Participants
Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
|
Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID
n=81 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
|
Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID
n=83 Participants
Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Fasting Blood Glucose (Week 52).
|
-13.3 mg/dL
Standard Deviation 31.74
|
-11.9 mg/dL
Standard Deviation 30.11
|
-14.0 mg/dL
Standard Deviation 26.92
|
-16.1 mg/dL
Standard Deviation 29.60
|
SECONDARY outcome
Timeframe: Baseline and Final Visit (up to Week 52).Population: Values are from the Full Analysis Set.
The change between the value of fasting blood glucose collected at final visit and baseline.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID
n=149 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
|
Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID
n=152 Participants
Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
|
Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID
n=141 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
|
Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID
n=145 Participants
Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Fasting Blood Glucose (Final Visit).
|
-16.0 mg/dL
Standard Deviation 33.73
|
-13.0 mg/dL
Standard Deviation 34.68
|
-16.4 mg/dL
Standard Deviation 25.81
|
-17.7 mg/dL
Standard Deviation 29.54
|
SECONDARY outcome
Timeframe: Baseline and Week 12.Population: Values are from the Full Analysis Set.
The change between the value of blood glucose measured by the meal tolerance test collected at week 12 and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID
n=146 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
|
Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID
n=149 Participants
Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
|
Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID
n=141 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
|
Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID
n=143 Participants
Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 12).
|
80.2 mg/dL
Standard Deviation 43.24
|
80.1 mg/dL
Standard Deviation 47.77
|
61.6 mg/dL
Standard Deviation 38.72
|
64.0 mg/dL
Standard Deviation 34.39
|
SECONDARY outcome
Timeframe: Baseline and Week 24.Population: Values are from the Full Analysis Set.
The change between the value of blood glucose measured by the meal tolerance test collected at week 24 and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID
n=97 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
|
Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID
n=101 Participants
Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
|
Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID
n=85 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
|
Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID
n=84 Participants
Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 24).
|
87.4 mg/dL
Standard Deviation 38.74
|
77.9 mg/dL
Standard Deviation 42.68
|
60.7 mg/dL
Standard Deviation 34.96
|
62.4 mg/dL
Standard Deviation 32.23
|
SECONDARY outcome
Timeframe: Baseline and Week 52.Population: Values are from the Full Analysis Set.
The change between the value of blood glucose measured by the meal tolerance test collected at week 52 and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID
n=120 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
|
Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID
n=135 Participants
Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
|
Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID
n=130 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
|
Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID
n=129 Participants
Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 52).
|
83.8 mg/dL
Standard Deviation 46.24
|
83.2 mg/dL
Standard Deviation 43.61
|
62.5 mg/dL
Standard Deviation 42.91
|
62.7 mg/dL
Standard Deviation 32.81
|
SECONDARY outcome
Timeframe: Baseline and Final Visit (up to Week 52).Population: Values are from the Full Analysis Set.
The change between the value of blood glucose measured by the meal tolerance test collected at final visit and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID
n=146 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
|
Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID
n=149 Participants
Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
|
Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID
n=141 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
|
Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID
n=143 Participants
Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Final Visit).
|
84.8 mg/dL
Standard Deviation 45.47
|
84.9 mg/dL
Standard Deviation 44.35
|
63.5 mg/dL
Standard Deviation 43.06
|
63.7 mg/dL
Standard Deviation 32.32
|
Adverse Events
Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID
Serious events: 16 serious events
Other events: 116 other events
Deaths: 0 deaths
Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID
Serious events: 3 serious events
Other events: 134 other events
Deaths: 0 deaths
Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID
Serious events: 7 serious events
Other events: 108 other events
Deaths: 0 deaths
Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID
Serious events: 5 serious events
Other events: 113 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID
n=150 participants at risk
Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
|
Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID
n=152 participants at risk
Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
|
Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID
n=142 participants at risk
Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
|
Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID
n=145 participants at risk
Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
|
|---|---|---|---|---|
|
Nervous system disorders
Cerebral infarction
|
0.67%
1/150 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/152 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/142 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/145 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.67%
1/150 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/152 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
1.4%
2/142 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/145 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
|
Cardiac disorders
Angina pectoris
|
0.67%
1/150 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.66%
1/152 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/142 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/145 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.67%
1/150 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
—
0/0 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/142 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.69%
1/145 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/150 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/152 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/142 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.69%
1/145 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
|
Infections and infestations
Cellulitis
|
0.67%
1/150 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/152 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/142 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/145 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
|
Nervous system disorders
Cerebral circulatory failure
|
0.00%
0/150 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/152 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/142 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.69%
1/145 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
|
Nervous system disorders
Embolic stroke
|
0.67%
1/150 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/152 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/142 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/145 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
|
Infections and infestations
Enteritis infectious
|
0.00%
0/150 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/152 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.70%
1/142 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/145 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
|
Injury, poisoning and procedural complications
Fall
|
0.67%
1/150 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/152 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.70%
1/142 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/145 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
|
Infections and infestations
Gas gangrene
|
0.67%
1/150 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/152 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/142 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/145 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
1.3%
2/150 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/152 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/142 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/145 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
|
Gastrointestinal disorders
Gastritis
|
0.67%
1/150 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/152 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/142 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/145 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.67%
1/150 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
—
0/0 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/142 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.69%
1/145 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of renal pelvis
|
0.67%
1/150 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/152 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/142 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/145 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
|
Gastrointestinal disorders
Mallory-Weiss syndrome
|
0.00%
0/150 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/152 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/142 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.69%
1/145 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/150 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/1 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.70%
1/142 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/145 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
|
Infections and infestations
Pneumonia legionella
|
0.00%
0/150 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/152 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.70%
1/142 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/145 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.67%
1/150 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/152 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/142 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/145 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
1.3%
2/150 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.66%
1/152 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.70%
1/142 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/145 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
|
Nervous system disorders
Sciatica
|
0.67%
1/150 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/152 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/142 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/145 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
|
General disorders
Sudden death
|
0.67%
1/150 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/152 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/142 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/145 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/150 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.66%
1/152 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/142 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/145 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
Other adverse events
| Measure |
Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID
n=150 participants at risk
Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
|
Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID
n=152 participants at risk
Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
|
Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID
n=142 participants at risk
Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
|
Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID
n=145 participants at risk
Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
|
|---|---|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/150 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/152 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
4.2%
6/142 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
1.4%
2/145 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.0%
6/150 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
2.6%
4/152 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
1.4%
2/142 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
4.1%
6/145 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.3%
8/150 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
7.2%
11/152 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
6.3%
9/142 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
4.1%
6/145 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
|
Investigations
Blood creatine phosphokinase increased
|
1.3%
2/150 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
3.3%
5/152 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/142 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/145 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/150 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/152 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.70%
1/142 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
4.1%
6/145 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
|
Eye disorders
Cataract
|
4.0%
6/150 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
4.6%
7/152 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/142 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/145 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
|
General disorders
Chest pain
|
0.67%
1/150 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
3.3%
5/152 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/142 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/145 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/150 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/152 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.70%
1/142 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
4.1%
6/145 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
|
Gastrointestinal disorders
Constipation
|
4.7%
7/150 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
4.6%
7/152 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
4.9%
7/142 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
5.5%
8/145 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
|
Infections and infestations
Cystitis
|
3.3%
5/150 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
3.3%
5/152 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
3.5%
5/142 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
2.8%
4/145 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
|
Gastrointestinal disorders
Dental caries
|
4.0%
6/150 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.66%
1/152 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.70%
1/142 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
4.8%
7/145 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
|
Eye disorders
Diabetic retinopathy
|
2.7%
4/150 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
5.3%
8/152 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
4.2%
6/142 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
6.9%
10/145 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.3%
5/150 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
2.0%
3/152 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
4.2%
6/142 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
2.1%
3/145 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/150 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/152 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
4.9%
7/142 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
4.1%
6/145 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
|
Injury, poisoning and procedural complications
Fall
|
4.7%
7/150 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
7.9%
12/152 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/142 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/145 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
|
Gastrointestinal disorders
Gastritis
|
2.7%
4/150 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
5.3%
8/152 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/142 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/145 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
|
Infections and infestations
Gastroenteritis
|
4.7%
7/150 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
2.6%
4/152 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/142 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/145 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
|
Nervous system disorders
Headache
|
0.00%
0/150 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/152 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
6.3%
9/142 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
2.1%
3/145 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/150 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/152 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
1.4%
2/142 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
3.4%
5/145 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
|
Vascular disorders
Hypertension
|
0.00%
0/150 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/152 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
4.9%
7/142 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
2.8%
4/145 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
2.7%
4/150 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
5.3%
8/152 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/142 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/145 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/150 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/152 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.70%
1/142 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
3.4%
5/145 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
|
Infections and infestations
Nasopharyngitis
|
30.7%
46/150 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
37.5%
57/152 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
31.0%
44/142 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
36.6%
53/145 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
4.0%
6/150 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.66%
1/152 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/142 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/145 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
4.7%
7/150 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
2.6%
4/152 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/142 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/145 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
6.7%
10/150 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
10.5%
16/152 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
4.2%
6/142 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
4.1%
6/145 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.3%
2/150 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
3.3%
5/152 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/142 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/145 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
|
Investigations
White blood cell count increased
|
0.00%
0/150 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
0.00%
0/152 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
2.1%
3/142 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
3.4%
5/145 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.
The following are included in Adverse Events tables: Column 1: 7 patients participated in CCT-005 but not entered OCT-005; Column 2: 1 participated in CCT-005 but not entered OCT-005; Column 3: 2 participated in CCT-006 but not entered OCT-005; Column 4: 9 participated in CCT-006 but not entered OCT-005.
|
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