Trial Outcomes & Findings for A Study of an Investigational Drug Sitagliptin for Type 2 Diabetes Mellitus (0431-044) (NCT NCT00127192)
NCT ID: NCT00127192
Last Updated: 2015-06-15
Results Overview
HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the Week 0 HbA1c percent.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
363 participants
Primary outcome timeframe
Baseline and Week 12
Results posted on
2015-06-15
Participant Flow
Phase II. First patient in: 11 July 2005. Last patient, last visit: 8 March 2006. The study was conducted at 97 centers in Japan.
Patients 20-75 years of age with type 2 diabetes mellitus and inadequate glycemic control (HbA1c ≥6.5% and \<10% at Week -2) were eligible for randomization following at least 8 weeks of diet/exercise and antihyperglycemic agent (AHA) wash-off (for patients previously on an AHA), including a 2-week placebo run-in.
Participant milestones
| Measure |
Sitagliptin 25 mg QD
The Sitagliptin 25 mg group includes data from all patients randomized to receive treatment with sitagliptin 25 mg orally once daily (QD=once daily).
|
Sitagliptin 50 mg QD
The Sitagliptin 50 mg group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).
|
Sitagliptin 100 mg QD
The Sitagliptin 100 mg group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily).
|
Sitagliptin 200 mg QD
The Sitagliptin 200 mg group includes data from all patients randomized to receive treatment with sitagliptin 200 mg orally once daily (QD=once daily).
|
Placebo
The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally once daily.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
80
|
72
|
70
|
68
|
73
|
|
Overall Study
COMPLETED
|
77
|
71
|
68
|
67
|
68
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
2
|
1
|
5
|
Reasons for withdrawal
| Measure |
Sitagliptin 25 mg QD
The Sitagliptin 25 mg group includes data from all patients randomized to receive treatment with sitagliptin 25 mg orally once daily (QD=once daily).
|
Sitagliptin 50 mg QD
The Sitagliptin 50 mg group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).
|
Sitagliptin 100 mg QD
The Sitagliptin 100 mg group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily).
|
Sitagliptin 200 mg QD
The Sitagliptin 200 mg group includes data from all patients randomized to receive treatment with sitagliptin 200 mg orally once daily (QD=once daily).
|
Placebo
The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally once daily.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
1
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
2
|
0
|
0
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
3
|
|
Overall Study
Adverse event in pre-treatment period
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Study of an Investigational Drug Sitagliptin for Type 2 Diabetes Mellitus (0431-044)
Baseline characteristics by cohort
| Measure |
Sitagliptin 25 mg QD
n=80 Participants
The Sitagliptin 25 mg group includes data from all patients randomized to receive treatment with sitagliptin 25 mg orally once daily (QD=once daily).
|
Sitagliptin 50 mg QD
n=72 Participants
The Sitagliptin 50 mg group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).
|
Sitagliptin 100 mg QD
n=70 Participants
The Sitagliptin 100 mg group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily).
|
Sitagliptin 200 mg QD
n=68 Participants
The Sitagliptin 200 mg group includes data from all patients randomized to receive treatment with sitagliptin 200 mg orally once daily (QD=once daily).
|
Placebo
n=73 Participants
The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally once daily.
|
Total
n=363 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
59.9 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
60.2 years
STANDARD_DEVIATION 9.4 • n=7 Participants
|
58.3 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
60.6 years
STANDARD_DEVIATION 7.7 • n=4 Participants
|
60.2 years
STANDARD_DEVIATION 8.0 • n=21 Participants
|
59.8 years
STANDARD_DEVIATION 8.5 • n=10 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
139 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
50 Participants
n=21 Participants
|
224 Participants
n=10 Participants
|
|
Fasting Plasma Glucose (FPG)
|
145.7 mg/dL
STANDARD_DEVIATION 37.6 • n=5 Participants
|
144.3 mg/dL
STANDARD_DEVIATION 29.0 • n=7 Participants
|
142.6 mg/dL
STANDARD_DEVIATION 31.8 • n=5 Participants
|
148.4 mg/dL
STANDARD_DEVIATION 33.3 • n=4 Participants
|
156.5 mg/dL
STANDARD_DEVIATION 35.1 • n=21 Participants
|
147.5 mg/dL
STANDARD_DEVIATION 33.8 • n=10 Participants
|
|
Glycosylated albumin
|
21.5 percent
STANDARD_DEVIATION 3.9 • n=5 Participants
|
22.0 percent
STANDARD_DEVIATION 4.2 • n=7 Participants
|
21.9 percent
STANDARD_DEVIATION 4.5 • n=5 Participants
|
21.9 percent
STANDARD_DEVIATION 3.9 • n=4 Participants
|
23.7 percent
STANDARD_DEVIATION 4.5 • n=21 Participants
|
22.2 percent
STANDARD_DEVIATION 4.3 • n=10 Participants
|
|
Hemoglobin A1c (HbA1c)
|
7.5 percent
STANDARD_DEVIATION 0.8 • n=5 Participants
|
7.6 percent
STANDARD_DEVIATION 0.8 • n=7 Participants
|
7.6 percent
STANDARD_DEVIATION 0.8 • n=5 Participants
|
7.7 percent
STANDARD_DEVIATION 0.8 • n=4 Participants
|
7.7 percent
STANDARD_DEVIATION 0.9 • n=21 Participants
|
7.6 percent
STANDARD_DEVIATION 0.8 • n=10 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. For FAS patients with no data at Week 12, the last non-baseline observed measurement was carried forward to Week 12.
HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the Week 0 HbA1c percent.
Outcome measures
| Measure |
Sitagliptin 25 mg QD
n=80 Participants
The Sitagliptin 25 mg group includes data from all patients randomized to receive treatment with sitagliptin 25 mg orally once daily (QD=once daily).
|
Sitagliptin 50 mg QD
n=72 Participants
The Sitagliptin 50 mg group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).
|
Sitagliptin 100 mg QD
n=70 Participants
The Sitagliptin 100 mg group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily).
|
Sitagliptin 200 mg QD
n=68 Participants
The Sitagliptin 200 mg group includes data from all patients randomized to receive treatment with sitagliptin 200 mg orally once daily (QD=once daily).
|
Placebo
n=73 Participants
The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally once daily.
|
|---|---|---|---|---|---|
|
Change From Baseline in HbA1c at Week 12
|
-0.41 Percent
Interval -0.52 to 0.29
|
-0.71 Percent
Interval -0.83 to 0.59
|
-0.69 Percent
Interval -0.81 to 0.56
|
-0.76 Percent
Interval -0.89 to 0.64
|
0.28 Percent
Interval 0.16 to 0.4
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. For FAS patients with no data at Week 12, the last non-baseline observed measurement was carried forward to Week 12.
Change from baseline at Week 12 is defined as Week 12 minus Week 0.
Outcome measures
| Measure |
Sitagliptin 25 mg QD
n=80 Participants
The Sitagliptin 25 mg group includes data from all patients randomized to receive treatment with sitagliptin 25 mg orally once daily (QD=once daily).
|
Sitagliptin 50 mg QD
n=72 Participants
The Sitagliptin 50 mg group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).
|
Sitagliptin 100 mg QD
n=70 Participants
The Sitagliptin 100 mg group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily).
|
Sitagliptin 200 mg QD
n=68 Participants
The Sitagliptin 200 mg group includes data from all patients randomized to receive treatment with sitagliptin 200 mg orally once daily (QD=once daily).
|
Placebo
n=73 Participants
The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally once daily.
|
|---|---|---|---|---|---|
|
Change From Baseline in Glycosylated Albumin at Week 12
|
-1.9 Percent
Interval -2.4 to 1.5
|
-2.6 Percent
Interval -3.1 to 2.2
|
-2.6 Percent
Interval -3.0 to 2.1
|
-2.9 Percent
Interval -3.4 to 2.5
|
0.7 Percent
Interval 0.2 to 1.1
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. For FAS patients with no data at Week 12, the last non-baseline observed measurement was carried forward to Week 12.
Change from baseline at Week 12 is defined as Week 12 minus Week 0.
Outcome measures
| Measure |
Sitagliptin 25 mg QD
n=80 Participants
The Sitagliptin 25 mg group includes data from all patients randomized to receive treatment with sitagliptin 25 mg orally once daily (QD=once daily).
|
Sitagliptin 50 mg QD
n=72 Participants
The Sitagliptin 50 mg group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).
|
Sitagliptin 100 mg QD
n=70 Participants
The Sitagliptin 100 mg group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily).
|
Sitagliptin 200 mg QD
n=68 Participants
The Sitagliptin 200 mg group includes data from all patients randomized to receive treatment with sitagliptin 200 mg orally once daily (QD=once daily).
|
Placebo
n=73 Participants
The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally once daily.
|
|---|---|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose at Week 12
|
-9.6 mg/dL
Interval -14.0 to 5.3
|
-11.4 mg/dL
Interval -16.0 to 6.8
|
-14.6 mg/dL
Interval -19.2 to 9.9
|
-16.9 mg/dL
Interval -21.6 to 12.1
|
6.3 mg/dL
Interval 1.7 to 10.9
|
Adverse Events
Sitagliptin 25 mg QD
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
Sitagliptin 50 mg QD
Serious events: 1 serious events
Other events: 25 other events
Deaths: 0 deaths
Sitagliptin 100 mg QD
Serious events: 0 serious events
Other events: 32 other events
Deaths: 0 deaths
Sitagliptin 200 mg QD
Serious events: 2 serious events
Other events: 20 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sitagliptin 25 mg QD
The Sitagliptin 25 mg group includes data from all patients randomized to receive treatment with sitagliptin 25 mg orally once daily (QD=once daily).
|
Sitagliptin 50 mg QD
The Sitagliptin 50 mg group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).
|
Sitagliptin 100 mg QD
The Sitagliptin 100 mg group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily).
|
Sitagliptin 200 mg QD
The Sitagliptin 200 mg group includes data from all patients randomized to receive treatment with sitagliptin 200 mg orally once daily (QD=once daily).
|
Placebo
The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally once daily.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/80
Reported overdoses, regardless of association with reported adverse events, were considered as serious adverse events in this study. The patients for whom the event of overdose was reported had no concomitant AEs with the overdose.
|
1.4%
1/72
Reported overdoses, regardless of association with reported adverse events, were considered as serious adverse events in this study. The patients for whom the event of overdose was reported had no concomitant AEs with the overdose.
|
0.00%
0/70
Reported overdoses, regardless of association with reported adverse events, were considered as serious adverse events in this study. The patients for whom the event of overdose was reported had no concomitant AEs with the overdose.
|
0.00%
0/68
Reported overdoses, regardless of association with reported adverse events, were considered as serious adverse events in this study. The patients for whom the event of overdose was reported had no concomitant AEs with the overdose.
|
0.00%
0/73
Reported overdoses, regardless of association with reported adverse events, were considered as serious adverse events in this study. The patients for whom the event of overdose was reported had no concomitant AEs with the overdose.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.00%
0/80
Reported overdoses, regardless of association with reported adverse events, were considered as serious adverse events in this study. The patients for whom the event of overdose was reported had no concomitant AEs with the overdose.
|
0.00%
0/72
Reported overdoses, regardless of association with reported adverse events, were considered as serious adverse events in this study. The patients for whom the event of overdose was reported had no concomitant AEs with the overdose.
|
0.00%
0/70
Reported overdoses, regardless of association with reported adverse events, were considered as serious adverse events in this study. The patients for whom the event of overdose was reported had no concomitant AEs with the overdose.
|
1.5%
1/68
Reported overdoses, regardless of association with reported adverse events, were considered as serious adverse events in this study. The patients for whom the event of overdose was reported had no concomitant AEs with the overdose.
|
0.00%
0/73
Reported overdoses, regardless of association with reported adverse events, were considered as serious adverse events in this study. The patients for whom the event of overdose was reported had no concomitant AEs with the overdose.
|
|
Cardiac disorders
Hypertensive heart disease
|
0.00%
0/80
Reported overdoses, regardless of association with reported adverse events, were considered as serious adverse events in this study. The patients for whom the event of overdose was reported had no concomitant AEs with the overdose.
|
0.00%
0/72
Reported overdoses, regardless of association with reported adverse events, were considered as serious adverse events in this study. The patients for whom the event of overdose was reported had no concomitant AEs with the overdose.
|
0.00%
0/70
Reported overdoses, regardless of association with reported adverse events, were considered as serious adverse events in this study. The patients for whom the event of overdose was reported had no concomitant AEs with the overdose.
|
1.5%
1/68
Reported overdoses, regardless of association with reported adverse events, were considered as serious adverse events in this study. The patients for whom the event of overdose was reported had no concomitant AEs with the overdose.
|
0.00%
0/73
Reported overdoses, regardless of association with reported adverse events, were considered as serious adverse events in this study. The patients for whom the event of overdose was reported had no concomitant AEs with the overdose.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/80
Reported overdoses, regardless of association with reported adverse events, were considered as serious adverse events in this study. The patients for whom the event of overdose was reported had no concomitant AEs with the overdose.
|
0.00%
0/72
Reported overdoses, regardless of association with reported adverse events, were considered as serious adverse events in this study. The patients for whom the event of overdose was reported had no concomitant AEs with the overdose.
|
0.00%
0/70
Reported overdoses, regardless of association with reported adverse events, were considered as serious adverse events in this study. The patients for whom the event of overdose was reported had no concomitant AEs with the overdose.
|
1.5%
1/68
Reported overdoses, regardless of association with reported adverse events, were considered as serious adverse events in this study. The patients for whom the event of overdose was reported had no concomitant AEs with the overdose.
|
0.00%
0/73
Reported overdoses, regardless of association with reported adverse events, were considered as serious adverse events in this study. The patients for whom the event of overdose was reported had no concomitant AEs with the overdose.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/80
Reported overdoses, regardless of association with reported adverse events, were considered as serious adverse events in this study. The patients for whom the event of overdose was reported had no concomitant AEs with the overdose.
|
0.00%
0/72
Reported overdoses, regardless of association with reported adverse events, were considered as serious adverse events in this study. The patients for whom the event of overdose was reported had no concomitant AEs with the overdose.
|
0.00%
0/70
Reported overdoses, regardless of association with reported adverse events, were considered as serious adverse events in this study. The patients for whom the event of overdose was reported had no concomitant AEs with the overdose.
|
1.5%
1/68
Reported overdoses, regardless of association with reported adverse events, were considered as serious adverse events in this study. The patients for whom the event of overdose was reported had no concomitant AEs with the overdose.
|
0.00%
0/73
Reported overdoses, regardless of association with reported adverse events, were considered as serious adverse events in this study. The patients for whom the event of overdose was reported had no concomitant AEs with the overdose.
|
Other adverse events
| Measure |
Sitagliptin 25 mg QD
The Sitagliptin 25 mg group includes data from all patients randomized to receive treatment with sitagliptin 25 mg orally once daily (QD=once daily).
|
Sitagliptin 50 mg QD
The Sitagliptin 50 mg group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).
|
Sitagliptin 100 mg QD
The Sitagliptin 100 mg group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily).
|
Sitagliptin 200 mg QD
The Sitagliptin 200 mg group includes data from all patients randomized to receive treatment with sitagliptin 200 mg orally once daily (QD=once daily).
|
Placebo
The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally once daily.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
7.5%
6/80
Reported overdoses, regardless of association with reported adverse events, were considered as serious adverse events in this study. The patients for whom the event of overdose was reported had no concomitant AEs with the overdose.
|
2.8%
2/72
Reported overdoses, regardless of association with reported adverse events, were considered as serious adverse events in this study. The patients for whom the event of overdose was reported had no concomitant AEs with the overdose.
|
4.3%
3/70
Reported overdoses, regardless of association with reported adverse events, were considered as serious adverse events in this study. The patients for whom the event of overdose was reported had no concomitant AEs with the overdose.
|
1.5%
1/68
Reported overdoses, regardless of association with reported adverse events, were considered as serious adverse events in this study. The patients for whom the event of overdose was reported had no concomitant AEs with the overdose.
|
4.1%
3/73
Reported overdoses, regardless of association with reported adverse events, were considered as serious adverse events in this study. The patients for whom the event of overdose was reported had no concomitant AEs with the overdose.
|
|
Infections and infestations
Nasopharyngitis
|
20.0%
16/80
Reported overdoses, regardless of association with reported adverse events, were considered as serious adverse events in this study. The patients for whom the event of overdose was reported had no concomitant AEs with the overdose.
|
22.2%
16/72
Reported overdoses, regardless of association with reported adverse events, were considered as serious adverse events in this study. The patients for whom the event of overdose was reported had no concomitant AEs with the overdose.
|
32.9%
23/70
Reported overdoses, regardless of association with reported adverse events, were considered as serious adverse events in this study. The patients for whom the event of overdose was reported had no concomitant AEs with the overdose.
|
17.6%
12/68
Reported overdoses, regardless of association with reported adverse events, were considered as serious adverse events in this study. The patients for whom the event of overdose was reported had no concomitant AEs with the overdose.
|
23.3%
17/73
Reported overdoses, regardless of association with reported adverse events, were considered as serious adverse events in this study. The patients for whom the event of overdose was reported had no concomitant AEs with the overdose.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/80
Reported overdoses, regardless of association with reported adverse events, were considered as serious adverse events in this study. The patients for whom the event of overdose was reported had no concomitant AEs with the overdose.
|
2.8%
2/72
Reported overdoses, regardless of association with reported adverse events, were considered as serious adverse events in this study. The patients for whom the event of overdose was reported had no concomitant AEs with the overdose.
|
5.7%
4/70
Reported overdoses, regardless of association with reported adverse events, were considered as serious adverse events in this study. The patients for whom the event of overdose was reported had no concomitant AEs with the overdose.
|
2.9%
2/68
Reported overdoses, regardless of association with reported adverse events, were considered as serious adverse events in this study. The patients for whom the event of overdose was reported had no concomitant AEs with the overdose.
|
0.00%
0/73
Reported overdoses, regardless of association with reported adverse events, were considered as serious adverse events in this study. The patients for whom the event of overdose was reported had no concomitant AEs with the overdose.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
3.8%
3/80
Reported overdoses, regardless of association with reported adverse events, were considered as serious adverse events in this study. The patients for whom the event of overdose was reported had no concomitant AEs with the overdose.
|
4.2%
3/72
Reported overdoses, regardless of association with reported adverse events, were considered as serious adverse events in this study. The patients for whom the event of overdose was reported had no concomitant AEs with the overdose.
|
2.9%
2/70
Reported overdoses, regardless of association with reported adverse events, were considered as serious adverse events in this study. The patients for whom the event of overdose was reported had no concomitant AEs with the overdose.
|
5.9%
4/68
Reported overdoses, regardless of association with reported adverse events, were considered as serious adverse events in this study. The patients for whom the event of overdose was reported had no concomitant AEs with the overdose.
|
4.1%
3/73
Reported overdoses, regardless of association with reported adverse events, were considered as serious adverse events in this study. The patients for whom the event of overdose was reported had no concomitant AEs with the overdose.
|
|
Nervous system disorders
Headache
|
0.00%
0/80
Reported overdoses, regardless of association with reported adverse events, were considered as serious adverse events in this study. The patients for whom the event of overdose was reported had no concomitant AEs with the overdose.
|
1.4%
1/72
Reported overdoses, regardless of association with reported adverse events, were considered as serious adverse events in this study. The patients for whom the event of overdose was reported had no concomitant AEs with the overdose.
|
0.00%
0/70
Reported overdoses, regardless of association with reported adverse events, were considered as serious adverse events in this study. The patients for whom the event of overdose was reported had no concomitant AEs with the overdose.
|
1.5%
1/68
Reported overdoses, regardless of association with reported adverse events, were considered as serious adverse events in this study. The patients for whom the event of overdose was reported had no concomitant AEs with the overdose.
|
6.8%
5/73
Reported overdoses, regardless of association with reported adverse events, were considered as serious adverse events in this study. The patients for whom the event of overdose was reported had no concomitant AEs with the overdose.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/80
Reported overdoses, regardless of association with reported adverse events, were considered as serious adverse events in this study. The patients for whom the event of overdose was reported had no concomitant AEs with the overdose.
|
5.6%
4/72
Reported overdoses, regardless of association with reported adverse events, were considered as serious adverse events in this study. The patients for whom the event of overdose was reported had no concomitant AEs with the overdose.
|
0.00%
0/70
Reported overdoses, regardless of association with reported adverse events, were considered as serious adverse events in this study. The patients for whom the event of overdose was reported had no concomitant AEs with the overdose.
|
0.00%
0/68
Reported overdoses, regardless of association with reported adverse events, were considered as serious adverse events in this study. The patients for whom the event of overdose was reported had no concomitant AEs with the overdose.
|
1.4%
1/73
Reported overdoses, regardless of association with reported adverse events, were considered as serious adverse events in this study. The patients for whom the event of overdose was reported had no concomitant AEs with the overdose.
|
|
Investigations
Blood creatine phosphokinase increased
|
8.8%
7/80
Reported overdoses, regardless of association with reported adverse events, were considered as serious adverse events in this study. The patients for whom the event of overdose was reported had no concomitant AEs with the overdose.
|
2.8%
2/72
Reported overdoses, regardless of association with reported adverse events, were considered as serious adverse events in this study. The patients for whom the event of overdose was reported had no concomitant AEs with the overdose.
|
1.4%
1/70
Reported overdoses, regardless of association with reported adverse events, were considered as serious adverse events in this study. The patients for whom the event of overdose was reported had no concomitant AEs with the overdose.
|
1.5%
1/68
Reported overdoses, regardless of association with reported adverse events, were considered as serious adverse events in this study. The patients for whom the event of overdose was reported had no concomitant AEs with the overdose.
|
2.7%
2/73
Reported overdoses, regardless of association with reported adverse events, were considered as serious adverse events in this study. The patients for whom the event of overdose was reported had no concomitant AEs with the overdose.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Results disclosure agreements
- Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER