Trial Outcomes & Findings for A Study Assessing Saxagliptin Treatment in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise (NCT NCT00374907)
NCT ID: NCT00374907
Last Updated: 2015-05-07
Results Overview
Adjusted percent change in the insulin secretion rate AUC during a hyperglycemic clamp with an enteral glucose load \[intravenous-oral hyperglycemic clamp (180-480 minutes)\] at Week 12. The method used for calculating the insulin secretion rate was C-peptide deconvolution.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
156 participants
Primary outcome timeframe
Baseline, Week 12
Results posted on
2015-05-07
Participant Flow
156 participants were enrolled in the study; 110 participants failed screening; 10 subjects entered lead-in and discontinued prior to randomization.
Participant milestones
| Measure |
Saxagliptin 5 mg
Tablet, Oral, 5 mg, once daily, up to 12 weeks (short-term) and up to 104 weeks (long-term). Metformin 500-1500 mg (open-label, as needed for rescue in LT).
|
Placebo / Metformin
Placebo Tablet, Oral, 0 mg, once daily, up to 12 weeks; Metformin Tablet, Oral, 500 mg/1000 mg, once daily, up to 104 weeks starting at Week 12 (end of ST period). Metformin 500-1500 mg (open-label, as needed for rescue in LT).
|
|---|---|---|
|
12-Week Short-term Period
STARTED
|
20
|
16
|
|
12-Week Short-term Period
COMPLETED
|
17
|
15
|
|
12-Week Short-term Period
NOT COMPLETED
|
3
|
1
|
|
116-Week Short-term + Long-term Period
STARTED
|
20
|
16
|
|
116-Week Short-term + Long-term Period
Completed 12-week Short Term Period
|
17
|
15
|
|
116-Week Short-term + Long-term Period
COMPLETED
|
7
|
2
|
|
116-Week Short-term + Long-term Period
NOT COMPLETED
|
13
|
14
|
Reasons for withdrawal
| Measure |
Saxagliptin 5 mg
Tablet, Oral, 5 mg, once daily, up to 12 weeks (short-term) and up to 104 weeks (long-term). Metformin 500-1500 mg (open-label, as needed for rescue in LT).
|
Placebo / Metformin
Placebo Tablet, Oral, 0 mg, once daily, up to 12 weeks; Metformin Tablet, Oral, 500 mg/1000 mg, once daily, up to 104 weeks starting at Week 12 (end of ST period). Metformin 500-1500 mg (open-label, as needed for rescue in LT).
|
|---|---|---|
|
12-Week Short-term Period
Subject Withdrew Consent
|
3
|
1
|
|
116-Week Short-term + Long-term Period
Subject Withdrew Consent
|
8
|
9
|
|
116-Week Short-term + Long-term Period
Lack of Efficacy
|
4
|
2
|
|
116-Week Short-term + Long-term Period
Adverse Event
|
0
|
2
|
|
116-Week Short-term + Long-term Period
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
A Study Assessing Saxagliptin Treatment in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise
Baseline characteristics by cohort
| Measure |
Saxagliptin 5 mg
n=20 Participants
Tablet, Oral, 5 mg, once daily, up to 12 weeks (short-term) and up to 104 weeks (long-term)
|
Placebo / Metformin
n=16 Participants
Placebo Tablet, Oral, 0 mg, once daily, up to 12 weeks; Metformin Tablet, Oral, 500 mg/1000 mg, once daily, starting at Week 12 and up to 104 weeks
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58 years
n=5 Participants
|
55 years
n=7 Participants
|
55.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
16 participants
n=5 Participants
|
12 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
North America
|
20 participants
n=5 Participants
|
16 participants
n=7 Participants
|
36 participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
33.36 kg/m^2
n=5 Participants
|
32.31 kg/m^2
n=7 Participants
|
33.01 kg/m^2
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: Randomized participants with both a baseline and post-baseline value (up to Week 12).
Adjusted percent change in the insulin secretion rate AUC during a hyperglycemic clamp with an enteral glucose load \[intravenous-oral hyperglycemic clamp (180-480 minutes)\] at Week 12. The method used for calculating the insulin secretion rate was C-peptide deconvolution.
Outcome measures
| Measure |
Short Term Period: Saxagliptin 5 mg
n=16 Participants
Tablet, Oral, 5 mg, once daily, up to 12 weeks
|
Short Term Period: Placebo
n=15 Participants
Tablet, Oral, 0 mg, once daily, up to 12 weeks
|
|---|---|---|
|
Insulin Secretion Rate Area Under the Curve (AUC) During Intravenous (IV)-Oral Hyperglycemic Clamp - Percent Change From Baseline at Week 12
|
15.9 Percent Change (Percentage of Baseline)
Interval 4.2 to 29.0
|
-2.2 Percent Change (Percentage of Baseline)
Interval -12.4 to 9.3
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Randomized Participants with both a baseline and post-baseline value (up to Week 12).
Adjusted percent change in the insulin secretion rate AUC during an intravenous hyperglycemic clamp (120-180 minutes) at Week 12. The method used for calculating the insulin secretion rate was C-peptide deconvolution.
Outcome measures
| Measure |
Short Term Period: Saxagliptin 5 mg
n=18 Participants
Tablet, Oral, 5 mg, once daily, up to 12 weeks
|
Short Term Period: Placebo
n=16 Participants
Tablet, Oral, 0 mg, once daily, up to 12 weeks
|
|---|---|---|
|
Insulin Secretion Rate AUC During IV Hyperglycemic Clamp - Percent Change From Baseline at Week 12
|
22.6 Percent Change (Percentage of Baseline)
Interval 7.2 to 40.4
|
-4.1 Percent Change (Percentage of Baseline)
Interval -17.4 to 11.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 116 weeksPopulation: Treated participants
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Related events=relationship of certain, probable, possible, or missing.
Outcome measures
| Measure |
Short Term Period: Saxagliptin 5 mg
n=20 Participants
Tablet, Oral, 5 mg, once daily, up to 12 weeks
|
Short Term Period: Placebo
n=16 Participants
Tablet, Oral, 0 mg, once daily, up to 12 weeks
|
|---|---|---|
|
Overall Summary of Adverse Events (AEs) Serious AEs (SAEs), Discontinuations, and Deaths During the ST + LT Treatment Period
At Least 1 Related AE
|
7 participants
|
6 participants
|
|
Overall Summary of Adverse Events (AEs) Serious AEs (SAEs), Discontinuations, and Deaths During the ST + LT Treatment Period
Deaths
|
0 participants
|
0 participants
|
|
Overall Summary of Adverse Events (AEs) Serious AEs (SAEs), Discontinuations, and Deaths During the ST + LT Treatment Period
At Least 1 SAE
|
1 participants
|
2 participants
|
|
Overall Summary of Adverse Events (AEs) Serious AEs (SAEs), Discontinuations, and Deaths During the ST + LT Treatment Period
At Least 1 Related SAE
|
0 participants
|
0 participants
|
|
Overall Summary of Adverse Events (AEs) Serious AEs (SAEs), Discontinuations, and Deaths During the ST + LT Treatment Period
Discontinuations Due to SAEs
|
0 participants
|
1 participants
|
|
Overall Summary of Adverse Events (AEs) Serious AEs (SAEs), Discontinuations, and Deaths During the ST + LT Treatment Period
Discontinuations Due to AEs
|
0 participants
|
2 participants
|
|
Overall Summary of Adverse Events (AEs) Serious AEs (SAEs), Discontinuations, and Deaths During the ST + LT Treatment Period
At Least 1 AE
|
17 participants
|
14 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 116 weeksPopulation: Number of Participants Analyzed=Treated participants; n=number of treated subjects with baseline value and at least one value during the ST + LT treatment period.
A laboratory value was considered a marked abnormality if it is outside the pre-defined criteria for marked abnormality and the on-treatment value was more extreme (farther from the limit) than the baseline value. Pre-Rx=pretreatment; ULN=upper limit of normal; ALP=alkaline phosphatase; AST=aspartate aminotransferase; ALT=alanine aminotransferase; BUN=blood urea nitrogen; unspec.=unspecified; sodium serum low: \<0.9 x Pre-Rx \& \<=130mEq/L / high: \>1.1 x Pre-Rx \& \>=150mEq/L; potassium, serum low: \<=0.8 x Pre-Rx \& \>=6.0mEq/L / high: 1.2 x Pre-Rx \& \>=6.0mEq/L; LLN=lower limit of normal.
Outcome measures
| Measure |
Short Term Period: Saxagliptin 5 mg
n=20 Participants
Tablet, Oral, 5 mg, once daily, up to 12 weeks
|
Short Term Period: Placebo
n=16 Participants
Tablet, Oral, 0 mg, once daily, up to 12 weeks
|
|---|---|---|
|
Marked Laboratory Abnormalities - During ST + LT Treatment Period
Hemoglobin < 8 g/dL (n=0, 0)
|
0 participants
|
0 participants
|
|
Marked Laboratory Abnormalities - During ST + LT Treatment Period
Hematocrit < 0.75 x pre-Rx (n=0, 0)
|
0 participants
|
0 participants
|
|
Marked Laboratory Abnormalities - During ST + LT Treatment Period
Platelets > 1.5 x ULN (n=0, 0)
|
0 participants
|
0 participants
|
|
Marked Laboratory Abnormalities - During ST + LT Treatment Period
Leukocytes < 2 x 1000 c/uL (n=0, 0)
|
0 participants
|
0 participants
|
|
Marked Laboratory Abnormalities - During ST + LT Treatment Period
Neutrophils+Bands <1x1000 c/uL (n=18, 0)
|
1 participants
|
0 participants
|
|
Marked Laboratory Abnormalities - During ST + LT Treatment Period
Eosinophils >0.9x1000 c/uL (n=18, 0)
|
1 participants
|
0 participants
|
|
Marked Laboratory Abnormalities - During ST + LT Treatment Period
Lymphocytes <=0.75x1000 c/uL (n=18, 0)
|
2 participants
|
0 participants
|
|
Marked Laboratory Abnormalities - During ST + LT Treatment Period
ALP >3 x pre-Rx and >ULN (n=0, 0)
|
0 participants
|
0 participants
|
|
Marked Laboratory Abnormalities - During ST + LT Treatment Period
ALT >5 x ULN (n=0, 0)
|
0 participants
|
0 participants
|
|
Marked Laboratory Abnormalities - During ST + LT Treatment Period
Bilirubin Total >2mg/dL (n=0, 0)
|
0 participants
|
0 participants
|
|
Marked Laboratory Abnormalities - During ST + LT Treatment Period
BUN >2 x pre-Rx and >ULN (n=0, 0)
|
0 participants
|
0 participants
|
|
Marked Laboratory Abnormalities - During ST + LT Treatment Period
Creatinine >2.5 mg/dL (n=0, 0)
|
0 participants
|
0 participants
|
|
Marked Laboratory Abnormalities - During ST + LT Treatment Period
Glucose, Serum Fasting < 50 mg/dL (n=0, 0)
|
0 participants
|
0 participants
|
|
Marked Laboratory Abnormalities - During ST + LT Treatment Period
Glucose, Serum Fasting > 500 mg/dL (n=0, 0)
|
0 participants
|
0 participants
|
|
Marked Laboratory Abnormalities - During ST + LT Treatment Period
Glucose, Serum Unspec. < 50 mg/dL (n=0, 0)
|
0 participants
|
0 participants
|
|
Marked Laboratory Abnormalities - During ST + LT Treatment Period
Glucose, Serum Unspec. > 500 mg/dL (n=0, 0)
|
0 participants
|
0 participants
|
|
Marked Laboratory Abnormalities - During ST + LT Treatment Period
Glucose, Plasma Fasting <50 mg/dL (n=0, 0)
|
0 participants
|
0 participants
|
|
Marked Laboratory Abnormalities - During ST + LT Treatment Period
Glucose,Plasma Fasting >500 mg/dL (n=0, 0)
|
0 participants
|
0 participants
|
|
Marked Laboratory Abnormalities - During ST + LT Treatment Period
Glucose, Plasma Unspec. <50 mg/dL (n=0, 0)
|
0 participants
|
0 participants
|
|
Marked Laboratory Abnormalities - During ST + LT Treatment Period
Glucose, Plasma Unspec. >500 mg/dL (n=18, 16)
|
8 participants
|
9 participants
|
|
Marked Laboratory Abnormalities - During ST + LT Treatment Period
Sodium, Serum Low (see description) (n=0, 0)
|
0 participants
|
0 participants
|
|
Marked Laboratory Abnormalities - During ST + LT Treatment Period
Sodium, Serum High (see description) (n=0, 0)
|
0 participants
|
0 participants
|
|
Marked Laboratory Abnormalities - During ST + LT Treatment Period
Potassium, Serum Low (see description) (n=0, 0)
|
0 participants
|
0 participants
|
|
Marked Laboratory Abnormalities - During ST + LT Treatment Period
Potassium, Serum High (see description) (n=0, 0)
|
0 participants
|
0 participants
|
|
Marked Laboratory Abnormalities - During ST + LT Treatment Period
Chloride < 90 mEq/L (n=0, 0)
|
0 participants
|
0 participants
|
|
Marked Laboratory Abnormalities - During ST + LT Treatment Period
Chloride > 120 mEq/L (n=0, 0)
|
0 participants
|
0 participants
|
|
Marked Laboratory Abnormalities - During ST + LT Treatment Period
Albumin < 0.9 LLN (n=0, 0)
|
0 participants
|
0 participants
|
|
Marked Laboratory Abnormalities - During ST + LT Treatment Period
Creatine Kinase > 5 x ULN (n=18, 16)
|
1 participants
|
1 participants
|
|
Marked Laboratory Abnormalities - During ST + LT Treatment Period
Uric Acid > 1.5 x ULN (n=0, 0)
|
0 participants
|
0 participants
|
|
Marked Laboratory Abnormalities - During ST + LT Treatment Period
Protein Urine, >=2-4 (n=0, 0)
|
0 participants
|
0 participants
|
|
Marked Laboratory Abnormalities - During ST + LT Treatment Period
Blood Urine >=2-4 (n=18, 0)
|
1 participants
|
0 participants
|
|
Marked Laboratory Abnormalities - During ST + LT Treatment Period
Red Blood Cells Urine >=2-4 (n=0, 0)
|
0 participants
|
0 participants
|
|
Marked Laboratory Abnormalities - During ST + LT Treatment Period
White Blood Cells Urine >=2-4 (n=0, 0)
|
2 participants
|
1 participants
|
|
Marked Laboratory Abnormalities - During ST + LT Treatment Period
Platelets < 50 x 10^9 c/L (n=0, 0)
|
0 participants
|
0 participants
|
|
Marked Laboratory Abnormalities - During ST + LT Treatment Period
AST >3 x ULN (n=0, 0)
|
0 participants
|
0 participants
|
|
Marked Laboratory Abnormalities - During ST + LT Treatment Period
AST >5 x ULN (n=0, 0)
|
0 participants
|
0 participants
|
|
Marked Laboratory Abnormalities - During ST + LT Treatment Period
ALT >3 x ULN (n=0, 0)
|
0 participants
|
0 participants
|
Adverse Events
PLACEBO/METFORMIN
Serious events: 2 serious events
Other events: 14 other events
Deaths: 0 deaths
SAXAGLIPTIN 5 MG
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PLACEBO/METFORMIN
n=16 participants at risk
Placebo Tablet, Oral, 0 mg, once daily, up to 12 weeks (short term); Metformin Tablet, Oral, 500 mg titrated to 1000 mg, once daily, up to 104 weeks (long term)
|
SAXAGLIPTIN 5 MG
n=20 participants at risk
Tablet, Oral, 5 mg, once daily, up to 12 weeks (short term); Tablet, Oral, 5 mg, once daily, up to 104 weeks (long term)
|
|---|---|---|
|
Cardiac disorders
ANGINA UNSTABLE
|
6.2%
1/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
0.00%
0/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
6.2%
1/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
0.00%
0/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
General disorders
CHEST DISCOMFORT
|
0.00%
0/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
5.0%
1/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
COLON CANCER
|
6.2%
1/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
0.00%
0/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
Other adverse events
| Measure |
PLACEBO/METFORMIN
n=16 participants at risk
Placebo Tablet, Oral, 0 mg, once daily, up to 12 weeks (short term); Metformin Tablet, Oral, 500 mg titrated to 1000 mg, once daily, up to 104 weeks (long term)
|
SAXAGLIPTIN 5 MG
n=20 participants at risk
Tablet, Oral, 5 mg, once daily, up to 12 weeks (short term); Tablet, Oral, 5 mg, once daily, up to 104 weeks (long term)
|
|---|---|---|
|
Eye disorders
EYE IRRITATION
|
6.2%
1/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
0.00%
0/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Eye disorders
LACRIMATION INCREASED
|
0.00%
0/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
5.0%
1/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Investigations
CARDIAC MURMUR
|
0.00%
0/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
5.0%
1/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Investigations
URINE OUTPUT DECREASED
|
0.00%
0/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
5.0%
1/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Investigations
BLOOD PRESSURE INCREASED
|
6.2%
1/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
0.00%
0/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Investigations
EOSINOPHIL COUNT INCREASED
|
0.00%
0/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
5.0%
1/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Investigations
LYMPHOCYTE COUNT DECREASED
|
0.00%
0/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
5.0%
1/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
0.00%
0/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
5.0%
1/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Investigations
BLOOD CREATINE PHOSPHOKINASE INCREASED
|
6.2%
1/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
0.00%
0/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Cardiac disorders
TACHYCARDIA
|
6.2%
1/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
0.00%
0/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Vascular disorders
HAEMATOMA
|
6.2%
1/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
0.00%
0/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Vascular disorders
HOT FLUSH
|
6.2%
1/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
0.00%
0/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Vascular disorders
HYPERTENSION
|
12.5%
2/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
0.00%
0/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Vascular disorders
PERIPHERAL COLDNESS
|
6.2%
1/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
0.00%
0/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Psychiatric disorders
STRESS
|
0.00%
0/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
5.0%
1/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Psychiatric disorders
INSOMNIA
|
6.2%
1/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
0.00%
0/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Psychiatric disorders
AGITATION
|
0.00%
0/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
5.0%
1/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Immune system disorders
HYPERSENSITIVITY
|
6.2%
1/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
0.00%
0/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Immune system disorders
SEASONAL ALLERGY
|
6.2%
1/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
0.00%
0/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Nervous system disorders
TREMOR
|
0.00%
0/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
5.0%
1/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Nervous system disorders
AGEUSIA
|
0.00%
0/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
5.0%
1/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Nervous system disorders
HEADACHE
|
18.8%
3/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
25.0%
5/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Nervous system disorders
DIZZINESS
|
6.2%
1/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
0.00%
0/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Nervous system disorders
DYSGEUSIA
|
0.00%
0/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
5.0%
1/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Nervous system disorders
PRESYNCOPE
|
6.2%
1/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
0.00%
0/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Nervous system disorders
PARAESTHESIA
|
0.00%
0/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
10.0%
2/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Nervous system disorders
HYPOAESTHESIA
|
6.2%
1/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
5.0%
1/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Nervous system disorders
SINUS HEADACHE
|
6.2%
1/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
0.00%
0/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
0.00%
0/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
5.0%
1/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Nervous system disorders
CARPAL TUNNEL SYNDROME
|
0.00%
0/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
5.0%
1/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Gastrointestinal disorders
NAUSEA
|
18.8%
3/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
10.0%
2/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
5.0%
1/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Gastrointestinal disorders
DIARRHOEA
|
6.2%
1/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
10.0%
2/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Gastrointestinal disorders
DYSPEPSIA
|
0.00%
0/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
5.0%
1/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Gastrointestinal disorders
GASTRITIS
|
0.00%
0/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
10.0%
2/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Gastrointestinal disorders
FLATULENCE
|
12.5%
2/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
0.00%
0/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Gastrointestinal disorders
GASTRIC ULCER
|
0.00%
0/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
5.0%
1/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
12.5%
2/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
0.00%
0/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Gastrointestinal disorders
FAECES DISCOLOURED
|
0.00%
0/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
5.0%
1/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Gastrointestinal disorders
ABDOMINAL DISCOMFORT
|
12.5%
2/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
10.0%
2/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
5.0%
1/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
0.00%
0/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
5.0%
1/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Ear and labyrinth disorders
VERTIGO
|
0.00%
0/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
5.0%
1/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Ear and labyrinth disorders
MIDDLE EAR EFFUSION
|
0.00%
0/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
5.0%
1/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Infections and infestations
CYSTITIS
|
0.00%
0/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
5.0%
1/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Infections and infestations
RHINITIS
|
0.00%
0/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
5.0%
1/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Infections and infestations
INFLUENZA
|
31.2%
5/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
0.00%
0/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Infections and infestations
SINUSITIS
|
0.00%
0/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
15.0%
3/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Infections and infestations
BRONCHITIS
|
6.2%
1/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
0.00%
0/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Infections and infestations
BACTERIURIA
|
0.00%
0/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
5.0%
1/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Infections and infestations
INFECTED CYST
|
6.2%
1/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
0.00%
0/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Infections and infestations
LABYRINTHITIS
|
0.00%
0/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
5.0%
1/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Infections and infestations
TOOTH ABSCESS
|
6.2%
1/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
0.00%
0/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Infections and infestations
OTITIS EXTERNA
|
6.2%
1/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
0.00%
0/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Infections and infestations
GASTROENTERITIS
|
0.00%
0/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
10.0%
2/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Infections and infestations
NASOPHARYNGITIS
|
18.8%
3/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
15.0%
3/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Infections and infestations
KIDNEY INFECTION
|
6.2%
1/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
0.00%
0/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
6.2%
1/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
5.0%
1/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Infections and infestations
HELICOBACTER INFECTION
|
0.00%
0/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
5.0%
1/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Infections and infestations
URINARY TRACT INFECTION
|
6.2%
1/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
0.00%
0/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
6.2%
1/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
0.00%
0/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Infections and infestations
VULVOVAGINAL MYCOTIC INFECTION
|
0.00%
0/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
5.0%
1/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
18.8%
3/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
15.0%
3/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Infections and infestations
VIRAL UPPER RESPIRATORY TRACT INFECTION
|
0.00%
0/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
5.0%
1/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Renal and urinary disorders
BLADDER DILATATION
|
0.00%
0/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
5.0%
1/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Metabolism and nutrition disorders
HYPERLIPIDAEMIA
|
6.2%
1/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
0.00%
0/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.00%
0/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
5.0%
1/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Blood and lymphatic system disorders
LYMPHOPENIA
|
0.00%
0/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
5.0%
1/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.00%
0/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
10.0%
2/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
6.2%
1/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
0.00%
0/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
0.00%
0/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
5.0%
1/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Skin and subcutaneous tissue disorders
SKIN LESION
|
12.5%
2/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
0.00%
0/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Skin and subcutaneous tissue disorders
RASH GENERALISED
|
0.00%
0/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
5.0%
1/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Reproductive system and breast disorders
PROSTATITIS
|
6.2%
1/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
0.00%
0/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Reproductive system and breast disorders
GYNAECOMASTIA
|
0.00%
0/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
5.0%
1/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Reproductive system and breast disorders
TESTICULAR PAIN
|
0.00%
0/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
5.0%
1/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Reproductive system and breast disorders
UTERINE PROLAPSE
|
0.00%
0/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
5.0%
1/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Reproductive system and breast disorders
ENDOMETRIAL HYPERTROPHY
|
6.2%
1/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
0.00%
0/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Reproductive system and breast disorders
PROSTATIC CALCIFICATION
|
0.00%
0/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
5.0%
1/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Reproductive system and breast disorders
BENIGN PROSTATIC HYPERPLASIA
|
0.00%
0/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
5.0%
1/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Injury, poisoning and procedural complications
LIMB INJURY
|
6.2%
1/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
0.00%
0/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Injury, poisoning and procedural complications
MUSCLE STRAIN
|
0.00%
0/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
5.0%
1/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Injury, poisoning and procedural complications
ANKLE FRACTURE
|
0.00%
0/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
5.0%
1/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Injury, poisoning and procedural complications
HEAT EXHAUSTION
|
0.00%
0/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
5.0%
1/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Injury, poisoning and procedural complications
PROCEDURAL PAIN
|
6.2%
1/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
0.00%
0/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Injury, poisoning and procedural complications
ROAD TRAFFIC ACCIDENT
|
6.2%
1/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
5.0%
1/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL SWELLING
|
0.00%
0/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
5.0%
1/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
6.2%
1/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
5.0%
1/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
12.5%
2/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
10.0%
2/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
0.00%
0/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
5.0%
1/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
6.2%
1/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
5.0%
1/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Musculoskeletal and connective tissue disorders
TENDONITIS
|
0.00%
0/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
5.0%
1/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
0.00%
0/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
25.0%
5/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Musculoskeletal and connective tissue disorders
JOINT SWELLING
|
6.2%
1/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
0.00%
0/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.00%
0/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
10.0%
2/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
12.5%
2/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
0.00%
0/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
18.8%
3/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
0.00%
0/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
6.2%
1/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
0.00%
0/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
SINUS CONGESTION
|
12.5%
2/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
0.00%
0/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
6.2%
1/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
5.0%
1/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
SLEEP APNOEA SYNDROME
|
0.00%
0/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
5.0%
1/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
General disorders
PAIN
|
6.2%
1/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
0.00%
0/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
General disorders
FATIGUE
|
12.5%
2/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
10.0%
2/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
General disorders
CHEST PAIN
|
6.2%
1/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
0.00%
0/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
General disorders
HERNIA PAIN
|
0.00%
0/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
5.0%
1/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
General disorders
CHEST DISCOMFORT
|
6.2%
1/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
0.00%
0/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
General disorders
OEDEMA PERIPHERAL
|
6.2%
1/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
10.0%
2/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
General disorders
INFUSION SITE PAIN
|
12.5%
2/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
20.0%
4/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
|
General disorders
INFUSION SITE DISCOMFORT
|
0.00%
0/16 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
5.0%
1/20 • Short term period (up to 12 weeks) + long term period (up to 104 weeks)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER