Trial Outcomes & Findings for Ertugliflozin and Sitagliptin Co-administration Factorial Study (VERTIS FACTORAL, MK-8835-005) (NCT NCT02099110)
NCT ID: NCT02099110
Last Updated: 2018-09-12
Results Overview
A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). This change from baseline reflects the Week 26 A1C minus the Week 0 A1C. Excluding recue approach data analysis excluded all data following the initiation of rescue therapy at any time point, in order to avoid the confounding influence of the rescue therapy.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1233 participants
Primary outcome timeframe
Baseline and Week 26
Results posted on
2018-09-12
Participant Flow
The trial was conducted in 21 countries and included 242 trial centers.
Participants on ≥1500 mg/day of metformin for ≥8 weeks with A1C ≥7.5 and ≤11% at screening could directly enter a 2-week, single-blind, placebo run-in period. Participants who did not meet these criteria, received diet/exercise counseling and metformin titration (as necessary) for \~8 weeks before entering the 2-week, placebo run-in period.
Participant milestones
| Measure |
Ertugliflozin 5 mg
Ertugliflozin 5 mg, oral, once daily for 52 weeks
|
Ertugliflozin 15 mg
Ertugliflozin, oral, once daily for 52 weeks
|
Sitagliptin 100 mg
Sitagliptin 100 mg, oral, once daily for 52 weeks
|
Ertugliflozin 5 mg + Sitagliptin 100 mg
Ertugliflozin 5 mg + sitagliptin 100 mg, oral, once daily for 52 weeks
|
Ertugliflozin 15 mg + Sitagliptin 100 mg
Ertugliflozin 15 mg + sitagliptin 100 mg, oral, once daily for 52 weeks
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
250
|
248
|
247
|
243
|
245
|
|
Overall Study
Treated
|
250
|
248
|
247
|
243
|
244
|
|
Overall Study
COMPLETED
|
226
|
217
|
219
|
221
|
218
|
|
Overall Study
NOT COMPLETED
|
24
|
31
|
28
|
22
|
27
|
Reasons for withdrawal
| Measure |
Ertugliflozin 5 mg
Ertugliflozin 5 mg, oral, once daily for 52 weeks
|
Ertugliflozin 15 mg
Ertugliflozin, oral, once daily for 52 weeks
|
Sitagliptin 100 mg
Sitagliptin 100 mg, oral, once daily for 52 weeks
|
Ertugliflozin 5 mg + Sitagliptin 100 mg
Ertugliflozin 5 mg + sitagliptin 100 mg, oral, once daily for 52 weeks
|
Ertugliflozin 15 mg + Sitagliptin 100 mg
Ertugliflozin 15 mg + sitagliptin 100 mg, oral, once daily for 52 weeks
|
|---|---|---|---|---|---|
|
Overall Study
Protocol Violation
|
2
|
1
|
0
|
3
|
1
|
|
Overall Study
Participant moved
|
1
|
1
|
1
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
7
|
11
|
13
|
9
|
13
|
|
Overall Study
Adverse Event
|
3
|
5
|
2
|
3
|
2
|
|
Overall Study
Lost to Follow-up
|
6
|
12
|
11
|
5
|
6
|
|
Overall Study
Death
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Screen failure
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Non-compliance with study drug
|
2
|
0
|
0
|
0
|
1
|
|
Overall Study
Physician Decision
|
3
|
0
|
1
|
2
|
1
|
Baseline Characteristics
Participants with baseline data for A1C.
Baseline characteristics by cohort
| Measure |
Ertugliflozin 5 mg
n=250 Participants
Ertugliflozin 5 mg, oral, once daily for 52 weeks
|
Ertugliflozin 15 mg
n=248 Participants
Ertugliflozin, oral, once daily for 52 weeks
|
Sitagliptin 100 mg
n=247 Participants
Sitagliptin 100 mg, oral, once daily for 52 weeks
|
Ertugliflozin 5 mg + Sitagliptin 100 mg
n=243 Participants
Ertugliflozin 5 mg + sitagliptin 100 mg, oral, once daily for 52 weeks
|
Ertugliflozin 15 mg + Sitagliptin 100 mg
n=244 Participants
Ertugliflozin 15 mg + sitagliptin 100 mg, oral, once daily for 52 weeks
|
Total
n=1232 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
55.1 Years
STANDARD_DEVIATION 10.1 • n=250 Participants
|
55.3 Years
STANDARD_DEVIATION 9.5 • n=248 Participants
|
54.8 Years
STANDARD_DEVIATION 10.7 • n=247 Participants
|
55.2 Years
STANDARD_DEVIATION 10.4 • n=243 Participants
|
55.1 Years
STANDARD_DEVIATION 9.8 • n=244 Participants
|
55.1 Years
STANDARD_DEVIATION 10.1 • n=1232 Participants
|
|
Sex: Female, Male
Female
|
123 Participants
n=250 Participants
|
114 Participants
n=248 Participants
|
93 Participants
n=247 Participants
|
120 Participants
n=243 Participants
|
118 Participants
n=244 Participants
|
568 Participants
n=1232 Participants
|
|
Sex: Female, Male
Male
|
127 Participants
n=250 Participants
|
134 Participants
n=248 Participants
|
154 Participants
n=247 Participants
|
123 Participants
n=243 Participants
|
126 Participants
n=244 Participants
|
664 Participants
n=1232 Participants
|
|
Baseline Hemoglobin A1C (A1C)
|
8.6 Percent
STANDARD_DEVIATION 1.0 • n=244 Participants • Participants with baseline data for A1C.
|
8.6 Percent
STANDARD_DEVIATION 1.0 • n=247 Participants • Participants with baseline data for A1C.
|
8.5 Percent
STANDARD_DEVIATION 1.0 • n=242 Participants • Participants with baseline data for A1C.
|
8.6 Percent
STANDARD_DEVIATION 1.0 • n=237 Participants • Participants with baseline data for A1C.
|
8.6 Percent
STANDARD_DEVIATION 1.0 • n=241 Participants • Participants with baseline data for A1C.
|
8.6 Percent
STANDARD_DEVIATION 1.0 • n=1211 Participants • Participants with baseline data for A1C.
|
|
Baseline Body Weight
|
88.6 Kilograms
STANDARD_DEVIATION 22.2 • n=250 Participants
|
88.0 Kilograms
STANDARD_DEVIATION 20.3 • n=248 Participants
|
89.8 Kilograms
STANDARD_DEVIATION 23.4 • n=247 Participants
|
89.5 Kilograms
STANDARD_DEVIATION 20.8 • n=243 Participants
|
87.5 Kilograms
STANDARD_DEVIATION 20.5 • n=244 Participants
|
88.7 Kilograms
STANDARD_DEVIATION 21.5 • n=1232 Participants
|
|
Baseline Fasting Plasma Glucose
|
184.1 mg/dL
STANDARD_DEVIATION 52.2 • n=250 Participants • Participants with baseline data for Fasting Plasma Glucose.
|
179.5 mg/dL
STANDARD_DEVIATION 45.7 • n=247 Participants • Participants with baseline data for Fasting Plasma Glucose.
|
177.4 mg/dL
STANDARD_DEVIATION 46.6 • n=246 Participants • Participants with baseline data for Fasting Plasma Glucose.
|
183.8 mg/dL
STANDARD_DEVIATION 44.3 • n=240 Participants • Participants with baseline data for Fasting Plasma Glucose.
|
177.2 mg/dL
STANDARD_DEVIATION 49.4 • n=241 Participants • Participants with baseline data for Fasting Plasma Glucose.
|
180.4 mg/dL
STANDARD_DEVIATION 47.8 • n=1224 Participants • Participants with baseline data for Fasting Plasma Glucose.
|
|
Static Beta-Cell Sensitivity to Glucose Index
|
20.9 SBCSGI (10^-9min^-1)
STANDARD_DEVIATION 26.1 • n=58 Participants • Participants with baseline data for SBCSGI.
|
18.0 SBCSGI (10^-9min^-1)
STANDARD_DEVIATION 16.3 • n=58 Participants • Participants with baseline data for SBCSGI.
|
20.2 SBCSGI (10^-9min^-1)
STANDARD_DEVIATION 21.2 • n=55 Participants • Participants with baseline data for SBCSGI.
|
20.0 SBCSGI (10^-9min^-1)
STANDARD_DEVIATION 16.6 • n=48 Participants • Participants with baseline data for SBCSGI.
|
19.3 SBCSGI (10^-9min^-1)
STANDARD_DEVIATION 21.0 • n=50 Participants • Participants with baseline data for SBCSGI.
|
19.7 SBCSGI (10^-9min^-1)
STANDARD_DEVIATION 20.5 • n=269 Participants • Participants with baseline data for SBCSGI.
|
|
Sitting Systolic Blood Pressure
|
129.7 mm Hg
STANDARD_DEVIATION 12.5 • n=250 Participants
|
128.9 mm Hg
STANDARD_DEVIATION 12.5 • n=248 Participants
|
128.3 mm Hg
STANDARD_DEVIATION 12.2 • n=247 Participants
|
130.2 mm Hg
STANDARD_DEVIATION 12.6 • n=243 Participants
|
129.1 mm Hg
STANDARD_DEVIATION 13.3 • n=244 Participants
|
129.3 mm Hg
STANDARD_DEVIATION 12.6 • n=1232 Participants
|
|
Baseline estimated glomerular filtration rate, eGFR
|
91.9 mL/min/1.73m^2
STANDARD_DEVIATION 20.6 • n=250 Participants • Participants with baseline data for eGFR.
|
92.8 mL/min/1.73m^2
STANDARD_DEVIATION 21.4 • n=248 Participants • Participants with baseline data for eGFR.
|
92.6 mL/min/1.73m^2
STANDARD_DEVIATION 18.2 • n=247 Participants • Participants with baseline data for eGFR.
|
91.9 mL/min/1.73m^2
STANDARD_DEVIATION 20.4 • n=242 Participants • Participants with baseline data for eGFR.
|
92.6 mL/min/1.73m^2
STANDARD_DEVIATION 19.2 • n=244 Participants • Participants with baseline data for eGFR.
|
92.4 mL/min/1.73m^2
STANDARD_DEVIATION 20.0 • n=1231 Participants • Participants with baseline data for eGFR.
|
PRIMARY outcome
Timeframe: Baseline and Week 26Population: The analysis population consisted of all randomized participants who received at least one dose of study treatment, had a baseline measurement or a post-randomization measurement for the A1C change from baseline at Week 26 analysis endpoint subsequent to at least one dose of study treatment.
A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). This change from baseline reflects the Week 26 A1C minus the Week 0 A1C. Excluding recue approach data analysis excluded all data following the initiation of rescue therapy at any time point, in order to avoid the confounding influence of the rescue therapy.
Outcome measures
| Measure |
Ertugliflozin 5 mg
n=250 Participants
Ertugliflozin 5 mg, oral, once daily for 52 weeks
|
Ertugliflozin 15 mg
n=248 Participants
Ertugliflozin, oral, once daily for 52 weeks
|
Sitagliptin 100 mg
n=247 Participants
Sitagliptin 100 mg, oral, once daily for 52 weeks
|
Ertugliflozin 5 mg + Sitagliptin 100 mg
n=243 Participants
Ertugliflozin 5 mg + sitagliptin 100 mg, oral, once daily for 52 weeks
|
Ertugliflozin 15 mg + Sitagliptin 100 mg
n=244 Participants
Ertugliflozin 15 mg + sitagliptin 100 mg, oral, once daily for 52 weeks
|
|---|---|---|---|---|---|
|
Change From Baseline in A1C at Week 26: Excluding Rescue Approach
|
-1.02 Percentage
Interval -1.14 to -0.9
|
-1.08 Percentage
Interval -1.2 to -0.96
|
-1.05 Percentage
Interval -1.17 to -0.93
|
-1.49 Percentage
Interval -1.61 to -1.36
|
-1.52 Percentage
Interval -1.64 to -1.4
|
PRIMARY outcome
Timeframe: Up to 54 weeksPopulation: The analysis population consists of all randomized participants who received at least 1 dose of study treatment.
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Including rescue approach data analysis included data following the initiation of rescue therapy.
Outcome measures
| Measure |
Ertugliflozin 5 mg
n=250 Participants
Ertugliflozin 5 mg, oral, once daily for 52 weeks
|
Ertugliflozin 15 mg
n=248 Participants
Ertugliflozin, oral, once daily for 52 weeks
|
Sitagliptin 100 mg
n=247 Participants
Sitagliptin 100 mg, oral, once daily for 52 weeks
|
Ertugliflozin 5 mg + Sitagliptin 100 mg
n=243 Participants
Ertugliflozin 5 mg + sitagliptin 100 mg, oral, once daily for 52 weeks
|
Ertugliflozin 15 mg + Sitagliptin 100 mg
n=244 Participants
Ertugliflozin 15 mg + sitagliptin 100 mg, oral, once daily for 52 weeks
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Experienced an Adverse Event (AE): Including Rescue Approach
|
62.0 Percentage of participants
|
57.7 Percentage of participants
|
57.5 Percentage of participants
|
58.8 Percentage of participants
|
55.7 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to 52 weeksPopulation: The analysis population consists of all randomized participants who received at least 1 dose of study treatment.
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Including rescue approach data analysis included data following the initiation of rescue therapy.
Outcome measures
| Measure |
Ertugliflozin 5 mg
n=250 Participants
Ertugliflozin 5 mg, oral, once daily for 52 weeks
|
Ertugliflozin 15 mg
n=248 Participants
Ertugliflozin, oral, once daily for 52 weeks
|
Sitagliptin 100 mg
n=247 Participants
Sitagliptin 100 mg, oral, once daily for 52 weeks
|
Ertugliflozin 5 mg + Sitagliptin 100 mg
n=243 Participants
Ertugliflozin 5 mg + sitagliptin 100 mg, oral, once daily for 52 weeks
|
Ertugliflozin 15 mg + Sitagliptin 100 mg
n=244 Participants
Ertugliflozin 15 mg + sitagliptin 100 mg, oral, once daily for 52 weeks
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Discontinued Study Treatment Due to an AE: Including Rescue Approach
|
3.2 Percentage of participants
|
3.2 Percentage of participants
|
2.8 Percentage of participants
|
3.3 Percentage of participants
|
3.7 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 26Population: The analysis population consisted of all randomized participants who received at least one dose of study treatment, had a baseline measurement or a post-randomization measurement for the body weight change from baseline at Week 26 analysis endpoint subsequent to at least one dose of study treatment.
This change from baseline reflects the Week 26 body weight minus the Week 0 body weight. Excluding recue approach data analysis excluded all data following the initiation of rescue therapy at any time point, in order to avoid the confounding influence of the rescue therapy.
Outcome measures
| Measure |
Ertugliflozin 5 mg
n=250 Participants
Ertugliflozin 5 mg, oral, once daily for 52 weeks
|
Ertugliflozin 15 mg
n=248 Participants
Ertugliflozin, oral, once daily for 52 weeks
|
Sitagliptin 100 mg
n=247 Participants
Sitagliptin 100 mg, oral, once daily for 52 weeks
|
Ertugliflozin 5 mg + Sitagliptin 100 mg
n=243 Participants
Ertugliflozin 5 mg + sitagliptin 100 mg, oral, once daily for 52 weeks
|
Ertugliflozin 15 mg + Sitagliptin 100 mg
n=244 Participants
Ertugliflozin 15 mg + sitagliptin 100 mg, oral, once daily for 52 weeks
|
|---|---|---|---|---|---|
|
Change From Baseline in Body Weight at Week 26: Excluding Rescue Approach
|
-2.69 Kilograms
Interval -3.13 to -2.25
|
-3.74 Kilograms
Interval -4.18 to -3.29
|
-0.67 Kilograms
Interval -1.12 to -0.22
|
-2.52 Kilograms
Interval -2.97 to -2.07
|
-2.94 Kilograms
Interval -3.39 to -2.49
|
SECONDARY outcome
Timeframe: Baseline and Week 26Population: The analysis population consisted of all randomized participants who received at least one dose of study treatment, had a baseline measurement or a post-randomization measurement for the FPG change from baseline at Week 26 analysis endpoint subsequent to at least one dose of study treatment.
Blood glucose was measured on a fasting basis after at least a 10-hour fast. This change from baseline reflects the Week 26 FPG minus the Week 0 FPG. Excluding recue approach data analysis excluded all data following the initiation of rescue therapy at any time point, in order to avoid the confounding influence of the rescue therapy.
Outcome measures
| Measure |
Ertugliflozin 5 mg
n=250 Participants
Ertugliflozin 5 mg, oral, once daily for 52 weeks
|
Ertugliflozin 15 mg
n=248 Participants
Ertugliflozin, oral, once daily for 52 weeks
|
Sitagliptin 100 mg
n=247 Participants
Sitagliptin 100 mg, oral, once daily for 52 weeks
|
Ertugliflozin 5 mg + Sitagliptin 100 mg
n=243 Participants
Ertugliflozin 5 mg + sitagliptin 100 mg, oral, once daily for 52 weeks
|
Ertugliflozin 15 mg + Sitagliptin 100 mg
n=244 Participants
Ertugliflozin 15 mg + sitagliptin 100 mg, oral, once daily for 52 weeks
|
|---|---|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 - Excluding Rescue Approach
|
-35.73 mg/dL
Interval -40.04 to -31.42
|
-36.91 mg/dL
Interval -41.21 to -32.62
|
-25.56 mg/dL
Interval -29.93 to -21.19
|
-43.96 mg/dL
Interval -48.29 to -39.63
|
-48.70 mg/dL
Interval -53.01 to -44.39
|
SECONDARY outcome
Timeframe: Week 26Population: The analysis population consisted of all randomized participants who received at least one dose of study treatment, had a post-randomization measurement for the A1C change from baseline at Week 26 analysis endpoint subsequent to at least one dose of study treatment.
A1C is blood marker used to report average blood glucose levels over a prolonged periods of time and is reported as a percentage (%). Excluding recue approach data analysis excluded all data following the initiation of rescue therapy at any time point, in order to avoid the confounding influence of the rescue therapy.
Outcome measures
| Measure |
Ertugliflozin 5 mg
n=250 Participants
Ertugliflozin 5 mg, oral, once daily for 52 weeks
|
Ertugliflozin 15 mg
n=248 Participants
Ertugliflozin, oral, once daily for 52 weeks
|
Sitagliptin 100 mg
n=247 Participants
Sitagliptin 100 mg, oral, once daily for 52 weeks
|
Ertugliflozin 5 mg + Sitagliptin 100 mg
n=243 Participants
Ertugliflozin 5 mg + sitagliptin 100 mg, oral, once daily for 52 weeks
|
Ertugliflozin 15 mg + Sitagliptin 100 mg
n=244 Participants
Ertugliflozin 15 mg + sitagliptin 100 mg, oral, once daily for 52 weeks
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving a Hemoglobin A1C of <7% (<53 mmol/Mol) (Raw Proportions): Excluding Rescue Approach
|
26.4 Percentage of participants
|
31.9 Percentage of participants
|
32.8 Percentage of participants
|
52.3 Percentage of participants
|
49.2 Percentage of participants
|
SECONDARY outcome
Timeframe: 30 min. before and 0, 15, 30, 60, 90, 120, and 180 minutes following the start of the standard meal at Baseline and Week 26Population: The analysis population consisted of all randomized participants who received at least one dose of study treatment, had a baseline measurement or a post-randomization measurement for the beta-cell responsivity static component change from baseline at Week 26 analysis endpoint subsequent to at least one dose of study treatment.
Static beta-cell sensitivity to glucose index (SBCSGI) estimates the ratio of insulin secretion (expressed in pmol/min) related to above-basal glucose concentration (expressed in mmol/L \* L) following a meal. Blood samples were collected before and after a standard meal and glucose, insulin, and C-peptide levels were analyzed. The C-peptides minimal model was used to estimate the insulin secretion rate (ISR). Analysis included both non-model-based \[including insulinogenic index with C-peptide, glucose area under the curve (AUC)/insulin AUC\] and model-based \[beta cell function and insulin secretion rate at 9 mM glucose\] testing. Analysis was performed with non-linear least squares using the Software Architecture Analysis Method (SAAM) II software. SBCSGI was expressed in units of 10\^-9 min\^-1. Excluding rescue approach data analysis excluded all data following the initiation of rescue therapy at any time point, in order to avoid the confounding influence of the rescue therapy.
Outcome measures
| Measure |
Ertugliflozin 5 mg
n=66 Participants
Ertugliflozin 5 mg, oral, once daily for 52 weeks
|
Ertugliflozin 15 mg
n=67 Participants
Ertugliflozin, oral, once daily for 52 weeks
|
Sitagliptin 100 mg
n=63 Participants
Sitagliptin 100 mg, oral, once daily for 52 weeks
|
Ertugliflozin 5 mg + Sitagliptin 100 mg
n=55 Participants
Ertugliflozin 5 mg + sitagliptin 100 mg, oral, once daily for 52 weeks
|
Ertugliflozin 15 mg + Sitagliptin 100 mg
n=61 Participants
Ertugliflozin 15 mg + sitagliptin 100 mg, oral, once daily for 52 weeks
|
|---|---|---|---|---|---|
|
Change From Baseline in Static Beta-Cell Sensitivity to Glucose Index at Week 26; Excluding Rescue Approach
|
8.62 SBCSGI (10^-9min^-1)
Interval 1.28 to 15.96
|
9.71 SBCSGI (10^-9min^-1)
Interval 2.29 to 17.13
|
21.11 SBCSGI (10^-9min^-1)
Interval 13.55 to 28.67
|
16.24 SBCSGI (10^-9min^-1)
Interval 8.36 to 24.11
|
11.51 SBCSGI (10^-9min^-1)
Interval 3.76 to 19.26
|
SECONDARY outcome
Timeframe: Baseline and Week 26Population: The analysis population consisted of all randomized participants who received at least one dose of study treatment, had a baseline measurement or a post-randomization measurement for the systolic blood pressure change from baseline at Week 26 analysis endpoint subsequent to at least one dose of study treatment.
This change from baseline reflects the Week 26 systolic blood pressure minus the Week 0 systolic blood pressure. Excluding recue approach data analysis excluded all data following the initiation of rescue therapy at any time point, in order to avoid the confounding influence of the rescue therapy.
Outcome measures
| Measure |
Ertugliflozin 5 mg
n=250 Participants
Ertugliflozin 5 mg, oral, once daily for 52 weeks
|
Ertugliflozin 15 mg
n=248 Participants
Ertugliflozin, oral, once daily for 52 weeks
|
Sitagliptin 100 mg
n=247 Participants
Sitagliptin 100 mg, oral, once daily for 52 weeks
|
Ertugliflozin 5 mg + Sitagliptin 100 mg
n=243 Participants
Ertugliflozin 5 mg + sitagliptin 100 mg, oral, once daily for 52 weeks
|
Ertugliflozin 15 mg + Sitagliptin 100 mg
n=245 Participants
Ertugliflozin 15 mg + sitagliptin 100 mg, oral, once daily for 52 weeks
|
|---|---|---|---|---|---|
|
Change From Baseline in Sitting Systolic Blood Pressure at Week 26: Excluding Rescue Approach
|
-3.89 mm Hg
Interval -5.28 to -2.5
|
-3.69 mm Hg
Interval -5.08 to -2.3
|
-0.66 mm Hg
Interval -2.07 to 0.76
|
-3.42 mm Hg
Interval -4.82 to -2.03
|
-3.67 mm Hg
Interval -5.06 to -2.29
|
Adverse Events
Ertugliflozin 5 mg
Serious events: 12 serious events
Other events: 36 other events
Deaths: 0 deaths
Ertugliflozin 15 mg
Serious events: 5 serious events
Other events: 43 other events
Deaths: 0 deaths
Sitagliptin 100 mg
Serious events: 8 serious events
Other events: 28 other events
Deaths: 0 deaths
Ertugliflozin 5 mg + Sitagliptin 100 mg
Serious events: 9 serious events
Other events: 31 other events
Deaths: 0 deaths
Ertugliflozin 15 mg + Sitagliptin 100 mg
Serious events: 12 serious events
Other events: 38 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ertugliflozin 5 mg
n=250 participants at risk
Ertugliflozin 5 mg, oral, once daily for 52 weeks
|
Ertugliflozin 15 mg
n=248 participants at risk
Ertugliflozin, oral, once daily for 52 weeks
|
Sitagliptin 100 mg
n=247 participants at risk
Sitagliptin 100 mg, oral, once daily for 52 weeks
|
Ertugliflozin 5 mg + Sitagliptin 100 mg
n=243 participants at risk
Ertugliflozin 5 mg + sitagliptin 100 mg, oral, once daily for 52 weeks
|
Ertugliflozin 15 mg + Sitagliptin 100 mg
n=244 participants at risk
Ertugliflozin 15 mg + sitagliptin 100 mg, oral, once daily for 52 weeks
|
|---|---|---|---|---|---|
|
Investigations
Blood potassium decreased
|
0.00%
0/250 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/248 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/247 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.41%
1/243 • Number of events 1 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/244 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
|
Investigations
Blood sodium decreased
|
0.00%
0/250 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/248 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/247 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.41%
1/243 • Number of events 1 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/244 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.40%
1/250 • Number of events 1 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/248 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/247 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.41%
1/243 • Number of events 1 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/244 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.40%
1/250 • Number of events 1 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/248 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.40%
1/247 • Number of events 1 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/243 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.82%
2/244 • Number of events 2 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
|
Cardiac disorders
Angina pectoris
|
0.40%
1/250 • Number of events 1 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/248 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/247 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/243 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.41%
1/244 • Number of events 1 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/250 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/248 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.40%
1/247 • Number of events 1 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/243 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/244 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.40%
1/250 • Number of events 1 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/248 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/247 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/243 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/244 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/250 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/248 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/247 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/243 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.41%
1/244 • Number of events 1 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
|
Cardiac disorders
Microvascular coronary artery disease
|
0.40%
1/250 • Number of events 1 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/248 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/247 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/243 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/244 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/250 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/248 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.40%
1/247 • Number of events 1 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.41%
1/243 • Number of events 1 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.41%
1/244 • Number of events 1 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/250 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/248 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/247 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.41%
1/243 • Number of events 1 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/244 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/250 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.40%
1/248 • Number of events 1 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/247 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/243 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/244 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/250 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.40%
1/248 • Number of events 1 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.40%
1/247 • Number of events 1 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.41%
1/243 • Number of events 1 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/244 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/250 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.40%
1/248 • Number of events 1 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/247 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/243 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/244 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
|
Nervous system disorders
Syncope
|
0.40%
1/250 • Number of events 1 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/248 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/247 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/243 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/244 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.00%
0/250 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.40%
1/248 • Number of events 1 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/247 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/243 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/244 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/250 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.40%
1/248 • Number of events 1 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/247 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/243 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/244 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.00%
0/250 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/248 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/247 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.41%
1/243 • Number of events 1 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/244 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
|
Gastrointestinal disorders
Femoral hernia
|
0.40%
1/250 • Number of events 1 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/248 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/247 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/243 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/244 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.40%
1/250 • Number of events 1 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/248 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/247 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/243 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/244 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
|
Gastrointestinal disorders
Haematochezia
|
0.40%
1/250 • Number of events 1 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/248 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/247 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/243 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/244 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.40%
1/250 • Number of events 1 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/248 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/247 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/243 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/244 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.40%
1/250 • Number of events 1 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/248 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/247 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/243 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/244 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/250 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/248 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.40%
1/247 • Number of events 1 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/243 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/244 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
|
Gastrointestinal disorders
Vomiting
|
0.80%
2/250 • Number of events 2 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/248 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/247 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/243 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/244 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/250 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/248 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.40%
1/247 • Number of events 1 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/243 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/244 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/250 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/248 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/247 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.41%
1/243 • Number of events 1 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/244 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/250 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/248 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/247 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/243 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.41%
1/244 • Number of events 1 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/250 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/248 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/247 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/243 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.41%
1/244 • Number of events 1 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/250 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/248 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/247 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.41%
1/243 • Number of events 1 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/244 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/250 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/248 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/247 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/243 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.41%
1/244 • Number of events 1 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
|
Infections and infestations
Cellulitis orbital
|
0.00%
0/250 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/248 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/247 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.41%
1/243 • Number of events 1 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/244 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/250 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/248 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.40%
1/247 • Number of events 1 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/243 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/244 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
|
Infections and infestations
Gangrene
|
0.00%
0/250 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.40%
1/248 • Number of events 1 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/247 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/243 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/244 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.00%
0/250 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/248 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.40%
1/247 • Number of events 1 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/243 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/244 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
|
Infections and infestations
Pneumococcal sepsis
|
0.00%
0/250 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/248 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/247 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/243 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.41%
1/244 • Number of events 1 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/250 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/248 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.40%
1/247 • Number of events 1 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/243 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.41%
1/244 • Number of events 1 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/250 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/248 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/247 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/243 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.41%
1/244 • Number of events 1 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/250 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/248 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/247 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.41%
1/243 • Number of events 1 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/244 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/250 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/248 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/247 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/243 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.41%
1/244 • Number of events 1 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/250 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/248 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/247 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/243 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.41%
1/244 • Number of events 1 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.40%
1/250 • Number of events 1 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/248 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/247 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/243 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/244 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nodal marginal zone B-cell lymphoma stage III
|
0.00%
0/250 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/248 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/247 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.41%
1/243 • Number of events 1 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/244 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/250 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/248 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/247 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/243 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.41%
1/244 • Number of events 1 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic neoplasm
|
0.00%
0/250 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/248 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/247 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/243 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.41%
1/244 • Number of events 1 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
|
Vascular disorders
Deep vein thrombosis
|
0.40%
1/250 • Number of events 1 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/248 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/247 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/243 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/244 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
|
Vascular disorders
Hypertension
|
0.40%
1/250 • Number of events 1 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/248 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/247 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/243 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/244 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/250 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/248 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.40%
1/247 • Number of events 2 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/243 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/244 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/250 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/248 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/247 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/243 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.41%
1/244 • Number of events 1 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/250 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/248 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/247 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/243 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.41%
1/244 • Number of events 1 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/250 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/248 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/247 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/243 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.41%
1/244 • Number of events 1 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.40%
1/250 • Number of events 1 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/248 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/247 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/243 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
0.00%
0/244 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
Other adverse events
| Measure |
Ertugliflozin 5 mg
n=250 participants at risk
Ertugliflozin 5 mg, oral, once daily for 52 weeks
|
Ertugliflozin 15 mg
n=248 participants at risk
Ertugliflozin, oral, once daily for 52 weeks
|
Sitagliptin 100 mg
n=247 participants at risk
Sitagliptin 100 mg, oral, once daily for 52 weeks
|
Ertugliflozin 5 mg + Sitagliptin 100 mg
n=243 participants at risk
Ertugliflozin 5 mg + sitagliptin 100 mg, oral, once daily for 52 weeks
|
Ertugliflozin 15 mg + Sitagliptin 100 mg
n=244 participants at risk
Ertugliflozin 15 mg + sitagliptin 100 mg, oral, once daily for 52 weeks
|
|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
4.8%
12/250 • Number of events 25 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
5.2%
13/248 • Number of events 29 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
4.5%
11/247 • Number of events 22 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
3.7%
9/243 • Number of events 17 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
8.2%
20/244 • Number of events 42 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
|
Infections and infestations
Nasopharyngitis
|
2.4%
6/250 • Number of events 6 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
5.2%
13/248 • Number of events 14 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
2.4%
6/247 • Number of events 7 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
4.9%
12/243 • Number of events 14 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
4.9%
12/244 • Number of events 13 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
|
Infections and infestations
Urinary tract infection
|
8.0%
20/250 • Number of events 24 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
7.7%
19/248 • Number of events 23 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
5.3%
13/247 • Number of events 13 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
5.8%
14/243 • Number of events 18 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
3.3%
8/244 • Number of events 12 • Up to 54 weeks
The safety population consisted of all randomized participants who took at least one dose of trial treatment. Participants were included in the treatment group corresponding to the trial treatment they actually took. This analysis included events that occurred following the initiation of rescue therapy.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
- Publication restrictions are in place
Restriction type: OTHER