Trial Outcomes & Findings for Efficacy, Safety, and Tolerability Study of Sotagliflozin as Adjunct Therapy in Adult Patients With Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control With Insulin Therapy (NCT NCT02421510)
NCT ID: NCT02421510
Last Updated: 2020-02-12
Results Overview
Baseline value was defined as the last value collected prior to the first dose of double-blind study medication. Least square (LS) means were obtained from a mixed-effects model for repeated measures (MMRM) that included fixed, categorical effects of treatment, randomization strata of insulin delivery method (MDI, CSII), randomization strata of Week -2 A1C (\<= 8.5%, \>8.5%), time (study week), a treatment-by-time interaction, and baseline A1C-by-time interaction as a covariate. A negative change from baseline (a reduction of A1C value at Week 24) indicates an improvement.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
782 participants
Primary outcome timeframe
Baseline to Week 24
Results posted on
2020-02-12
Participant Flow
Participants took part in the study at 96 investigative sites throughout 17 countries from 21 May 2015 to 23 June 2017.
995 participants were screened and 782 participants with a diagnosis of Type 1 diabetes mellitus were randomized equally in 1 of 3 treatment groups: sotagliflozin 400 mg, sotagliflozin 200 mg or placebo.
Participant milestones
| Measure |
Placebo
Two placebo-matching sotagliflozin tablets, once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period.
|
Sotagliflozin 200 mg
Sotagliflozin 200 mg (one 200 mg tablet and one placebo tablet), once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period.
|
Sotagliflozin 400 mg
Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period.
|
|---|---|---|---|
|
Overall Study
STARTED
|
258
|
261
|
263
|
|
Overall Study
Completed the 24 Week Treatment Period
|
236
|
239
|
240
|
|
Overall Study
COMPLETED
|
225
|
226
|
227
|
|
Overall Study
NOT COMPLETED
|
33
|
35
|
36
|
Reasons for withdrawal
| Measure |
Placebo
Two placebo-matching sotagliflozin tablets, once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period.
|
Sotagliflozin 200 mg
Sotagliflozin 200 mg (one 200 mg tablet and one placebo tablet), once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period.
|
Sotagliflozin 400 mg
Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period.
|
|---|---|---|---|
|
Overall Study
Other
|
4
|
2
|
3
|
|
Overall Study
Protocol Violation
|
1
|
2
|
0
|
|
Overall Study
Death
|
1
|
0
|
0
|
|
Overall Study
Noncompliance with study drug
|
1
|
0
|
0
|
|
Overall Study
Physician Decision
|
1
|
1
|
3
|
|
Overall Study
Adverse Event
|
9
|
10
|
18
|
|
Overall Study
Pregnancy
|
1
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
14
|
18
|
12
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
0
|
Baseline Characteristics
Efficacy, Safety, and Tolerability Study of Sotagliflozin as Adjunct Therapy in Adult Patients With Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control With Insulin Therapy
Baseline characteristics by cohort
| Measure |
Sotagliflozin 400 mg
n=263 Participants
Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period.
|
Total
n=782 Participants
Total of all reporting groups
|
Placebo
n=258 Participants
Two placebo-matching sotagliflozin tablets, once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period.
|
Sotagliflozin 200 mg
n=261 Participants
Sotagliflozin 200 mg (one 200 mg tablet and one placebo tablet), once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period.
|
|---|---|---|---|---|
|
Age, Continuous
|
41.7 Years
STANDARD_DEVIATION 13.23 • n=5 Participants
|
41.2 Years
STANDARD_DEVIATION 13.44 • n=4 Participants
|
39.7 Years
STANDARD_DEVIATION 13.42 • n=5 Participants
|
42.3 Years
STANDARD_DEVIATION 13.59 • n=7 Participants
|
|
Age, Customized
Adults (18-64 years)
|
253 Participants
n=5 Participants
|
749 Participants
n=4 Participants
|
244 Participants
n=5 Participants
|
252 Participants
n=7 Participants
|
|
Age, Customized
From 65-84 years
|
10 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
14 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
|
Sex: Female, Male
Female
|
130 Participants
n=5 Participants
|
376 Participants
n=4 Participants
|
124 Participants
n=5 Participants
|
122 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
133 Participants
n=5 Participants
|
406 Participants
n=4 Participants
|
134 Participants
n=5 Participants
|
139 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
250 Participants
n=5 Participants
|
752 Participants
n=4 Participants
|
250 Participants
n=5 Participants
|
252 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
|
Insulin Delivery Method
Continuous Subcutaneous Insulin Infusion (CSII)
|
67 Participants
n=5 Participants
|
201 Participants
n=4 Participants
|
66 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
|
Insulin Delivery Method
Multiple Daily Injections (MDI)
|
196 Participants
n=5 Participants
|
581 Participants
n=4 Participants
|
192 Participants
n=5 Participants
|
193 Participants
n=7 Participants
|
|
Hemoglobin A1C (A1C)
<= 8.5%
|
204 Participants
n=5 Participants
|
607 Participants
n=4 Participants
|
200 Participants
n=5 Participants
|
203 Participants
n=7 Participants
|
|
Hemoglobin A1C (A1C)
>8.5%
|
59 Participants
n=5 Participants
|
175 Participants
n=4 Participants
|
58 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
|
Hemoglobin A1C Value at Actual Week -2 Value
<= 8.5%
|
208 Participants
n=5 Participants
|
615 Participants
n=4 Participants
|
202 Participants
n=5 Participants
|
205 Participants
n=7 Participants
|
|
Hemoglobin A1C Value at Actual Week -2 Value
>8.5%
|
55 Participants
n=5 Participants
|
167 Participants
n=4 Participants
|
56 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
|
Body Weight
|
81.97 Kilograms (kg)
STANDARD_DEVIATION 17.963 • n=5 Participants
|
81.66 Kilograms (kg)
STANDARD_DEVIATION 17.394 • n=4 Participants
|
81.08 Kilograms (kg)
STANDARD_DEVIATION 16.857 • n=5 Participants
|
81.93 Kilograms (kg)
STANDARD_DEVIATION 17.386 • n=7 Participants
|
|
Duration of Diabetes
|
18.9 Years
STANDARD_DEVIATION 11.18 • n=5 Participants
|
18.4 Years
STANDARD_DEVIATION 10.90 • n=4 Participants
|
18.1 Years
STANDARD_DEVIATION 10.72 • n=5 Participants
|
18.2 Years
STANDARD_DEVIATION 10.82 • n=7 Participants
|
|
Daily Total Insulin Dose
|
0.74 International units per kilogram (IU/kg)
STANDARD_DEVIATION 0.267 • n=5 Participants
|
0.74 International units per kilogram (IU/kg)
STANDARD_DEVIATION 0.280 • n=4 Participants
|
0.75 International units per kilogram (IU/kg)
STANDARD_DEVIATION 0.295 • n=5 Participants
|
0.73 International units per kilogram (IU/kg)
STANDARD_DEVIATION 0.277 • n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 24Population: Analysis included participants from the modified intent to treat (mITT) population. Here, overall number of participants analyzed = participants with available data for this outcome measure.
Baseline value was defined as the last value collected prior to the first dose of double-blind study medication. Least square (LS) means were obtained from a mixed-effects model for repeated measures (MMRM) that included fixed, categorical effects of treatment, randomization strata of insulin delivery method (MDI, CSII), randomization strata of Week -2 A1C (\<= 8.5%, \>8.5%), time (study week), a treatment-by-time interaction, and baseline A1C-by-time interaction as a covariate. A negative change from baseline (a reduction of A1C value at Week 24) indicates an improvement.
Outcome measures
| Measure |
Placebo
n=239 Participants
Two placebo-matching sotagliflozin tablets, once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period.
|
Sotagliflozin 200 mg
n=239 Participants
Sotagliflozin 200 mg (one 200 mg tablet and one placebo tablet), once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period.
|
Sotagliflozin 400 mg
n=241 Participants
Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period.
|
|---|---|---|---|
|
Change From Baseline in A1C at Week 24
|
-0.02 Percentage of A1C
Standard Error 0.044
|
-0.39 Percentage of A1C
Standard Error 0.044
|
-0.37 Percentage of A1C
Standard Error 0.043
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Analysis included participants from the mITT population.
The composite endpoint included blood samples for the assessment of Hemoglobin A1C to determine the participants with a value \<7.0% and a central blinded adjudication process to determine whether participants experienced either DKA or severe hypoglycemia. Only positively adjudicated severe hypoglycemia and diabetic ketoacidosis were included in the analysis.
Outcome measures
| Measure |
Placebo
n=258 Participants
Two placebo-matching sotagliflozin tablets, once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period.
|
Sotagliflozin 200 mg
n=261 Participants
Sotagliflozin 200 mg (one 200 mg tablet and one placebo tablet), once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period.
|
Sotagliflozin 400 mg
n=263 Participants
Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period.
|
|---|---|---|---|
|
Percentage of Participants With A1C <7.0% at Week 24 and no Episode of Severe Hypoglycemia, and no Episode of Diabetic Ketoacidosis (DKA) From Baseline to Week 24
|
15.1 Percentage of participants
|
31.4 Percentage of participants
|
32.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Analysis included participants from the mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure.
Baseline value was defined as the last value collected prior to the first dose of double-blind study medication. LS means were obtained from MMRM model. A negative change from baseline indicates a loss in body weight from baseline to Week 24.
Outcome measures
| Measure |
Placebo
n=240 Participants
Two placebo-matching sotagliflozin tablets, once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period.
|
Sotagliflozin 200 mg
n=240 Participants
Sotagliflozin 200 mg (one 200 mg tablet and one placebo tablet), once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period.
|
Sotagliflozin 400 mg
n=241 Participants
Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period.
|
|---|---|---|---|
|
Change From Baseline in Body Weight at Week 24
|
0.11 Kilograms (kg)
Standard Error 0.201
|
-1.88 Kilograms (kg)
Standard Error 0.200
|
-2.47 Kilograms (kg)
Standard Error 0.199
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Analysis included participants from the mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure.
The mean bolus insulin dose in international units/day (IU/day) for Week 24 was the average over the 3 to 5 days prior to the Week 24 visit. The Baseline value was defined as the last value collected prior to the first dose of double-blind study medication. LS means were obtained from MMRM model including all available post baseline values. A negative change from baseline indicated a reduction in the amount of bolus insulin used and a positive change from baseline indicated an increase in the amount of bolus insulin used between baseline and Week 24.
Outcome measures
| Measure |
Placebo
n=238 Participants
Two placebo-matching sotagliflozin tablets, once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period.
|
Sotagliflozin 200 mg
n=237 Participants
Sotagliflozin 200 mg (one 200 mg tablet and one placebo tablet), once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period.
|
Sotagliflozin 400 mg
n=239 Participants
Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period.
|
|---|---|---|---|
|
Change From Baseline in Mean Daily Bolus Insulin Dose at Week 24
|
-1.19 IU/day
Standard Error 0.635
|
-4.38 IU/day
Standard Error 0.636
|
-4.78 IU/day
Standard Error 0.634
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Analysis included participants from the mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure.
The Baseline value was defined as the last value collected prior to the first dose of double-blind study medication. LS means were obtained from MMRM model including all available post baseline values. A negative change from baseline indicates a lower glucose level at Week 24 compared to baseline and a positive change from baseline indicates an increase in glucose level at Week 24 compared to baseline.
Outcome measures
| Measure |
Placebo
n=239 Participants
Two placebo-matching sotagliflozin tablets, once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period.
|
Sotagliflozin 200 mg
n=237 Participants
Sotagliflozin 200 mg (one 200 mg tablet and one placebo tablet), once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period.
|
Sotagliflozin 400 mg
n=239 Participants
Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period.
|
|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
|
8.8 Milligram per deciliter (mg/dL)
Standard Error 3.95
|
-12.8 Milligram per deciliter (mg/dL)
Standard Error 3.97
|
-16.9 Milligram per deciliter (mg/dL)
Standard Error 3.96
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Analysis included participants from the mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure.
The DTSQ instrument contains 8 items assessing overall treatment satisfaction, treatment convenience and flexibility, satisfaction with understanding of diabetes, willingness to continue present treatment and to recommend it to others, and frequency of unacceptably high and unacceptably low blood glucose levels. 6 items (1, 4, 5, 6, 7 and 8) (excluding perceived hyperglycemia and hypoglycemia items) were scored using a 7- point scale where 0=very dissatisfied to 6= very satisfied for a total possible score of 0 (very dissatisfied) to 36 (very satisfied), where higher scores indicate higher satisfaction from treatment. Two items (Q2 and 3), which were not included, measured perceived hyperglycemia and hypoglycemia, respectively. The baseline value was defined as the last value collected prior to the first dose of double-blind study medication. LS means were obtained from MMRM model including all available post baseline values. A positive change from baseline indicates improvement.
Outcome measures
| Measure |
Placebo
n=228 Participants
Two placebo-matching sotagliflozin tablets, once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period.
|
Sotagliflozin 200 mg
n=229 Participants
Sotagliflozin 200 mg (one 200 mg tablet and one placebo tablet), once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period.
|
Sotagliflozin 400 mg
n=240 Participants
Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period.
|
|---|---|---|---|
|
Change From Baseline in Diabetes Treatment Satisfaction Questionnaire (DTSQ) Score at Week 24
|
-0.1 Score on a scale
Standard Error 0.28
|
1.9 Score on a scale
Standard Error 0.28
|
1.6 Score on a scale
Standard Error 0.28
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Analysis included participants from the mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure.
DDS2 is a 2-item diabetes distress screening instrument where participants rated the degree to which the following items caused distress: (1) feeling overwhelmed by the demands of living with diabetes, and (2) feeling that I am often failing with my diabetes regimen using a 6-point scale: where 1=no distress to 6=severe distress for a total possible score of 2 to 12. LS means were obtained from MMRM model including all available post baseline values. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Placebo
n=232 Participants
Two placebo-matching sotagliflozin tablets, once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period.
|
Sotagliflozin 200 mg
n=232 Participants
Sotagliflozin 200 mg (one 200 mg tablet and one placebo tablet), once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period.
|
Sotagliflozin 400 mg
n=243 Participants
Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period.
|
|---|---|---|---|
|
Change From Baseline in 2-Item Diabetes Distress Screen 2 (DDS2) Score at Week 24
|
0.0 Score on a scale
Standard Error 0.12
|
-0.3 Score on a scale
Standard Error 0.12
|
-0.4 Score on a scale
Standard Error 0.11
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Analysis included participants from the mITT population, including all available post baseline values. Here, overall number of participants analyzed = participants with available data for this outcome measure.
Baseline value was defined as the last value collected prior to the first dose of double-blind study medication. LS means were obtained from MMRM model. A negative percent change from baseline indicates a loss in body weight from baseline to Week 24.
Outcome measures
| Measure |
Placebo
n=240 Participants
Two placebo-matching sotagliflozin tablets, once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period.
|
Sotagliflozin 200 mg
n=240 Participants
Sotagliflozin 200 mg (one 200 mg tablet and one placebo tablet), once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period.
|
Sotagliflozin 400 mg
n=241 Participants
Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period.
|
|---|---|---|---|
|
Percent Change From Baseline in Body Weight at Week 24
|
0.10 Percent change
Standard Error 0.245
|
-2.38 Percent change
Standard Error 0.245
|
-2.99 Percent change
Standard Error 0.244
|
Adverse Events
Placebo
Serious events: 17 serious events
Other events: 46 other events
Deaths: 2 deaths
Sotagliflozin 200 mg
Serious events: 26 serious events
Other events: 52 other events
Deaths: 0 deaths
Sotagliflozin 400 mg
Serious events: 21 serious events
Other events: 64 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=258 participants at risk
Two placebo-matching sotagliflozin tablets, once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period.
|
Sotagliflozin 200 mg
n=261 participants at risk
Sotagliflozin 200 mg (one 200 mg tablet and one placebo tablet), once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period.
|
Sotagliflozin 400 mg
n=263 participants at risk
Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period.
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.39%
1/258 • Number of events 1 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.38%
1/261 • Number of events 1 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.00%
0/263 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.39%
1/258 • Number of events 1 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.00%
0/261 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.00%
0/263 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myeloid leukaemia
|
0.00%
0/258 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.38%
1/261 • Number of events 1 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.00%
0/263 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell renal cell carcinoma
|
0.00%
0/258 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.00%
0/261 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.38%
1/263 • Number of events 1 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive breast carcinoma
|
0.00%
0/258 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.38%
1/261 • Number of events 1 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.00%
0/263 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.39%
1/258 • Number of events 1 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.00%
0/261 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.00%
0/263 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion
|
0.39%
1/258 • Number of events 1 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.00%
0/261 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.00%
0/263 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
|
General disorders
Impaired healing
|
0.00%
0/258 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.38%
1/261 • Number of events 1 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.00%
0/263 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
|
General disorders
Pyrexia
|
0.00%
0/258 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.38%
1/261 • Number of events 1 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.00%
0/263 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/258 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.38%
1/261 • Number of events 1 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.00%
0/263 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/258 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.00%
0/261 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.38%
1/263 • Number of events 1 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.39%
1/258 • Number of events 1 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.00%
0/261 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.00%
0/263 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/258 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.38%
1/261 • Number of events 1 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.00%
0/263 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.00%
0/258 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.00%
0/261 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.38%
1/263 • Number of events 1 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/258 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.00%
0/261 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.38%
1/263 • Number of events 1 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.39%
1/258 • Number of events 1 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.00%
0/261 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.00%
0/263 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/258 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.00%
0/261 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.38%
1/263 • Number of events 1 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/258 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.00%
0/261 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.76%
2/263 • Number of events 2 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/258 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.00%
0/261 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.38%
1/263 • Number of events 1 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.39%
1/258 • Number of events 1 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.00%
0/261 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.00%
0/263 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/258 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.00%
0/261 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.38%
1/263 • Number of events 1 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/258 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.38%
1/261 • Number of events 1 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.00%
0/263 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/258 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.38%
1/261 • Number of events 1 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.00%
0/263 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
|
Nervous system disorders
Hypoglycaemic unconsciousness
|
1.2%
3/258 • Number of events 3 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.77%
2/261 • Number of events 2 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.38%
1/263 • Number of events 1 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
|
Nervous system disorders
Hypoglycaemic seizure
|
0.39%
1/258 • Number of events 1 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.00%
0/261 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.00%
0/263 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
|
Nervous system disorders
Ischaemic stroke
|
0.39%
1/258 • Number of events 1 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.00%
0/261 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.00%
0/263 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
|
Nervous system disorders
Sciatica
|
0.39%
1/258 • Number of events 1 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.00%
0/261 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.00%
0/263 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
|
Nervous system disorders
Syncope
|
0.39%
1/258 • Number of events 1 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.00%
0/261 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.00%
0/263 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/258 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.00%
0/261 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.38%
1/263 • Number of events 1 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
|
Nervous system disorders
Vascular headache
|
0.00%
0/258 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.38%
1/261 • Number of events 1 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.00%
0/263 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
|
Eye disorders
Cataract
|
0.39%
1/258 • Number of events 1 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.38%
1/261 • Number of events 1 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.00%
0/263 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
|
Eye disorders
Angle closure glaucoma
|
0.00%
0/258 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.00%
0/261 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.38%
1/263 • Number of events 1 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
|
Eye disorders
Vitreous haemorrhage
|
0.39%
1/258 • Number of events 1 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.00%
0/261 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.00%
0/263 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/258 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.38%
1/261 • Number of events 1 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.00%
0/263 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
|
Gastrointestinal disorders
Oedematous pancreatitis
|
0.00%
0/258 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.00%
0/261 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.38%
1/263 • Number of events 1 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
|
Gastrointestinal disorders
Prepyloric stenosis
|
0.00%
0/258 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.38%
1/261 • Number of events 1 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.00%
0/263 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.00%
0/258 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.00%
0/261 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.38%
1/263 • Number of events 1 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/258 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.38%
1/261 • Number of events 1 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.00%
0/263 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.39%
1/258 • Number of events 1 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.00%
0/261 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.00%
0/263 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.00%
0/258 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.38%
1/261 • Number of events 1 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.00%
0/263 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.39%
1/258 • Number of events 1 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.00%
0/261 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.00%
0/263 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.39%
1/258 • Number of events 1 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.00%
0/261 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.00%
0/263 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
|
Endocrine disorders
Goiter
|
0.00%
0/258 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.00%
0/261 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.38%
1/263 • Number of events 1 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/258 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
2.7%
7/261 • Number of events 7 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
4.6%
12/263 • Number of events 12 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/258 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.77%
2/261 • Number of events 2 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.38%
1/263 • Number of events 1 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.39%
1/258 • Number of events 1 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.00%
0/261 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.00%
0/263 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
|
Metabolism and nutrition disorders
Ketosis
|
0.00%
0/258 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.00%
0/261 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.38%
1/263 • Number of events 1 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/258 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.77%
2/261 • Number of events 2 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.38%
1/263 • Number of events 1 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
|
Infections and infestations
Pneumonia
|
0.39%
1/258 • Number of events 1 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.38%
1/261 • Number of events 1 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.00%
0/263 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
|
Infections and infestations
Cystitis
|
0.00%
0/258 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.00%
0/261 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.38%
1/263 • Number of events 1 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
|
Infections and infestations
Ecthyma
|
0.00%
0/258 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.38%
1/261 • Number of events 1 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.00%
0/263 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
|
Infections and infestations
Erysipelas
|
0.39%
1/258 • Number of events 1 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.00%
0/261 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.00%
0/263 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/258 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.38%
1/261 • Number of events 1 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.00%
0/263 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
|
Infections and infestations
Pilonidal cyst
|
0.00%
0/258 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.38%
1/261 • Number of events 1 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.00%
0/263 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
|
Infections and infestations
Pyoderma
|
0.00%
0/258 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.38%
1/261 • Number of events 1 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.00%
0/263 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
|
Infections and infestations
Rotavirus infection
|
0.00%
0/258 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.38%
1/261 • Number of events 1 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
0.00%
0/263 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
Other adverse events
| Measure |
Placebo
n=258 participants at risk
Two placebo-matching sotagliflozin tablets, once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period.
|
Sotagliflozin 200 mg
n=261 participants at risk
Sotagliflozin 200 mg (one 200 mg tablet and one placebo tablet), once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period.
|
Sotagliflozin 400 mg
n=263 participants at risk
Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
3.9%
10/258 • Number of events 13 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
4.6%
12/261 • Number of events 18 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
7.6%
20/263 • Number of events 29 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Viral upper respiratory tract infection
|
15.5%
40/258 • Number of events 58 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
16.9%
44/261 • Number of events 60 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
18.6%
49/263 • Number of events 70 • First dose and up to 30 days after the last dose of double-blind study treatment. Some Adverse events may have been attributed to the long-term effects of study drug; included even if the onset was >30 days after the last dose of study drug (up to 393 days).
Safety Population consisted of all randomly assigned participants treated with at least 1 dose of study drug, analyzed according to their actual treatment received.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
- Publication restrictions are in place
Restriction type: OTHER