Trial Outcomes & Findings for Effect of Liraglutide on Body Weight in Non-diabetic Obese Subjects or Overweight Subjects With Co-morbidities: SCALE™ - Obesity and Pre-diabetes (NCT NCT01272219)
NCT ID: NCT01272219
Last Updated: 2018-01-19
Results Overview
The observed mean change from baseline in fasting body weight (%) after 56-weeks of treatment (main treatment period).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
3731 participants
Primary outcome timeframe
Week 0, Week 56
Results posted on
2018-01-19
Participant Flow
The trial was conducted at 191 sites in 27 countries: Australia:4,Austria:3,Belgium:2, Brazil:5,Canada:11, Denmark:3,Finland:3, France:5, Germany:8,Hong Kong:1, Hungary:2, India:8, Ireland:1,Israel:7, Italy:7, Mexico:4, Netherlands:5, Norway:3, Poland:5, Russian:7, Serbia:2, South Africa:3, Spain:6, Switzerland:5,Turkey:4, UK:8, US:69.
Subjects were stratified based on pre-diabetes status and BMI at screening. The Main Period table, below, reflects the stratification that should have occurred at baseline. The Re-randomized Period and Main + Extension Period tables reflect the actual distribution of subjects, factoring in an incorrect stratification of 43 subjects at screening.
Participant milestones
| Measure |
Liraglutide 3.0 mg, no Pre-diabetes
Arm 1 (Arm 1A + Arm 1B): Subjects with no pre-diabetes at screening received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks followed by a re-randomisation (1:1 into liraglutide 3.0 mg or liraglutide placebo) period of 12 weeks (weeks 56-68) and then an off-drug follow-up period of 2 weeks. The total duration of this treatment arm from randomisation to follow-up was 70 weeks.
|
Liraglutide 3.0mg (week0-56)/Liraglutide 3.0mg (week56-68)
Arm 1A: Subjects of Arm 1 (with no pre-diabetes at screening) receiving liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks were re-randomised (1:1 into liraglutide 3.0 mg or liraglutide placebo) to continue treatment with liraglutide 3.0 mg for the next 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period.
|
Liraglutide 3.0mg (week0-56)/Liraglutide Placebo (week56-68)
Arm 1B: Subjects of Arm 1 (with no pre-diabetes at screening) receiving liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks were re-randomised (1:1 into liraglutide 3.0 mg or liraglutide placebo) to receive liraglutide placebo for the next 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period.
|
Liraglutide Placebo, no Pre-diabetes
Arm 2: Subjects with no pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks and then continued with liraglutide placebo for additional 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period. The total duration of this treatment arm from randomisation to follow-up was 70 weeks.
|
Liraglutide 3.0 mg, Pre-diabetes
Arm 3: Subjects with pre-diabetes at screening received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for initial 56 weeks then continued treatment till 160 weeks, followed by an off-drug, observational follow-up period of 12 weeks. The total duration of this treatment arm from randomisation to follow-up was 172 weeks.
|
Liraglutide Placebo, Pre-diabetes
Arm 4: Subjects with pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for initial 56 weeks then continued treatment till 160 weeks, followed by an off-drug, observational follow-up period of 12 weeks. The total duration of this treatment arm from randomisation to follow-up was 172 weeks.
|
|---|---|---|---|---|---|---|
|
Main Period: Week 0 to Week 56
STARTED
|
959
|
0
|
0
|
487
|
1528
|
757
|
|
Main Period: Week 0 to Week 56
Exposed
|
957
|
0
|
0
|
487
|
1524
|
755
|
|
Main Period: Week 0 to Week 56
COMPLETED
|
679
|
0
|
0
|
296
|
1110
|
505
|
|
Main Period: Week 0 to Week 56
NOT COMPLETED
|
280
|
0
|
0
|
191
|
418
|
252
|
|
Re-randomised Period: Week 56 to Week 68
STARTED
|
0
|
351
|
350
|
304
|
0
|
0
|
|
Re-randomised Period: Week 56 to Week 68
COMPLETED
|
0
|
342
|
343
|
289
|
0
|
0
|
|
Re-randomised Period: Week 56 to Week 68
NOT COMPLETED
|
0
|
9
|
7
|
15
|
0
|
0
|
|
Main + Extension Period: Week 0-172
STARTED
|
0
|
0
|
0
|
0
|
1505
|
749
|
|
Main + Extension Period: Week 0-172
Exposed
|
0
|
0
|
0
|
0
|
1501
|
747
|
|
Main + Extension Period: Week 0-172
COMPLETED
|
0
|
0
|
0
|
0
|
783
|
327
|
|
Main + Extension Period: Week 0-172
NOT COMPLETED
|
0
|
0
|
0
|
0
|
722
|
422
|
Reasons for withdrawal
| Measure |
Liraglutide 3.0 mg, no Pre-diabetes
Arm 1 (Arm 1A + Arm 1B): Subjects with no pre-diabetes at screening received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks followed by a re-randomisation (1:1 into liraglutide 3.0 mg or liraglutide placebo) period of 12 weeks (weeks 56-68) and then an off-drug follow-up period of 2 weeks. The total duration of this treatment arm from randomisation to follow-up was 70 weeks.
|
Liraglutide 3.0mg (week0-56)/Liraglutide 3.0mg (week56-68)
Arm 1A: Subjects of Arm 1 (with no pre-diabetes at screening) receiving liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks were re-randomised (1:1 into liraglutide 3.0 mg or liraglutide placebo) to continue treatment with liraglutide 3.0 mg for the next 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period.
|
Liraglutide 3.0mg (week0-56)/Liraglutide Placebo (week56-68)
Arm 1B: Subjects of Arm 1 (with no pre-diabetes at screening) receiving liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks were re-randomised (1:1 into liraglutide 3.0 mg or liraglutide placebo) to receive liraglutide placebo for the next 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period.
|
Liraglutide Placebo, no Pre-diabetes
Arm 2: Subjects with no pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks and then continued with liraglutide placebo for additional 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period. The total duration of this treatment arm from randomisation to follow-up was 70 weeks.
|
Liraglutide 3.0 mg, Pre-diabetes
Arm 3: Subjects with pre-diabetes at screening received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for initial 56 weeks then continued treatment till 160 weeks, followed by an off-drug, observational follow-up period of 12 weeks. The total duration of this treatment arm from randomisation to follow-up was 172 weeks.
|
Liraglutide Placebo, Pre-diabetes
Arm 4: Subjects with pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for initial 56 weeks then continued treatment till 160 weeks, followed by an off-drug, observational follow-up period of 12 weeks. The total duration of this treatment arm from randomisation to follow-up was 172 weeks.
|
|---|---|---|---|---|---|---|
|
Main Period: Week 0 to Week 56
Adverse Event
|
86
|
0
|
0
|
16
|
152
|
29
|
|
Main Period: Week 0 to Week 56
Lack of Efficacy
|
11
|
0
|
0
|
14
|
12
|
22
|
|
Main Period: Week 0 to Week 56
Protocol Violation
|
25
|
0
|
0
|
18
|
40
|
20
|
|
Main Period: Week 0 to Week 56
Withdrawal criteria
|
122
|
0
|
0
|
114
|
172
|
147
|
|
Main Period: Week 0 to Week 56
Unclassified
|
36
|
0
|
0
|
29
|
42
|
34
|
|
Re-randomised Period: Week 56 to Week 68
Adverse Event
|
0
|
1
|
1
|
2
|
0
|
0
|
|
Re-randomised Period: Week 56 to Week 68
Lack of Efficacy
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Re-randomised Period: Week 56 to Week 68
Protocol Violation
|
0
|
1
|
0
|
3
|
0
|
0
|
|
Re-randomised Period: Week 56 to Week 68
Withdrawal criteria
|
0
|
6
|
4
|
7
|
0
|
0
|
|
Re-randomised Period: Week 56 to Week 68
Unclassified
|
0
|
1
|
2
|
2
|
0
|
0
|
|
Main + Extension Period: Week 0-172
Adverse Event
|
0
|
0
|
0
|
0
|
191
|
43
|
|
Main + Extension Period: Week 0-172
Lack of Efficacy
|
0
|
0
|
0
|
0
|
29
|
36
|
|
Main + Extension Period: Week 0-172
Protocol Violation
|
0
|
0
|
0
|
0
|
76
|
36
|
|
Main + Extension Period: Week 0-172
Withdrawal criteria
|
0
|
0
|
0
|
0
|
364
|
256
|
|
Main + Extension Period: Week 0-172
Missing reason
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Main + Extension Period: Week 0-172
Unclassified
|
0
|
0
|
0
|
0
|
61
|
51
|
Baseline Characteristics
Effect of Liraglutide on Body Weight in Non-diabetic Obese Subjects or Overweight Subjects With Co-morbidities: SCALE™ - Obesity and Pre-diabetes
Baseline characteristics by cohort
| Measure |
Liraglutide 3.0 mg, no Pre-diabetes
n=959 Participants
Arm 1 (Arm 1A + Arm 1B): Subjects with no pre-diabetes at screening received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks followed by a re-randomisation (1:1 into liraglutide 3.0 mg or liraglutide placebo) period of 12 weeks (weeks 56-68) and then an off-drug follow-up period of 2 weeks. The total duration of this treatment arm from randomisation to follow-up was 70 weeks.
|
Liraglutide Placebo, no Pre-diabetes
n=487 Participants
Arm 2: Subjects with no pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks and then continued with liraglutide placebo for additional 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period. The total duration of this treatment arm from randomisation to follow-up was 70 weeks.
|
Liraglutide 3.0 mg, Pre-diabetes
n=1528 Participants
Arm 3: Subjects with pre-diabetes at screening received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for initial 56 weeks then continued treatment till 160 weeks, followed by an off-drug, observational follow-up period of 12 weeks. The total duration of this treatment arm from randomisation to follow-up was 172 weeks.
|
Liraglutide Placebo, Pre-diabetes
n=757 Participants
Arm 4: Subjects with pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for initial 56 weeks then continued treatment till 160 weeks, followed by an off-drug, observational follow-up period of 12 weeks. The total duration of this treatment arm from randomisation to follow-up was 172 weeks.
|
Total
n=3731 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
41.6 years
STANDARD_DEVIATION 11.7 • n=99 Participants
|
41.5 years
STANDARD_DEVIATION 11.5 • n=107 Participants
|
47.4 years
STANDARD_DEVIATION 11.8 • n=206 Participants
|
47.2 years
STANDARD_DEVIATION 11.8 • n=7 Participants
|
45.1 years
STANDARD_DEVIATION 12.0 • n=31 Participants
|
|
Sex: Female, Male
Female
|
801 Participants
n=99 Participants
|
390 Participants
n=107 Participants
|
1156 Participants
n=206 Participants
|
581 Participants
n=7 Participants
|
2928 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
158 Participants
n=99 Participants
|
97 Participants
n=107 Participants
|
372 Participants
n=206 Participants
|
176 Participants
n=7 Participants
|
803 Participants
n=31 Participants
|
|
Fasting Body Weight
|
104.0 kg
STANDARD_DEVIATION 20.1 • n=99 Participants
|
103.6 kg
STANDARD_DEVIATION 21.2 • n=107 Participants
|
107.6 kg
STANDARD_DEVIATION 21.8 • n=206 Participants
|
107.9 kg
STANDARD_DEVIATION 21.8 • n=7 Participants
|
106.2 kg
STANDARD_DEVIATION 21.4 • n=31 Participants
|
|
Body Mass Index (BMI)
|
37.5 kg/m^2
STANDARD_DEVIATION 6.2 • n=99 Participants
|
37.4 kg/m^2
STANDARD_DEVIATION 6.2 • n=107 Participants
|
38.8 kg/m^2
STANDARD_DEVIATION 6.4 • n=206 Participants
|
39.0 kg/m^2
STANDARD_DEVIATION 6.3 • n=7 Participants
|
38.3 kg/m^2
STANDARD_DEVIATION 6.4 • n=31 Participants
|
|
Glycosylated Haemoglobin (HbA1c)
|
5.3 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 0.3 • n=99 Participants
|
5.3 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 0.3 • n=107 Participants
|
5.8 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 0.3 • n=206 Participants
|
5.7 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 0.3 • n=7 Participants
|
5.6 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 0.4 • n=31 Participants
|
|
Fasting Plasma Glucose (FPG)
|
5.0 mmol/L
STANDARD_DEVIATION 0.4 • n=99 Participants
|
5.1 mmol/L
STANDARD_DEVIATION 0.5 • n=107 Participants
|
5.5 mmol/L
STANDARD_DEVIATION 0.6 • n=206 Participants
|
5.5 mmol/L
STANDARD_DEVIATION 0.5 • n=7 Participants
|
5.3 mmol/L
STANDARD_DEVIATION 0.6 • n=31 Participants
|
PRIMARY outcome
Timeframe: Week 0, Week 56Population: The full analysis set (FAS) included all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and who provided at least one post-baseline efficacy value. Missing data were imputed using last observation carried forward (LOCF).
The observed mean change from baseline in fasting body weight (%) after 56-weeks of treatment (main treatment period).
Outcome measures
| Measure |
Liraglutide Placebo, no Pre-diabetes
Arm 2: Subjects with no pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks and then continued with liraglutide placebo for additional 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period. The total duration of this treatment arm from randomisation to follow-up was 70 weeks.
|
Liraglutide 3.0mg (week0-56)/Liraglutide 3.0mg (week56-68)
n=2432 Participants
Arm 1A: Subjects of Arm 1 (with no pre-diabetes at screening) receiving liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks were re-randomised (1:1 into liraglutide 3.0 mg or liraglutide placebo) to continue treatment with liraglutide 3.0 mg for the next 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period.
|
Liraglutide 3.0mg (week0-56)/Liraglutide Placebo (week56-68)
n=1220 Participants
Arm 1B: Subjects of Arm 1 (with no pre-diabetes at screening) receiving liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks were re-randomised (1:1 into liraglutide 3.0 mg or liraglutide placebo) to receive liraglutide placebo for the next 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period.
|
|---|---|---|---|
|
Change From Baseline in Fasting Body Weight
|
—
|
-7.98 percent change
Standard Deviation 6.67
|
-2.62 percent change
Standard Deviation 5.74
|
PRIMARY outcome
Timeframe: At Week 56Population: The FAS included all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and who provided at least one post-baseline efficacy value. Missing data were imputed using LOCF.
Percentage of subjects losing at least 5% of baseline fasting body weight after 56-weeks of treatment (main treatment period).
Outcome measures
| Measure |
Liraglutide Placebo, no Pre-diabetes
Arm 2: Subjects with no pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks and then continued with liraglutide placebo for additional 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period. The total duration of this treatment arm from randomisation to follow-up was 70 weeks.
|
Liraglutide 3.0mg (week0-56)/Liraglutide 3.0mg (week56-68)
n=2432 Participants
Arm 1A: Subjects of Arm 1 (with no pre-diabetes at screening) receiving liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks were re-randomised (1:1 into liraglutide 3.0 mg or liraglutide placebo) to continue treatment with liraglutide 3.0 mg for the next 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period.
|
Liraglutide 3.0mg (week0-56)/Liraglutide Placebo (week56-68)
n=1220 Participants
Arm 1B: Subjects of Arm 1 (with no pre-diabetes at screening) receiving liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks were re-randomised (1:1 into liraglutide 3.0 mg or liraglutide placebo) to receive liraglutide placebo for the next 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period.
|
|---|---|---|---|
|
Proportion of Subjects Losing at Least 5% of Baseline Fasting Body Weight.
|
—
|
63.2 percentage of subjects
|
27.1 percentage of subjects
|
PRIMARY outcome
Timeframe: At 56 weeksPopulation: The FAS) included all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and who provided at least one post-baseline efficacy value. Missing data were imputed using LOCF.
Percentage of subjects losing \>10% of baseline fasting body weight after 56-weeks of treatment (main treatment period).
Outcome measures
| Measure |
Liraglutide Placebo, no Pre-diabetes
Arm 2: Subjects with no pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks and then continued with liraglutide placebo for additional 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period. The total duration of this treatment arm from randomisation to follow-up was 70 weeks.
|
Liraglutide 3.0mg (week0-56)/Liraglutide 3.0mg (week56-68)
n=2432 Participants
Arm 1A: Subjects of Arm 1 (with no pre-diabetes at screening) receiving liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks were re-randomised (1:1 into liraglutide 3.0 mg or liraglutide placebo) to continue treatment with liraglutide 3.0 mg for the next 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period.
|
Liraglutide 3.0mg (week0-56)/Liraglutide Placebo (week56-68)
n=1220 Participants
Arm 1B: Subjects of Arm 1 (with no pre-diabetes at screening) receiving liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks were re-randomised (1:1 into liraglutide 3.0 mg or liraglutide placebo) to receive liraglutide placebo for the next 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period.
|
|---|---|---|---|
|
Proportion of Subjects Losing More Than 10% of Baseline Fasting Body Weight
|
—
|
33.1 percentage of subjects
|
10.6 percentage of subjects
|
PRIMARY outcome
Timeframe: At 160 weeksPopulation: Subjects included in the FAS, who were stratified to 160-weeks of treatment; all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and with at least one post-baseline efficacy measurement, who were stratified to 160-weeks of treatment. Missing data were imputed using LOCF.
Proportion of subjects with onset of Type 2 diabetes mellitus (T2DM) at week 160 (main + extension treatment period) among subjects with pre-diabetes at baseline - evaluated as time to onset of T2DM. Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period).
Outcome measures
| Measure |
Liraglutide Placebo, no Pre-diabetes
Arm 2: Subjects with no pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks and then continued with liraglutide placebo for additional 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period. The total duration of this treatment arm from randomisation to follow-up was 70 weeks.
|
Liraglutide 3.0mg (week0-56)/Liraglutide 3.0mg (week56-68)
n=1472 Participants
Arm 1A: Subjects of Arm 1 (with no pre-diabetes at screening) receiving liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks were re-randomised (1:1 into liraglutide 3.0 mg or liraglutide placebo) to continue treatment with liraglutide 3.0 mg for the next 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period.
|
Liraglutide 3.0mg (week0-56)/Liraglutide Placebo (week56-68)
n=738 Participants
Arm 1B: Subjects of Arm 1 (with no pre-diabetes at screening) receiving liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks were re-randomised (1:1 into liraglutide 3.0 mg or liraglutide placebo) to receive liraglutide placebo for the next 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period.
|
|---|---|---|---|
|
Proportion of Subjects With Onset of Type 2 Diabetes
|
—
|
26 Subject
|
46 Subject
|
SECONDARY outcome
Timeframe: Week 0, Week 56Population: The FAS included all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and who provided at least one post-baseline efficacy value. Missing data were imputed using LOCF.
The observed mean change from baseline in waist circumference (cm) after 56-weeks of treatment (main treatment period).
Outcome measures
| Measure |
Liraglutide Placebo, no Pre-diabetes
Arm 2: Subjects with no pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks and then continued with liraglutide placebo for additional 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period. The total duration of this treatment arm from randomisation to follow-up was 70 weeks.
|
Liraglutide 3.0mg (week0-56)/Liraglutide 3.0mg (week56-68)
n=2437 Participants
Arm 1A: Subjects of Arm 1 (with no pre-diabetes at screening) receiving liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks were re-randomised (1:1 into liraglutide 3.0 mg or liraglutide placebo) to continue treatment with liraglutide 3.0 mg for the next 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period.
|
Liraglutide 3.0mg (week0-56)/Liraglutide Placebo (week56-68)
n=1225 Participants
Arm 1B: Subjects of Arm 1 (with no pre-diabetes at screening) receiving liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks were re-randomised (1:1 into liraglutide 3.0 mg or liraglutide placebo) to receive liraglutide placebo for the next 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period.
|
|---|---|---|---|
|
Change From Baseline in Waist Circumference (cm)
|
—
|
-8.19 cm
Standard Deviation 7.31
|
-3.94 cm
Standard Deviation 6.58
|
SECONDARY outcome
Timeframe: Week 0, week 160Population: Subjects included in the FAS, who were stratified to 160-weeks of treatment; all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and with at least one post-baseline efficacy measurement, who were stratified to 160-weeks of treatment. Missing data were imputed using LOCF.
The observed mean change from baseline in waist circumference (subjects with pre-diabetes at baseline) after 160 weeks of treatment (main + extension treatment period). Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period).
Outcome measures
| Measure |
Liraglutide Placebo, no Pre-diabetes
Arm 2: Subjects with no pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks and then continued with liraglutide placebo for additional 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period. The total duration of this treatment arm from randomisation to follow-up was 70 weeks.
|
Liraglutide 3.0mg (week0-56)/Liraglutide 3.0mg (week56-68)
n=1472 Participants
Arm 1A: Subjects of Arm 1 (with no pre-diabetes at screening) receiving liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks were re-randomised (1:1 into liraglutide 3.0 mg or liraglutide placebo) to continue treatment with liraglutide 3.0 mg for the next 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period.
|
Liraglutide 3.0mg (week0-56)/Liraglutide Placebo (week56-68)
n=738 Participants
Arm 1B: Subjects of Arm 1 (with no pre-diabetes at screening) receiving liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks were re-randomised (1:1 into liraglutide 3.0 mg or liraglutide placebo) to receive liraglutide placebo for the next 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period.
|
|---|---|---|---|
|
Change From Baseline in Waist Circumference (Subjects With Pre-diabetes at Baseline)
|
—
|
-6.87 cm
Standard Deviation 8.28
|
-3.37 cm
Standard Deviation 7.47
|
SECONDARY outcome
Timeframe: Week 0, Week 56Population: The FAS included all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and who provided at least one post-baseline efficacy value. Missing data were imputed using LOCF.
Observed percentage of subjects with pre-diabetes status after 56 weeks of treatment (main treatment period).
Outcome measures
| Measure |
Liraglutide Placebo, no Pre-diabetes
Arm 2: Subjects with no pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks and then continued with liraglutide placebo for additional 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period. The total duration of this treatment arm from randomisation to follow-up was 70 weeks.
|
Liraglutide 3.0mg (week0-56)/Liraglutide 3.0mg (week56-68)
n=2437 Participants
Arm 1A: Subjects of Arm 1 (with no pre-diabetes at screening) receiving liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks were re-randomised (1:1 into liraglutide 3.0 mg or liraglutide placebo) to continue treatment with liraglutide 3.0 mg for the next 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period.
|
Liraglutide 3.0mg (week0-56)/Liraglutide Placebo (week56-68)
n=1225 Participants
Arm 1B: Subjects of Arm 1 (with no pre-diabetes at screening) receiving liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks were re-randomised (1:1 into liraglutide 3.0 mg or liraglutide placebo) to receive liraglutide placebo for the next 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period.
|
|---|---|---|---|
|
Pre-diabetes Status After 56 Weeks of Treatment
With Confirmed Type 2 Diabetes
|
—
|
0.2 percentage of subjects
|
1.1 percentage of subjects
|
|
Pre-diabetes Status After 56 Weeks of Treatment
With No Pre-diabetes
|
—
|
78.3 percentage of subjects
|
50.9 percentage of subjects
|
|
Pre-diabetes Status After 56 Weeks of Treatment
With Pre-diabetes
|
—
|
20.6 percentage of subjects
|
46.1 percentage of subjects
|
|
Pre-diabetes Status After 56 Weeks of Treatment
With Transient Type 2 Diabetes
|
—
|
0.9 percentage of subjects
|
1.8 percentage of subjects
|
SECONDARY outcome
Timeframe: Week 0, week 160Population: Subjects included in the FAS, who were stratified to 160-weeks of treatment; all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and with at least one post-baseline efficacy measurement, who were stratified to 160-weeks of treatment. Missing data were imputed using LOCF.
Observed percentage of subjects (subjects with pre-diabetes at baseline) with pre-diabetes status after 160 weeks of treatment (main + extension treatment period). Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period).
Outcome measures
| Measure |
Liraglutide Placebo, no Pre-diabetes
Arm 2: Subjects with no pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks and then continued with liraglutide placebo for additional 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period. The total duration of this treatment arm from randomisation to follow-up was 70 weeks.
|
Liraglutide 3.0mg (week0-56)/Liraglutide 3.0mg (week56-68)
n=1472 Participants
Arm 1A: Subjects of Arm 1 (with no pre-diabetes at screening) receiving liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks were re-randomised (1:1 into liraglutide 3.0 mg or liraglutide placebo) to continue treatment with liraglutide 3.0 mg for the next 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period.
|
Liraglutide 3.0mg (week0-56)/Liraglutide Placebo (week56-68)
n=738 Participants
Arm 1B: Subjects of Arm 1 (with no pre-diabetes at screening) receiving liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks were re-randomised (1:1 into liraglutide 3.0 mg or liraglutide placebo) to receive liraglutide placebo for the next 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period.
|
|---|---|---|---|
|
Pre-diabetes Status in Subject With Pre-diabetes at Baseline After 160 Weeks of Treatment
With Pre-diabetes
|
—
|
31.3 percentage of subjects
|
54.9 percentage of subjects
|
|
Pre-diabetes Status in Subject With Pre-diabetes at Baseline After 160 Weeks of Treatment
With No Pre-diabetes
|
—
|
65.9 percentage of subjects
|
36.3 percentage of subjects
|
|
Pre-diabetes Status in Subject With Pre-diabetes at Baseline After 160 Weeks of Treatment
With Transient Type 2 Diabetes
|
—
|
1.1 percentage of subjects
|
2.6 percentage of subjects
|
|
Pre-diabetes Status in Subject With Pre-diabetes at Baseline After 160 Weeks of Treatment
With Confirmed Type 2 Diabetes
|
—
|
1.8 percentage of subjects
|
6.2 percentage of subjects
|
SECONDARY outcome
Timeframe: Week 0, week 160Population: Subjects included in the FAS, who were stratified to 160-weeks of treatment; all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and with at least one post-baseline efficacy measurement, who were stratified to 160-weeks of treatment. Missing data were imputed using LOCF.
The observed mean change from baseline in fasting body weight (subjects with pre-diabetes at baseline) after 160 weeks of treatment (main + extension treatment period). Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period).
Outcome measures
| Measure |
Liraglutide Placebo, no Pre-diabetes
Arm 2: Subjects with no pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks and then continued with liraglutide placebo for additional 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period. The total duration of this treatment arm from randomisation to follow-up was 70 weeks.
|
Liraglutide 3.0mg (week0-56)/Liraglutide 3.0mg (week56-68)
n=1467 Participants
Arm 1A: Subjects of Arm 1 (with no pre-diabetes at screening) receiving liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks were re-randomised (1:1 into liraglutide 3.0 mg or liraglutide placebo) to continue treatment with liraglutide 3.0 mg for the next 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period.
|
Liraglutide 3.0mg (week0-56)/Liraglutide Placebo (week56-68)
n=734 Participants
Arm 1B: Subjects of Arm 1 (with no pre-diabetes at screening) receiving liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks were re-randomised (1:1 into liraglutide 3.0 mg or liraglutide placebo) to receive liraglutide placebo for the next 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period.
|
|---|---|---|---|
|
Mean Change From Baseline in Fasting Body Weight (Subjects With Pre-diabetes at Baseline)
|
—
|
-6.14 percent change
Standard Deviation 7.34
|
-1.89 percent change
Standard Deviation 6.27
|
SECONDARY outcome
Timeframe: At 160 weeksPopulation: Subjects included in the FAS, who were stratified to 160-weeks of treatment; all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and with at least one post-baseline efficacy measurement, who were stratified to 160-weeks of treatment. Missing data were imputed using LOCF.
Percentage of subjects losing \>=5% and percentage of subjects losing \>10% of baseline fasting body weight (pre-diabetic subjects at baseline) after 160-weeks of treatment (main + extension treatment period). Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period).
Outcome measures
| Measure |
Liraglutide Placebo, no Pre-diabetes
Arm 2: Subjects with no pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks and then continued with liraglutide placebo for additional 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period. The total duration of this treatment arm from randomisation to follow-up was 70 weeks.
|
Liraglutide 3.0mg (week0-56)/Liraglutide 3.0mg (week56-68)
n=1467 Participants
Arm 1A: Subjects of Arm 1 (with no pre-diabetes at screening) receiving liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks were re-randomised (1:1 into liraglutide 3.0 mg or liraglutide placebo) to continue treatment with liraglutide 3.0 mg for the next 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period.
|
Liraglutide 3.0mg (week0-56)/Liraglutide Placebo (week56-68)
n=734 Participants
Arm 1B: Subjects of Arm 1 (with no pre-diabetes at screening) receiving liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks were re-randomised (1:1 into liraglutide 3.0 mg or liraglutide placebo) to receive liraglutide placebo for the next 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period.
|
|---|---|---|---|
|
Proportion of Subjects Losing at Least 5% and Proportion of Subjects Losing More Than 10% of Baseline Fasting Body Weight (Subjects With Pre-diabetes at Baseline)
Losing >=5% of baseline body weight
|
—
|
49.6 percentage of subjects
|
23.7 percentage of subjects
|
|
Proportion of Subjects Losing at Least 5% and Proportion of Subjects Losing More Than 10% of Baseline Fasting Body Weight (Subjects With Pre-diabetes at Baseline)
Losing >10% of baseline body weight
|
—
|
24.8 percentage of subjects
|
9.9 percentage of subjects
|
SECONDARY outcome
Timeframe: Week 56, Week 68Population: The FAS included all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and who provided at least one post-baseline efficacy value. Missing data were imputed using LOCF.
The observed mean change in fasting body weight (%) from week 56 to week 68 in re-randomised subjects (with no pre-diabetes at baseline) after 12-weeks of treatment (re-randomised treatment period).
Outcome measures
| Measure |
Liraglutide Placebo, no Pre-diabetes
n=299 Participants
Arm 2: Subjects with no pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks and then continued with liraglutide placebo for additional 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period. The total duration of this treatment arm from randomisation to follow-up was 70 weeks.
|
Liraglutide 3.0mg (week0-56)/Liraglutide 3.0mg (week56-68)
n=349 Participants
Arm 1A: Subjects of Arm 1 (with no pre-diabetes at screening) receiving liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks were re-randomised (1:1 into liraglutide 3.0 mg or liraglutide placebo) to continue treatment with liraglutide 3.0 mg for the next 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period.
|
Liraglutide 3.0mg (week0-56)/Liraglutide Placebo (week56-68)
n=346 Participants
Arm 1B: Subjects of Arm 1 (with no pre-diabetes at screening) receiving liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks were re-randomised (1:1 into liraglutide 3.0 mg or liraglutide placebo) to receive liraglutide placebo for the next 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period.
|
|---|---|---|---|
|
Change From Week 56 in Fasting Body Weight (%) (Re-randomised Subjects With No Pre-diabetes)
|
0.28 percent change
Standard Deviation 2.39
|
0.69 percent change
Standard Deviation 2.58
|
2.91 percent change
Standard Deviation 3.01
|
SECONDARY outcome
Timeframe: Week 0, Week 68Population: The FAS included all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and who provided at least one post-baseline efficacy value. Missing data were imputed using LOCF.
The observed mean change from baseline in fasting body weight (%) in re-randomised subjects (with no pre-diabetes at baseline) after 68 weeks of treatment (main + re-randomised treatment period).
Outcome measures
| Measure |
Liraglutide Placebo, no Pre-diabetes
n=298 Participants
Arm 2: Subjects with no pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks and then continued with liraglutide placebo for additional 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period. The total duration of this treatment arm from randomisation to follow-up was 70 weeks.
|
Liraglutide 3.0mg (week0-56)/Liraglutide 3.0mg (week56-68)
n=349 Participants
Arm 1A: Subjects of Arm 1 (with no pre-diabetes at screening) receiving liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks were re-randomised (1:1 into liraglutide 3.0 mg or liraglutide placebo) to continue treatment with liraglutide 3.0 mg for the next 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period.
|
Liraglutide 3.0mg (week0-56)/Liraglutide Placebo (week56-68)
n=347 Participants
Arm 1B: Subjects of Arm 1 (with no pre-diabetes at screening) receiving liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks were re-randomised (1:1 into liraglutide 3.0 mg or liraglutide placebo) to receive liraglutide placebo for the next 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period.
|
|---|---|---|---|
|
Change From Baseline in Fasting Body Weight (%) (Re-randomised Subjects With No Pre-diabetes)
|
-3.11 percent change
Standard Deviation 7.52
|
-8.44 percent change
Standard Deviation 7.23
|
-6.77 percent change
Standard Deviation 7.67
|
Adverse Events
Liraglutide 3.0 mg, Pre-diabetes
Serious events: 230 serious events
Other events: 1342 other events
Deaths: 0 deaths
Liraglutide Placebo, Pre-diabetes
Serious events: 96 serious events
Other events: 586 other events
Deaths: 0 deaths
Liraglutide 3.0 mg, no Pre-diabetes
Serious events: 59 serious events
Other events: 843 other events
Deaths: 0 deaths
Liraglutide Placebo, no Pre-diabetes
Serious events: 19 serious events
Other events: 345 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Liraglutide 3.0 mg, Pre-diabetes
n=1524 participants at risk
Arm 3: Subjects with pre-diabetes at screening received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for initial 56 weeks then continued treatment till 160 weeks, followed by an off-drug, observational follow-up period of 12 weeks. The total duration of this treatment arm from randomisation to follow-up was 172 weeks.
|
Liraglutide Placebo, Pre-diabetes
n=755 participants at risk
Arm 4: Subjects with pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for initial 56 weeks then continued treatment till 160 weeks, followed by an off-drug, observational follow-up period of 12 weeks. The total duration of this treatment arm from randomisation to follow-up was 172 weeks.
|
Liraglutide 3.0 mg, no Pre-diabetes
n=957 participants at risk
Arm 1 (Arm 1A + Arm 1B): Subjects with no pre-diabetes at screening received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks followed by a re-randomisation (1:1 into liraglutide 3.0 mg or liraglutide placebo) period of 12 weeks (weeks 56-68) and then an off-drug follow-up period of 2 weeks. The total duration of this treatment arm from randomisation to follow-up was 70 weeks.
|
Liraglutide Placebo, no Pre-diabetes
n=487 participants at risk
Arm 2: Subjects with no pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks and then continued with liraglutide placebo for additional 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period. The total duration of this treatment arm from randomisation to follow-up was 70 weeks.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Blood and lymphatic system disorders
Bandaemia
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Blood and lymphatic system disorders
Hypercoagulation
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.10%
1/957 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Cardiac disorders
Acute coronary syndrome
|
0.13%
2/1524 • Number of events 2 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Cardiac disorders
Angina unstable
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Cardiac disorders
Aortic valve disease mixed
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Cardiac disorders
Atrial fibrillation
|
0.26%
4/1524 • Number of events 4 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.26%
2/755 • Number of events 2 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.21%
2/957 • Number of events 2 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Cardiac disorders
Cardiac failure
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Cardiac disorders
Cardiac failure chronic
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Cardiac disorders
Cardiac tamponade
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Cardiac disorders
Cardiomegaly
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.10%
1/957 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Cardiac disorders
Coronary artery disease
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Cardiac disorders
Coronary artery stenosis
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Cardiac disorders
Hypertensive heart disease
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.10%
1/957 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Cardiac disorders
Myocardial infarction
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Cardiac disorders
Myocardial ischaemia
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Cardiac disorders
Palpitations
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Cardiac disorders
Pericarditis
|
0.13%
2/1524 • Number of events 2 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Cardiac disorders
Tachycardia
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Cardiac disorders
Ventricular fibrillation
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Cardiac disorders
Ventricular tachycardia
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Congenital, familial and genetic disorders
Dermoid cyst
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Congenital, familial and genetic disorders
Multiple endocrine adenomatosis Type I
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.10%
1/957 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Ear and labyrinth disorders
Vertigo
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Endocrine disorders
Basedow
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Endocrine disorders
Goitre
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Endocrine disorders
Hyperparathyroidism primary
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Endocrine disorders
Toxic nodular goitre
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Eye disorders
Cataract
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Eye disorders
Retinal detachment
|
0.13%
2/1524 • Number of events 2 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.20%
3/1524 • Number of events 4 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.20%
3/1524 • Number of events 3 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.13%
2/1524 • Number of events 2 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.21%
1/487 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Gastrointestinal disorders
Barrett
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Gastrointestinal disorders
Caecitis
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.10%
1/957 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.26%
2/755 • Number of events 2 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Gastrointestinal disorders
Faecal incontinence
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Gastrointestinal disorders
Gastritis
|
0.13%
2/1524 • Number of events 2 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 2 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.21%
1/487 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.13%
2/1524 • Number of events 2 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.26%
4/1524 • Number of events 4 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Gastrointestinal disorders
Intestinal prolapse
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Gastrointestinal disorders
Nausea
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.10%
1/957 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Gastrointestinal disorders
Pancreatic cyst
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Gastrointestinal disorders
Pancreatitis
|
0.13%
2/1524 • Number of events 2 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.20%
3/1524 • Number of events 3 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.21%
2/957 • Number of events 2 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.07%
1/1524 • Number of events 2 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.10%
1/957 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Gastrointestinal disorders
Umbilical hernia, obstructive
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Gastrointestinal disorders
Vomiting
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
General disorders
Chest discomfort
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
General disorders
Chest pain
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.26%
2/755 • Number of events 2 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.10%
1/957 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.41%
2/487 • Number of events 2 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
General disorders
Cyst
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
General disorders
Device dislocation
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
General disorders
Inflammation
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
General disorders
Medical device complication
|
0.13%
2/1524 • Number of events 2 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
General disorders
Metaplasia
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
General disorders
Non-cardiac chest pain
|
0.33%
5/1524 • Number of events 5 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.21%
1/487 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
General disorders
Ulcer haemorrhage
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Hepatobiliary disorders
Bile duct stone
|
0.20%
3/1524 • Number of events 3 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.10%
1/957 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Hepatobiliary disorders
Biliary colic
|
0.13%
2/1524 • Number of events 2 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Hepatobiliary disorders
Cholecystitis
|
0.39%
6/1524 • Number of events 6 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.21%
2/957 • Number of events 2 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.21%
1/487 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.59%
9/1524 • Number of events 9 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.42%
4/957 • Number of events 4 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.4%
22/1524 • Number of events 23 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.79%
6/755 • Number of events 6 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.73%
7/957 • Number of events 7 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.21%
1/487 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Hepatobiliary disorders
Gallbladder polyp
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.10%
1/957 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.10%
1/957 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Hepatobiliary disorders
Hepatic lesion
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Hepatobiliary disorders
Hepatitis
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Immune system disorders
Amyloidosis
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Immune system disorders
Anaphylactic reaction
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.21%
1/487 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.21%
1/487 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Infections and infestations
Abdominal wall infection
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Infections and infestations
Abscess neck
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.10%
1/957 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Infections and infestations
Alveolar osteitis
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Infections and infestations
Anal abscess
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.10%
1/957 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Infections and infestations
Appendicitis
|
0.26%
4/1524 • Number of events 4 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.21%
1/487 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Infections and infestations
Arthritis bacterial
|
0.13%
2/1524 • Number of events 2 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Infections and infestations
Arthritis infective
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Infections and infestations
Brain abscess
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.10%
1/957 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Infections and infestations
Breast abscess
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.10%
1/957 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Infections and infestations
Bronchitis
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.26%
2/755 • Number of events 2 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Infections and infestations
Bronchopneumonia
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.10%
1/957 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Infections and infestations
Cellulitis
|
0.20%
3/1524 • Number of events 3 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.40%
3/755 • Number of events 3 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Infections and infestations
Cytomegalovirus infection
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Infections and infestations
Diverticulitis
|
0.20%
3/1524 • Number of events 3 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.10%
1/957 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Infections and infestations
Empyema
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Infections and infestations
Erysipelas
|
0.20%
3/1524 • Number of events 3 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Infections and infestations
Gastroenteritis
|
0.26%
4/1524 • Number of events 4 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.21%
2/957 • Number of events 2 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.21%
1/487 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.21%
2/957 • Number of events 2 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Infections and infestations
Hepatitis A
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Infections and infestations
Incision site infection
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Infections and infestations
Localised infection
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Infections and infestations
Meningitis
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.10%
1/957 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Infections and infestations
Oophoritis
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Infections and infestations
Pharyngotonsillitis
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Infections and infestations
Pneumonia
|
0.13%
2/1524 • Number of events 2 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.10%
1/957 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Infections and infestations
Post procedural infection
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Infections and infestations
Pyelonephritis
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Infections and infestations
Sepsis
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.26%
2/755 • Number of events 2 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Infections and infestations
Septic shock
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Infections and infestations
Urinary tract infection
|
0.13%
2/1524 • Number of events 3 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Infections and infestations
Urosepsis
|
0.20%
3/1524 • Number of events 3 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Infections and infestations
Vulval abscess
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Injury, poisoning and procedural complications
Accident
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.13%
2/1524 • Number of events 2 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.10%
1/957 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Injury, poisoning and procedural complications
Cartilage injury
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.10%
1/957 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Injury, poisoning and procedural complications
Drug dispensing error
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.53%
4/755 • Number of events 4 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.13%
2/1524 • Number of events 2 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.10%
1/957 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Injury, poisoning and procedural complications
Limb traumatic amputation
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.10%
1/957 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.26%
2/755 • Number of events 2 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Injury, poisoning and procedural complications
Muscle injury
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Injury, poisoning and procedural complications
Post laminectomy syndrome
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.10%
1/957 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.13%
2/1524 • Number of events 2 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.21%
2/957 • Number of events 2 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.26%
2/755 • Number of events 2 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Injury, poisoning and procedural complications
Stab wound
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.10%
1/957 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.13%
2/1524 • Number of events 2 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Injury, poisoning and procedural complications
Ureteric injury
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Injury, poisoning and procedural complications
Wound
|
0.13%
2/1524 • Number of events 2 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Injury, poisoning and procedural complications
Wrong drug administered
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.10%
1/957 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Investigations
Amylase increased
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.10%
1/957 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Investigations
Blood creatine phosphokinase increased
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.10%
1/957 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Investigations
Catheterisation cardiac
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Investigations
Lipase increased
|
0.13%
2/1524 • Number of events 2 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.10%
1/957 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Investigations
Weight decreased
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Investigations
Weight increased
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Metabolism and nutrition disorders
Central obesity
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.10%
1/957 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Metabolism and nutrition disorders
Obesity
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.40%
3/755 • Number of events 3 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.26%
2/755 • Number of events 2 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.21%
2/957 • Number of events 2 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.26%
2/755 • Number of events 3 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.26%
4/1524 • Number of events 4 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.40%
3/755 • Number of events 3 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.21%
1/487 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Musculoskeletal and connective tissue disorders
Chondromalacia
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Musculoskeletal and connective tissue disorders
Chondropathy
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Musculoskeletal and connective tissue disorders
Dupuytren
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.39%
6/1524 • Number of events 6 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.10%
1/957 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Musculoskeletal and connective tissue disorders
Joint laxity
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.13%
2/1524 • Number of events 2 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.21%
1/487 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.79%
12/1524 • Number of events 14 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.66%
5/755 • Number of events 6 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.21%
1/487 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal adenoma
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign salivary gland neoplasm
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.10%
1/957 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.33%
5/1524 • Number of events 5 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.10%
1/957 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.41%
2/487 • Number of events 2 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer in situ
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.10%
1/957 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer stage III
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour of the small bowel
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholesteatoma
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myeloid leukaemia
|
0.13%
2/1524 • Number of events 2 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.13%
2/1524 • Number of events 2 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.10%
1/957 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer stage 0
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Dysplastic naevus
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroadenoma of breast
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of bone
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic adenoma
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lentigo maligna
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.07%
1/1524 • Number of events 4 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mantle cell lymphoma stage I
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm skin
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.13%
2/1524 • Number of events 2 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.10%
1/957 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.20%
3/1524 • Number of events 3 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.26%
2/755 • Number of events 2 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vaginal cancer
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.10%
1/957 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Nervous system disorders
Brain stem infarction
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Nervous system disorders
Carotid artery aneurysm
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.21%
1/487 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Nervous system disorders
Convulsion
|
0.07%
1/1524 • Number of events 2 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Nervous system disorders
Dizziness
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Nervous system disorders
Headache
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.21%
1/487 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Nervous system disorders
Intercostal neuralgia
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Nervous system disorders
Intracranial pressure increased
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Nervous system disorders
Migraine
|
0.13%
2/1524 • Number of events 2 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.21%
2/957 • Number of events 2 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Nervous system disorders
Presyncope
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.10%
1/957 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Nervous system disorders
Spinal cord herniation
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Nervous system disorders
Syncope
|
0.20%
3/1524 • Number of events 3 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.10%
1/957 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Nervous system disorders
Transient ischaemic attack
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.26%
2/755 • Number of events 3 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Pregnancy, puerperium and perinatal conditions
Abortion missed
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.13%
2/1524 • Number of events 2 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Pregnancy, puerperium and perinatal conditions
Abortion threatened
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.21%
1/487 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.21%
1/487 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Psychiatric disorders
Depression
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.10%
1/957 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Psychiatric disorders
Suicidal ideation
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Psychiatric disorders
Suicide attempt
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Renal and urinary disorders
Bladder prolapse
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.21%
1/487 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Renal and urinary disorders
Calculus ureteric
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.10%
1/957 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Renal and urinary disorders
IgA nephropathy
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.26%
4/1524 • Number of events 4 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.10%
1/957 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Renal and urinary disorders
Oliguria
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.10%
1/957 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Renal and urinary disorders
Renal cyst
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Renal and urinary disorders
Renal failure acute
|
0.13%
2/1524 • Number of events 2 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.26%
2/755 • Number of events 2 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Renal and urinary disorders
Renal impairment
|
0.13%
2/1524 • Number of events 2 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Renal and urinary disorders
Renal infarct
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Reproductive system and breast disorders
Adnexa uteri cyst
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.21%
1/487 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Reproductive system and breast disorders
Endometrial disorder
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.13%
2/1524 • Number of events 2 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Reproductive system and breast disorders
Endometriosis
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.10%
1/957 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Reproductive system and breast disorders
Menometrorrhagia
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.20%
3/1524 • Number of events 3 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Reproductive system and breast disorders
Pelvic adhesions
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Reproductive system and breast disorders
Polymenorrhoea
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Reproductive system and breast disorders
Rectocele
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.21%
1/487 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.10%
1/957 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.10%
1/957 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.20%
3/1524 • Number of events 3 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal turbinate hypertrophy
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.13%
2/1524 • Number of events 2 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.10%
1/957 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.21%
1/487 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.13%
2/1524 • Number of events 2 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Skin and subcutaneous tissue disorders
Cutis laxa
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Skin and subcutaneous tissue disorders
Excessive skin
|
0.13%
2/1524 • Number of events 2 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Skin and subcutaneous tissue disorders
Panniculitis
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Social circumstances
Miscarriage of partner
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Surgical and medical procedures
Abdominoplasty
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Surgical and medical procedures
Abortion induced
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Surgical and medical procedures
Coronary arterial stent insertion
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Surgical and medical procedures
Coronary revascularisation
|
0.20%
3/1524 • Number of events 4 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Surgical and medical procedures
Gastrectomy
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Surgical and medical procedures
Gastric bypass
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Surgical and medical procedures
Heart transplant
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Surgical and medical procedures
Ligament operation
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Surgical and medical procedures
Lipectomy
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Surgical and medical procedures
Mammoplasty
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Surgical and medical procedures
Obesity surgery
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Surgical and medical procedures
Rectocele repair
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Vascular disorders
Circulatory collapse
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Vascular disorders
Deep vein thrombosis
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Vascular disorders
Embolism venous
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Vascular disorders
Hypertension
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Vascular disorders
Hypotension
|
0.00%
0/1524 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Vascular disorders
Orthostatic hypotension
|
0.13%
2/1524 • Number of events 2 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Vascular disorders
Varicophlebitis
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/755 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.10%
1/957 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Vascular disorders
Varicose vein
|
0.07%
1/1524 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.13%
1/755 • Number of events 1 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/957 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.00%
0/487 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
Other adverse events
| Measure |
Liraglutide 3.0 mg, Pre-diabetes
n=1524 participants at risk
Arm 3: Subjects with pre-diabetes at screening received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for initial 56 weeks then continued treatment till 160 weeks, followed by an off-drug, observational follow-up period of 12 weeks. The total duration of this treatment arm from randomisation to follow-up was 172 weeks.
|
Liraglutide Placebo, Pre-diabetes
n=755 participants at risk
Arm 4: Subjects with pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for initial 56 weeks then continued treatment till 160 weeks, followed by an off-drug, observational follow-up period of 12 weeks. The total duration of this treatment arm from randomisation to follow-up was 172 weeks.
|
Liraglutide 3.0 mg, no Pre-diabetes
n=957 participants at risk
Arm 1 (Arm 1A + Arm 1B): Subjects with no pre-diabetes at screening received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks followed by a re-randomisation (1:1 into liraglutide 3.0 mg or liraglutide placebo) period of 12 weeks (weeks 56-68) and then an off-drug follow-up period of 2 weeks. The total duration of this treatment arm from randomisation to follow-up was 70 weeks.
|
Liraglutide Placebo, no Pre-diabetes
n=487 participants at risk
Arm 2: Subjects with no pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks and then continued with liraglutide placebo for additional 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period. The total duration of this treatment arm from randomisation to follow-up was 70 weeks.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
7.3%
112/1524 • Number of events 150 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
4.9%
37/755 • Number of events 49 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
6.5%
62/957 • Number of events 79 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
3.9%
19/487 • Number of events 22 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.2%
110/1524 • Number of events 137 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
5.3%
40/755 • Number of events 49 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
6.6%
63/957 • Number of events 84 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
3.7%
18/487 • Number of events 20 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Gastrointestinal disorders
Constipation
|
21.9%
333/1524 • Number of events 422 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
11.3%
85/755 • Number of events 100 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
21.2%
203/957 • Number of events 255 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
9.0%
44/487 • Number of events 52 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Gastrointestinal disorders
Diarrhoea
|
25.5%
388/1524 • Number of events 626 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
14.2%
107/755 • Number of events 144 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
21.0%
201/957 • Number of events 308 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
9.4%
46/487 • Number of events 58 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Gastrointestinal disorders
Dyspepsia
|
10.2%
156/1524 • Number of events 196 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
4.6%
35/755 • Number of events 40 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
10.7%
102/957 • Number of events 121 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
2.9%
14/487 • Number of events 16 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Gastrointestinal disorders
Eructation
|
5.6%
86/1524 • Number of events 96 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.53%
4/755 • Number of events 4 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
4.0%
38/957 • Number of events 52 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
0.41%
2/487 • Number of events 2 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Gastrointestinal disorders
Flatulence
|
5.3%
81/1524 • Number of events 94 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
2.9%
22/755 • Number of events 25 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
3.0%
29/957 • Number of events 35 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
3.1%
15/487 • Number of events 17 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
6.6%
101/1524 • Number of events 112 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
2.4%
18/755 • Number of events 19 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
4.9%
47/957 • Number of events 50 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
1.6%
8/487 • Number of events 8 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Gastrointestinal disorders
Nausea
|
40.8%
622/1524 • Number of events 974 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
17.0%
128/755 • Number of events 170 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
43.7%
418/957 • Number of events 616 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
16.0%
78/487 • Number of events 96 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Gastrointestinal disorders
Vomiting
|
19.7%
300/1524 • Number of events 476 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
5.6%
42/755 • Number of events 55 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
18.0%
172/957 • Number of events 267 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
5.1%
25/487 • Number of events 29 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
General disorders
Fatigue
|
10.1%
154/1524 • Number of events 190 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
7.7%
58/755 • Number of events 67 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
8.3%
79/957 • Number of events 89 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
5.5%
27/487 • Number of events 31 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
General disorders
Injection site haematoma
|
6.0%
91/1524 • Number of events 102 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
8.1%
61/755 • Number of events 69 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
6.7%
64/957 • Number of events 68 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
8.6%
42/487 • Number of events 45 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
General disorders
Oedema peripheral
|
3.5%
53/1524 • Number of events 60 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
6.2%
47/755 • Number of events 58 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
2.3%
22/957 • Number of events 25 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
1.2%
6/487 • Number of events 7 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Infections and infestations
Bronchitis
|
7.5%
114/1524 • Number of events 139 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
8.2%
62/755 • Number of events 80 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
3.7%
35/957 • Number of events 41 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
5.3%
26/487 • Number of events 27 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Infections and infestations
Gastroenteritis
|
9.1%
138/1524 • Number of events 171 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
6.1%
46/755 • Number of events 53 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
5.0%
48/957 • Number of events 53 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
4.9%
24/487 • Number of events 32 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Infections and infestations
Influenza
|
11.9%
181/1524 • Number of events 249 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
10.6%
80/755 • Number of events 123 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
6.8%
65/957 • Number of events 84 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
5.3%
26/487 • Number of events 37 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Infections and infestations
Nasopharyngitis
|
26.5%
404/1524 • Number of events 764 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
27.8%
210/755 • Number of events 408 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
20.2%
193/957 • Number of events 290 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
22.6%
110/487 • Number of events 166 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Infections and infestations
Sinusitis
|
8.5%
129/1524 • Number of events 174 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
8.6%
65/755 • Number of events 111 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
8.8%
84/957 • Number of events 99 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
7.2%
35/487 • Number of events 47 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Infections and infestations
Upper respiratory tract infection
|
15.5%
236/1524 • Number of events 389 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
15.9%
120/755 • Number of events 213 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
10.6%
101/957 • Number of events 122 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
11.1%
54/487 • Number of events 68 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Infections and infestations
Urinary tract infection
|
8.1%
123/1524 • Number of events 176 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
5.7%
43/755 • Number of events 62 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
5.0%
48/957 • Number of events 60 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
3.1%
15/487 • Number of events 19 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Investigations
Lipase increased
|
9.5%
145/1524 • Number of events 207 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
3.2%
24/755 • Number of events 26 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
3.7%
35/957 • Number of events 41 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
2.1%
10/487 • Number of events 10 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
11.1%
169/1524 • Number of events 181 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
3.6%
27/755 • Number of events 28 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
10.7%
102/957 • Number of events 111 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
3.3%
16/487 • Number of events 17 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
19.4%
295/1524 • Number of events 637 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
4.6%
35/755 • Number of events 52 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
18.4%
176/957 • Number of events 302 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
6.0%
29/487 • Number of events 37 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.2%
186/1524 • Number of events 231 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
12.8%
97/755 • Number of events 134 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
4.0%
38/957 • Number of events 41 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
4.7%
23/487 • Number of events 29 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.0%
198/1524 • Number of events 283 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
15.6%
118/755 • Number of events 159 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
8.0%
77/957 • Number of events 97 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
8.4%
41/487 • Number of events 50 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.1%
108/1524 • Number of events 127 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
7.2%
54/755 • Number of events 64 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
2.6%
25/957 • Number of events 27 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
4.5%
22/487 • Number of events 24 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Nervous system disorders
Dizziness
|
9.8%
149/1524 • Number of events 197 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
7.3%
55/755 • Number of events 73 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
7.0%
67/957 • Number of events 81 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
3.9%
19/487 • Number of events 20 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Nervous system disorders
Headache
|
17.9%
273/1524 • Number of events 432 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
16.4%
124/755 • Number of events 223 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
13.3%
127/957 • Number of events 178 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
11.9%
58/487 • Number of events 80 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.3%
112/1524 • Number of events 133 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
7.9%
60/755 • Number of events 87 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
3.6%
34/957 • Number of events 35 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
4.5%
22/487 • Number of events 23 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.9%
74/1524 • Number of events 81 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
5.8%
44/755 • Number of events 52 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
3.2%
31/957 • Number of events 34 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
4.3%
21/487 • Number of events 22 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
|
Vascular disorders
Hypertension
|
4.9%
74/1524 • Number of events 86 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
6.4%
48/755 • Number of events 58 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
2.3%
22/957 • Number of events 23 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
2.7%
13/487 • Number of events 13 • For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).
A total of 37 pre-diabetic subjects erroneously entered the re randomised period and their adverse events (AEs) were counted under the "pre-diabetic arms" (Arm 3 and Arm 4). A total of 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period and their AEs were counted under the "no pre-diabetes arms" (Arm 1 and Arm 2)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee When the primary results are available, Novo Nordisk plans to discuss the interpretation of these with the principal Investigator, but reserves the right to release results that may impact Novo Nordisk financial expectations (e.g. a press release directly to the public or similar) without prior consultation with the remaining participating Investigators. Novo Nordisk reserves the right not to release data until specified milestones, e.g. a clinical trial report is available.
- Publication restrictions are in place
Restriction type: OTHER