parallel randomized trial
SUSTAIN™ 6
A Long-term, Randomised, Double-blind, Placebo-controlled, Multinational, Multi-centre Trial to Evaluate Cardiovascular and Other Long-term Outcomes With Semaglutide in Subjects With Type 2 Diabetes (SUSTAIN™ 6 - Long-term Outcomes)
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | Semaglutide 0.5 mg subcutaneous once weekly Semaglutide 0.5 mg | standard of care; lifestyle: not reported | 826 | 826 | |
| A2 | Semaglutide 1.0 mg subcutaneous once weekly Semaglutide 1.0 mg | standard of care; lifestyle: not reported | 822 | 822 | |
| A3 | Placebo Placebo 0.5 mg | standard of care; lifestyle: not reported | 824 | 824 | |
| A4 | Placebo Placebo 1.0 mg | standard of care; lifestyle: not reported | 825 | 825 | |
| A5 | Pooled Semaglutide pooled 0.5 and 1.0 mg | lifestyle: not reported | 1,648 | 1,297 | |
| A6 | Placebo Placebo pooled 0.5 and 1.0 mg | lifestyle: not reported | 1,649 | 1,339 |
Baseline characteristics
As printed in the trial reports or registry, per arm or for the whole trial.
| Characteristic | Statistic | Semaglutide 0.5 mg subcutaneous once weekly A1 | Semaglutide 1.0 mg subcutaneous once weekly A2 | Placebo A3 | Placebo A4 | Pooled A5 | Placebo A6 | Whole trial ALL |
|---|---|---|---|---|---|---|---|---|
| age: 50 to 64 | n | 440 | 415 | 419 | 425 | |||
| age: 65 to 74 | n | 312 | 324 | 324 | 317 | |||
| age: 75 to 84 | n | 71 | 76 | 75 | 79 | |||
| age: 85 or more | n | 3 | 7 | 6 | 4 | |||
| age | mean (years) | 64.7 | 64.6 | |||||
| age | sd (years) | 7.2 | 7.5 | |||||
| asian | n | 63 | 58 | |||||
| bmi | mean (kg/m2) | 32.8 | 32.8 | |||||
| bmi | sd (kg/m2) | 6.2 | 6.2 | |||||
| diabetes duration | mean (years) | 14.2 | 13.6 | |||||
| diabetes duration | sd (years) | 8.2 | 8.0 | |||||
| egfr | mean (mL/min/1.73 m2) | 75.9 | 76.4 | |||||
| egfr | sd (mL/min/1.73 m2) | 25.9 | 27.2 | |||||
| established cvd | n | 1262 | 1271 | 2533 | ||||
| established cvd | percent | 76.8 | ||||||
| female | n | 331 | 304 | 342 | 318 | 635 | 660 | |
| female | percent | 38.5 | 40.0 | |||||
| hba1c | mean (percent) | 8.67 | 8.73 | 8.70 | 8.70 | 8.7 | 8.7 | |
| hba1c | sd (percent) | 1.39 | 1.51 | 1.49 | 1.45 | 1.5 | 1.5 | |
| insulin use | n | 956 | 957 | |||||
| insulin use | percent | 58.0 | 58.0 | |||||
| other insulin regimen: basal | n | 515 | 426 | |||||
| other insulin regimen: basal | percent | 31.3 | 25.8 | |||||
| other insulin regimen: premixed | n | 441 | 692 | |||||
| other insulin regimen: premixed | percent | 26.8 | 42.0 | |||||
| sbp | mean (mmHg) | 136.1 | 135.8 | 135.8 | 134.8 | 136.0 | 135.3 | |
| sbp | sd (mmHg) | 17.97 | 16.96 | 16.16 | 17.45 | 17.5 | 16.8 | |
| weight | mean (kg) | 91.80 | 92.86 | 91.83 | 91.90 | 92.3 | 91.9 | |
| weight | sd (kg) | 20.25 | 21.05 | 20.35 | 20.75 | 20.7 | 20.5 |
Analyses this trial contributes to
- Systolic blood pressure changeType 2 diabetes (adults); weeks 64 to 130 (target week 104); network meta-analysis
- Systolic blood pressure changeType 2 diabetes (adults); weeks 64 to 130 (target week 104); network meta-analysis
- Three point MACEType 2 diabetes (adults); longest follow-up; network meta-analysis
- Four point MACE including unstable anginaType 2 diabetes (adults); longest follow-up; descriptive only
- Kidney composite including albuminuria or smaller eGFR declinesType 2 diabetes (adults); longest follow-up; descriptive only
- Hospitalization for heart failureType 2 diabetes (adults); longest follow-up; network meta-analysis
- SF-36 physical component summary changeType 2 diabetes (adults); weeks 20 to 130 (target week 52); network meta-analysis
- SF-36 physical component summary changeType 2 diabetes (adults); weeks 20 to 130 (target week 52); network meta-analysis
- Serious adverse eventsType 2 diabetes (adults); longest follow-up; network meta-analysis
- Serious adverse eventsType 2 diabetes (adults); longest follow-up; network meta-analysis
- NauseaType 2 diabetes (adults); longest follow-up; network meta-analysis
- NauseaType 2 diabetes (adults); longest follow-up; network meta-analysis
- VomitingType 2 diabetes (adults); longest follow-up; network meta-analysis
- VomitingType 2 diabetes (adults); longest follow-up; network meta-analysis
- DiarrheaType 2 diabetes (adults); longest follow-up; network meta-analysis
- DiarrheaType 2 diabetes (adults); longest follow-up; network meta-analysis
- ConstipationType 2 diabetes (adults); longest follow-up; network meta-analysis
- ConstipationType 2 diabetes (adults); longest follow-up; network meta-analysis
- Thyroid cancer (any)Type 2 diabetes (adults); longest follow-up; descriptive only
- Diabetic retinopathy complicationsType 2 diabetes (adults); longest follow-up; network meta-analysis
- Diabetic retinopathy complicationsType 2 diabetes (adults); longest follow-up; network meta-analysis
Results
271 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
HbA1c change (14 lines; O01)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 104 | A1 vs A3 | md | -0.72 percent | -0.88 to -0.56 | not stated; full analysis; age:65_or_less; R0025777:Results | ||
| 104 | A1 vs A3 | md | -0.66 percent | -0.80 to -0.52 | not stated; full analysis; registry:outcomes | ||
| 104 | A1 vs A3 | md | -0.66 percent | -0.84 to -0.47 | not stated; full analysis; age:more_than_65; R0025777:Results | ||
| 104 | A1 | change | -1.09 percent | 0.05 | 826 | not stated; full analysis; registry:outcomes | |
| 104 | A1 vs A3 | md | -0.65 percent | -0.80 to -0.49 | not stated; full analysis; sex:male; R0025777:Results | ||
| 104 | A1 vs A3 | md | -0.75 percent | -0.94 to -0.56 | not stated; full analysis; sex:female; R0025777:Results | ||
| 104 | A2 | change | -1.41 percent | 0.05 | 822 | not stated; full analysis; registry:outcomes | |
| 104 | A2 vs A4 | md | -1.05 percent | -1.19 to -0.91 | not stated; full analysis; registry:outcomes | ||
| 104 | A2 vs A4 | md | -1.13 percent | -1.29 to -0.97 | not stated; full analysis; age:65_or_less; R0025777:Results | ||
| 104 | A2 vs A4 | md | -0.85 percent | -1.03 to -0.67 | not stated; full analysis; age:more_than_65; R0025777:Results | ||
| 104 | A2 vs A4 | md | -1.09 percent | -1.28 to -0.89 | not stated; full analysis; sex:female; R0025777:Results | ||
| 104 | A2 vs A4 | md | -0.96 percent | -1.11 to -0.81 | not stated; full analysis; sex:male; R0025777:Results | ||
| 104 | A3 | change | -0.44 percent | 0.05 | 824 | not stated; full analysis; registry:outcomes | |
| 104 | A4 | change | -0.36 percent | 0.05 | 825 | not stated; full analysis; registry:outcomes |
Body weight change in kilograms (diabetes) (13 lines; O02)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 104 | A1 vs A6 | md | -2.95 kg | -3.47 to -2.44 | not stated; full analysis; registry:outcomes | ||
| 104 | A1 vs A6 | md | -2.86 kg | -3.52 to -2.19 | not stated; full analysis; sex:male; R0025777:Results | ||
| 104 | A1 | change | -3.57 kg | 0.21 | 826 | not stated; full analysis; registry:outcomes | |
| 104 | A1 vs A6 | md | -2.90 kg | -3.58 to -2.23 | not stated; full analysis; age:65_or_less; R0025777:Results | ||
| 104 | A1 vs A6 | md | -3.02 kg | -3.82 to -2.22 | not stated; full analysis; age:more_than_65; R0025777:Results | ||
| 104 | A1 vs A6 | md | -3.04 kg | -3.85 to -2.23 | not stated; full analysis; sex:female; R0025777:Results | ||
| 104 | A2 vs A6 | md | -3.68 kg | -4.33 to -3.03 | not stated; full analysis; sex:male; R0025777:Results | ||
| 104 | A2 | change | -4.88 kg | 0.22 | 822 | not stated; full analysis; registry:outcomes | |
| 104 | A2 vs A6 | md | -4.72 kg | -5.50 to -3.95 | not stated; full analysis; age:more_than_65; R0025777:Results | ||
| 104 | A2 vs A6 | md | -3.87 kg | -4.56 to -3.18 | not stated; full analysis; age:65_or_less; R0025777:Results | ||
| 104 | A2 vs A6 | md | -4.27 kg | -4.78 to -3.75 | not stated; full analysis; registry:outcomes | ||
| 104 | A2 vs A6 | md | -5.27 kg | -6.11 to -4.43 | not stated; full analysis; sex:female; R0025777:Results | ||
| 104 | A6 | change | -0.62 kg | 0.15 | 1649 | not stated; full analysis; registry:outcomes |
Level 2 or 3 hypoglycemia (participants) (12 lines; O04)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 826 | not stated; safety; hypoglycaemic coma; registry:adverse_events | ||||
| A1 | events | 7 / 826 | not stated; safety; hypoglycaemia; registry:adverse_events | ||||
| A1 | events | 5 / 826 | not stated; safety; hypoglycaemic unconsciousness; registry:adverse_events | ||||
| A2 | events | 2 / 822 | not stated; safety; hypoglycaemia; registry:adverse_events | ||||
| A2 | events | 0 / 822 | not stated; safety; hypoglycaemic coma; registry:adverse_events | ||||
| A2 | events | 3 / 822 | not stated; safety; hypoglycaemic unconsciousness; registry:adverse_events | ||||
| A3 | events | 5 / 824 | not stated; safety; hypoglycaemia; registry:adverse_events | ||||
| A3 | events | 1 / 824 | not stated; safety; hypoglycaemic coma; registry:adverse_events | ||||
| A3 | events | 1 / 824 | not stated; safety; hypoglycaemic unconsciousness; registry:adverse_events | ||||
| A4 | events | 6 / 825 | not stated; safety; hypoglycaemia; registry:adverse_events | ||||
| A4 | events | 0 / 825 | not stated; safety; hypoglycaemic coma; registry:adverse_events | ||||
| A4 | events | 3 / 825 | not stated; safety; hypoglycaemic unconsciousness; registry:adverse_events |
Level 2 or 3 hypoglycemia (episode rate) (4 lines; O04B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | rate | 37.5 | 826 | not stated; full analysis; registry:outcomes | |||
| A2 | rate | 36.2 | 822 | not stated; full analysis; registry:outcomes | |||
| A3 | rate | 35.3 | 824 | not stated; full analysis; registry:outcomes | |||
| A4 | rate | 39.7 | 825 | not stated; full analysis; registry:outcomes |
Systolic blood pressure change (6 lines; O05)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 104 | A1 | change | -3.44 mmHg | 0.54 | 826 | not stated; full analysis; registry:outcomes | |
| 104 | A1 vs A3 | md | -1.27 mmHg | -2.77 to 0.23 | not stated; full analysis; registry:outcomes | ||
| 104 | A2 | change | -5.37 mmHg | 0.54 | 822 | not stated; full analysis; registry:outcomes | |
| 104 | A2 vs A4 | md | -2.59 mmHg | -4.09 to -1.08 | not stated; full analysis; registry:outcomes | ||
| 104 | A3 | change | -2.17 mmHg | 0.54 | 824 | not stated; full analysis; registry:outcomes | |
| 104 | A4 | change | -2.78 mmHg | 0.54 | 825 | not stated; full analysis; registry:outcomes |
Acute kidney injury (8 lines; O121)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 18 / 826 | not stated; safety; registry:adverse_events | ||||
| A1 | events | 1 / 826 | not stated; safety; acute prerenal failure; registry:adverse_events | ||||
| A2 | events | 6 / 822 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 0 / 822 | not stated; safety; acute prerenal failure; registry:adverse_events | ||||
| A3 | events | 14 / 824 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 0 / 824 | not stated; safety; acute prerenal failure; registry:adverse_events | ||||
| A4 | events | 22 / 825 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 0 / 825 | not stated; safety; acute prerenal failure; registry:adverse_events |
Three point MACE (12 lines; O21)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A5 vs A6 | hr | 0.68 | 0.46 to 0.99 | not stated; full analysis; duration:5_to_less_than_15; R0017025:Figure 1 | |||
| A5 | events | 108 / 1648 | not stated; full analysis; R0017025:Figure 1 | ||||
| A5 vs A6 | hr | 0.74 | 0.58 to 0.95 | not stated; full analysis; registry:outcomes | |||
| A5 vs A6 | hr | 0.74 | 0.58 to 0.95 | not stated; full analysis; registry:outcomes | |||
| A5 vs A6 | hr | 0.56 | 0.35 to 0.88 | not stated; other; bmi:25_to_less_than_30; R0006154:Figure 1 | |||
| A5 vs A6 | hr | 1.42 | 0.85 to 2.35 | not stated; other; bmi:30_to_less_than_35; R0006154:Figure 1 | |||
| A5 vs A6 | hr | 0.57 | 0.37 to 0.87 | not stated; other; bmi:35_or_more; R0006154:Figure 1 | |||
| A5 vs A6 | hr | 0.61 | 0.27 to 1.40 | not stated; other; bmi:less_than_25; R0006154:Figure 1 | |||
| A5 vs A6 | hr | 0.90 | 0.57 to 1.40 | not stated; full analysis; duration:15_to_less_than_25; R0017025:Figure 1 | |||
| A5 vs A6 | hr | 0.76 | 0.38 to 1.51 | not stated; full analysis; duration:25_or_more; R0017025:Figure 1 | |||
| A5 vs A6 | hr | 0.61 | 0.30 to 1.22 | not stated; full analysis; duration:less_than_5; R0017025:Figure 1 | |||
| A6 | events | 146 / 1649 | not stated; full analysis; R0017025:Figure 1 |
Four point MACE including unstable angina (3 lines; O21B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A5 | events | 199 / 1648 | not stated; full analysis; R0017025:Figure 1 | ||||
| A5 vs A6 | hr | 0.74 | 0.62 to 0.89 | not stated; full analysis; registry:outcomes | |||
| A6 | events | 264 / 1649 | not stated; full analysis; R0017025:Figure 1 |
Kidney composite including albuminuria or smaller eGFR declines (3 lines; O22E)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A5 | events | 62 / 1648 | not stated; full analysis; R0017025:Figure 1 | ||||
| A5 vs A6 | hr | 0.64 | 0.46 to 0.88 | not stated; full analysis; R0020578:Introduction | |||
| A6 | events | 100 / 1649 | not stated; full analysis; R0017025:Figure 1 |
Hospitalization for heart failure (19 lines; O23)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 2 / 826 | not stated; safety; cardiac failure acute; registry:adverse_events | ||||
| A1 | events | 8 / 826 | not stated; safety; cardiac failure chronic; registry:adverse_events | ||||
| A1 | events | 21 / 826 | not stated; safety; cardiac failure congestive; registry:adverse_events | ||||
| A1 | events | 10 / 826 | not stated; safety; cardiac failure; registry:adverse_events | ||||
| A2 | events | 0 / 822 | not stated; safety; cardiac failure acute; registry:adverse_events | ||||
| A2 | events | 4 / 822 | not stated; safety; cardiac failure chronic; registry:adverse_events | ||||
| A2 | events | 14 / 822 | not stated; safety; cardiac failure congestive; registry:adverse_events | ||||
| A2 | events | 10 / 822 | not stated; safety; cardiac failure; registry:adverse_events | ||||
| A3 | events | 6 / 824 | not stated; safety; cardiac failure chronic; registry:adverse_events | ||||
| A3 | events | 4 / 824 | not stated; safety; cardiac failure acute; registry:adverse_events | ||||
| A3 | events | 15 / 824 | not stated; safety; cardiac failure congestive; registry:adverse_events | ||||
| A3 | events | 7 / 824 | not stated; safety; cardiac failure; registry:adverse_events | ||||
| A4 | events | 1 / 825 | not stated; safety; cardiac failure acute; registry:adverse_events | ||||
| A4 | events | 3 / 825 | not stated; safety; cardiac failure chronic; registry:adverse_events | ||||
| A4 | events | 18 / 825 | not stated; safety; cardiac failure congestive; registry:adverse_events | ||||
| A4 | events | 3 / 825 | not stated; safety; cardiac failure; registry:adverse_events | ||||
| A5 | events | 59 / 1648 | not stated; full analysis; R0009517:Table 1 | ||||
| A5 vs A6 | hr | 1.11 | 0.77 to 1.61 | not stated; full analysis; registry:outcomes | |||
| A6 | events | 54 / 1649 | not stated; full analysis; R0009517:Table 1 |
SF-36 physical component summary change (9 lines; O24A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 104 | A1 | change | 0.76 points | 0.28 | 826 | not stated; full analysis; registry:outcomes | |
| 104 | A1 vs A3 | md | 0.68 points | -0.09 to 1.45 | not stated; full analysis; registry:outcomes | ||
| 104 | A2 | change | 1.74 points | 0.28 | 822 | not stated; full analysis; registry:outcomes | |
| 104 | A2 vs A4 | md | 1.40 points | 0.62 to 2.17 | not stated; full analysis; registry:outcomes | ||
| 104 | A3 | change | 0.07 points | 0.28 | 824 | not stated; full analysis; registry:outcomes | |
| 104 | A4 | change | 0.35 points | 0.28 | 825 | not stated; full analysis; registry:outcomes | |
| 104 | A5 vs A6 | md | 0.7 points | 0.1 to 1.2 | not stated; other; R0024109:Table 2 | ||
| 104 | A5 | change | 1.0 points | 0.2 | 0.6 to 1.4 | not stated; other; R0024109:Results | |
| 104 | A6 | change | 0.4 points | 0.2 | -0.0 to 0.8 | not stated; other; R0024109:Results |
Physical functioning (any instrument) (6 lines; O24B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 104 | A1 | change | 0.42 points | 0.32 | 826 | not stated; full analysis; registry:outcomes | |
| 104 | A1 vs A3 | md | 0.80 points | -0.10 to 1.69 | not stated; full analysis; registry:outcomes | ||
| 104 | A2 | change | 1.12 points | 0.32 | 822 | not stated; full analysis; registry:outcomes | |
| 104 | A2 vs A4 | md | 1.50 points | 0.60 to 2.40 | not stated; full analysis; registry:outcomes | ||
| 104 | A3 | change | -0.38 points | 0.32 | 824 | not stated; full analysis; registry:outcomes | |
| 104 | A4 | change | -0.37 points | 0.33 | 825 | not stated; full analysis; registry:outcomes |
Serious adverse events (4 lines; O25)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 289 / 826 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 276 / 822 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 329 / 824 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 298 / 825 | not stated; safety; registry:adverse_events |
Nausea (8 lines; O27A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 143 / 826 | not stated; safety; registry:adverse_events | ||||
| A1 | events | 0 / 826 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 179 / 822 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 3 / 822 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 62 / 824 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 1 / 824 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 66 / 825 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 1 / 825 | not stated; safety; registry:adverse_events |
Vomiting (8 lines; O27B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 87 / 826 | not stated; safety; registry:adverse_events | ||||
| A1 | events | 0 / 826 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 122 / 822 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 3 / 822 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 42 / 824 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 2 / 824 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 33 / 825 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 2 / 825 | not stated; safety; registry:adverse_events |
Diarrhea (8 lines; O27C)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 148 / 826 | not stated; safety; registry:adverse_events | ||||
| A1 | events | 2 / 826 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 148 / 822 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 6 / 822 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 97 / 824 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 2 / 824 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 87 / 825 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 1 / 825 | not stated; safety; registry:adverse_events |
Constipation (8 lines; O27D)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 46 / 826 | not stated; safety; registry:adverse_events | ||||
| A1 | events | 1 / 826 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 1 / 822 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 79 / 822 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 37 / 824 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 1 / 824 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 36 / 825 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 0 / 825 | not stated; safety; registry:adverse_events |
Gallbladder and biliary disease (44 lines; O28)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 826 | not stated; safety; gallbladder polyp; registry:adverse_events | ||||
| A1 | events | 1 / 826 | not stated; safety; hydrocholecystis; registry:adverse_events | ||||
| A1 | events | 1 / 826 | not stated; safety; cholelithiasis obstructive; registry:adverse_events | ||||
| A1 | events | 4 / 826 | not stated; safety; cholelithiasis; registry:adverse_events | ||||
| A1 | events | 0 / 826 | not stated; safety; bile duct stone; registry:adverse_events | ||||
| A1 | events | 0 / 826 | not stated; safety; cholecystitis; registry:adverse_events | ||||
| A1 | events | 0 / 826 | not stated; safety; cholecystitis chronic; registry:adverse_events | ||||
| A1 | events | 3 / 826 | not stated; safety; cholecystitis acute; registry:adverse_events | ||||
| A1 | events | 1 / 826 | not stated; safety; biliary colic; registry:adverse_events | ||||
| A1 | events | 1 / 826 | not stated; safety; cholangitis; registry:adverse_events | ||||
| A1 | events | 0 / 826 | not stated; safety; gallbladder necrosis; registry:adverse_events | ||||
| A2 | events | 1 / 822 | not stated; safety; cholecystitis; registry:adverse_events | ||||
| A2 | events | 0 / 822 | not stated; safety; biliary colic; registry:adverse_events | ||||
| A2 | events | 0 / 822 | not stated; safety; cholangitis; registry:adverse_events | ||||
| A2 | events | 0 / 822 | not stated; safety; gallbladder necrosis; registry:adverse_events | ||||
| A2 | events | 0 / 822 | not stated; safety; gallbladder polyp; registry:adverse_events | ||||
| A2 | events | 0 / 822 | not stated; safety; hydrocholecystis; registry:adverse_events | ||||
| A2 | events | 0 / 822 | not stated; safety; cholecystitis acute; registry:adverse_events | ||||
| A2 | events | 0 / 822 | not stated; safety; cholecystitis chronic; registry:adverse_events | ||||
| A2 | events | 2 / 822 | not stated; safety; bile duct stone; registry:adverse_events | ||||
| A2 | events | 0 / 822 | not stated; safety; cholelithiasis obstructive; registry:adverse_events | ||||
| A2 | events | 2 / 822 | not stated; safety; cholelithiasis; registry:adverse_events | ||||
| A3 | events | 0 / 824 | not stated; safety; hydrocholecystis; registry:adverse_events | ||||
| A3 | events | 1 / 824 | not stated; safety; gallbladder polyp; registry:adverse_events | ||||
| A3 | events | 6 / 824 | not stated; safety; cholecystitis acute; registry:adverse_events | ||||
| A3 | events | 0 / 824 | not stated; safety; cholecystitis chronic; registry:adverse_events | ||||
| A3 | events | 4 / 824 | not stated; safety; cholecystitis; registry:adverse_events | ||||
| A3 | events | 1 / 824 | not stated; safety; gallbladder necrosis; registry:adverse_events | ||||
| A3 | events | 0 / 824 | not stated; safety; cholangitis; registry:adverse_events | ||||
| A3 | events | 1 / 824 | not stated; safety; biliary colic; registry:adverse_events | ||||
| A3 | events | 2 / 824 | not stated; safety; bile duct stone; registry:adverse_events | ||||
| A3 | events | 0 / 824 | not stated; safety; cholelithiasis obstructive; registry:adverse_events | ||||
| A3 | events | 4 / 824 | not stated; safety; cholelithiasis; registry:adverse_events | ||||
| A4 | events | 0 / 825 | not stated; safety; gallbladder polyp; registry:adverse_events | ||||
| A4 | events | 0 / 825 | not stated; safety; gallbladder necrosis; registry:adverse_events | ||||
| A4 | events | 2 / 825 | not stated; safety; cholecystitis; registry:adverse_events | ||||
| A4 | events | 1 / 825 | not stated; safety; cholecystitis chronic; registry:adverse_events | ||||
| A4 | events | 2 / 825 | not stated; safety; cholecystitis acute; registry:adverse_events | ||||
| A4 | events | 0 / 825 | not stated; safety; hydrocholecystis; registry:adverse_events | ||||
| A4 | events | 0 / 825 | not stated; safety; cholangitis; registry:adverse_events | ||||
| A4 | events | 0 / 825 | not stated; safety; biliary colic; registry:adverse_events | ||||
| A4 | events | 1 / 825 | not stated; safety; bile duct stone; registry:adverse_events | ||||
| A4 | events | 0 / 825 | not stated; safety; cholelithiasis obstructive; registry:adverse_events | ||||
| A4 | events | 1 / 825 | not stated; safety; cholelithiasis; registry:adverse_events |
Acute pancreatitis (8 lines; O29)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 2 / 826 | not stated; safety; pancreatitis; registry:adverse_events | ||||
| A1 | events | 1 / 826 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 0 / 822 | not stated; safety; pancreatitis; registry:adverse_events | ||||
| A2 | events | 1 / 822 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 1 / 824 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 1 / 824 | not stated; safety; pancreatitis; registry:adverse_events | ||||
| A4 | events | 2 / 825 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 4 / 825 | not stated; safety; pancreatitis; registry:adverse_events |
Thyroid cancer (any) (10 lines; O32B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 826 | not stated; safety; thyroid cancer metastatic; registry:adverse_events | ||||
| A1 | events | 0 / 826 | not stated; safety; papillary thyroid cancer; registry:adverse_events | ||||
| A2 | events | 1 / 822 | not stated; safety; thyroid cancer metastatic; registry:adverse_events | ||||
| A2 | events | 0 / 822 | not stated; safety; papillary thyroid cancer; registry:adverse_events | ||||
| A3 | events | 0 / 824 | not stated; safety; thyroid cancer metastatic; registry:adverse_events | ||||
| A3 | events | 1 / 824 | not stated; safety; papillary thyroid cancer; registry:adverse_events | ||||
| A4 | events | 0 / 825 | not stated; safety; thyroid cancer metastatic; registry:adverse_events | ||||
| A4 | events | 0 / 825 | not stated; safety; papillary thyroid cancer; registry:adverse_events | ||||
| A5 | events | 1 / 1648 | not stated; randomized; R0000453:Table 1 | ||||
| A6 | events | 1 / 1649 | not stated; randomized; R0000453:Table 1 |
Diabetic retinopathy complications (27 lines; O33)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 25 / 826 | not stated; full analysis; R0020578:Results | ||||
| A1 | events | 74 / 826 | not stated; randomized; diabetic retinopathy; R0020578:Table 2 | ||||
| A1 | events | 46 / 826 | not stated; safety; diabetic retinopathy; registry:adverse_events | ||||
| A1 | events | 6 / 826 | not stated; randomized; diabetic retinopathy; R0020578:Table 2 | ||||
| A1 | events | 4 / 826 | not stated; safety; diabetic retinopathy; registry:adverse_events | ||||
| A1 | events | 1 / 826 | not stated; safety; retinopathy haemorrhagic; registry:adverse_events | ||||
| A1 | events | 2 / 826 | not stated; safety; vitreous haemorrhage; registry:adverse_events | ||||
| A2 | events | 25 / 822 | not stated; full analysis; R0020578:Results | ||||
| A2 | events | 82 / 822 | not stated; randomized; diabetic retinopathy; R0020578:Table 2 | ||||
| A2 | events | 56 / 822 | not stated; safety; diabetic retinopathy; registry:adverse_events | ||||
| A2 | events | 5 / 822 | not stated; randomized; diabetic retinopathy; R0020578:Table 2 | ||||
| A2 | events | 2 / 822 | not stated; safety; diabetic retinopathy; registry:adverse_events | ||||
| A2 | events | 0 / 822 | not stated; safety; retinopathy haemorrhagic; registry:adverse_events | ||||
| A2 | events | 2 / 822 | not stated; safety; vitreous haemorrhage; registry:adverse_events | ||||
| A3 | events | 39 / 824 | not stated; safety; diabetic retinopathy; registry:adverse_events | ||||
| A3 | events | 2 / 824 | not stated; safety; diabetic retinopathy; registry:adverse_events | ||||
| A3 | events | 0 / 824 | not stated; safety; retinopathy haemorrhagic; registry:adverse_events | ||||
| A3 | events | 0 / 824 | not stated; safety; vitreous haemorrhage; registry:adverse_events | ||||
| A4 | events | 38 / 825 | not stated; safety; diabetic retinopathy; registry:adverse_events | ||||
| A4 | events | 4 / 825 | not stated; safety; diabetic retinopathy; registry:adverse_events | ||||
| A4 | events | 0 / 825 | not stated; safety; retinopathy haemorrhagic; registry:adverse_events | ||||
| A4 | events | 0 / 825 | not stated; safety; vitreous haemorrhage; registry:adverse_events | ||||
| A5 | events | 50 / 1648 | not stated; full analysis; R0020578:Results | ||||
| A5 vs A6 | hr | 1.76 | 1.11 to 2.78 | not stated; full analysis; R0020578:Introduction | |||
| A6 | events | 29 / 1649 | not stated; full analysis; R0020578:Results | ||||
| A6 | events | 125 / 1649 | not stated; randomized; diabetic retinopathy; R0020578:Table 2 | ||||
| A6 | events | 8 / 1649 | not stated; randomized; diabetic retinopathy; R0020578:Table 2 |
Nonarteritic anterior ischemic optic neuropathy (4 lines; O34)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 826 | not stated; safety; optic ischaemic neuropathy; registry:adverse_events | ||||
| A2 | events | 2 / 822 | not stated; safety; optic ischaemic neuropathy; registry:adverse_events | ||||
| A3 | events | 0 / 824 | not stated; safety; optic ischaemic neuropathy; registry:adverse_events | ||||
| A4 | events | 0 / 825 | not stated; safety; optic ischaemic neuropathy; registry:adverse_events |
Intestinal obstruction or ileus (12 lines; O37B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 1 / 826 | not stated; safety; registry:adverse_events | ||||
| A1 | events | 0 / 826 | not stated; safety; gastric ileus; registry:adverse_events | ||||
| A1 | events | 0 / 826 | not stated; safety; small intestinal obstruction; registry:adverse_events | ||||
| A2 | events | 1 / 822 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 0 / 822 | not stated; safety; gastric ileus; registry:adverse_events | ||||
| A2 | events | 0 / 822 | not stated; safety; small intestinal obstruction; registry:adverse_events | ||||
| A3 | events | 0 / 824 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 0 / 824 | not stated; safety; gastric ileus; registry:adverse_events | ||||
| A3 | events | 0 / 824 | not stated; safety; small intestinal obstruction; registry:adverse_events | ||||
| A4 | events | 0 / 825 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 1 / 825 | not stated; safety; gastric ileus; registry:adverse_events | ||||
| A4 | events | 2 / 825 | not stated; safety; small intestinal obstruction; registry:adverse_events |
Pancreatic cancer (16 lines; O38)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 826 | not stated; safety; registry:adverse_events | ||||
| A1 | events | 0 / 826 | not stated; safety; adenocarcinoma pancreas; registry:adverse_events | ||||
| A1 | events | 0 / 826 | not stated; safety; pancreatic carcinoma metastatic; registry:adverse_events | ||||
| A1 | events | 0 / 826 | not stated; safety; pancreatic carcinoma stage iv; registry:adverse_events | ||||
| A2 | events | 0 / 822 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 0 / 822 | not stated; safety; adenocarcinoma pancreas; registry:adverse_events | ||||
| A2 | events | 0 / 822 | not stated; safety; pancreatic carcinoma metastatic; registry:adverse_events | ||||
| A2 | events | 1 / 822 | not stated; safety; pancreatic carcinoma stage iv; registry:adverse_events | ||||
| A3 | events | 0 / 824 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 1 / 824 | not stated; safety; adenocarcinoma pancreas; registry:adverse_events | ||||
| A3 | events | 1 / 824 | not stated; safety; pancreatic carcinoma metastatic; registry:adverse_events | ||||
| A3 | events | 0 / 824 | not stated; safety; pancreatic carcinoma stage iv; registry:adverse_events | ||||
| A4 | events | 1 / 825 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 0 / 825 | not stated; safety; adenocarcinoma pancreas; registry:adverse_events | ||||
| A4 | events | 1 / 825 | not stated; safety; pancreatic carcinoma metastatic; registry:adverse_events | ||||
| A4 | events | 0 / 825 | not stated; safety; pancreatic carcinoma stage iv; registry:adverse_events |
eGFR total slope (5 lines; O51)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 104.36 | A1 | slope | -1.59 mL/min/1.73 m2/year | -1.95 to -1.23 | 825 | not stated; randomized; R0010293:Figure 2 | |
| 104.36 | A1 vs A6 | md | 0.33 mL/min/1.73 m2/year | not stated; randomized; R0010293:Figure 2 | |||
| 104.36 | A2 | slope | -1.05 mL/min/1.73 m2/year | -1.41 to -0.69 | 821 | not stated; randomized; R0010293:Figure 2 | |
| 104.36 | A2 vs A6 | md | 0.87 mL/min/1.73 m2/year | not stated; randomized; R0010293:Figure 2 | |||
| 104.36 | A6 | slope | -1.92 mL/min/1.73 m2/year | -2.18 to -1.67 | 1648 | not stated; randomized; R0010293:Figure 2 |