parallel randomized trial
PIONEER 10
Safety and Efficacy of Oral Semaglutide Versus Dulaglutide Both in Combination With One OAD in Japanese Subjects With Type 2 Diabetes
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | Semaglutide 3 mg oral once daily (original tablet) Oral semaglutide 3 mg | one oral glucose lowering drug (SU, glinide, TZD, AGI or SGLT2i); lifestyle: not reported | 131 | 131 | 124 |
| A2 | Semaglutide 7 mg oral once daily (original tablet) Oral semaglutide 7 mg | one oral glucose lowering drug (SU, glinide, TZD, AGI or SGLT2i); lifestyle: not reported | 132 | 132 | 123 |
| A3 | Semaglutide 14 mg oral once daily (original tablet) Oral semaglutide 14 mg | one oral glucose lowering drug (SU, glinide, TZD, AGI or SGLT2i); lifestyle: not reported | 130 | 130 | 115 |
| A4 | Dulaglutide 0.75 mg subcutaneous once weekly Dulaglutide 0.75 mg | one oral glucose lowering drug (SU, glinide, TZD, AGI or SGLT2i); lifestyle: not reported | 65 | 65 | 61 |
Baseline characteristics
As printed in the trial reports or registry, per arm or for the whole trial.
| Characteristic | Statistic | Semaglutide 3 mg oral once daily (original tablet) A1 | Semaglutide 7 mg oral once daily (original tablet) A2 | Semaglutide 14 mg oral once daily (original tablet) A3 | Dulaglutide 0.75 mg subcutaneous once weekly A4 | Whole trial ALL |
|---|---|---|---|---|---|---|
| age: 75 or older | n | 24 | ||||
| age: 75 or older | percent | 5 | ||||
| age | mean (years) | 59 | 58 | 57 | 61 | |
| age | sd (years) | 10 | 11 | 10 | 9 | |
| asian | n | 131 | 132 | 130 | 65 | |
| black | n | 0 | 0 | 0 | 0 | |
| bmi | mean (kg/m2) | 25.8 | 26.8 | 26.3 | 26.0 | |
| bmi | sd (kg/m2) | 4.5 | 5.0 | 5.2 | 4.0 | |
| diabetes duration | mean (years) | 9.4 | 9.3 | 9.1 | 9.9 | |
| diabetes duration | sd (years) | 6.3 | 6.3 | 6.4 | 6.3 | |
| egfr: 30 to 59 | n | 0 | 2 | 1 | 1 | |
| egfr: 30 to 59 | percent | 2 | 1 | 2 | ||
| egfr: 60 to 89 | n | 36 | 37 | 35 | 14 | |
| egfr: 60 to 89 | percent | 27 | 28 | 27 | 22 | |
| egfr: 90 or more | n | 95 | 93 | 94 | 50 | |
| egfr: 90 or more | percent | 73 | 70 | 72 | 77 | |
| egfr: less than 30 | n | 0 | 0 | 0 | 0 | |
| egfr | mean (mL/min/1.73 m2) | 96 | 97 | 97 | 96 | |
| egfr | sd (mL/min/1.73 m2) | 13 | 14 | 14 | 13 | |
| female | n | 31 | 42 | 30 | 14 | |
| female | percent | 24 | 32 | 23 | 22 | |
| hba1c | mean (percent) | 8.2 | 8.3 | 8.4 | 8.4 | |
| hba1c | sd (percent) | 0.9 | 0.9 | 1.0 | 0.9 | |
| hispanic | n | 0 | 0 | 0 | 0 | |
| other background: alpha glucosidase inhibitor only | n | 22 | 22 | 22 | 11 | |
| other background: alpha glucosidase inhibitor only | percent | 17 | 17 | 17 | 17 | |
| other background: glinide only | n | 22 | 22 | 22 | 11 | |
| other background: glinide only | percent | 17 | 17 | 17 | 17 | |
| other background: sglt2i only | n | 22 | 23 | 22 | 11 | |
| other background: sglt2i only | percent | 17 | 17 | 17 | 17 | |
| other background: sulfonylurea only | n | 42 | 42 | 42 | 21 | |
| other background: sulfonylurea only | percent | 32 | 32 | 32 | 32 | |
| other background: thiazolidinedione only | n | 23 | 23 | 22 | 11 | |
| other background: thiazolidinedione only | percent | 18 | 17 | 17 | 17 | |
| waist | mean (cm) | 90.1 | 91.8 | 90.8 | 91.2 | |
| waist | sd (cm) | 11.5 | 11.1 | 10.7 | 10.1 | |
| weight | mean (kg) | 71.5 | 72.7 | 72.6 | 71.2 | |
| weight | sd (kg) | 16.0 | 16.4 | 15.2 | 14.3 | |
| white | n | 0 | 0 | 0 | 0 |
Analyses this trial contributes to
- HbA1c changeType 2 diabetes (adults); weeks 36 to 64 (target week 52); network meta-analysis
- HbA1c changeType 2 diabetes (adults); weeks 36 to 64 (target week 52); network meta-analysis
- HbA1c changeType 2 diabetes (adults); weeks 20 to 36 (target week 26); network meta-analysis
- HbA1c changeType 2 diabetes (adults); weeks 20 to 36 (target week 26); network meta-analysis
- HbA1c changeType 2 diabetes (adults); weeks 20 to 36 (target week 26); network meta-analysis
- HbA1c changeType 2 diabetes (adults); weeks 36 to 64 (target week 52); network meta-analysis
- HbA1c changeType 2 diabetes (adults); weeks 20 to 36 (target week 26); network meta-analysis
- HbA1c changeType 2 diabetes (adults); weeks 36 to 64 (target week 52); network meta-analysis
- Body weight change in kilograms (diabetes)Type 2 diabetes (adults); weeks 20 to 36 (target week 26); network meta-analysis
- Body weight change in kilograms (diabetes)Type 2 diabetes (adults); weeks 20 to 36 (target week 26); network meta-analysis
- Body weight change in kilograms (diabetes)Type 2 diabetes (adults); weeks 20 to 36 (target week 26); network meta-analysis
- Body weight change in kilograms (diabetes)Type 2 diabetes (adults); weeks 36 to 64 (target week 52); network meta-analysis
- Body weight change in kilograms (diabetes)Type 2 diabetes (adults); weeks 36 to 64 (target week 52); network meta-analysis
- Body weight change in kilograms (diabetes)Type 2 diabetes (adults); weeks 36 to 64 (target week 52); network meta-analysis
- Body weight change in kilograms (diabetes)Type 2 diabetes (adults); weeks 36 to 64 (target week 52); network meta-analysis
- Body weight change in kilograms (diabetes)Type 2 diabetes (adults); weeks 20 to 36 (target week 26); network meta-analysis
- HbA1c below 7 percentType 2 diabetes (adults); weeks 20 to 36 (target week 26); network meta-analysis
- HbA1c below 7 percentType 2 diabetes (adults); weeks 36 to 64 (target week 52); network meta-analysis
- HbA1c below 7 percentType 2 diabetes (adults); weeks 20 to 36 (target week 26); network meta-analysis
- HbA1c below 7 percentType 2 diabetes (adults); weeks 20 to 36 (target week 26); network meta-analysis
- HbA1c below 7 percentType 2 diabetes (adults); weeks 36 to 64 (target week 52); network meta-analysis
- HbA1c below 7 percentType 2 diabetes (adults); weeks 36 to 64 (target week 52); network meta-analysis
- HbA1c below 7 percentType 2 diabetes (adults); weeks 20 to 36 (target week 26); network meta-analysis
- HbA1c below 7 percentType 2 diabetes (adults); weeks 36 to 64 (target week 52); network meta-analysis
- Level 2 or 3 hypoglycemia (participants)Type 2 diabetes (adults); longest follow-up; network meta-analysis
- Level 2 or 3 hypoglycemia (participants)Type 2 diabetes (adults); longest follow-up; network meta-analysis
- Level 2 or 3 hypoglycemia (participants)Type 2 diabetes (adults); longest follow-up; network meta-analysis
- Level 2 or 3 hypoglycemia (participants)Type 2 diabetes (adults); longest follow-up; network meta-analysis
- Level 2 or 3 hypoglycemia (participants)Type 2 diabetes (adults); longest follow-up; network meta-analysis
- Level 2 or 3 hypoglycemia (participants)Type 2 diabetes (adults); longest follow-up; network meta-analysis
- Systolic blood pressure changeType 2 diabetes (adults); weeks 36 to 64 (target week 52); descriptive only
- Systolic blood pressure changeType 2 diabetes (adults); weeks 36 to 64 (target week 52); network meta-analysis
- Systolic blood pressure changeType 2 diabetes (adults); weeks 20 to 36 (target week 26); network meta-analysis
- Systolic blood pressure changeType 2 diabetes (adults); weeks 20 to 36 (target week 26); network meta-analysis
- Systolic blood pressure changeType 2 diabetes (adults); weeks 20 to 36 (target week 26); network meta-analysis
- Systolic blood pressure changeType 2 diabetes (adults); weeks 20 to 36 (target week 26); network meta-analysis
- Systolic blood pressure changeType 2 diabetes (adults); weeks 36 to 64 (target week 52); network meta-analysis
- Systolic blood pressure changeType 2 diabetes (adults); weeks 36 to 64 (target week 52); network meta-analysis
- Systolic blood pressure changeType 2 diabetes (adults); weeks 36 to 64 (target week 52); network meta-analysis
- Systolic blood pressure changeType 2 diabetes (adults); weeks 36 to 64 (target week 52); network meta-analysis
- Systolic blood pressure changeType 2 diabetes (adults); weeks 20 to 36 (target week 26); descriptive only
- Systolic blood pressure changeType 2 diabetes (adults); weeks 20 to 36 (target week 26); network meta-analysis
- Percent body weight changeType 2 diabetes (adults); weeks 40 to 104 (target week 68); network meta-analysis
- Percent body weight changeType 2 diabetes (adults); weeks 20 to 40 (target week 26); network meta-analysis
- Percent body weight changeType 2 diabetes (adults); weeks 40 to 104 (target week 68); network meta-analysis
- Percent body weight changeType 2 diabetes (adults); weeks 20 to 40 (target week 26); network meta-analysis
- Percent body weight changeType 2 diabetes (adults); weeks 20 to 40 (target week 26); network meta-analysis
- Percent body weight changeType 2 diabetes (adults); weeks 20 to 40 (target week 26); network meta-analysis
- Percent body weight changeType 2 diabetes (adults); weeks 40 to 104 (target week 68); descriptive only
- Percent body weight changeType 2 diabetes (adults); weeks 40 to 104 (target week 68); network meta-analysis
- Weight loss of 5 percent or moreType 2 diabetes (adults); weeks 20 to 40 (target week 26); network meta-analysis
- Weight loss of 5 percent or moreType 2 diabetes (adults); weeks 20 to 40 (target week 26); network meta-analysis
- Weight loss of 5 percent or moreType 2 diabetes (adults); weeks 40 to 104 (target week 68); network meta-analysis
- Weight loss of 5 percent or moreType 2 diabetes (adults); weeks 40 to 104 (target week 68); network meta-analysis
- Weight loss of 5 percent or moreType 2 diabetes (adults); weeks 20 to 40 (target week 26); network meta-analysis
- Weight loss of 5 percent or moreType 2 diabetes (adults); weeks 40 to 104 (target week 68); network meta-analysis
- Weight loss of 5 percent or moreType 2 diabetes (adults); weeks 40 to 104 (target week 68); network meta-analysis
- Weight loss of 5 percent or moreType 2 diabetes (adults); weeks 20 to 40 (target week 26); network meta-analysis
- Weight loss of 10 percent or moreType 2 diabetes (adults); weeks 20 to 40 (target week 26); network meta-analysis
- Weight loss of 10 percent or moreType 2 diabetes (adults); weeks 20 to 40 (target week 26); network meta-analysis
- Weight loss of 10 percent or moreType 2 diabetes (adults); weeks 20 to 40 (target week 26); network meta-analysis
- Weight loss of 10 percent or moreType 2 diabetes (adults); weeks 40 to 104 (target week 68); network meta-analysis
- Weight loss of 10 percent or moreType 2 diabetes (adults); weeks 40 to 104 (target week 68); network meta-analysis
- Weight loss of 10 percent or moreType 2 diabetes (adults); weeks 20 to 40 (target week 26); network meta-analysis
- Weight loss of 10 percent or moreType 2 diabetes (adults); weeks 40 to 104 (target week 68); network meta-analysis
- Weight loss of 10 percent or moreType 2 diabetes (adults); weeks 40 to 104 (target week 68); network meta-analysis
- Acute kidney injuryType 2 diabetes (adults); longest follow-up; descriptive only
- Acute kidney injuryType 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
- 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
- Discontinuation due to adverse eventsType 2 diabetes (adults); longest follow-up; network meta-analysis
- Discontinuation due to 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
- Discontinuation due to gastrointestinal adverse eventsType 2 diabetes (adults); longest follow-up; network meta-analysis
- Discontinuation due to gastrointestinal adverse eventsType 2 diabetes (adults); longest follow-up; network meta-analysis
- Gallbladder and biliary diseaseType 2 diabetes (adults); longest follow-up; network meta-analysis
- Gallbladder and biliary diseaseType 2 diabetes (adults); longest follow-up; network meta-analysis
- Acute pancreatitisType 2 diabetes (adults); longest follow-up; network meta-analysis
- Acute pancreatitisType 2 diabetes (adults); longest follow-up; network meta-analysis
- Medullary thyroid carcinomaType 2 diabetes (adults); longest follow-up; descriptive only
- Medullary thyroid carcinomaType 2 diabetes (adults); longest follow-up; descriptive only
- Thyroid cancer (any)Type 2 diabetes (adults); longest follow-up; descriptive only
- 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
- Death by suicideType 2 diabetes (adults); longest follow-up; descriptive only
- Death by suicideType 2 diabetes (adults); longest follow-up; descriptive only
- Any cancerType 2 diabetes (adults); longest follow-up; network meta-analysis
- Any cancerType 2 diabetes (adults); longest follow-up; network meta-analysis
Results
435 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
HbA1c change (50 lines; O01)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26 | A1 | change | -1.1 percent | 0.1 | 126 | hypothetical; full analysis; R0018421:Figure 2D | |
| 26 | A1 vs A4 | md | 0.5 percent | 0.3 to 0.7 | hypothetical; full analysis; R0018421:Figure 2D | ||
| 26 | A1 | change | -1.1 percent | 87 | treatment policy; randomized; age:less_than_65; R0016956:Figure 1A | ||
| 26 | A1 | change | -1.1 percent | 0.1 | 131 | treatment policy; full analysis; R0018421:Figure 2C | |
| 26 | A1 | change | -1.1 percent | 0.9 | 131 | treatment policy; full analysis; registry:outcomes | |
| 26 | A1 vs A4 | md | 0.4 percent | 0.1 to 0.7 | treatment policy; full analysis; R0018421:Figure 2C | ||
| 26 | A1 vs A4 | md | 0.4 percent | -0.1 to 0.8 | treatment policy; randomized; age:65_or_older; R0016956:Supplement Figure S1 | ||
| 26 | A1 | change | -1.2 percent | 44 | treatment policy; randomized; age:65_or_older; R0016956:Figure 1A | ||
| 26 | A1 vs A4 | md | 0.4 percent | 0.1 to 0.7 | treatment policy; randomized; age:less_than_65; R0016956:Supplement Figure S1 | ||
| 26 | A2 vs A4 | md | -0.1 percent | -0.6 to 0.4 | treatment policy; randomized; age:65_or_older; R0016956:Supplement Figure S1 | ||
| 26 | A2 vs A4 | md | -0.1 percent | -0.3 to 0.1 | hypothetical; full analysis; R0018421:Figure 2D | ||
| 26 | A2 | change | -1.7 percent | 0.1 | 124 | hypothetical; full analysis; R0018421:Figure 2D | |
| 26 | A2 | change | -1.7 percent | 41 | treatment policy; randomized; age:65_or_older; R0016956:Figure 1A | ||
| 26 | A2 | change | -1.7 percent | 0.1 | 132 | treatment policy; full analysis; R0018421:Figure 2C | |
| 26 | A2 vs A4 | md | -0.2 percent | -0.5 to 0.1 | treatment policy; randomized; age:less_than_65; R0016956:Supplement Figure S1 | ||
| 26 | A2 | change | -1.7 percent | 91 | treatment policy; randomized; age:less_than_65; R0016956:Figure 1A | ||
| 26 | A2 vs A4 | md | -0.1 percent | -0.4 to 0.1 | treatment policy; full analysis; R0018421:Figure 2C | ||
| 26 | A2 | change | -1.7 percent | 0.9 | 132 | treatment policy; full analysis; registry:outcomes | |
| 26 | A3 | change | -2.3 percent | 34 | treatment policy; randomized; age:65_or_older; R0016956:Figure 1A | ||
| 26 | A3 | change | -2.0 percent | 0.1 | 120 | hypothetical; full analysis; R0018421:Figure 2D | |
| 26 | A3 vs A4 | md | -0.4 percent | -0.6 to -0.2 | hypothetical; full analysis; R0018421:Figure 2D | ||
| 26 | A3 | change | -2.0 percent | 0.1 | 130 | treatment policy; full analysis; R0018421:Figure 2C | |
| 26 | A3 | change | -2.0 percent | 1.0 | 130 | treatment policy; full analysis; registry:outcomes | |
| 26 | A3 vs A4 | md | -0.4 percent | -0.7 to -0.2 | treatment policy; full analysis; R0018421:Figure 2C | ||
| 26 | A3 vs A4 | md | -0.3 percent | -0.6 to 0.0 | treatment policy; randomized; age:less_than_65; R0016956:Supplement Figure S1 | ||
| 26 | A3 | change | -1.8 percent | 96 | treatment policy; randomized; age:less_than_65; R0016956:Figure 1A | ||
| 26 | A3 vs A4 | md | -0.7 percent | -1.2 to -0.3 | treatment policy; randomized; age:65_or_older; R0016956:Supplement Figure S1 | ||
| 26 | A4 | change | -1.6 percent | 0.9 | 65 | treatment policy; full analysis; registry:outcomes | |
| 26 | A4 | change | -1.5 percent | 0.1 | 65 | treatment policy; full analysis; R0018421:Figure 2C | |
| 26 | A4 | change | -1.6 percent | 0.1 | 62 | hypothetical; full analysis; R0018421:Figure 2D | |
| 26 | A4 | change | -1.6 percent | 18 | treatment policy; randomized; age:65_or_older; R0016956:Figure 1A | ||
| 26 | A4 | change | -1.5 percent | 47 | treatment policy; randomized; age:less_than_65; R0016956:Figure 1A | ||
| 52 | A1 | change | -0.7 percent | 0.1 | 102 | hypothetical; full analysis; R0018421:Figure 2D | |
| 52 | A1 vs A4 | md | 0.6 percent | 0.3 to 0.9 | hypothetical; full analysis; R0018421:Figure 2D | ||
| 52 | A1 | change | -0.9 percent | 0.1 | 131 | treatment policy; full analysis; R0018421:Figure 2C | |
| 52 | A1 | change | -0.8 percent | 1.0 | 131 | treatment policy; full analysis; registry:outcomes | |
| 52 | A1 vs A4 | md | 0.5 percent | 0.2 to 0.8 | treatment policy; full analysis; R0018421:Figure 2C | ||
| 52 | A2 | change | -1.4 percent | 0.1 | 114 | hypothetical; full analysis; R0018421:Figure 2D | |
| 52 | A2 vs A4 | md | -0.1 percent | -0.3 to 0.2 | treatment policy; full analysis; R0018421:Figure 2C | ||
| 52 | A2 | change | -1.4 percent | 1.0 | 132 | treatment policy; full analysis; registry:outcomes | |
| 52 | A2 | change | -1.4 percent | 0.1 | 132 | treatment policy; full analysis; R0018421:Figure 2C | |
| 52 | A2 vs A4 | md | -0.1 percent | -0.4 to 0.2 | hypothetical; full analysis; R0018421:Figure 2D | ||
| 52 | A3 | change | -1.7 percent | 0.1 | 130 | treatment policy; full analysis; R0018421:Figure 2C | |
| 52 | A3 | change | -1.8 percent | 0.1 | 113 | hypothetical; full analysis; R0018421:Figure 2D | |
| 52 | A3 vs A4 | md | -0.3 percent | -0.6 to -0.1 | treatment policy; full analysis; R0018421:Figure 2C | ||
| 52 | A3 | change | -1.8 percent | 1.0 | 130 | treatment policy; full analysis; registry:outcomes | |
| 52 | A3 vs A4 | md | -0.5 percent | -0.8 to -0.2 | hypothetical; full analysis; R0018421:Figure 2D | ||
| 52 | A4 | change | -1.4 percent | 0.1 | 65 | treatment policy; full analysis; R0018421:Figure 2C | |
| 52 | A4 | change | -1.3 percent | 0.1 | 56 | hypothetical; full analysis; R0018421:Figure 2D | |
| 52 | A4 | change | -1.4 percent | 0.9 | 65 | treatment policy; full analysis; registry:outcomes |
Body weight change in kilograms (diabetes) (50 lines; O02)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26 | A1 | change | -0.2 kg | 0.3 | 131 | treatment policy; full analysis; R0018421:Figure 3C | |
| 26 | A1 | change | -0.1 kg | 0.2 | 126 | hypothetical; full analysis; R0018421:Figure 3D | |
| 26 | A1 vs A4 | md | -0.4 kg | -1.2 to 0.4 | hypothetical; full analysis; R0018421:Figure 3D | ||
| 26 | A1 | change | -0.1 kg | 2.0 | 131 | treatment policy; full analysis; registry:outcomes | |
| 26 | A1 vs A4 | md | -0.5 kg | -1.3 to 0.4 | treatment policy; full analysis; R0018421:Figure 3C | ||
| 26 | A1 | change | -1.0 kg | 44 | treatment policy; randomized; age:65_or_older; R0016956:Figure 1B | ||
| 26 | A1 vs A4 | md | -0.5 kg | -2.0 to 1.0 | treatment policy; randomized; age:65_or_older; R0016956:Supplement Figure S2 | ||
| 26 | A1 vs A4 | md | -0.4 kg | -1.4 to 0.6 | treatment policy; randomized; age:less_than_65; R0016956:Supplement Figure S2 | ||
| 26 | A1 | change | 0.2 kg | 87 | treatment policy; randomized; age:less_than_65; R0016956:Figure 1B | ||
| 26 | A2 | change | -1.0 kg | 3.0 | 132 | treatment policy; full analysis; registry:outcomes | |
| 26 | A2 vs A4 | md | -1.3 kg | -2.2 to -0.5 | treatment policy; full analysis; R0018421:Figure 3C | ||
| 26 | A2 vs A4 | md | -1.5 kg | -2.5 to -0.5 | treatment policy; randomized; age:less_than_65; R0016956:Supplement Figure S2 | ||
| 26 | A2 vs A4 | md | -1.5 kg | -2.3 to -0.6 | hypothetical; full analysis; R0018421:Figure 3D | ||
| 26 | A2 vs A4 | md | -0.7 kg | -2.3 to 0.9 | treatment policy; randomized; age:65_or_older; R0016956:Supplement Figure S2 | ||
| 26 | A2 | change | -1.0 kg | 0.3 | 132 | treatment policy; full analysis; R0018421:Figure 3C | |
| 26 | A2 | change | -1.2 kg | 41 | treatment policy; randomized; age:65_or_older; R0016956:Figure 1B | ||
| 26 | A2 | change | -1.2 kg | 0.2 | 124 | hypothetical; full analysis; R0018421:Figure 3D | |
| 26 | A2 | change | -1.0 kg | 91 | treatment policy; randomized; age:less_than_65; R0016956:Figure 1B | ||
| 26 | A3 vs A4 | md | -2.6 kg | -3.6 to -1.6 | treatment policy; randomized; age:less_than_65; R0016956:Supplement Figure S2 | ||
| 26 | A3 | change | -2.2 kg | 0.2 | 130 | treatment policy; full analysis; R0018421:Figure 3C | |
| 26 | A3 | change | -2.2 kg | 3.2 | 130 | treatment policy; full analysis; registry:outcomes | |
| 26 | A3 vs A4 | md | -2.5 kg | -3.3 to -1.7 | treatment policy; full analysis; R0018421:Figure 3C | ||
| 26 | A3 vs A4 | md | -2.2 kg | -3.8 to -0.7 | treatment policy; randomized; age:65_or_older; R0016956:Supplement Figure S2 | ||
| 26 | A3 | change | -2.7 kg | 34 | treatment policy; randomized; age:65_or_older; R0016956:Figure 1B | ||
| 26 | A3 | change | -2.1 kg | 96 | treatment policy; randomized; age:less_than_65; R0016956:Figure 1B | ||
| 26 | A3 | change | -2.3 kg | 0.2 | 120 | hypothetical; full analysis; R0018421:Figure 3D | |
| 26 | A3 vs A4 | md | -2.6 kg | -3.5 to -1.8 | hypothetical; full analysis; R0018421:Figure 3D | ||
| 26 | A4 | change | 0.3 kg | 0.3 | 64 | hypothetical; full analysis; R0018421:Figure 3D | |
| 26 | A4 | change | 0.3 kg | 0.3 | 65 | treatment policy; full analysis; R0018421:Figure 3C | |
| 26 | A4 | change | 0.3 kg | 2.1 | 65 | treatment policy; full analysis; registry:outcomes | |
| 26 | A4 | change | -0.5 kg | 18 | treatment policy; randomized; age:65_or_older; R0016956:Figure 1B | ||
| 26 | A4 | change | 0.6 kg | 47 | treatment policy; randomized; age:less_than_65; R0016956:Figure 1B | ||
| 52 | A1 | change | 0.1 kg | 0.3 | 103 | hypothetical; full analysis; R0018421:Figure 3D | |
| 52 | A1 vs A4 | md | -0.9 kg | -1.9 to 0.0 | treatment policy; full analysis; R0018421:Figure 3C | ||
| 52 | A1 | change | 0.0 kg | 2.4 | 131 | treatment policy; full analysis; registry:outcomes | |
| 52 | A1 | change | 0.0 kg | 0.3 | 131 | treatment policy; full analysis; R0018421:Figure 3C | |
| 52 | A1 vs A4 | md | -0.9 kg | -1.9 to 0.1 | hypothetical; full analysis; R0018421:Figure 3D | ||
| 52 | A2 | change | -0.9 kg | 0.3 | 132 | treatment policy; full analysis; R0018421:Figure 3C | |
| 52 | A2 vs A4 | md | -1.9 kg | -2.8 to -0.9 | treatment policy; full analysis; R0018421:Figure 3C | ||
| 52 | A2 vs A4 | md | -2.1 kg | -3.1 to -1.1 | hypothetical; full analysis; R0018421:Figure 3D | ||
| 52 | A2 | change | -0.9 kg | 3.4 | 132 | treatment policy; full analysis; registry:outcomes | |
| 52 | A2 | change | -1.0 kg | 0.3 | 115 | hypothetical; full analysis; R0018421:Figure 3D | |
| 52 | A3 | change | -1.6 kg | 0.3 | 130 | treatment policy; full analysis; R0018421:Figure 3C | |
| 52 | A3 vs A4 | md | -2.6 kg | -3.5 to -1.6 | treatment policy; full analysis; R0018421:Figure 3C | ||
| 52 | A3 vs A4 | md | -3.0 kg | hypothetical; full analysis; R0018421:Figure 3D | |||
| 52 | A3 | change | -1.9 kg | 0.3 | 113 | hypothetical; full analysis; R0018421:Figure 3D | |
| 52 | A3 | change | -1.7 kg | 3.5 | 130 | treatment policy; full analysis; registry:outcomes | |
| 52 | A4 | change | 1.0 kg | 0.4 | 65 | treatment policy; full analysis; R0018421:Figure 3C | |
| 52 | A4 | change | 1.0 kg | 2.7 | 65 | treatment policy; full analysis; registry:outcomes | |
| 52 | A4 | change | 1.1 kg | 0.4 | 56 | hypothetical; full analysis; R0018421:Figure 3D |
HbA1c below 7 percent (28 lines; O03)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26 | A1 vs A4 | or | 0.20 | 0.09 to 0.42 | hypothetical; full analysis; R0018421:Table 4 | ||
| 26 | A1 | responders | 58 / 126 | hypothetical; full analysis; R0018421:Table 4 | |||
| 26 | A1 vs A4 | or | 0.26 | 0.13 to 0.54 | treatment policy; full analysis; R0018421:Table 4 | ||
| 26 | A1 | responders | 59 / 128 | treatment policy; full analysis; R0018421:Table 4 | |||
| 26 | A2 vs A4 | or | 1.33 | 0.64 to 2.77 | treatment policy; full analysis; R0018421:Table 4 | ||
| 26 | A2 | responders | 94 / 124 | hypothetical; full analysis; R0018421:Table 4 | |||
| 26 | A2 vs A4 | or | 1.27 | 0.58 to 2.78 | hypothetical; full analysis; R0018421:Table 4 | ||
| 26 | A2 | responders | 96 / 128 | treatment policy; full analysis; R0018421:Table 4 | |||
| 26 | A3 vs A4 | or | 2.83 | 1.22 to 6.57 | hypothetical; full analysis; R0018421:Table 4 | ||
| 26 | A3 | responders | 105 / 128 | treatment policy; full analysis; R0018421:Table 4 | |||
| 26 | A3 | responders | 101 / 120 | hypothetical; full analysis; R0018421:Table 4 | |||
| 26 | A3 vs A4 | or | 2.63 | 1.20 to 5.73 | treatment policy; full analysis; R0018421:Table 4 | ||
| 26 | A4 | responders | 45 / 62 | hypothetical; full analysis; R0018421:Table 4 | |||
| 26 | A4 | responders | 45 / 64 | treatment policy; full analysis; R0018421:Table 4 | |||
| 52 | A1 vs A4 | or | 0.41 | 0.21 to 0.80 | treatment policy; full analysis; R0018421:Table 4 | ||
| 52 | A1 | responders | 43 / 126 | treatment policy; full analysis; R0018421:Table 4 | |||
| 52 | A1 vs A4 | or | 0.34 | 0.17 to 0.68 | hypothetical; full analysis; R0018421:Table 4 | ||
| 52 | A1 | responders | 40 / 102 | hypothetical; full analysis; R0018421:Table 4 | |||
| 52 | A2 vs A4 | or | 1.58 | 0.80 to 3.11 | hypothetical; full analysis; R0018421:Table 4 | ||
| 52 | A2 | responders | 74 / 114 | hypothetical; full analysis; R0018421:Table 4 | |||
| 52 | A2 | responders | 77 / 129 | treatment policy; full analysis; R0018421:Table 4 | |||
| 52 | A2 vs A4 | or | 1.51 | 0.78 to 2.92 | treatment policy; full analysis; R0018421:Table 4 | ||
| 52 | A3 | responders | 85 / 113 | hypothetical; full analysis; R0018421:Table 4 | |||
| 52 | A3 vs A4 | or | 3.07 | 1.53 to 6.16 | treatment policy; full analysis; R0018421:Table 4 | ||
| 52 | A3 | responders | 90 / 127 | treatment policy; full analysis; R0018421:Table 4 | |||
| 52 | A3 vs A4 | or | 3.82 | 1.85 to 7.92 | hypothetical; full analysis; R0018421:Table 4 | ||
| 52 | A4 | responders | 32 / 63 | treatment policy; full analysis; R0018421:Table 4 | |||
| 52 | A4 | responders | 32 / 56 | hypothetical; full analysis; R0018421:Table 4 |
Level 2 or 3 hypoglycemia (participants) (12 lines; O04)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 14 / 131 | while on treatment; safety; R0018421:Table 3 | ||||
| A1 | events | 3 / 131 | while on treatment; safety; R0018421:Table 3 | ||||
| A1 | events | 0 / 131 | while on treatment; safety; R0018421:Table 3 | ||||
| A2 | events | 3 / 132 | while on treatment; safety; R0018421:Table 3 | ||||
| A2 | events | 26 / 132 | while on treatment; safety; R0018421:Table 3 | ||||
| A2 | events | 0 / 132 | while on treatment; safety; R0018421:Table 3 | ||||
| A3 | events | 0 / 130 | while on treatment; safety; R0018421:Table 3 | ||||
| A3 | events | 27 / 130 | while on treatment; safety; R0018421:Table 3 | ||||
| A3 | events | 4 / 130 | while on treatment; safety; R0018421:Table 3 | ||||
| A4 | events | 0 / 65 | while on treatment; safety; R0018421:Table 3 | ||||
| A4 | events | 0 / 65 | while on treatment; safety; R0018421:Table 3 | ||||
| A4 | events | 13 / 65 | while on treatment; safety; R0018421:Table 3 |
Level 2 or 3 hypoglycemia (episode rate) (8 lines; O04B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | rate | 3 | 131 | while on treatment; safety; R0018421:Table 3 | |||
| A1 | rate | 22 | 131 | while on treatment; safety; R0018421:Table 3 | |||
| A2 | rate | 41 | 132 | while on treatment; safety; R0018421:Table 3 | |||
| A2 | rate | 3 | 132 | while on treatment; safety; R0018421:Table 3 | |||
| A3 | rate | 3 | 130 | while on treatment; safety; R0018421:Table 3 | |||
| A3 | rate | 38 | 130 | while on treatment; safety; R0018421:Table 3 | |||
| A4 | rate | 65 | while on treatment; safety; R0018421:Table 3 | ||||
| A4 | rate | 28 | 65 | while on treatment; safety; R0018421:Table 3 |
Systolic blood pressure change (36 lines; O05)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26 | A1 | change | -3.0 mmHg | 13.0 | 131 | while on treatment; safety; registry:outcomes | |
| 26 | A1 | change | -3 mmHg | 131 | treatment policy; safety; R0018421:Supplement Table S4 | ||
| 26 | A1 | change | -3 mmHg | 126 | hypothetical; safety; R0018421:Supplement Table S4 | ||
| 26 | A1 vs A4 | md | -0 mmHg | -4 to 3 | hypothetical; safety; R0018421:Supplement Table S4 | ||
| 26 | A1 vs A4 | md | -1 mmHg | -4 to 3 | treatment policy; safety; R0018421:Supplement Table S4 | ||
| 26 | A2 vs A4 | md | -2 mmHg | -5 to 2 | hypothetical; safety; R0018421:Supplement Table S4 | ||
| 26 | A2 | change | -5 mmHg | 124 | hypothetical; safety; R0018421:Supplement Table S4 | ||
| 26 | A2 | change | -5 mmHg | 132 | treatment policy; safety; R0018421:Supplement Table S4 | ||
| 26 | A2 vs A4 | md | -2 mmHg | -5 to 2 | treatment policy; safety; R0018421:Supplement Table S4 | ||
| 26 | A2 | change | -5.0 mmHg | 13.0 | 132 | while on treatment; safety; registry:outcomes | |
| 26 | A3 vs A4 | md | -3 mmHg | -7 to 0 | treatment policy; safety; R0018421:Supplement Table S4 | ||
| 26 | A3 | change | -6 mmHg | 121 | hypothetical; safety; R0018421:Supplement Table S4 | ||
| 26 | A3 vs A4 | md | -3 mmHg | -7 to 0 | hypothetical; safety; R0018421:Supplement Table S4 | ||
| 26 | A3 | change | -6.0 mmHg | 15.0 | 130 | while on treatment; safety; registry:outcomes | |
| 26 | A3 | change | -6 mmHg | 130 | treatment policy; safety; R0018421:Supplement Table S4 | ||
| 26 | A4 | change | -3 mmHg | 63 | hypothetical; safety; R0018421:Supplement Table S4 | ||
| 26 | A4 | change | -3 mmHg | 65 | treatment policy; safety; R0018421:Supplement Table S4 | ||
| 26 | A4 | change | -4.0 mmHg | 12.0 | 65 | while on treatment; safety; registry:outcomes | |
| 52 | A1 | change | -2 mmHg | 124 | hypothetical; safety; R0018421:Supplement Table S4 | ||
| 52 | A1 | change | -2.0 mmHg | 14.0 | 131 | while on treatment; safety; registry:outcomes | |
| 52 | A1 | change | -3 mmHg | 131 | treatment policy; safety; R0018421:Supplement Table S4 | ||
| 52 | A1 vs A4 | md | -1 mmHg | -5 to 2 | treatment policy; safety; R0018421:Supplement Table S4 | ||
| 52 | A1 vs A4 | md | -1 mmHg | -5 to 2 | hypothetical; safety; R0018421:Supplement Table S4 | ||
| 52 | A2 | change | -2 mmHg | 132 | treatment policy; safety; R0018421:Supplement Table S4 | ||
| 52 | A2 | change | -2 mmHg | 123 | hypothetical; safety; R0018421:Supplement Table S4 | ||
| 52 | A2 vs A4 | md | -1 mmHg | -4 to 3 | hypothetical; safety; R0018421:Supplement Table S4 | ||
| 52 | A2 | change | -2.0 mmHg | 13.0 | 132 | while on treatment; safety; registry:outcomes | |
| 52 | A2 vs A4 | md | -0 mmHg | -4 to 3 | treatment policy; safety; R0018421:Supplement Table S4 | ||
| 52 | A3 vs A4 | md | -1 mmHg | -4 to 2 | hypothetical; safety; R0018421:Supplement Table S4 | ||
| 52 | A3 | change | -2 mmHg | 114 | hypothetical; safety; R0018421:Supplement Table S4 | ||
| 52 | A3 | change | -1 mmHg | 130 | treatment policy; safety; R0018421:Supplement Table S4 | ||
| 52 | A3 vs A4 | md | 0 mmHg | -3 to 4 | treatment policy; safety; R0018421:Supplement Table S4 | ||
| 52 | A3 | change | -2.0 mmHg | 13.0 | 130 | while on treatment; safety; registry:outcomes | |
| 52 | A4 | change | -1 mmHg | 61 | hypothetical; safety; R0018421:Supplement Table S4 | ||
| 52 | A4 | change | -3.0 mmHg | 13.0 | 65 | while on treatment; safety; registry:outcomes | |
| 52 | A4 | change | -2 mmHg | 65 | treatment policy; safety; R0018421:Supplement Table S4 |
Percent body weight change (36 lines; O10)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26 | A1 | percent change | -0.4 percent | 131 | treatment policy; full analysis; R0018421:Supplement Table S5 | ||
| 26 | A1 | percent change | -0.2 percent | 126 | hypothetical; full analysis; R0018421:Supplement Table S5 | ||
| 26 | A1 vs A4 | md | -0.5 percent | -1.6 to 0.7 | hypothetical; full analysis; R0018421:Supplement Table S5 | ||
| 26 | A1 | percent change | -0.28 percent | 2.79 | 131 | treatment policy; full analysis; registry:outcomes | |
| 26 | A1 vs A4 | md | -0.6 percent | -1.9 to 0.6 | treatment policy; full analysis; R0018421:Supplement Table S5 | ||
| 26 | A2 | percent change | -1.6 percent | 132 | treatment policy; full analysis; R0018421:Supplement Table S5 | ||
| 26 | A2 vs A4 | md | -2.0 percent | -3.1 to -0.8 | hypothetical; full analysis; R0018421:Supplement Table S5 | ||
| 26 | A2 | percent change | -1.7 percent | 124 | hypothetical; full analysis; R0018421:Supplement Table S5 | ||
| 26 | A2 vs A4 | md | -1.8 percent | -3.1 to -0.6 | treatment policy; full analysis; R0018421:Supplement Table S5 | ||
| 26 | A2 | percent change | -1.49 percent | 4.25 | 132 | treatment policy; full analysis; registry:outcomes | |
| 26 | A3 vs A4 | md | -3.7 percent | -4.8 to -2.5 | hypothetical; full analysis; R0018421:Supplement Table S5 | ||
| 26 | A3 | percent change | -3.2 percent | 130 | treatment policy; full analysis; R0018421:Supplement Table S5 | ||
| 26 | A3 | percent change | -3.21 percent | 4.32 | 130 | treatment policy; full analysis; registry:outcomes | |
| 26 | A3 vs A4 | md | -3.5 percent | -4.7 to -2.3 | treatment policy; full analysis; R0018421:Supplement Table S5 | ||
| 26 | A3 | percent change | -3.4 percent | 120 | hypothetical; full analysis; R0018421:Supplement Table S5 | ||
| 26 | A4 | percent change | 0.3 percent | 65 | treatment policy; full analysis; R0018421:Supplement Table S5 | ||
| 26 | A4 | percent change | 0.25 percent | 3.33 | 65 | treatment policy; full analysis; registry:outcomes | |
| 26 | A4 | percent change | 0.3 percent | 62 | hypothetical; full analysis; R0018421:Supplement Table S5 | ||
| 52 | A1 | percent change | -0.02 percent | 3.28 | 131 | treatment policy; full analysis; registry:outcomes | |
| 52 | A1 | percent change | 0.2 percent | 103 | hypothetical; full analysis; R0018421:Supplement Table S5 | ||
| 52 | A1 vs A4 | md | -1.2 percent | -2.6 to 0.2 | hypothetical; full analysis; R0018421:Supplement Table S5 | ||
| 52 | A1 | percent change | -0.0 percent | 131 | treatment policy; full analysis; R0018421:Supplement Table S5 | ||
| 52 | A1 vs A4 | md | -1.3 percent | -2.5 to 0.0 | treatment policy; full analysis; R0018421:Supplement Table S5 | ||
| 52 | A2 vs A4 | md | -2.6 percent | -3.9 to -1.3 | treatment policy; full analysis; R0018421:Supplement Table S5 | ||
| 52 | A2 | percent change | -1.34 percent | 4.77 | 132 | treatment policy; full analysis; registry:outcomes | |
| 52 | A2 | percent change | -1.6 percent | 115 | hypothetical; full analysis; R0018421:Supplement Table S5 | ||
| 52 | A2 vs A4 | md | -3.0 percent | -4.4 to -1.6 | hypothetical; full analysis; R0018421:Supplement Table S5 | ||
| 52 | A2 | percent change | -1.4 percent | 132 | treatment policy; full analysis; R0018421:Supplement Table S5 | ||
| 52 | A3 vs A4 | md | -3.5 percent | -4.8 to -2.3 | treatment policy; full analysis; R0018421:Supplement Table S5 | ||
| 52 | A3 | percent change | -2.8 percent | 113 | hypothetical; full analysis; R0018421:Supplement Table S5 | ||
| 52 | A3 vs A4 | md | -4.2 percent | -5.5 to -2.8 | hypothetical; full analysis; R0018421:Supplement Table S5 | ||
| 52 | A3 | percent change | -2.3 percent | 130 | treatment policy; full analysis; R0018421:Supplement Table S5 | ||
| 52 | A3 | percent change | -2.33 percent | 4.67 | 130 | treatment policy; full analysis; registry:outcomes | |
| 52 | A4 | percent change | 1.2 percent | 65 | treatment policy; full analysis; R0018421:Supplement Table S5 | ||
| 52 | A4 | percent change | 1.4 percent | 56 | hypothetical; full analysis; R0018421:Supplement Table S5 | ||
| 52 | A4 | percent change | 1.25 percent | 4.06 | 65 | treatment policy; full analysis; registry:outcomes |
Weight loss of 5 percent or more (28 lines; O11A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26 | A1 vs A4 | or | 0.85 | 0.23 to 3.12 | treatment policy; full analysis; R0018421:Table 4 | ||
| 26 | A1 | responders | 6 / 126 | hypothetical; full analysis; R0018421:Table 4 | |||
| 26 | A1 vs A4 | or | 0.70 | 0.19 to 2.60 | hypothetical; full analysis; R0018421:Table 4 | ||
| 26 | A1 | responders | 6 / 128 | treatment policy; full analysis; R0018421:Table 4 | |||
| 26 | A2 | responders | 22 / 124 | hypothetical; full analysis; R0018421:Table 4 | |||
| 26 | A2 | responders | 23 / 128 | treatment policy; full analysis; R0018421:Table 4 | |||
| 26 | A2 vs A4 | or | 3.47 | 1.14 to 10.59 | treatment policy; full analysis; R0018421:Table 4 | ||
| 26 | A2 vs A4 | or | 3.81 | 1.25 to 11.63 | hypothetical; full analysis; R0018421:Table 4 | ||
| 26 | A3 vs A4 | or | 7.37 | 2.46 to 22.07 | hypothetical; full analysis; R0018421:Table 4 | ||
| 26 | A3 | responders | 36 / 120 | hypothetical; full analysis; R0018421:Table 4 | |||
| 26 | A3 | responders | 39 / 128 | treatment policy; full analysis; R0018421:Table 4 | |||
| 26 | A3 vs A4 | or | 6.89 | 2.31 to 20.49 | treatment policy; full analysis; R0018421:Table 4 | ||
| 26 | A4 | responders | 4 / 62 | hypothetical; full analysis; R0018421:Table 4 | |||
| 26 | A4 | responders | 4 / 64 | treatment policy; full analysis; R0018421:Table 4 | |||
| 52 | A1 | responders | 7 / 127 | treatment policy; full analysis; R0018421:Table 4 | |||
| 52 | A1 | responders | 5 / 103 | hypothetical; full analysis; R0018421:Table 4 | |||
| 52 | A1 vs A4 | or | 0.73 | 0.19 to 2.71 | hypothetical; full analysis; R0018421:Table 4 | ||
| 52 | A1 vs A4 | or | 0.89 | 0.25 to 3.16 | treatment policy; full analysis; R0018421:Table 4 | ||
| 52 | A2 | responders | 20 / 115 | hypothetical; full analysis; R0018421:Table 4 | |||
| 52 | A2 | responders | 21 / 129 | treatment policy; full analysis; R0018421:Table 4 | |||
| 52 | A2 vs A4 | or | 2.94 | 0.96 to 9.01 | treatment policy; full analysis; R0018421:Table 4 | ||
| 52 | A2 vs A4 | or | 3.26 | 1.07 to 9.94 | hypothetical; full analysis; R0018421:Table 4 | ||
| 52 | A3 | responders | 28 / 113 | hypothetical; full analysis; R0018421:Table 4 | |||
| 52 | A3 vs A4 | or | 5.14 | 1.71 to 15.46 | hypothetical; full analysis; R0018421:Table 4 | ||
| 52 | A3 | responders | 28 / 127 | treatment policy; full analysis; R0018421:Table 4 | |||
| 52 | A3 vs A4 | or | 4.23 | 1.41 to 12.70 | treatment policy; full analysis; R0018421:Table 4 | ||
| 52 | A4 | responders | 4 / 56 | hypothetical; full analysis; R0018421:Table 4 | |||
| 52 | A4 | responders | 4 / 63 | treatment policy; full analysis; R0018421:Table 4 |
Weight loss of 10 percent or more (16 lines; O11B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26 | A1 | responders | 0 / 128 | treatment policy; full analysis; R0018421:Supplement Table S5 | |||
| 26 | A1 | responders | 0 / 126 | hypothetical; full analysis; R0018421:Supplement Table S5 | |||
| 26 | A2 | responders | 6 / 128 | treatment policy; full analysis; R0018421:Supplement Table S5 | |||
| 26 | A2 | responders | 5 / 124 | hypothetical; full analysis; R0018421:Supplement Table S5 | |||
| 26 | A3 | responders | 8 / 128 | treatment policy; full analysis; R0018421:Supplement Table S5 | |||
| 26 | A3 | responders | 8 / 120 | hypothetical; full analysis; R0018421:Supplement Table S5 | |||
| 26 | A4 | responders | 1 / 62 | hypothetical; full analysis; R0018421:Supplement Table S5 | |||
| 26 | A4 | responders | 1 / 64 | treatment policy; full analysis; R0018421:Supplement Table S5 | |||
| 52 | A1 | responders | 0 / 103 | hypothetical; full analysis; R0018421:Supplement Table S5 | |||
| 52 | A1 | responders | 0 / 127 | treatment policy; full analysis; R0018421:Supplement Table S5 | |||
| 52 | A2 | responders | 9 / 129 | treatment policy; full analysis; R0018421:Supplement Table S5 | |||
| 52 | A2 | responders | 9 / 115 | hypothetical; full analysis; R0018421:Supplement Table S5 | |||
| 52 | A3 | responders | 7 / 113 | hypothetical; full analysis; R0018421:Supplement Table S5 | |||
| 52 | A3 | responders | 7 / 127 | treatment policy; full analysis; R0018421:Supplement Table S5 | |||
| 52 | A4 | responders | 0 / 56 | hypothetical; full analysis; R0018421:Supplement Table S5 | |||
| 52 | A4 | responders | 0 / 63 | treatment policy; full analysis; R0018421:Supplement Table S5 |
Acute kidney injury (8 lines; O121)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 131 | treatment policy; safety; R0018421:Supplement Table S3 | ||||
| A1 | events | 0 / 131 | while on treatment; safety; R0018421:Table 2 | ||||
| A2 | events | 0 / 132 | while on treatment; safety; R0018421:Table 2 | ||||
| A2 | events | 0 / 132 | treatment policy; safety; R0018421:Supplement Table S3 | ||||
| A3 | events | 0 / 130 | treatment policy; safety; R0018421:Supplement Table S3 | ||||
| A3 | events | 0 / 130 | while on treatment; safety; R0018421:Table 2 | ||||
| A4 | events | 0 / 65 | treatment policy; safety; R0018421:Supplement Table S3 | ||||
| A4 | events | 0 / 65 | while on treatment; safety; R0018421:Table 2 |
All cause mortality (4 lines; O20)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 131 | treatment policy; safety; R0018421:Table 2 | ||||
| A2 | events | 0 / 132 | treatment policy; safety; R0018421:Table 2 | ||||
| A3 | events | 0 / 130 | treatment policy; safety; R0018421:Table 2 | ||||
| A4 | events | 0 / 65 | treatment policy; safety; R0018421:Table 2 |
Three point MACE (2 lines; O21)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A2 | events | 0 / 132 | while on treatment; safety; R0018421:Table 2 | ||||
| A4 | events | 0 / 65 | while on treatment; safety; R0018421:Table 2 |
Four point MACE including unstable angina (2 lines; O21B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A2 | events | 0 / 132 | while on treatment; safety; R0018421:Table 2 | ||||
| A4 | events | 0 / 65 | while on treatment; safety; R0018421:Table 2 |
Hospitalization for heart failure (4 lines; O23)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 131 | while on treatment; safety; R0018421:Table 2 | ||||
| A2 | events | 0 / 132 | while on treatment; safety; R0018421:Table 2 | ||||
| A3 | events | 0 / 130 | while on treatment; safety; R0018421:Table 2 | ||||
| A4 | events | 0 / 65 | while on treatment; safety; R0018421:Table 2 |
Heart failure events (2 lines; O23B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A2 | events | 0 / 132 | while on treatment; safety; R0018421:Table 2 | ||||
| A4 | events | 0 / 65 | while on treatment; safety; R0018421:Table 2 |
SF-36 physical component summary change (12 lines; O24A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26 | A1 vs A4 | md | 0.36 points | -0.88 to 1.60 | hypothetical; full analysis; R0018421:Supplement Figure S5B | ||
| 26 | A1 vs A4 | md | 0.57 points | -0.74 to 1.87 | treatment policy; full analysis; R0018421:Supplement Figure S5A | ||
| 26 | A2 vs A4 | md | 0.37 points | -0.95 to 1.70 | treatment policy; full analysis; R0018421:Supplement Figure S5A | ||
| 26 | A2 vs A4 | md | 0.53 points | -0.72 to 1.78 | hypothetical; full analysis; R0018421:Supplement Figure S5B | ||
| 26 | A3 vs A4 | md | 0.01 points | -1.24 to 1.27 | hypothetical; full analysis; R0018421:Supplement Figure S5B | ||
| 26 | A3 vs A4 | md | 0.32 points | -0.97 to 1.62 | treatment policy; full analysis; R0018421:Supplement Figure S5A | ||
| 52 | A1 vs A4 | md | -0.67 points | -2.06 to 0.72 | hypothetical; full analysis; R0018421:Supplement Figure S5B | ||
| 52 | A1 vs A4 | md | -0.55 points | -1.86 to 0.77 | treatment policy; full analysis; R0018421:Supplement Figure S5A | ||
| 52 | A2 vs A4 | md | 0.47 points | -0.91 to 1.84 | hypothetical; full analysis; R0018421:Supplement Figure S5B | ||
| 52 | A2 vs A4 | md | 0.16 points | -1.15 to 1.46 | treatment policy; full analysis; R0018421:Supplement Figure S5A | ||
| 52 | A3 vs A4 | md | 0.12 points | -1.26 to 1.50 | hypothetical; full analysis; R0018421:Supplement Figure S5B | ||
| 52 | A3 vs A4 | md | 0.03 points | -1.28 to 1.35 | treatment policy; full analysis; R0018421:Supplement Figure S5A |
Physical functioning (any instrument) (12 lines; O24B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26 | A1 vs A4 | md | 0.09 points | -1.00 to 1.18 | treatment policy; full analysis; R0018421:Supplement Figure S5A | ||
| 26 | A1 vs A4 | md | 0.07 points | -0.98 to 1.12 | hypothetical; full analysis; R0018421:Supplement Figure S5B | ||
| 26 | A2 vs A4 | md | 0.32 points | -0.74 to 1.37 | hypothetical; full analysis; R0018421:Supplement Figure S5B | ||
| 26 | A2 vs A4 | md | 0.02 points | -1.08 to 1.12 | treatment policy; full analysis; R0018421:Supplement Figure S5A | ||
| 26 | A3 vs A4 | md | 0.29 points | -0.79 to 1.37 | treatment policy; full analysis; R0018421:Supplement Figure S5A | ||
| 26 | A3 vs A4 | md | 0.33 points | -0.73 to 1.39 | hypothetical; full analysis; R0018421:Supplement Figure S5B | ||
| 52 | A1 vs A4 | md | 0.10 points | -1.07 to 1.28 | hypothetical; full analysis; R0018421:Supplement Figure S5B | ||
| 52 | A1 vs A4 | md | 0.26 points | -0.89 to 1.42 | treatment policy; full analysis; R0018421:Supplement Figure S5A | ||
| 52 | A2 vs A4 | md | 1.16 points | 0.01 to 2.32 | hypothetical; full analysis; R0018421:Supplement Figure S5B | ||
| 52 | A2 vs A4 | md | 1.16 points | 0.01 to 2.31 | treatment policy; full analysis; R0018421:Supplement Figure S5A | ||
| 52 | A3 vs A4 | md | 0.52 points | -0.64 to 1.68 | hypothetical; full analysis; R0018421:Supplement Figure S5B | ||
| 52 | A3 vs A4 | md | 0.72 points | -0.44 to 1.88 | treatment policy; full analysis; R0018421:Supplement Figure S5A |
Health related quality of life total score (any instrument) (28 lines; O24C)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26 | A1 | change | 7.0 points | 131 | treatment policy; full analysis; R0009540:Figure 1 | ||
| 26 | A1 vs A4 | md | 0.28 points | -3.44 to 3.99 | treatment policy; full analysis; R0018421:Supplement Figure S4A | ||
| 26 | A1 vs A4 | md | -1.22 points | -4.78 to 2.35 | hypothetical; full analysis; R0018421:Supplement Figure S4B | ||
| 26 | A1 | change | 6.74 points | 13.01 | 131 | treatment policy; full analysis; registry:outcomes | |
| 26 | A2 vs A4 | md | 1.09 points | -2.64 to 4.82 | treatment policy; full analysis; R0018421:Supplement Figure S4A | ||
| 26 | A2 vs A4 | md | -0.01 points | -3.58 to 3.57 | hypothetical; full analysis; R0018421:Supplement Figure S4B | ||
| 26 | A2 | change | 7.8 points | 132 | treatment policy; full analysis; R0009540:Results | ||
| 26 | A2 | change | 7.88 points | 14.40 | 132 | treatment policy; full analysis; registry:outcomes | |
| 26 | A3 vs A4 | md | 1.01 points | -2.67 to 4.69 | treatment policy; full analysis; R0018421:Supplement Figure S4A | ||
| 26 | A3 | change | 7.7 points | 130 | treatment policy; full analysis; R0009540:Results | ||
| 26 | A3 | change | 7.90 points | 12.72 | 130 | treatment policy; full analysis; registry:outcomes | |
| 26 | A3 vs A4 | md | -0.54 points | -4.14 to 3.06 | hypothetical; full analysis; R0018421:Supplement Figure S4B | ||
| 26 | A4 | change | 6.7 points | 65 | treatment policy; full analysis; R0009540:Results | ||
| 26 | A4 | change | 7.18 points | 15.56 | 65 | treatment policy; full analysis; registry:outcomes | |
| 52 | A1 | change | 3.5 points | 131 | treatment policy; full analysis; R0009540:Figure 1 | ||
| 52 | A1 vs A4 | md | 0.13 points | -3.67 to 3.93 | treatment policy; full analysis; R0018421:Supplement Figure S4A | ||
| 52 | A1 vs A4 | md | -0.33 points | -4.38 to 3.71 | hypothetical; full analysis; R0018421:Supplement Figure S4B | ||
| 52 | A1 | change | 3.31 points | 13.47 | 131 | treatment policy; full analysis; registry:outcomes | |
| 52 | A2 | change | 7.15 points | 15.69 | 132 | treatment policy; full analysis; registry:outcomes | |
| 52 | A2 vs A4 | md | 3.01 points | -1.01 to 7.02 | hypothetical; full analysis; R0018421:Supplement Figure S4B | ||
| 52 | A2 vs A4 | md | 3.93 points | 0.15 to 7.71 | treatment policy; full analysis; R0018421:Supplement Figure S4A | ||
| 52 | A2 | change | 7.3 points | 132 | treatment policy; full analysis; R0009540:Results | ||
| 52 | A3 vs A4 | md | 4.51 points | 0.49 to 8.54 | hypothetical; full analysis; R0018421:Supplement Figure S4B | ||
| 52 | A3 | change | 8.1 points | 130 | treatment policy; full analysis; R0009540:Results | ||
| 52 | A3 | change | 8.25 points | 12.81 | 130 | treatment policy; full analysis; registry:outcomes | |
| 52 | A3 vs A4 | md | 4.78 points | 0.99 to 8.58 | treatment policy; full analysis; R0018421:Supplement Figure S4A | ||
| 52 | A4 | change | 3.44 points | 14.89 | 65 | treatment policy; full analysis; registry:outcomes | |
| 52 | A4 | change | 3.3 points | 65 | treatment policy; full analysis; R0009540:Results |
Serious adverse events (4 lines; O25)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 9 / 131 | while on treatment; safety; R0018421:Table 2 | ||||
| A2 | events | 4 / 132 | while on treatment; safety; R0018421:Table 2 | ||||
| A3 | events | 7 / 130 | while on treatment; safety; R0018421:Table 2 | ||||
| A4 | events | 1 / 65 | while on treatment; safety; R0018421:Table 2 |
Discontinuation due to adverse events (5 lines; O26)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 5 / 131 | not stated; safety; R0018421:Figure 1 | ||||
| A1 | events | 4 / 131 | while on treatment; safety; R0018421:Table 2 | ||||
| A2 | events | 8 / 132 | while on treatment; safety; R0018421:Table 2 | ||||
| A3 | events | 8 / 130 | while on treatment; safety; R0018421:Table 2 | ||||
| A4 | events | 2 / 65 | while on treatment; safety; R0018421:Table 2 |
Nausea (4 lines; O27A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 7 / 131 | while on treatment; safety; R0018421:Table 2 | ||||
| A2 | events | 11 / 132 | while on treatment; safety; R0018421:Table 2 | ||||
| A3 | events | 12 / 130 | while on treatment; safety; R0018421:Table 2 | ||||
| A4 | events | 6 / 65 | while on treatment; safety; R0018421:Table 2 |
Vomiting (4 lines; O27B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 3 / 131 | while on treatment; safety; R0018421:Table 2 | ||||
| A2 | events | 1 / 132 | while on treatment; safety; R0018421:Table 2 | ||||
| A3 | events | 9 / 130 | while on treatment; safety; R0018421:Table 2 | ||||
| A4 | events | 1 / 65 | while on treatment; safety; R0018421:Table 2 |
Diarrhea (4 lines; O27C)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 2 / 131 | while on treatment; safety; R0018421:Table 2 | ||||
| A2 | events | 2 / 132 | while on treatment; safety; R0018421:Table 2 | ||||
| A3 | events | 10 / 130 | while on treatment; safety; R0018421:Table 2 | ||||
| A4 | events | 4 / 65 | while on treatment; safety; R0018421:Table 2 |
Constipation (4 lines; O27D)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 12 / 131 | while on treatment; safety; R0018421:Table 2 | ||||
| A2 | events | 16 / 132 | while on treatment; safety; R0018421:Table 2 | ||||
| A3 | events | 20 / 130 | while on treatment; safety; R0018421:Table 2 | ||||
| A4 | events | 6 / 65 | while on treatment; safety; R0018421:Table 2 |
Discontinuation due to gastrointestinal adverse events (4 lines; O27E)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 2 / 131 | while on treatment; safety; R0018421:Table 2 | ||||
| A2 | events | 4 / 132 | while on treatment; safety; R0018421:Table 2 | ||||
| A3 | events | 5 / 130 | while on treatment; safety; R0018421:Table 2 | ||||
| A4 | events | 1 / 65 | while on treatment; safety; R0018421:Table 2 |
Gallbladder and biliary disease (4 lines; O28)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 2 / 131 | while on treatment; safety; R0018421:Table 2 | ||||
| A2 | events | 1 / 132 | while on treatment; safety; R0018421:Table 2 | ||||
| A3 | events | 0 / 130 | while on treatment; safety; R0018421:Table 2 | ||||
| A4 | events | 1 / 65 | while on treatment; safety; R0018421:Table 2 |
Acute pancreatitis (8 lines; O29)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 131 | treatment policy; safety; R0018421:Supplement Table S3 | ||||
| A1 | events | 0 / 131 | while on treatment; safety; R0018421:Table 2 | ||||
| A2 | events | 0 / 132 | while on treatment; safety; R0018421:Table 2 | ||||
| A2 | events | 0 / 132 | treatment policy; safety; R0018421:Supplement Table S3 | ||||
| A3 | events | 0 / 130 | treatment policy; safety; R0018421:Supplement Table S3 | ||||
| A3 | events | 0 / 130 | while on treatment; safety; R0018421:Table 2 | ||||
| A4 | events | 0 / 65 | treatment policy; safety; R0018421:Supplement Table S3 | ||||
| A4 | events | 0 / 65 | while on treatment; safety; R0018421:Table 2 |
Medullary thyroid carcinoma (8 lines; O32A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 131 | treatment policy; safety; R0018421:Supplement Table S3 | ||||
| A1 | events | 0 / 131 | while on treatment; safety; R0018421:Table 2 | ||||
| A2 | events | 0 / 132 | treatment policy; safety; R0018421:Supplement Table S3 | ||||
| A2 | events | 0 / 132 | while on treatment; safety; R0018421:Table 2 | ||||
| A3 | events | 0 / 130 | while on treatment; safety; R0018421:Table 2 | ||||
| A3 | events | 0 / 130 | treatment policy; safety; R0018421:Supplement Table S3 | ||||
| A4 | events | 0 / 65 | treatment policy; safety; R0018421:Supplement Table S3 | ||||
| A4 | events | 0 / 65 | while on treatment; safety; R0018421:Table 2 |
Thyroid cancer (any) (8 lines; O32B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 131 | while on treatment; safety; R0018421:Table 2 | ||||
| A1 | events | 0 / 131 | treatment policy; safety; R0018421:Supplement Table S3 | ||||
| A2 | events | 0 / 132 | while on treatment; safety; R0018421:Table 2 | ||||
| A2 | events | 0 / 132 | treatment policy; safety; R0018421:Supplement Table S3 | ||||
| A3 | events | 0 / 130 | treatment policy; safety; R0018421:Supplement Table S3 | ||||
| A3 | events | 0 / 130 | while on treatment; safety; R0018421:Table 2 | ||||
| A4 | events | 0 / 65 | while on treatment; safety; R0018421:Table 2 | ||||
| A4 | events | 0 / 65 | treatment policy; safety; R0018421:Supplement Table S3 |
Diabetic retinopathy complications (28 lines; O33)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 131 | treatment policy; safety; retinal haemorrhage; R0018421:Table 2 | ||||
| A1 | events | 9 / 131 | treatment policy; safety; R0018421:Table 2 | ||||
| A1 | events | 7 / 131 | treatment policy; safety; diabetic retinopathy; R0018421:Table 2 | ||||
| A1 | events | 6 / 131 | not stated; safety; diabetic retinopathy; registry:adverse_events | ||||
| A1 | events | 1 / 131 | not stated; safety; diabetic retinopathy; registry:adverse_events | ||||
| A1 | events | 2 / 131 | treatment policy; safety; retinopathy; R0018421:Table 2 | ||||
| A1 | events | 0 / 131 | treatment policy; safety; maculopathy; R0018421:Table 2 | ||||
| A2 | events | 0 / 132 | treatment policy; safety; maculopathy; R0018421:Table 2 | ||||
| A2 | events | 12 / 132 | not stated; safety; diabetic retinopathy; registry:adverse_events | ||||
| A2 | events | 0 / 132 | not stated; safety; diabetic retinopathy; registry:adverse_events | ||||
| A2 | events | 12 / 132 | treatment policy; safety; R0018421:Table 2 | ||||
| A2 | events | 12 / 132 | treatment policy; safety; diabetic retinopathy; R0018421:Table 2 | ||||
| A2 | events | 0 / 132 | treatment policy; safety; retinal haemorrhage; R0018421:Table 2 | ||||
| A2 | events | 0 / 132 | treatment policy; safety; retinopathy; R0018421:Table 2 | ||||
| A3 | events | 1 / 130 | treatment policy; safety; retinal haemorrhage; R0018421:Table 2 | ||||
| A3 | events | 0 / 130 | treatment policy; safety; retinopathy; R0018421:Table 2 | ||||
| A3 | events | 5 / 130 | not stated; safety; diabetic retinopathy; registry:adverse_events | ||||
| A3 | events | 0 / 130 | not stated; safety; diabetic retinopathy; registry:adverse_events | ||||
| A3 | events | 7 / 130 | treatment policy; safety; R0018421:Table 2 | ||||
| A3 | events | 5 / 130 | treatment policy; safety; diabetic retinopathy; R0018421:Table 2 | ||||
| A3 | events | 1 / 130 | treatment policy; safety; maculopathy; R0018421:Table 2 | ||||
| A4 | events | 3 / 65 | treatment policy; safety; R0018421:Table 2 | ||||
| A4 | events | 0 / 65 | not stated; safety; diabetic retinopathy; registry:adverse_events | ||||
| A4 | events | 2 / 65 | not stated; safety; diabetic retinopathy; registry:adverse_events | ||||
| A4 | events | 2 / 65 | treatment policy; safety; diabetic retinopathy; R0018421:Table 2 | ||||
| A4 | events | 0 / 65 | treatment policy; safety; maculopathy; R0018421:Table 2 | ||||
| A4 | events | 0 / 65 | treatment policy; safety; retinal haemorrhage; R0018421:Table 2 | ||||
| A4 | events | 1 / 65 | treatment policy; safety; retinopathy; R0018421:Table 2 |
Death by suicide (4 lines; O35B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 131 | treatment policy; safety; R0018421:Table 2 | ||||
| A2 | events | 0 / 132 | treatment policy; safety; R0018421:Table 2 | ||||
| A3 | events | 0 / 130 | treatment policy; safety; R0018421:Table 2 | ||||
| A4 | events | 0 / 65 | treatment policy; safety; R0018421:Table 2 |
Any cancer (8 lines; O39)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 1 / 131 | while on treatment; safety; R0018421:Table 2 | ||||
| A1 | events | 2 / 131 | treatment policy; safety; R0018421:Supplement Table S3 | ||||
| A2 | events | 2 / 132 | treatment policy; safety; R0018421:Supplement Table S3 | ||||
| A2 | events | 1 / 132 | while on treatment; safety; R0018421:Table 2 | ||||
| A3 | events | 1 / 130 | treatment policy; safety; R0018421:Supplement Table S3 | ||||
| A3 | events | 1 / 130 | while on treatment; safety; R0018421:Table 2 | ||||
| A4 | events | 1 / 65 | treatment policy; safety; R0018421:Supplement Table S3 | ||||
| A4 | events | 0 / 65 | while on treatment; safety; R0018421:Table 2 |