parallel randomized trial
FLOW
Effect of Semaglutide Versus Placebo on the Progression of Renal Impairment in Subjects With Type 2 Diabetes and Chronic Kidney Disease
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | Semaglutide 1.0 mg subcutaneous once weekly Semaglutide 1.0 mg | RAS inhibitor at maximum labeled or tolerated dose with standard care; lifestyle: not reported | 1,767 | 1,767 | |
| A2 | Placebo Placebo | RAS inhibitor at maximum labeled or tolerated dose with standard care; lifestyle: not reported | 1,766 | 1,766 |
Baseline characteristics
As printed in the trial reports or registry, per arm or for the whole trial.
| Characteristic | Statistic | Semaglutide 1.0 mg subcutaneous once weekly A1 | Placebo A2 | Whole trial ALL |
|---|---|---|---|---|
| age | mean (years) | 66.6 | 66.7 | |
| age | sd (years) | 9.0 | 9.0 | |
| asian | n | 439 | 407 | |
| black | n | 78 | 82 | |
| bmi kdigo:high | median (kg/m2) | 31.4 | 31.8 | |
| bmi kdigo:high | q1 (kg/m2) | 28.0 | 27.6 | |
| bmi kdigo:high | q3 (kg/m2) | 35.0 | 36.2 | |
| bmi kdigo:low_moderate | median (kg/m2) | 31.8 | 30.1 | |
| bmi kdigo:low_moderate | q1 (kg/m2) | 27.5 | 27.0 | |
| bmi kdigo:low_moderate | q3 (kg/m2) | 35.4 | 35.0 | |
| bmi kdigo:very_high | median (kg/m2) | 31.2 | 31.3 | |
| bmi kdigo:very_high | q1 (kg/m2) | 27.4 | 27.3 | |
| bmi kdigo:very_high | q3 (kg/m2) | 35.4 | 35.6 | |
| diabetes duration | mean (years) | 17.4 | ||
| diabetes duration | sd (years) | 9.3 | ||
| egfr | mean (mL/min/1.73 m2) | 47 | ||
| egfr | sd (mL/min/1.73 m2) | 15 | ||
| established cvd | n | 1198 | ||
| established cvd | percent | 34 | ||
| female | n | 519 | 550 | |
| hba1c | mean (percent) | 7.8 | ||
| hba1c | sd (percent) | 1.3 | ||
| hispanic | n | 273 | 283 | |
| insulin use | n | 2168 | ||
| insulin use | percent | 61 | ||
| other race american indian alaska native | n | 9 | 16 | |
| other race native hawaiian pacific islander | n | 2 | 3 | |
| other race other | n | 45 | 50 | |
| sglt2i use | n | 277 | 273 | |
| uacr | median (mg/g) | 568 | ||
| weight kdigo:high | median (kg) | 89.8 | 89.1 | |
| weight kdigo:high | q1 (kg) | 76.0 | 75.3 | |
| weight kdigo:high | q3 (kg) | 102.3 | 104.0 | |
| weight kdigo:low_moderate | median (kg) | 89.0 | 85.8 | |
| weight kdigo:low_moderate | q1 (kg) | 77.6 | 73.9 | |
| weight kdigo:low_moderate | q3 (kg) | 102.0 | 97.1 | |
| weight kdigo:very_high | median (kg) | 87.0 | 87.2 | |
| weight kdigo:very_high | q1 (kg) | 75.0 | 74.3 | |
| weight kdigo:very_high | q3 (kg) | 101.0 | 103.0 | |
| white | n | 1155 | 1168 |
Results
186 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
HbA1c change (6 lines; O01)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 104 | A1 | change | -9.7 mmol/mol | 1490 | treatment policy; full analysis; background:no_sglt2i; R0006943:Results | ||
| 104 | A1 | change | -0.86 percent | 1.35 | 1448 | treatment policy; full analysis; registry:outcomes | |
| 104 | A1 | change | -8.2 mmol/mol | 277 | treatment policy; full analysis; background:sglt2i; R0006943:Results | ||
| 104 | A2 | change | -0.04 percent | 1.29 | 1427 | treatment policy; full analysis; registry:outcomes | |
| 104 | A2 | change | -1.0 mmol/mol | 1493 | treatment policy; full analysis; background:no_sglt2i; R0006943:Results | ||
| 104 | A2 | change | 1.2 mmol/mol | 273 | treatment policy; full analysis; background:sglt2i; R0006943:Results |
Body weight change in kilograms (diabetes) (6 lines; O02)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 104 | A1 | change | -5.54 kg | 6.57 | 1502 | treatment policy; full analysis; registry:outcomes | |
| 104 | A1 | change | -6.3 kg | 1490 | treatment policy; full analysis; background:no_sglt2i; R0006943:Results | ||
| 104 | A1 | change | -6.1 kg | 277 | treatment policy; full analysis; background:sglt2i; R0006943:Results | ||
| 104 | A2 | change | -1.5 kg | 1493 | treatment policy; full analysis; background:no_sglt2i; R0006943:Results | ||
| 104 | A2 | change | -1.43 kg | 6.33 | 1468 | treatment policy; full analysis; registry:outcomes | |
| 104 | A2 | change | -1.1 kg | 273 | treatment policy; full analysis; background:sglt2i; R0006943:Results |
Level 2 or 3 hypoglycemia (participants) (10 lines; O04)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 1 / 1767 | not stated; safety; registry:adverse_events | ||||
| A1 | events | 22 / 1767 | not stated; safety; registry:adverse_events | ||||
| A1 | events | 1 / 1767 | not stated; safety; registry:adverse_events | ||||
| A1 | events | 0 / 1767 | not stated; safety; registry:adverse_events | ||||
| A1 | events | 2 / 1767 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 24 / 1766 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 1 / 1766 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 1 / 1766 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 1 / 1766 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 4 / 1766 | not stated; safety; registry:adverse_events |
Level 2 or 3 hypoglycemia (episode rate) (2 lines; O04B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | rate | 1767 | treatment policy; full analysis; registry:outcomes | ||||
| A2 | rate | 1766 | treatment policy; full analysis; registry:outcomes |
Systolic blood pressure change (2 lines; O05)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 104 | A1 | change | -3.9 mmHg | 17.6 | 1511 | treatment policy; full analysis; registry:outcomes | |
| 104 | A2 | change | -1.4 mmHg | 18.3 | 1472 | treatment policy; full analysis; registry:outcomes |
Acute kidney injury (2 lines; O121)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 124 / 1767 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 123 / 1766 | not stated; safety; registry:adverse_events |
All cause mortality (32 lines; O20)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 vs A2 | hr | 0.97 | 0.53 to 1.77 | treatment policy; full analysis; uacr:less_than_100; R0015402:Results | |||
| A1 | events | 227 / 1767 | treatment policy; full analysis; R0015402:Abstract | ||||
| A1 vs A2 | hr | 0.80 | 0.67 to 0.95 | treatment policy; full analysis; R0018451:Abstract | |||
| A1 | events | 83 / 667 | treatment policy; full analysis; egfr:30_to_less_than_45; R0015402:Results | ||||
| A1 vs A2 | hr | 0.71 | 0.54 to 0.94 | treatment policy; full analysis; egfr:30_to_less_than_45; R0015402:Results | |||
| A1 | events | 63 / 515 | treatment policy; full analysis; egfr:45_to_less_than_60; R0015402:Results | ||||
| A1 vs A2 | hr | 0.81 | 0.58 to 1.13 | treatment policy; full analysis; egfr:45_to_less_than_60; R0015402:Results | |||
| A1 | events | 44 / 366 | treatment policy; full analysis; egfr:60_or_more; R0015402:Results | ||||
| A1 vs A2 | hr | 1.02 | 0.67 to 1.57 | treatment policy; full analysis; egfr:60_or_more; R0015402:Results | |||
| A1 | events | 37 / 218 | treatment policy; full analysis; egfr:less_than_30; R0015402:Results | ||||
| A1 vs A2 | hr | 0.72 | 0.46 to 1.12 | treatment policy; full analysis; egfr:less_than_30; R0015402:Results | |||
| A1 | events | 48 / 384 | treatment policy; full analysis; uacr:100_to_less_than_300; R0015402:Results | ||||
| A1 vs A2 | hr | 1.28 | 0.84 to 1.97 | treatment policy; full analysis; uacr:100_to_less_than_300; R0015402:Results | |||
| A1 | events | 43 / 312 | treatment policy; full analysis; uacr:1000_to_less_than_2000; R0015402:Results | ||||
| A1 vs A2 | hr | 0.79 | 0.53 to 1.18 | treatment policy; full analysis; uacr:1000_to_less_than_2000; R0015402:Results | |||
| A1 | events | 36 / 261 | treatment policy; full analysis; uacr:2000_or_more; R0015402:Results | ||||
| A1 vs A2 | hr | 0.47 | 0.31 to 0.70 | treatment policy; full analysis; uacr:2000_or_more; R0015402:Results | |||
| A1 vs A2 | hr | 0.70 | 0.57 to 0.85 | treatment policy; full analysis; uacr:300_or_more; R0018451:Abstract | |||
| A1 | events | 78 / 632 | treatment policy; full analysis; uacr:300_to_less_than_1000; R0015402:Results | ||||
| A1 vs A2 | hr | 0.78 | 0.58 to 1.04 | treatment policy; full analysis; uacr:300_to_less_than_1000; R0015402:Results | |||
| A1 | events | 22 / 177 | treatment policy; full analysis; uacr:less_than_100; R0015402:Results | ||||
| A1 vs A2 | hr | 1.17 | 0.83 to 1.65 | treatment policy; full analysis; uacr:less_than_300; R0018451:Abstract | |||
| A2 | events | 62 / 230 | treatment policy; full analysis; uacr:2000_or_more; R0015402:Results | ||||
| A2 | events | 55 / 328 | treatment policy; full analysis; uacr:1000_to_less_than_2000; R0015402:Results | ||||
| A2 | events | 118 / 691 | treatment policy; full analysis; egfr:30_to_less_than_45; R0015402:Results | ||||
| A2 | events | 38 / 379 | treatment policy; full analysis; uacr:100_to_less_than_300; R0015402:Results | ||||
| A2 | events | 40 / 182 | treatment policy; full analysis; egfr:less_than_30; R0015402:Results | ||||
| A2 | events | 103 / 656 | treatment policy; full analysis; uacr:300_to_less_than_1000; R0015402:Results | ||||
| A2 | events | 42 / 353 | treatment policy; full analysis; egfr:60_or_more; R0015402:Results | ||||
| A2 | events | 279 / 1766 | treatment policy; full analysis; R0015402:Abstract | ||||
| A2 | events | 21 / 173 | treatment policy; full analysis; uacr:less_than_100; R0015402:Results | ||||
| A2 | events | 79 / 540 | treatment policy; full analysis; egfr:45_to_less_than_60; R0015402:Results |
Three point MACE (3 lines; O21)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 vs A2 | hr | 0.82 | 0.68 to 0.98 | treatment policy; full analysis; R0018451:Abstract | |||
| A1 | events | 212 / 1767 | while on treatment; full analysis; registry:outcomes | ||||
| A2 | events | 254 / 1766 | while on treatment; full analysis; registry:outcomes |
Kidney composite outcome (6 lines; O22)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 32 / 277 | treatment policy; full analysis; background:sglt2i; R0006943:Results | ||||
| A1 | events | 186 / 1490 | treatment policy; full analysis; background:no_sglt2i; R0006943:Results | ||||
| A1 vs A2 | hr | 0.75 | 0.61 to 0.90 | treatment policy; full analysis; background:no_sglt2i; R0006943:Results | |||
| A1 vs A2 | hr | 1.18 | 0.71 to 1.98 | treatment policy; full analysis; background:sglt2i; R0006943:Results | |||
| A2 | events | 27 / 273 | treatment policy; full analysis; background:sglt2i; R0006943:Results | ||||
| A2 | events | 233 / 1493 | treatment policy; full analysis; background:no_sglt2i; R0006943:Results |
Kidney composite including cardiovascular death (3 lines; O22D)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 331 / 1767 | treatment policy; full analysis; R0015402:Abstract | ||||
| A1 vs A2 | hr | 0.76 | 0.66 to 0.88 | treatment policy; full analysis; R0015402:Abstract | |||
| A2 | events | 410 / 1766 | treatment policy; full analysis; R0015402:Abstract |
Hospitalization for heart failure (10 lines; O23)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 2 / 1767 | not stated; safety; acute left ventricular failure; registry:adverse_events | ||||
| A1 | events | 48 / 1767 | not stated; safety; cardiac failure; registry:adverse_events | ||||
| A1 | events | 27 / 1767 | not stated; safety; cardiac failure acute; registry:adverse_events | ||||
| A1 | events | 18 / 1767 | not stated; safety; cardiac failure chronic; registry:adverse_events | ||||
| A1 | events | 33 / 1767 | not stated; safety; cardiac failure congestive; registry:adverse_events | ||||
| A2 | events | 18 / 1766 | not stated; safety; cardiac failure chronic; registry:adverse_events | ||||
| A2 | events | 6 / 1766 | not stated; safety; acute left ventricular failure; registry:adverse_events | ||||
| A2 | events | 66 / 1766 | not stated; safety; cardiac failure; registry:adverse_events | ||||
| A2 | events | 26 / 1766 | not stated; safety; cardiac failure acute; registry:adverse_events | ||||
| A2 | events | 49 / 1766 | not stated; safety; cardiac failure congestive; registry:adverse_events |
Serious adverse events (2 lines; O25)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 877 / 1767 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 950 / 1766 | not stated; safety; registry:adverse_events |
Discontinuation due to adverse events (2 lines; O26)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 1767 | not stated; randomized; registry:flow | ||||
| A2 | events | 0 / 1766 | not stated; randomized; registry:flow |
Nausea (2 lines; O27A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 6 / 1767 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 1 / 1766 | not stated; safety; registry:adverse_events |
Vomiting (2 lines; O27B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 11 / 1767 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 5 / 1766 | not stated; safety; registry:adverse_events |
Diarrhea (2 lines; O27C)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 10 / 1767 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 4 / 1766 | not stated; safety; registry:adverse_events |
Constipation (2 lines; O27D)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 3 / 1767 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 5 / 1766 | not stated; safety; registry:adverse_events |
Discontinuation due to gastrointestinal adverse events (2 lines; O27E)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 1767 | not stated; randomized; registry:flow | ||||
| A2 | events | 0 / 1766 | not stated; randomized; registry:flow |
Gallbladder and biliary disease (26 lines; O28)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 1 / 1767 | not stated; safety; cholecystitis chronic; registry:adverse_events | ||||
| A1 | events | 5 / 1767 | not stated; safety; cholecystitis; registry:adverse_events | ||||
| A1 | events | 1 / 1767 | not stated; safety; gallbladder empyema; registry:adverse_events | ||||
| A1 | events | 0 / 1767 | not stated; safety; post cholecystectomy syndrome; registry:adverse_events | ||||
| A1 | events | 1 / 1767 | not stated; safety; biliary tract infection; registry:adverse_events | ||||
| A1 | events | 3 / 1767 | not stated; safety; bile duct stone; registry:adverse_events | ||||
| A1 | events | 13 / 1767 | not stated; safety; cholelithiasis; registry:adverse_events | ||||
| A1 | events | 3 / 1767 | not stated; safety; cholangitis acute; registry:adverse_events | ||||
| A1 | events | 1 / 1767 | not stated; safety; cholangitis infective; registry:adverse_events | ||||
| A1 | events | 1 / 1767 | not stated; safety; cholangitis; registry:adverse_events | ||||
| A1 | events | 0 / 1767 | not stated; safety; hydrocholecystis; registry:adverse_events | ||||
| A1 | events | 1 / 1767 | not stated; safety; gallbladder enlargement; registry:adverse_events | ||||
| A1 | events | 12 / 1767 | not stated; safety; cholecystitis acute; registry:adverse_events | ||||
| A2 | events | 0 / 1766 | not stated; safety; gallbladder empyema; registry:adverse_events | ||||
| A2 | events | 0 / 1766 | not stated; safety; biliary tract infection; registry:adverse_events | ||||
| A2 | events | 1 / 1766 | not stated; safety; cholangitis acute; registry:adverse_events | ||||
| A2 | events | 1 / 1766 | not stated; safety; cholangitis infective; registry:adverse_events | ||||
| A2 | events | 3 / 1766 | not stated; safety; cholangitis; registry:adverse_events | ||||
| A2 | events | 0 / 1766 | not stated; safety; gallbladder enlargement; registry:adverse_events | ||||
| A2 | events | 1 / 1766 | not stated; safety; hydrocholecystis; registry:adverse_events | ||||
| A2 | events | 1 / 1766 | not stated; safety; post cholecystectomy syndrome; registry:adverse_events | ||||
| A2 | events | 15 / 1766 | not stated; safety; cholecystitis acute; registry:adverse_events | ||||
| A2 | events | 0 / 1766 | not stated; safety; cholecystitis chronic; registry:adverse_events | ||||
| A2 | events | 1 / 1766 | not stated; safety; cholecystitis; registry:adverse_events | ||||
| A2 | events | 4 / 1766 | not stated; safety; bile duct stone; registry:adverse_events | ||||
| A2 | events | 12 / 1766 | 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 | 6 / 1767 | not stated; safety; pancreatitis acute; registry:adverse_events | ||||
| A1 | events | 1 / 1767 | not stated; safety; obstructive pancreatitis; registry:adverse_events | ||||
| A1 | events | 0 / 1767 | not stated; safety; pancreatitis necrotising; registry:adverse_events | ||||
| A1 | events | 1 / 1767 | not stated; safety; pancreatitis; registry:adverse_events | ||||
| A2 | events | 5 / 1766 | not stated; safety; pancreatitis acute; registry:adverse_events | ||||
| A2 | events | 1 / 1766 | not stated; safety; obstructive pancreatitis; registry:adverse_events | ||||
| A2 | events | 2 / 1766 | not stated; safety; pancreatitis necrotising; registry:adverse_events | ||||
| A2 | events | 1 / 1766 | not stated; safety; pancreatitis; registry:adverse_events |
Thyroid cancer (any) (4 lines; O32B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 1 / 1767 | not stated; randomized; R0000453:Table 1 | ||||
| A1 | events | 1 / 1767 | not stated; safety; papillary thyroid cancer; registry:adverse_events | ||||
| A2 | events | 1 / 1766 | not stated; randomized; R0000453:Table 1 | ||||
| A2 | events | 1 / 1766 | not stated; safety; papillary thyroid cancer; registry:adverse_events |
Diabetic retinopathy complications (12 lines; O33)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 1 / 1767 | not stated; safety; blindness unilateral; registry:adverse_events | ||||
| A1 | events | 339 / 1767 | not stated; safety; diabetic retinopathy; registry:adverse_events | ||||
| A1 | events | 12 / 1767 | not stated; safety; diabetic retinopathy; registry:adverse_events | ||||
| A1 | events | 1 / 1767 | not stated; safety; retinopathy proliferative; registry:adverse_events | ||||
| A1 | events | 1 / 1767 | not stated; safety; retinopathy; registry:adverse_events | ||||
| A1 | events | 3 / 1767 | not stated; safety; vitreous haemorrhage; registry:adverse_events | ||||
| A2 | events | 0 / 1766 | not stated; safety; blindness unilateral; registry:adverse_events | ||||
| A2 | events | 325 / 1766 | not stated; safety; diabetic retinopathy; registry:adverse_events | ||||
| A2 | events | 9 / 1766 | not stated; safety; diabetic retinopathy; registry:adverse_events | ||||
| A2 | events | 0 / 1766 | not stated; safety; retinopathy proliferative; registry:adverse_events | ||||
| A2 | events | 0 / 1766 | not stated; safety; retinopathy; registry:adverse_events | ||||
| A2 | events | 1 / 1766 | not stated; safety; vitreous haemorrhage; registry:adverse_events |
Suicidal ideation or behavior (4 lines; O35A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 1767 | not stated; safety; suicide attempt; registry:adverse_events | ||||
| A1 | events | 1 / | not stated; safety; R0040560:Figure 1 | ||||
| A2 | events | 3 / 1766 | not stated; safety; suicide attempt; registry:adverse_events | ||||
| A2 | events | 4 / | not stated; safety; R0040560:Figure 1 |
Gastroparesis (2 lines; O37A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 1 / 1767 | not stated; safety; impaired gastric emptying; registry:adverse_events | ||||
| A2 | events | 0 / 1766 | not stated; safety; impaired gastric emptying; registry:adverse_events |
Intestinal obstruction or ileus (14 lines; O37B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 1 / 1767 | not stated; safety; subileus; registry:adverse_events | ||||
| A1 | events | 1 / 1767 | not stated; safety; mechanical ileus; registry:adverse_events | ||||
| A1 | events | 1 / 1767 | not stated; safety; ileus paralytic; registry:adverse_events | ||||
| A1 | events | 1 / 1767 | not stated; safety; ileus; registry:adverse_events | ||||
| A1 | events | 2 / 1767 | not stated; safety; intestinal obstruction; registry:adverse_events | ||||
| A1 | events | 0 / 1767 | not stated; safety; large intestinal obstruction; registry:adverse_events | ||||
| A1 | events | 3 / 1767 | not stated; safety; small intestinal obstruction; registry:adverse_events | ||||
| A2 | events | 0 / 1766 | not stated; safety; ileus paralytic; registry:adverse_events | ||||
| A2 | events | 0 / 1766 | not stated; safety; ileus; registry:adverse_events | ||||
| A2 | events | 1 / 1766 | not stated; safety; intestinal obstruction; registry:adverse_events | ||||
| A2 | events | 1 / 1766 | not stated; safety; large intestinal obstruction; registry:adverse_events | ||||
| A2 | events | 0 / 1766 | not stated; safety; mechanical ileus; registry:adverse_events | ||||
| A2 | events | 2 / 1766 | not stated; safety; small intestinal obstruction; registry:adverse_events | ||||
| A2 | events | 0 / 1766 | not stated; safety; subileus; registry:adverse_events |
Pancreatic cancer (8 lines; O38)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 1 / 1767 | not stated; safety; adenocarcinoma pancreas; registry:adverse_events | ||||
| A1 | events | 1 / 1767 | not stated; safety; ductal adenocarcinoma of pancreas; registry:adverse_events | ||||
| A1 | events | 0 / 1767 | not stated; safety; pancreatic carcinoma metastatic; registry:adverse_events | ||||
| A1 | events | 0 / 1767 | not stated; safety; pancreatic carcinoma; registry:adverse_events | ||||
| A2 | events | 0 / 1766 | not stated; safety; ductal adenocarcinoma of pancreas; registry:adverse_events | ||||
| A2 | events | 3 / 1766 | not stated; safety; pancreatic carcinoma metastatic; registry:adverse_events | ||||
| A2 | events | 1 / 1766 | not stated; safety; adenocarcinoma pancreas; registry:adverse_events | ||||
| A2 | events | 1 / 1766 | not stated; safety; pancreatic carcinoma; registry:adverse_events |
Kidney composite outcome (kidney disease populations) (6 lines; O50)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 vs A2 | hr | 1.18 | 0.71 to 1.98 | treatment policy; full analysis; background:sglt2i; R0006943:Results | |||
| A1 | events | 186 / 1490 | treatment policy; full analysis; background:no_sglt2i; R0006943:Results | ||||
| A1 vs A2 | hr | 0.75 | 0.61 to 0.90 | treatment policy; full analysis; background:no_sglt2i; R0006943:Results | |||
| A1 | events | 32 / 277 | treatment policy; full analysis; background:sglt2i; R0006943:Results | ||||
| A2 | events | 233 / 1493 | treatment policy; full analysis; background:no_sglt2i; R0006943:Results | ||||
| A2 | events | 27 / 273 | treatment policy; full analysis; background:sglt2i; R0006943:Results |
eGFR total slope (6 lines; O51)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 234 | A1 vs A2 | md | 1.3 mL/min/1.73 m2/year | 0.8 to 1.8 | treatment policy; full analysis; egfr:30_to_less_than_45; R0015402:Results | ||
| 234 | A1 vs A2 | md | 1.0 mL/min/1.73 m2/year | 0.5 to 1.6 | treatment policy; full analysis; egfr:45_to_less_than_60; R0015402:Results | ||
| 234 | A1 vs A2 | md | 1.2 mL/min/1.73 m2/year | 0.5 to 1.8 | treatment policy; full analysis; egfr:60_or_more; R0015402:Results | ||
| 234 | A1 vs A2 | md | 0.9 mL/min/1.73 m2/year | -0.0 to 1.9 | treatment policy; full analysis; egfr:less_than_30; R0015402:Results | ||
| 234 | A1 | slope | -2.19 mL/min/1.73 m2/year | 0.1 | 1767 | treatment policy; full analysis; registry:outcomes | |
| 234 | A2 | slope | -3.36 mL/min/1.73 m2/year | 0.1 | 1766 | treatment policy; full analysis; registry:outcomes |