parallel randomized trial
NCT02453711
Investigation of Safety and Efficacy of Once-daily Semaglutide in Obese Subjects Without Diabetes Mellitus
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | Semaglutide 0.05 mg injection once daily Semaglutide 0.05 mg once daily | monthly hypocaloric diet and exercise counseling; lifestyle: standard | 103 | ||
| A2 | Semaglutide 0.1 mg injection once daily Semaglutide 0.1 mg once daily | monthly hypocaloric diet and exercise counseling; lifestyle: standard | 102 | ||
| A3 | Semaglutide 0.2 mg injection once daily Semaglutide 0.2 mg once daily | monthly hypocaloric diet and exercise counseling; lifestyle: standard | 103 | ||
| A4 | semaglutide Semaglutide 0.3 mg once daily | monthly hypocaloric diet and exercise counseling; lifestyle: standard | 103 | ||
| A5 | semaglutide Semaglutide 0.4 mg once daily | monthly hypocaloric diet and exercise counseling; lifestyle: standard | 102 | ||
| A6 | semaglutide Semaglutide 0.3 mg once daily fast escalation | monthly hypocaloric diet and exercise counseling; lifestyle: standard | 102 | ||
| A7 | semaglutide Semaglutide 0.4 mg once daily fast escalation | monthly hypocaloric diet and exercise counseling; lifestyle: standard | 103 | ||
| A8 | Liraglutide 3.0 mg subcutaneous once daily Liraglutide 3.0 mg once daily | monthly hypocaloric diet and exercise counseling; lifestyle: standard | 103 | ||
| A9 | Placebo Placebo pool | monthly hypocaloric diet and exercise counseling; lifestyle: standard | 136 |
Baseline characteristics
As printed in the trial reports or registry, per arm or for the whole trial.
| Characteristic | Statistic | Semaglutide 0.05 mg injection once daily A1 | Semaglutide 0.1 mg injection once daily A2 | Semaglutide 0.2 mg injection once daily A3 | Semaglutide 0.3 mg once daily A4 | Semaglutide 0.4 mg once daily A5 | Semaglutide 0.3 mg once daily fast escalation A6 | Semaglutide 0.4 mg once daily fast escalation A7 | Liraglutide 3.0 mg subcutaneous once daily A8 | Placebo A9 |
|---|---|---|---|---|---|---|---|---|---|---|
| age | mean (years) | 46.97 | 45.24 | 44.37 | 46.73 | 48.37 | 47.10 | 46.07 | 48.50 | 46.42 |
| age | sd (years) | 12.80 | 12.62 | 11.24 | 12.02 | 13.44 | 12.05 | 13.51 | 11.22 | 12.80 |
| asian | n | 2 | 0 | 1 | 0 | 0 | 3 | 1 | 1 | 1 |
| black | n | 5 | 7 | 10 | 3 | 10 | 0 | 7 | 9 | 10 |
| female | n | 67 | 66 | 66 | 66 | 66 | 66 | 67 | 67 | 88 |
| hba1c | mean (percent) | 5.51 | 5.45 | 5.41 | 5.51 | 5.47 | 5.48 | 5.49 | 5.53 | 5.54 |
| hba1c | sd (percent) | 0.35 | 0.43 | 0.39 | 0.38 | 0.42 | 0.41 | 0.42 | 0.38 | 0.38 |
| hispanic | n | 3 | 7 | 6 | 13 | 4 | 6 | 3 | 6 | 7 |
| other american indian alaska native | n | 0 | 0 | 0 | 1 | 1 | 0 | 1 | 0 | 1 |
| other pacific islander | n | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 1 |
| other race not applicable | n | 8 | 17 | 20 | 22 | 19 | 22 | 25 | 14 | 24 |
| other race other | n | 0 | 1 | 0 | 3 | 1 | 1 | 0 | 1 | 2 |
| weight | mean (kg) | 111.29 | 111.31 | 114.49 | 111.51 | 113.20 | 108.11 | 109.56 | 108.71 | 114.19 |
| weight | sd (kg) | 23.17 | 21.47 | 24.53 | 22.96 | 26.42 | 22.08 | 21.33 | 21.94 | 25.37 |
| white | n | 88 | 76 | 72 | 74 | 71 | 76 | 68 | 78 | 97 |
Analyses this trial contributes to
- Systolic blood pressure changeOverweight or obesity without diabetes (adults); weeks 40 to 104 (target week 68); network meta-analysis
- Systolic blood pressure changeOverweight or obesity without diabetes (adults); weeks 40 to 104 (target week 68); network meta-analysis
- Percent body weight changeOverweight or obesity without diabetes (adults); weeks 40 to 104 (target week 68); network meta-analysis
- Percent body weight changeOverweight or obesity without diabetes (adults); weeks 40 to 104 (target week 68); network meta-analysis
- SF-36 physical component summary changeOverweight or obesity without diabetes (adults); weeks 20 to 130 (target week 52); network meta-analysis
- SF-36 physical component summary changeOverweight or obesity without diabetes (adults); weeks 20 to 130 (target week 52); network meta-analysis
- Serious adverse eventsOverweight or obesity without diabetes (adults); longest follow-up; network meta-analysis
- Serious adverse eventsOverweight or obesity without diabetes (adults); longest follow-up; network meta-analysis
- NauseaOverweight or obesity without diabetes (adults); longest follow-up; network meta-analysis
- NauseaOverweight or obesity without diabetes (adults); longest follow-up; network meta-analysis
- VomitingOverweight or obesity without diabetes (adults); longest follow-up; network meta-analysis
- VomitingOverweight or obesity without diabetes (adults); longest follow-up; network meta-analysis
- DiarrheaOverweight or obesity without diabetes (adults); longest follow-up; network meta-analysis
- DiarrheaOverweight or obesity without diabetes (adults); longest follow-up; network meta-analysis
- ConstipationOverweight or obesity without diabetes (adults); longest follow-up; network meta-analysis
- ConstipationOverweight or obesity without diabetes (adults); longest follow-up; network meta-analysis
Results
194 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
Systolic blood pressure change (9 lines; O05)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 52 | A1 | change | -4.46 mmHg | 1.20 | 91 | not stated; full analysis; registry:outcomes | |
| 52 | A2 | change | -5.76 mmHg | 1.18 | 96 | not stated; full analysis; registry:outcomes | |
| 52 | A3 | change | -6.26 mmHg | 1.19 | 94 | not stated; full analysis; registry:outcomes | |
| 52 | A4 | change | -6.41 mmHg | 1.19 | 95 | not stated; full analysis; registry:outcomes | |
| 52 | A5 | change | -5.81 mmHg | 1.16 | 100 | not stated; full analysis; registry:outcomes | |
| 52 | A6 | change | -6.07 mmHg | 1.19 | 95 | not stated; full analysis; registry:outcomes | |
| 52 | A7 | change | -10.26 mmHg | 1.16 | 100 | not stated; full analysis; registry:outcomes | |
| 52 | A8 | change | -5.45 mmHg | 1.18 | 96 | not stated; full analysis; registry:outcomes | |
| 52 | A9 | change | -1.58 mmHg | 1.04 | 123 | not stated; full analysis; registry:outcomes |
Percent body weight change (14 lines; O10)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 52 | A1 | percent change | -5.99 percent | 0.85 | 92 | not stated; full analysis; registry:outcomes | |
| 52 | A1 vs A9 | md | -3.70 percent | -6.55 to -0.85 | not stated; full analysis; registry:outcomes | ||
| 52 | A2 | percent change | -8.62 percent | 0.84 | 96 | not stated; full analysis; registry:outcomes | |
| 52 | A2 vs A9 | md | -6.32 percent | -9.16 to -3.49 | not stated; full analysis; registry:outcomes | ||
| 52 | A3 | percent change | -11.60 percent | 0.85 | 94 | not stated; full analysis; registry:outcomes | |
| 52 | A3 vs A9 | md | -9.31 percent | -12.15 to -6.46 | not stated; full analysis; registry:outcomes | ||
| 52 | A4 | percent change | -11.17 percent | 0.85 | 95 | not stated; full analysis; registry:outcomes | |
| 52 | A4 vs A9 | md | -8.88 percent | -11.72 to -6.03 | not stated; full analysis; registry:outcomes | ||
| 52 | A5 | percent change | -13.84 percent | 0.83 | 100 | not stated; full analysis; registry:outcomes | |
| 52 | A5 vs A9 | md | -11.55 percent | -14.38 to -8.72 | not stated; full analysis; registry:outcomes | ||
| 52 | A6 | percent change | -11.38 percent | 0.85 | 95 | not stated; full analysis; registry:outcomes | |
| 52 | A7 | percent change | -16.29 percent | 0.83 | 100 | not stated; full analysis; registry:outcomes | |
| 52 | A8 | percent change | -7.76 percent | 0.85 | 96 | not stated; full analysis; registry:outcomes | |
| 52 | A9 | percent change | -2.29 percent | 0.74 | 123 | not stated; full analysis; registry:outcomes |
Weight loss of 5 percent or more (9 lines; O11A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 52 | A1 | responders | 53.50 | 92 | not stated; full analysis; registry:outcomes | ||
| 52 | A2 | responders | 67.49 | 96 | not stated; full analysis; registry:outcomes | ||
| 52 | A3 | responders | 74.91 | 94 | not stated; full analysis; registry:outcomes | ||
| 52 | A4 | responders | 80.52 | 95 | not stated; full analysis; registry:outcomes | ||
| 52 | A5 | responders | 82.52 | 100 | not stated; full analysis; registry:outcomes | ||
| 52 | A6 | responders | 72.19 | 95 | not stated; full analysis; registry:outcomes | ||
| 52 | A7 | responders | 89.58 | 100 | not stated; full analysis; registry:outcomes | ||
| 52 | A8 | responders | 66.12 | 96 | not stated; full analysis; registry:outcomes | ||
| 52 | A9 | responders | 22.87 | 123 | not stated; full analysis; registry:outcomes |
Weight loss of 10 percent or more (9 lines; O11B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 52 | A1 | responders | 18.94 | 92 | not stated; full analysis; registry:outcomes | ||
| 52 | A2 | responders | 36.57 | 96 | not stated; full analysis; registry:outcomes | ||
| 52 | A3 | responders | 55.95 | 94 | not stated; full analysis; registry:outcomes | ||
| 52 | A4 | responders | 57.76 | 95 | not stated; full analysis; registry:outcomes | ||
| 52 | A5 | responders | 64.61 | 100 | not stated; full analysis; registry:outcomes | ||
| 52 | A6 | responders | 58.45 | 95 | not stated; full analysis; registry:outcomes | ||
| 52 | A7 | responders | 71.91 | 100 | not stated; full analysis; registry:outcomes | ||
| 52 | A8 | responders | 33.98 | 96 | not stated; full analysis; registry:outcomes | ||
| 52 | A9 | responders | 10.08 | 123 | not stated; full analysis; registry:outcomes |
Acute kidney injury (9 lines; O121)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 103 | not stated; safety; acute kidney injury; registry:adverse_events | ||||
| A2 | events | 0 / 102 | not stated; safety; acute kidney injury; registry:adverse_events | ||||
| A3 | events | 0 / 103 | not stated; safety; acute kidney injury; registry:adverse_events | ||||
| A4 | events | 0 / 103 | not stated; safety; acute kidney injury; registry:adverse_events | ||||
| A5 | events | 1 / 102 | not stated; safety; acute kidney injury; registry:adverse_events | ||||
| A6 | events | 0 / 102 | not stated; safety; acute kidney injury; registry:adverse_events | ||||
| A7 | events | 0 / 103 | not stated; safety; acute kidney injury; registry:adverse_events | ||||
| A8 | events | 0 / 103 | not stated; safety; acute kidney injury; registry:adverse_events | ||||
| A9 | events | 0 / 136 | not stated; safety; acute kidney injury; registry:adverse_events |
All cause mortality (9 lines; O20)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 103 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 0 / 102 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 0 / 103 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 0 / 103 | not stated; safety; registry:adverse_events | ||||
| A5 | events | 0 / 102 | not stated; safety; registry:adverse_events | ||||
| A6 | events | 0 / 102 | not stated; safety; registry:adverse_events | ||||
| A7 | events | 1 / 103 | not stated; safety; registry:adverse_events | ||||
| A8 | events | 0 / 103 | not stated; safety; registry:adverse_events | ||||
| A9 | events | 0 / 136 | not stated; safety; registry:adverse_events |
SF-36 physical component summary change (9 lines; O24A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 52 | A1 | change | 4.16 points | 7.70 | 27 | not stated; full analysis; registry:outcomes | |
| 52 | A2 | change | 5.51 points | 8.04 | 23 | not stated; full analysis; registry:outcomes | |
| 52 | A3 | change | 7.14 points | 6.38 | 20 | not stated; full analysis; registry:outcomes | |
| 52 | A4 | change | 4.70 points | 4.67 | 31 | not stated; full analysis; registry:outcomes | |
| 52 | A5 | change | 7.67 points | 6.93 | 33 | not stated; full analysis; registry:outcomes | |
| 52 | A6 | change | 7.54 points | 8.29 | 22 | not stated; full analysis; registry:outcomes | |
| 52 | A7 | change | 7.28 points | 8.54 | 24 | not stated; full analysis; registry:outcomes | |
| 52 | A8 | change | 6.21 points | 5.68 | 31 | not stated; full analysis; registry:outcomes | |
| 52 | A9 | change | 2.29 points | 9.33 | 37 | not stated; full analysis; registry:outcomes |
Physical functioning (any instrument) (9 lines; O24B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 52 | A1 | change | 6.00 points | 6.92 | 27 | not stated; full analysis; registry:outcomes | |
| 52 | A2 | change | 4.67 points | 8.17 | 23 | not stated; full analysis; registry:outcomes | |
| 52 | A3 | change | 6.52 points | 5.91 | 20 | not stated; full analysis; registry:outcomes | |
| 52 | A4 | change | 4.75 points | 4.07 | 31 | not stated; full analysis; registry:outcomes | |
| 52 | A5 | change | 8.74 points | 7.66 | 33 | not stated; full analysis; registry:outcomes | |
| 52 | A6 | change | 7.27 points | 6.32 | 22 | not stated; full analysis; registry:outcomes | |
| 52 | A7 | change | 7.28 points | 6.27 | 24 | not stated; full analysis; registry:outcomes | |
| 52 | A8 | change | 6.79 points | 6.40 | 31 | not stated; full analysis; registry:outcomes | |
| 52 | A9 | change | 2.28 points | 7.56 | 37 | not stated; full analysis; registry:outcomes |
Serious adverse events (9 lines; O25)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 13 / 103 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 8 / 102 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 5 / 103 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 6 / 103 | not stated; safety; registry:adverse_events | ||||
| A5 | events | 13 / 102 | not stated; safety; registry:adverse_events | ||||
| A6 | events | 6 / 102 | not stated; safety; registry:adverse_events | ||||
| A7 | events | 7 / 103 | not stated; safety; registry:adverse_events | ||||
| A8 | events | 4 / 103 | not stated; safety; registry:adverse_events | ||||
| A9 | events | 11 / 136 | not stated; safety; registry:adverse_events |
Nausea (9 lines; O27A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 32 / 103 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 42 / 102 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 45 / 103 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 43 / 103 | not stated; safety; registry:adverse_events | ||||
| A5 | events | 49 / 102 | not stated; safety; registry:adverse_events | ||||
| A6 | events | 55 / 102 | not stated; safety; registry:adverse_events | ||||
| A7 | events | 50 / 103 | not stated; safety; registry:adverse_events | ||||
| A8 | events | 46 / 103 | not stated; safety; registry:adverse_events | ||||
| A9 | events | 24 / 136 | not stated; safety; registry:adverse_events |
Vomiting (9 lines; O27B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 8 / 103 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 18 / 102 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 24 / 103 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 11 / 103 | not stated; safety; registry:adverse_events | ||||
| A5 | events | 17 / 102 | not stated; safety; registry:adverse_events | ||||
| A6 | events | 21 / 102 | not stated; safety; registry:adverse_events | ||||
| A7 | events | 23 / 103 | not stated; safety; registry:adverse_events | ||||
| A8 | events | 11 / 103 | not stated; safety; registry:adverse_events | ||||
| A9 | events | 6 / 136 | not stated; safety; registry:adverse_events |
Diarrhea (9 lines; O27C)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 20 / 103 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 25 / 102 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 35 / 103 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 27 / 103 | not stated; safety; registry:adverse_events | ||||
| A5 | events | 38 / 102 | not stated; safety; registry:adverse_events | ||||
| A6 | events | 28 / 102 | not stated; safety; registry:adverse_events | ||||
| A7 | events | 28 / 103 | not stated; safety; registry:adverse_events | ||||
| A8 | events | 29 / 103 | not stated; safety; registry:adverse_events | ||||
| A9 | events | 16 / 136 | not stated; safety; registry:adverse_events |
Constipation (9 lines; O27D)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 13 / 103 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 22 / 102 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 26 / 103 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 18 / 103 | not stated; safety; registry:adverse_events | ||||
| A5 | events | 24 / 102 | not stated; safety; registry:adverse_events | ||||
| A6 | events | 19 / 102 | not stated; safety; registry:adverse_events | ||||
| A7 | events | 29 / 103 | not stated; safety; registry:adverse_events | ||||
| A8 | events | 24 / 103 | not stated; safety; registry:adverse_events | ||||
| A9 | events | 6 / 136 | not stated; safety; registry:adverse_events |
Gallbladder and biliary disease (36 lines; O28)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 103 | not stated; safety; cholecystitis acute; registry:adverse_events | ||||
| A1 | events | 1 / 103 | not stated; safety; cholecystitis infective; registry:adverse_events | ||||
| A1 | events | 1 / 103 | not stated; safety; cholecystitis; registry:adverse_events | ||||
| A1 | events | 0 / 103 | not stated; safety; cholelithiasis; registry:adverse_events | ||||
| A2 | events | 0 / 102 | not stated; safety; cholecystitis infective; registry:adverse_events | ||||
| A2 | events | 0 / 102 | not stated; safety; cholecystitis acute; registry:adverse_events | ||||
| A2 | events | 0 / 102 | not stated; safety; cholecystitis; registry:adverse_events | ||||
| A2 | events | 0 / 102 | not stated; safety; cholelithiasis; registry:adverse_events | ||||
| A3 | events | 0 / 103 | not stated; safety; cholecystitis; registry:adverse_events | ||||
| A3 | events | 0 / 103 | not stated; safety; cholecystitis acute; registry:adverse_events | ||||
| A3 | events | 1 / 103 | not stated; safety; cholelithiasis; registry:adverse_events | ||||
| A3 | events | 0 / 103 | not stated; safety; cholecystitis infective; registry:adverse_events | ||||
| A4 | events | 0 / 103 | not stated; safety; cholecystitis infective; registry:adverse_events | ||||
| A4 | events | 1 / 103 | not stated; safety; cholecystitis acute; registry:adverse_events | ||||
| A4 | events | 0 / 103 | not stated; safety; cholelithiasis; registry:adverse_events | ||||
| A4 | events | 0 / 103 | not stated; safety; cholecystitis; registry:adverse_events | ||||
| A5 | events | 0 / 102 | not stated; safety; cholecystitis acute; registry:adverse_events | ||||
| A5 | events | 0 / 102 | not stated; safety; cholecystitis infective; registry:adverse_events | ||||
| A5 | events | 0 / 102 | not stated; safety; cholecystitis; registry:adverse_events | ||||
| A5 | events | 1 / 102 | not stated; safety; cholelithiasis; registry:adverse_events | ||||
| A6 | events | 0 / 102 | not stated; safety; cholecystitis infective; registry:adverse_events | ||||
| A6 | events | 3 / 102 | not stated; safety; cholelithiasis; registry:adverse_events | ||||
| A6 | events | 0 / 102 | not stated; safety; cholecystitis; registry:adverse_events | ||||
| A6 | events | 0 / 102 | not stated; safety; cholecystitis acute; registry:adverse_events | ||||
| A7 | events | 0 / 103 | not stated; safety; cholecystitis; registry:adverse_events | ||||
| A7 | events | 0 / 103 | not stated; safety; cholecystitis acute; registry:adverse_events | ||||
| A7 | events | 1 / 103 | not stated; safety; cholelithiasis; registry:adverse_events | ||||
| A7 | events | 0 / 103 | not stated; safety; cholecystitis infective; registry:adverse_events | ||||
| A8 | events | 0 / 103 | not stated; safety; cholecystitis; registry:adverse_events | ||||
| A8 | events | 0 / 103 | not stated; safety; cholecystitis infective; registry:adverse_events | ||||
| A8 | events | 0 / 103 | not stated; safety; cholelithiasis; registry:adverse_events | ||||
| A8 | events | 0 / 103 | not stated; safety; cholecystitis acute; registry:adverse_events | ||||
| A9 | events | 1 / 136 | not stated; safety; cholecystitis acute; registry:adverse_events | ||||
| A9 | events | 0 / 136 | not stated; safety; cholecystitis infective; registry:adverse_events | ||||
| A9 | events | 0 / 136 | not stated; safety; cholecystitis; registry:adverse_events | ||||
| A9 | events | 0 / 136 | not stated; safety; cholelithiasis; registry:adverse_events |
Acute pancreatitis (18 lines; O29)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 103 | not stated; safety; pancreatitis acute; registry:adverse_events | ||||
| A1 | events | 1 / 103 | not stated; safety; pancreatitis; registry:adverse_events | ||||
| A2 | events | 0 / 102 | not stated; safety; pancreatitis acute; registry:adverse_events | ||||
| A2 | events | 0 / 102 | not stated; safety; pancreatitis; registry:adverse_events | ||||
| A3 | events | 0 / 103 | not stated; safety; pancreatitis acute; registry:adverse_events | ||||
| A3 | events | 0 / 103 | not stated; safety; pancreatitis; registry:adverse_events | ||||
| A4 | events | 0 / 103 | not stated; safety; pancreatitis acute; registry:adverse_events | ||||
| A4 | events | 1 / 103 | not stated; safety; pancreatitis; registry:adverse_events | ||||
| A5 | events | 0 / 102 | not stated; safety; pancreatitis acute; registry:adverse_events | ||||
| A5 | events | 0 / 102 | not stated; safety; pancreatitis; registry:adverse_events | ||||
| A6 | events | 2 / 102 | not stated; safety; pancreatitis acute; registry:adverse_events | ||||
| A6 | events | 0 / 102 | not stated; safety; pancreatitis; registry:adverse_events | ||||
| A7 | events | 0 / 103 | not stated; safety; pancreatitis acute; registry:adverse_events | ||||
| A7 | events | 0 / 103 | not stated; safety; pancreatitis; registry:adverse_events | ||||
| A8 | events | 0 / 103 | not stated; safety; pancreatitis acute; registry:adverse_events | ||||
| A8 | events | 0 / 103 | not stated; safety; pancreatitis; registry:adverse_events | ||||
| A9 | events | 0 / 136 | not stated; safety; pancreatitis acute; registry:adverse_events | ||||
| A9 | events | 1 / 136 | not stated; safety; pancreatitis; registry:adverse_events |
Thyroid cancer (any) (9 lines; O32B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 103 | not stated; safety; papillary thyroid cancer; registry:adverse_events | ||||
| A2 | events | 0 / 102 | not stated; safety; papillary thyroid cancer; registry:adverse_events | ||||
| A3 | events | 0 / 103 | not stated; safety; papillary thyroid cancer; registry:adverse_events | ||||
| A4 | events | 0 / 103 | not stated; safety; papillary thyroid cancer; registry:adverse_events | ||||
| A5 | events | 0 / 102 | not stated; safety; papillary thyroid cancer; registry:adverse_events | ||||
| A6 | events | 0 / 102 | not stated; safety; papillary thyroid cancer; registry:adverse_events | ||||
| A7 | events | 0 / 103 | not stated; safety; papillary thyroid cancer; registry:adverse_events | ||||
| A8 | events | 0 / 103 | not stated; safety; papillary thyroid cancer; registry:adverse_events | ||||
| A9 | events | 1 / 136 | not stated; safety; papillary thyroid cancer; registry:adverse_events |
Suicidal ideation or behavior (9 lines; O35A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 1 / 103 | not stated; safety; registry:outcomes | ||||
| A2 | events | 0 / 102 | not stated; safety; registry:outcomes | ||||
| A3 | events | 1 / 103 | not stated; safety; registry:outcomes | ||||
| A4 | events | 2 / 103 | not stated; safety; registry:outcomes | ||||
| A5 | events | 0 / 102 | not stated; safety; registry:outcomes | ||||
| A6 | events | 0 / 102 | not stated; safety; registry:outcomes | ||||
| A7 | events | 0 / 103 | not stated; safety; registry:outcomes | ||||
| A8 | events | 2 / 103 | not stated; safety; registry:outcomes | ||||
| A9 | events | 1 / 136 | not stated; safety; registry:outcomes |