parallel randomized trial
PIONEER 9
Dose-response, Safety and Efficacy of Oral Semaglutide Versus Placebo and Versus Liraglutide, All as Monotherapy 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 | none (monotherapy); lifestyle: not reported | 49 | 49 | |
| A2 | Semaglutide 7 mg oral once daily (original tablet) Oral semaglutide 7 mg | none (monotherapy); lifestyle: not reported | 49 | 49 | |
| A3 | Semaglutide 14 mg oral once daily (original tablet) Oral semaglutide 14 mg | none (monotherapy); lifestyle: not reported | 48 | 48 | |
| A4 | Liraglutide 0.9 mg injection once daily Liraglutide 0.9 mg | none (monotherapy); lifestyle: not reported | 48 | 48 | |
| A5 | Placebo Placebo | none (monotherapy); lifestyle: not reported | 49 | 49 |
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 | Liraglutide 0.9 mg injection once daily A4 | Placebo A5 | Whole trial ALL |
|---|---|---|---|---|---|---|---|
| age | mean (years) | 58 | 60 | 61 | 59 | 59 | |
| age | sd (years) | 9 | 10 | 9 | 10 | 9 | |
| asian | n | 49 | 49 | 48 | 48 | 49 | |
| black | n | 0 | 0 | 0 | 0 | 0 | |
| bmi | mean (kg/m2) | 25.9 | |||||
| bmi | sd (kg/m2) | 4.3 | |||||
| diabetes duration | mean (years) | 7.6 | |||||
| diabetes duration | sd (years) | 5.6 | |||||
| egfr | mean (mL/min/1.73 m2) | 97 | |||||
| egfr | sd (mL/min/1.73 m2) | 12 | |||||
| female | n | 13 | 13 | 8 | 9 | 9 | |
| hba1c | mean (percent) | 8.1 | 8.3 | 8.0 | 8.3 | 8.3 | |
| hba1c | sd (percent) | 0.8 | 1.0 | 0.9 | 0.8 | 1.1 | |
| hispanic | n | 0 | 0 | 0 | 0 | 0 | |
| weight | mean (kg) | 71.1 | |||||
| weight | sd (kg) | 13.3 | |||||
| white | n | 0 | 0 | 0 | 0 | 0 |
Analyses this trial contributes to
- 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 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
- 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
- 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
- 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
- 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); 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 20 to 36 (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 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
- 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); descriptive only
- Weight loss of 5 percent or moreType 2 diabetes (adults); weeks 40 to 104 (target week 68); descriptive only
- Weight loss of 10 percent or moreType 2 diabetes (adults); weeks 40 to 104 (target week 68); descriptive only
- 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); descriptive only
- SF-36 physical component summary changeType 2 diabetes (adults); weeks 20 to 130 (target week 52); network meta-analysis
- SF-36 physical component summary changeType 2 diabetes (adults); weeks 20 to 130 (target week 52); network meta-analysis
- Serious adverse eventsType 2 diabetes (adults); longest follow-up; network meta-analysis
- Serious adverse eventsType 2 diabetes (adults); longest follow-up; network meta-analysis
- NauseaType 2 diabetes (adults); longest follow-up; network meta-analysis
- NauseaType 2 diabetes (adults); longest follow-up; network meta-analysis
- 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
Results
172 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
HbA1c change (37 lines; O01)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26 | A1 vs A4 | md | 0.3 percent | -0.0 to 0.6 | hypothetical; full analysis; registry:outcomes | ||
| 26 | A1 vs A5 | md | -1.1 percent | -1.4 to -0.8 | hypothetical; full analysis; registry:outcomes | ||
| 26 | A1 | change | -1.2 percent | 33 | treatment policy; randomized; age:<65; R0016956:Figure 1A | ||
| 26 | A1 | change | -1.0 percent | 16 | treatment policy; randomized; age:>=65; R0016956:Figure 1A | ||
| 26 | A1 | change | -1.1 percent | 0.8 | 49 | treatment policy; full analysis; registry:outcomes | |
| 26 | A1 vs A4 | md | 0.2 percent | -0.1 to 0.5 | treatment policy; full analysis; registry:outcomes | ||
| 26 | A1 vs A5 | md | -0.8 percent | -1.1 to -0.5 | treatment policy; full analysis; registry:outcomes | ||
| 26 | A1 | change | -1.1 percent | 0.8 | 49 | hypothetical; full analysis; registry:outcomes | |
| 26 | A2 | change | -1.6 percent | 0.8 | 49 | treatment policy; full analysis; registry:outcomes | |
| 26 | A2 vs A5 | md | -1.2 percent | -1.5 to -0.9 | treatment policy; full analysis; registry:outcomes | ||
| 26 | A2 | change | -1.5 percent | 34 | treatment policy; randomized; age:<65; R0016956:Figure 1A | ||
| 26 | A2 | change | -1.7 percent | 0.8 | 49 | hypothetical; full analysis; registry:outcomes | |
| 26 | A2 vs A4 | md | -0.1 percent | -0.4 to 0.2 | hypothetical; full analysis; registry:outcomes | ||
| 26 | A2 vs A5 | md | -1.5 percent | -1.7 to -1.2 | hypothetical; full analysis; registry:outcomes | ||
| 26 | A2 | change | -1.6 percent | 15 | treatment policy; randomized; age:>=65; R0016956:Figure 1A | ||
| 26 | A2 vs A4 | md | -0.2 percent | -0.5 to 0.1 | treatment policy; full analysis; registry:outcomes | ||
| 26 | A3 | change | -1.7 percent | 0.9 | 48 | treatment policy; full analysis; registry:outcomes | |
| 26 | A3 | change | -1.7 percent | 0.8 | 48 | hypothetical; full analysis; registry:outcomes | |
| 26 | A3 vs A4 | md | -0.3 percent | -0.6 to -0.0 | hypothetical; full analysis; registry:outcomes | ||
| 26 | A3 vs A5 | md | -1.7 percent | -2.0 to -1.4 | hypothetical; full analysis; registry:outcomes | ||
| 26 | A3 vs A4 | md | -0.4 percent | -0.7 to -0.1 | treatment policy; full analysis; registry:outcomes | ||
| 26 | A3 vs A5 | md | -1.4 percent | -1.7 to -1.1 | treatment policy; full analysis; registry:outcomes | ||
| 26 | A3 | change | -1.8 percent | 27 | treatment policy; randomized; age:<65; R0016956:Figure 1A | ||
| 26 | A3 | change | -1.8 percent | 21 | treatment policy; randomized; age:>=65; R0016956:Figure 1A | ||
| 26 | A4 | change | -1.3 percent | 33 | treatment policy; randomized; age:<65; R0016956:Figure 1A | ||
| 26 | A4 | change | -1.6 percent | 15 | treatment policy; randomized; age:>=65; R0016956:Figure 1A | ||
| 26 | A4 | change | -1.4 percent | 1.1 | 48 | treatment policy; full analysis; registry:outcomes | |
| 26 | A4 | change | -1.4 percent | 1.1 | 48 | hypothetical; full analysis; registry:outcomes | |
| 26 | A5 | change | -0.2 percent | 0.7 | 49 | hypothetical; full analysis; registry:outcomes | |
| 26 | A5 | change | -0.4 percent | 1.0 | 49 | treatment policy; full analysis; registry:outcomes | |
| 26 | A5 | change | -0.7 percent | 16 | treatment policy; randomized; age:>=65; R0016956:Figure 1A | ||
| 26 | A5 | change | -0.2 percent | 33 | treatment policy; randomized; age:<65; R0016956:Figure 1A | ||
| 52 | A1 | change | -1.0 percent | 0.9 | 38 | not stated; full analysis; registry:outcomes | |
| 52 | A2 | change | -1.4 percent | 0.9 | 43 | not stated; full analysis; registry:outcomes | |
| 52 | A3 | change | -1.5 percent | 0.8 | 41 | not stated; full analysis; registry:outcomes | |
| 52 | A4 | change | -1.3 percent | 1.0 | 41 | not stated; full analysis; registry:outcomes | |
| 52 | A5 | change | 0.1 percent | 0.7 | 34 | not stated; full analysis; registry:outcomes |
Body weight change in kilograms (diabetes) (20 lines; O02)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26 | A1 | change | -1.1 kg | 16 | treatment policy; randomized; age:>=65; R0016956:Figure 1B | ||
| 26 | A1 | change | -0.4 kg | 1.9 | 49 | not stated; full analysis; registry:outcomes | |
| 26 | A1 | change | -0.3 kg | 33 | treatment policy; randomized; age:<65; R0016956:Figure 1B | ||
| 26 | A2 | change | -0.9 kg | 15 | treatment policy; randomized; age:>=65; R0016956:Figure 1B | ||
| 26 | A2 | change | -1.2 kg | 1.9 | 49 | not stated; full analysis; registry:outcomes | |
| 26 | A2 | change | -1.2 kg | 34 | treatment policy; randomized; age:<65; R0016956:Figure 1B | ||
| 26 | A3 | change | -2.8 kg | 27 | treatment policy; randomized; age:<65; R0016956:Figure 1B | ||
| 26 | A3 | change | -1.8 kg | 21 | treatment policy; randomized; age:>=65; R0016956:Figure 1B | ||
| 26 | A3 | change | -2.4 kg | 3.0 | 48 | not stated; full analysis; registry:outcomes | |
| 26 | A4 | change | 0.1 kg | 1.6 | 48 | not stated; full analysis; registry:outcomes | |
| 26 | A4 | change | 0.2 kg | 33 | treatment policy; randomized; age:<65; R0016956:Figure 1B | ||
| 26 | A4 | change | -0.6 kg | 15 | treatment policy; randomized; age:>=65; R0016956:Figure 1B | ||
| 26 | A5 | change | -1.1 kg | 33 | treatment policy; randomized; age:<65; R0016956:Figure 1B | ||
| 26 | A5 | change | -1.1 kg | 1.6 | 49 | not stated; full analysis; registry:outcomes | |
| 26 | A5 | change | -1.1 kg | 16 | treatment policy; randomized; age:>=65; R0016956:Figure 1B | ||
| 52 | A1 | change | 0.0 kg | 2.4 | 49 | not stated; full analysis; registry:outcomes | |
| 52 | A2 | change | -0.8 kg | 2.1 | 49 | not stated; full analysis; registry:outcomes | |
| 52 | A3 | change | -2.9 kg | 3.9 | 48 | not stated; full analysis; registry:outcomes | |
| 52 | A4 | change | 0.5 kg | 2.0 | 48 | not stated; full analysis; registry:outcomes | |
| 52 | A5 | change | -1.0 kg | 1.7 | 49 | not stated; full analysis; registry:outcomes |
HbA1c below 7 percent (10 lines; O03)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26 | A1 | responders | 24 / 49 | not stated; full analysis; registry:outcomes | |||
| 26 | A2 | responders | 33 / 49 | not stated; full analysis; registry:outcomes | |||
| 26 | A3 | responders | 35 / 48 | not stated; full analysis; registry:outcomes | |||
| 26 | A4 | responders | 24 / 48 | not stated; full analysis; registry:outcomes | |||
| 26 | A5 | responders | 6 / 49 | not stated; full analysis; registry:outcomes | |||
| 52 | A1 | responders | 19 / 49 | not stated; full analysis; registry:outcomes | |||
| 52 | A2 | responders | 29 / 49 | not stated; full analysis; registry:outcomes | |||
| 52 | A3 | responders | 33 / 48 | not stated; full analysis; registry:outcomes | |||
| 52 | A4 | responders | 20 / 48 | not stated; full analysis; registry:outcomes | |||
| 52 | A5 | responders | 4 / 49 | not stated; full analysis; registry:outcomes |
Level 2 or 3 hypoglycemia (participants) (5 lines; O04)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 49 | not stated; safety; registry:outcomes | ||||
| A2 | events | 0 / 49 | not stated; safety; registry:outcomes | ||||
| A3 | events | 0 / 48 | not stated; safety; registry:outcomes | ||||
| A4 | events | 2 / 48 | not stated; safety; registry:outcomes | ||||
| A5 | events | 0 / 49 | not stated; safety; registry:outcomes |
Systolic blood pressure change (10 lines; O05)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26 | A1 | change | -3 mmHg | 13 | 49 | not stated; safety; registry:outcomes | |
| 26 | A2 | change | -5 mmHg | 12 | 49 | not stated; safety; registry:outcomes | |
| 26 | A3 | change | -2 mmHg | 12 | 48 | not stated; safety; registry:outcomes | |
| 26 | A4 | change | -1 mmHg | 13 | 48 | not stated; safety; registry:outcomes | |
| 26 | A5 | change | -4 mmHg | 11 | 49 | not stated; safety; registry:outcomes | |
| 52 | A1 | change | -0 mmHg | 12 | 49 | not stated; safety; registry:outcomes | |
| 52 | A2 | change | -1 mmHg | 10 | 49 | not stated; safety; registry:outcomes | |
| 52 | A3 | change | -1 mmHg | 10 | 48 | not stated; safety; registry:outcomes | |
| 52 | A4 | change | 1 mmHg | 15 | 48 | not stated; safety; registry:outcomes | |
| 52 | A5 | change | -3 mmHg | 9 | 49 | not stated; safety; registry:outcomes |
Percent body weight change (10 lines; O10)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26 | A1 | percent change | -0.64 percent | 2.65 | 49 | not stated; full analysis; registry:outcomes | |
| 26 | A2 | percent change | -1.63 percent | 2.78 | 49 | not stated; full analysis; registry:outcomes | |
| 26 | A3 | percent change | -3.54 percent | 4.33 | 48 | not stated; full analysis; registry:outcomes | |
| 26 | A4 | percent change | 0.08 percent | 2.23 | 48 | not stated; full analysis; registry:outcomes | |
| 26 | A5 | percent change | -1.58 percent | 2.27 | 49 | not stated; full analysis; registry:outcomes | |
| 52 | A1 | percent change | -0.03 percent | 3.25 | 49 | not stated; full analysis; registry:outcomes | |
| 52 | A2 | percent change | -1.23 percent | 3.09 | 49 | not stated; full analysis; registry:outcomes | |
| 52 | A3 | percent change | -4.42 percent | 5.91 | 48 | not stated; full analysis; registry:outcomes | |
| 52 | A4 | percent change | 0.68 percent | 2.73 | 48 | not stated; full analysis; registry:outcomes | |
| 52 | A5 | percent change | -1.42 percent | 2.47 | 49 | not stated; full analysis; registry:outcomes |
Weight loss of 5 percent or more (10 lines; O11A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26 | A1 | responders | 1 / 49 | not stated; full analysis; registry:outcomes | |||
| 26 | A2 | responders | 5 / 49 | not stated; full analysis; registry:outcomes | |||
| 26 | A3 | responders | 16 / 48 | not stated; full analysis; registry:outcomes | |||
| 26 | A4 | responders | 0 / 48 | not stated; full analysis; registry:outcomes | |||
| 26 | A5 | responders | 3 / 49 | not stated; full analysis; registry:outcomes | |||
| 52 | A1 | responders | 1 / 49 | not stated; full analysis; registry:outcomes | |||
| 52 | A2 | responders | 5 / 49 | not stated; full analysis; registry:outcomes | |||
| 52 | A3 | responders | 17 / 48 | not stated; full analysis; registry:outcomes | |||
| 52 | A4 | responders | 2 / 48 | not stated; full analysis; registry:outcomes | |||
| 52 | A5 | responders | 2 / 49 | not stated; full analysis; registry:outcomes |
Weight loss of 10 percent or more (10 lines; O11B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26 | A1 | responders | 0 / 49 | not stated; full analysis; registry:outcomes | |||
| 26 | A2 | responders | 0 / 49 | not stated; full analysis; registry:outcomes | |||
| 26 | A3 | responders | 3 / 48 | not stated; full analysis; registry:outcomes | |||
| 26 | A4 | responders | 0 / 48 | not stated; full analysis; registry:outcomes | |||
| 26 | A5 | responders | 0 / 49 | not stated; full analysis; registry:outcomes | |||
| 52 | A1 | responders | 0 / 49 | not stated; full analysis; registry:outcomes | |||
| 52 | A2 | responders | 1 / 49 | not stated; full analysis; registry:outcomes | |||
| 52 | A3 | responders | 6 / 48 | not stated; full analysis; registry:outcomes | |||
| 52 | A4 | responders | 0 / 48 | not stated; full analysis; registry:outcomes | |||
| 52 | A5 | responders | 0 / 49 | not stated; full analysis; registry:outcomes |
All cause mortality (5 lines; O20)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 49 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 0 / 49 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 0 / 48 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 0 / 48 | not stated; safety; registry:adverse_events | ||||
| A5 | events | 0 / 49 | not stated; safety; registry:adverse_events |
SF-36 physical component summary change (10 lines; O24A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26 | A1 | change | -1.33 points | 4.56 | 49 | hypothetical; full analysis; registry:outcomes | |
| 26 | A2 | change | -0.38 points | 3.28 | 49 | hypothetical; full analysis; registry:outcomes | |
| 26 | A3 | change | 0.93 points | 3.49 | 48 | hypothetical; full analysis; registry:outcomes | |
| 26 | A4 | change | -0.14 points | 3.21 | 48 | hypothetical; full analysis; registry:outcomes | |
| 26 | A5 | change | 0.20 points | 4.11 | 49 | hypothetical; full analysis; registry:outcomes | |
| 52 | A1 | change | -1.28 points | 6.03 | 49 | hypothetical; full analysis; registry:outcomes | |
| 52 | A2 | change | -0.12 points | 4.30 | 49 | hypothetical; full analysis; registry:outcomes | |
| 52 | A3 | change | 0.02 points | 4.05 | 48 | hypothetical; full analysis; registry:outcomes | |
| 52 | A4 | change | 0.10 points | 3.42 | 48 | hypothetical; full analysis; registry:outcomes | |
| 52 | A5 | change | -0.10 points | 4.03 | 49 | hypothetical; full analysis; registry:outcomes |
Physical functioning (any instrument) (10 lines; O24B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26 | A1 | change | -0.22 points | 2.53 | 49 | hypothetical; full analysis; registry:outcomes | |
| 26 | A2 | change | -0.09 points | 1.93 | 49 | hypothetical; full analysis; registry:outcomes | |
| 26 | A3 | change | 0.04 points | 2.71 | 48 | hypothetical; full analysis; registry:outcomes | |
| 26 | A4 | change | 0.09 points | 2.01 | 48 | hypothetical; full analysis; registry:outcomes | |
| 26 | A5 | change | -0.14 points | 2.63 | 49 | hypothetical; full analysis; registry:outcomes | |
| 52 | A1 | change | -0.31 points | 3.63 | 49 | hypothetical; full analysis; registry:outcomes | |
| 52 | A2 | change | 0.30 points | 2.37 | 49 | hypothetical; full analysis; registry:outcomes | |
| 52 | A3 | change | -0.00 points | 3.42 | 48 | hypothetical; full analysis; registry:outcomes | |
| 52 | A4 | change | -0.09 points | 2.11 | 48 | hypothetical; full analysis; registry:outcomes | |
| 52 | A5 | change | -0.00 points | 2.96 | 49 | hypothetical; full analysis; registry:outcomes |
Health related quality of life total score (any instrument) (10 lines; O24C)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26 | A1 | change | 6.67 points | 15.81 | 49 | hypothetical; full analysis; registry:outcomes | |
| 26 | A2 | change | 7.98 points | 11.47 | 49 | hypothetical; full analysis; registry:outcomes | |
| 26 | A3 | change | 11.22 points | 12.99 | 48 | hypothetical; full analysis; registry:outcomes | |
| 26 | A4 | change | 9.77 points | 14.46 | 48 | hypothetical; full analysis; registry:outcomes | |
| 26 | A5 | change | 4.18 points | 14.13 | 49 | hypothetical; full analysis; registry:outcomes | |
| 52 | A1 | change | 6.97 points | 14.47 | 49 | hypothetical; full analysis; registry:outcomes | |
| 52 | A2 | change | 5.52 points | 12.29 | 49 | hypothetical; full analysis; registry:outcomes | |
| 52 | A3 | change | 8.02 points | 14.09 | 48 | hypothetical; full analysis; registry:outcomes | |
| 52 | A4 | change | 7.12 points | 15.09 | 48 | hypothetical; full analysis; registry:outcomes | |
| 52 | A5 | change | 0.57 points | 16.53 | 49 | hypothetical; full analysis; registry:outcomes |
Serious adverse events (5 lines; O25)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 2 / 49 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 3 / 49 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 0 / 48 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 0 / 48 | not stated; safety; registry:adverse_events | ||||
| A5 | events | 3 / 49 | not stated; safety; registry:adverse_events |
Nausea (5 lines; O27A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 2 / 49 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 5 / 49 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 4 / 48 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 0 / 48 | not stated; safety; registry:adverse_events | ||||
| A5 | events | 1 / 49 | not stated; safety; registry:adverse_events |
Diarrhea (5 lines; O27C)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 4 / 49 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 1 / 49 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 3 / 48 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 2 / 48 | not stated; safety; registry:adverse_events | ||||
| A5 | events | 1 / 49 | not stated; safety; registry:adverse_events |
Constipation (5 lines; O27D)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 5 / 49 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 6 / 49 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 6 / 48 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 9 / 48 | not stated; safety; registry:adverse_events | ||||
| A5 | events | 3 / 49 | not stated; safety; registry:adverse_events |
Thyroid cancer (any) (5 lines; O32B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 49 | not stated; safety; Papillary thyroid cancer; registry:adverse_events | ||||
| A2 | events | 1 / 49 | not stated; safety; Papillary thyroid cancer; registry:adverse_events | ||||
| A3 | events | 0 / 48 | not stated; safety; Papillary thyroid cancer; registry:adverse_events | ||||
| A4 | events | 0 / 48 | not stated; safety; Papillary thyroid cancer; registry:adverse_events | ||||
| A5 | events | 0 / 49 | not stated; safety; Papillary thyroid cancer; registry:adverse_events |