factorial randomized trial
NCT05616013
A Randomized, Double-Blind, Placebo-Controlled Multi-Center Study of Intravenous Bimagrumab, Alone or in Addition to Open Label Subcutaneous Semaglutide, to Investigate the Efficacy and Safety in Overweight or Obese Men and Women
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | Placebo Placebo | lifestyle: standard | 56 | 56 | |
| A2 | Bimagrumab Bimagrumab 10 mg/kg | lifestyle: standard | 56 | 56 | |
| A3 | Bimagrumab Bimagrumab 30 mg/kg | lifestyle: standard | 57 | 57 | |
| A4 | Semaglutide 1.0 mg subcutaneous once weekly Placebo plus semaglutide 1.0 mg | lifestyle: standard | 56 | 56 | |
| A5 | Semaglutide 2.4 mg subcutaneous once weekly Placebo plus semaglutide 2.4 mg | lifestyle: standard | 57 | 57 | |
| A6 | Semaglutide and bimagrumab 1.0 to 10 mg injection once weekly Bimagrumab 10 mg/kg plus semaglutide 1.0 mg | lifestyle: standard | 56 | 56 | |
| A7 | Semaglutide and bimagrumab 2.4 to 10 mg injection once weekly Bimagrumab 10 mg/kg plus semaglutide 2.4 mg | lifestyle: standard | 56 | 56 | |
| A8 | Semaglutide and bimagrumab 1.0 to 30 mg injection once weekly Bimagrumab 30 mg/kg plus semaglutide 1.0 mg | lifestyle: standard | 56 | 56 | |
| A9 | Semaglutide and bimagrumab 2.4 to 30 mg injection once weekly Bimagrumab 30 mg/kg plus semaglutide 2.4 mg | lifestyle: standard | 57 | 57 |
Baseline characteristics
As printed in the trial reports or registry, per arm or for the whole trial.
| Characteristic | Statistic | Placebo A1 | Bimagrumab A2 | Bimagrumab A3 | Semaglutide 1.0 mg subcutaneous once weekly A4 | Semaglutide 2.4 mg subcutaneous once weekly A5 | Semaglutide and bimagrumab 1.0 to 10 mg injection once weekly A6 | Semaglutide and bimagrumab 2.4 to 10 mg injection once weekly A7 | Semaglutide and bimagrumab 1.0 to 30 mg injection once weekly A8 | Semaglutide and bimagrumab 2.4 to 30 mg injection once weekly A9 |
|---|---|---|---|---|---|---|---|---|---|---|
| age | mean (years) | 47.8 | 44.4 | 49.2 | 50.3 | 49.6 | 44.8 | 46.2 | 47.7 | 47.5 |
| age | sd (years) | 14.6 | 10.9 | 12.2 | 11.2 | 11.8 | 12.0 | 11.7 | 10.4 | 12.7 |
| asian | n | 1 | 1 | 1 | 0 | 3 | 1 | 4 | 1 | 3 |
| asian | percent | 1.8 | 1.8 | 1.8 | 0.0 | 5.3 | 1.8 | 7.1 | 1.8 | 5.3 |
| black | n | 6 | 3 | 4 | 7 | 5 | 7 | 5 | 6 | 3 |
| black | percent | 10.7 | 5.4 | 7.0 | 12.5 | 8.8 | 12.5 | 8.9 | 10.7 | 5.3 |
| bmi | mean (kg/m2) | 38.0 | 36.5 | 37.5 | 36.6 | 36.6 | 37.9 | 38.0 | 37.1 | 37.5 |
| bmi | sd (kg/m2) | 5.5 | 5.3 | 4.6 | 5.8 | 5.1 | 5.0 | 5.8 | 3.7 | 5.5 |
| female | n | 32 | 32 | 33 | 32 | 33 | 32 | 32 | 32 | 33 |
| female | percent | 57.1 | 57.1 | 57.9 | 57.1 | 57.9 | 57.1 | 57.1 | 57.1 | 57.9 |
| hba1c | mean (percent) | 5.5 | 5.4 | 5.5 | 5.4 | 5.4 | 5.4 | 5.5 | 5.4 | 5.4 |
| hba1c | sd (percent) | 0.4 | 0.4 | 0.3 | 0.5 | 0.4 | 0.3 | 0.5 | 0.3 | 0.3 |
| hispanic | n | 6 | 11 | 3 | 4 | 2 | 5 | 7 | 7 | 8 |
| hispanic | percent | 10.7 | 19.6 | 5.3 | 7.1 | 3.5 | 8.9 | 12.5 | 12.5 | 14.0 |
| other race other or unknown | n | 11 | 8 | 7 | 9 | 3 | 7 | 8 | 6 | 6 |
| other race other or unknown | percent | 19.6 | 14.3 | 12.3 | 16.1 | 5.3 | 12.5 | 14.3 | 10.7 | 10.5 |
| sbp | mean (mmHg) | 131.0 | 125.1 | 128.0 | 133.9 | 131.4 | 128.9 | 128.3 | 129.4 | 128.4 |
| sbp | sd (mmHg) | 14.5 | 10.1 | 14.3 | 13.5 | 14.5 | 13.2 | 13.4 | 11.7 | 12.0 |
| waist | mean (cm) | 119.1 | 116.8 | 119.3 | 117.9 | 117.3 | 117.8 | 119.3 | 117.9 | 118.0 |
| waist | sd (cm) | 14.1 | 13.4 | 10.9 | 13.6 | 11.5 | 12.7 | 14.0 | 10.3 | 12.5 |
| weight | mean (kg) | 109.6 | 105.1 | 109.1 | 105.8 | 104.5 | 108.4 | 108.8 | 108.2 | 108.1 |
| weight | sd (kg) | 19.3 | 19.5 | 17.6 | 20.0 | 14.8 | 18.9 | 18.4 | 14.3 | 18.5 |
| white | n | 38 | 44 | 45 | 40 | 46 | 41 | 39 | 43 | 45 |
| white | percent | 67.9 | 78.6 | 78.9 | 71.4 | 80.7 | 73.2 | 69.6 | 76.8 | 78.9 |
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
- Weight loss of 5 percent or moreOverweight or obesity without diabetes (adults); weeks 40 to 104 (target week 68); network meta-analysis
- Weight loss of 5 percent or moreOverweight or obesity without diabetes (adults); weeks 40 to 104 (target week 68); network meta-analysis
- Weight loss of 10 percent or moreOverweight or obesity without diabetes (adults); weeks 40 to 104 (target week 68); network meta-analysis
- Weight loss of 10 percent or moreOverweight or obesity without diabetes (adults); weeks 40 to 104 (target week 68); network meta-analysis
- Weight loss of 15 percent or moreOverweight or obesity without diabetes (adults); weeks 40 to 104 (target week 68); network meta-analysis
- Weight loss of 15 percent or moreOverweight or obesity without diabetes (adults); weeks 40 to 104 (target week 68); network meta-analysis
- Acute kidney injuryOverweight or obesity without diabetes (adults); longest follow-up; descriptive only
- Acute kidney injuryOverweight or obesity without diabetes (adults); longest follow-up; descriptive only
- 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
- Discontinuation due to adverse eventsOverweight or obesity without diabetes (adults); longest follow-up; network meta-analysis
- Discontinuation due to 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
- Acute pancreatitisOverweight or obesity without diabetes (adults); longest follow-up; descriptive only
- Acute pancreatitisOverweight or obesity without diabetes (adults); longest follow-up; descriptive only
- Any cancerOverweight or obesity without diabetes (adults); longest follow-up; descriptive only
- Any cancerOverweight or obesity without diabetes (adults); longest follow-up; descriptive only
Results
457 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 |
|---|---|---|---|---|---|---|---|
| 48 | A1 | change | -6.9 mmHg | 2.1 | 56 | hypothetical; safety; R0015266:Table 2 | |
| 48 | A2 | change | -4.6 mmHg | 2.3 | 56 | hypothetical; safety; R0015266:Table 2 | |
| 48 | A3 | change | -3.1 mmHg | 1.7 | 57 | hypothetical; safety; R0015266:Table 2 | |
| 48 | A4 | change | -8.6 mmHg | 1.7 | 56 | hypothetical; safety; R0015266:Table 2 | |
| 48 | A5 | change | -7.9 mmHg | 1.7 | 57 | hypothetical; safety; R0015266:Table 2 | |
| 48 | A6 | change | -4.5 mmHg | 1.5 | 56 | hypothetical; safety; R0015266:Table 2 | |
| 48 | A7 | change | -7.9 mmHg | 1.9 | 56 | hypothetical; safety; R0015266:Table 2 | |
| 48 | A8 | change | -5.3 mmHg | 1.4 | 56 | hypothetical; safety; R0015266:Table 2 | |
| 48 | A9 | change | -10.4 mmHg | 1.7 | 57 | hypothetical; safety; R0015266:Table 2 |
Percent body weight change (5 lines; O10)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 48 | A1 | percent change | -2.5 percent | hypothetical; randomized; R0015266:Results | |||
| 48 | A1 | percent change | -3.5 percent | treatment policy; randomized; R0015266:Results | |||
| 72 | A3 | percent change | -10.8 percent | hypothetical; randomized; R0015266:Results | |||
| 72 | A5 | percent change | -15.7 percent | hypothetical; randomized; R0015266:Results | |||
| 72 | A9 | percent change | -22.1 percent | hypothetical; randomized; R0015266:Results |
Weight loss of 5 percent or more (9 lines; O11A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 48 | A1 | responders | 40.0 | 35 | not stated; completers; registry:outcomes | ||
| 48 | A2 | responders | 58.1 | 31 | not stated; completers; registry:outcomes | ||
| 48 | A3 | responders | 83.8 | 37 | not stated; completers; registry:outcomes | ||
| 48 | A4 | responders | 73.3 | 45 | not stated; completers; registry:outcomes | ||
| 48 | A5 | responders | 92.2 | 51 | not stated; completers; registry:outcomes | ||
| 48 | A6 | responders | 97.6 | 41 | not stated; completers; registry:outcomes | ||
| 48 | A7 | responders | 100.0 | 40 | not stated; completers; registry:outcomes | ||
| 48 | A8 | responders | 97.7 | 43 | not stated; completers; registry:outcomes | ||
| 48 | A9 | responders | 97.7 | 43 | not stated; completers; registry:outcomes |
Weight loss of 10 percent or more (9 lines; O11B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 48 | A1 | responders | 8.6 | 35 | not stated; completers; registry:outcomes | ||
| 48 | A2 | responders | 29.0 | 31 | not stated; completers; registry:outcomes | ||
| 48 | A3 | responders | 51.4 | 37 | not stated; completers; registry:outcomes | ||
| 48 | A4 | responders | 48.9 | 45 | not stated; completers; registry:outcomes | ||
| 48 | A5 | responders | 80.4 | 51 | not stated; completers; registry:outcomes | ||
| 48 | A6 | responders | 68.3 | 41 | not stated; completers; registry:outcomes | ||
| 48 | A7 | responders | 92.5 | 40 | not stated; completers; registry:outcomes | ||
| 48 | A8 | responders | 81.4 | 43 | not stated; completers; registry:outcomes | ||
| 48 | A9 | responders | 95.3 | 43 | not stated; completers; registry:outcomes |
Weight loss of 15 percent or more (15 lines; O11C)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 48 | A1 | responders | 5.7 | 35 | not stated; completers; registry:outcomes | ||
| 48 | A2 | responders | 16.1 | 31 | not stated; completers; registry:outcomes | ||
| 48 | A3 | responders | 32.4 | 37 | not stated; completers; registry:outcomes | ||
| 48 | A3 | responders | 23.3 | treatment policy; randomized; R0015266:Results | |||
| 48 | A4 | responders | 35.6 | 45 | not stated; completers; registry:outcomes | ||
| 48 | A5 | responders | 47.1 | 51 | not stated; completers; registry:outcomes | ||
| 48 | A5 | responders | 43.4 | treatment policy; randomized; R0015266:Results | |||
| 48 | A6 | responders | 41.5 | 41 | not stated; completers; registry:outcomes | ||
| 48 | A7 | responders | 55.0 | 40 | not stated; completers; registry:outcomes | ||
| 48 | A8 | responders | 60.5 | 43 | not stated; completers; registry:outcomes | ||
| 48 | A9 | responders | 63.9 | treatment policy; randomized; R0015266:Results | |||
| 48 | A9 | responders | 79.1 | 43 | not stated; completers; registry:outcomes | ||
| 72 | A3 | responders | 21.8 | hypothetical; randomized; R0015266:Results | |||
| 72 | A5 | responders | 51.8 | hypothetical; randomized; R0015266:Results | |||
| 72 | A9 | responders | 84.9 | hypothetical; randomized; R0015266:Results |
Acute kidney injury (7 lines; O121)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A3 | events | 1 / 57 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 1 / 55 | not stated; safety; registry:adverse_events | ||||
| A5 | events | 1 / 56 | not stated; safety; registry:adverse_events | ||||
| A6 | events | 0 / 56 | not stated; safety; registry:adverse_events | ||||
| A7 | events | 0 / 55 | not stated; safety; registry:adverse_events | ||||
| A8 | events | 0 / 56 | not stated; safety; registry:adverse_events | ||||
| A9 | events | 0 / 55 | not stated; safety; registry:adverse_events |
All cause mortality (16 lines; O20)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 55 | not stated; safety; R0015266:Table 3 | ||||
| A2 | events | 0 / 56 | not stated; safety; R0015266:Table 3 | ||||
| A3 | events | 0 / 57 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 0 / 57 | not stated; safety; R0015266:Table 3 | ||||
| A4 | events | 0 / 55 | not stated; safety; R0015266:Table 3 | ||||
| A4 | events | 0 / 55 | not stated; safety; registry:adverse_events | ||||
| A5 | events | 0 / 56 | not stated; safety; registry:adverse_events | ||||
| A5 | events | 0 / 56 | not stated; safety; R0015266:Table 3 | ||||
| A6 | events | 0 / 56 | not stated; safety; R0015266:Table 3 | ||||
| A6 | events | 0 / 56 | not stated; safety; registry:adverse_events | ||||
| A7 | events | 0 / 55 | not stated; safety; R0015266:Table 3 | ||||
| A7 | events | 0 / 55 | not stated; safety; registry:adverse_events | ||||
| A8 | events | 0 / 56 | not stated; safety; registry:adverse_events | ||||
| A8 | events | 0 / 56 | not stated; safety; R0015266:Table 3 | ||||
| A9 | events | 0 / 55 | not stated; safety; registry:adverse_events | ||||
| A9 | events | 0 / 55 | not stated; safety; R0015266:Table 3 |
Physical functioning (any instrument) (68 lines; O24B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 24 | A1 | change | 7.973 points | 15.919 | 37 | not stated; modified itt; registry:outcomes | |
| 24 | A1 | change | 6.91 t-score | 2.33 | 37 | not stated; modified itt; registry:outcomes | |
| 24 | A2 | change | 13.289 points | 13.115 | 38 | not stated; modified itt; registry:outcomes | |
| 24 | A2 | change | 9.74 t-score | 1.48 | 38 | not stated; modified itt; registry:outcomes | |
| 24 | A3 | change | 11.61 t-score | 1.62 | 38 | not stated; modified itt; registry:outcomes | |
| 24 | A3 | change | 13.974 points | 13.726 | 39 | not stated; modified itt; registry:outcomes | |
| 24 | A4 | change | 16.667 points | 14.616 | 45 | not stated; modified itt; registry:outcomes | |
| 24 | A4 | change | 11.50 t-score | 1.56 | 46 | not stated; modified itt; registry:outcomes | |
| 24 | A5 | change | 17.447 points | 16.677 | 47 | not stated; modified itt; registry:outcomes | |
| 24 | A5 | change | 11.02 t-score | 1.97 | 46 | not stated; modified itt; registry:outcomes | |
| 24 | A6 | change | 14.659 points | 16.474 | 44 | not stated; modified itt; registry:outcomes | |
| 24 | A6 | change | 12.20 t-score | 1.89 | 41 | not stated; modified itt; registry:outcomes | |
| 24 | A7 | change | 12.105 points | 22.680 | 38 | not stated; modified itt; registry:outcomes | |
| 24 | A7 | change | 12.75 t-score | 1.92 | 34 | not stated; modified itt; registry:outcomes | |
| 24 | A8 | change | 12.71 t-score | 1.94 | 39 | not stated; modified itt; registry:outcomes | |
| 24 | A8 | change | 18.690 points | 19.818 | 42 | not stated; modified itt; registry:outcomes | |
| 24 | A9 | change | 21.667 points | 17.113 | 36 | not stated; modified itt; registry:outcomes | |
| 24 | A9 | change | 12.45 t-score | 1.93 | 36 | not stated; modified itt; registry:outcomes | |
| 48 | A1 | change | 11.30 t-score | 1.80 | 33 | not stated; modified itt; registry:outcomes | |
| 48 | A1 | change | 13.3 points | 2.7 | 56 | treatment policy; randomized; R0015266:Table 2 | |
| 48 | A1 | change | 12.1 points | 2.2 | 56 | treatment policy; randomized; R0015266:Table 2 | |
| 48 | A1 | change | 13.45 points | 2.37 | 34 | not stated; modified itt; registry:outcomes | |
| 48 | A2 | change | 11.1 points | 2.3 | 56 | treatment policy; randomized; R0015266:Table 2 | |
| 48 | A2 | change | 17.96 points | 2.37 | 29 | not stated; modified itt; registry:outcomes | |
| 48 | A2 | change | 11.72 t-score | 2.51 | 29 | not stated; modified itt; registry:outcomes | |
| 48 | A2 | change | 15.6 points | 2.7 | 56 | treatment policy; randomized; R0015266:Table 2 | |
| 48 | A3 | change | 16.1 points | 2.6 | 57 | treatment policy; randomized; R0015266:Table 2 | |
| 48 | A3 | change | 19.39 points | 2.09 | 35 | not stated; modified itt; registry:outcomes | |
| 48 | A3 | change | 13.41 t-score | 1.64 | 34 | not stated; modified itt; registry:outcomes | |
| 48 | A3 | change | 12.6 points | 2.0 | 57 | treatment policy; randomized; R0015266:Table 2 | |
| 48 | A4 | change | 15.3 points | 2.4 | 56 | treatment policy; randomized; R0015266:Table 2 | |
| 48 | A4 | change | 10.7 points | 1.9 | 56 | treatment policy; randomized; R0015266:Table 2 | |
| 48 | A4 | change | 11.68 t-score | 2.42 | 44 | not stated; modified itt; registry:outcomes | |
| 48 | A4 | change | 16.98 points | 2.07 | 43 | not stated; modified itt; registry:outcomes | |
| 48 | A5 | change | 12.2 points | 1.9 | 57 | treatment policy; randomized; R0015266:Table 2 | |
| 48 | A5 | change | 19.5 points | 2.3 | 57 | treatment policy; randomized; R0015266:Table 2 | |
| 48 | A5 | change | 11.58 t-score | 2.14 | 45 | not stated; modified itt; registry:outcomes | |
| 48 | A5 | change | 21.39 points | 2.14 | 45 | not stated; modified itt; registry:outcomes | |
| 48 | A6 | change | 18.7 points | 2.6 | 56 | treatment policy; randomized; R0015266:Table 2 | |
| 48 | A6 | change | 16.34 t-score | 1.55 | 39 | not stated; modified itt; registry:outcomes | |
| 48 | A6 | change | 20.62 points | 2.62 | 40 | not stated; modified itt; registry:outcomes | |
| 48 | A6 | change | 15.3 points | 2.0 | 56 | treatment policy; randomized; R0015266:Table 2 | |
| 48 | A7 | change | 23.21 points | 2.97 | 37 | not stated; modified itt; registry:outcomes | |
| 48 | A7 | change | 15.14 t-score | 1.82 | 34 | not stated; modified itt; registry:outcomes | |
| 48 | A7 | change | 19.3 points | 2.5 | 56 | treatment policy; randomized; R0015266:Table 2 | |
| 48 | A7 | change | 13.5 points | 2.0 | 56 | treatment policy; randomized; R0015266:Table 2 | |
| 48 | A8 | change | 21.6 points | 2.6 | 56 | treatment policy; randomized; R0015266:Table 2 | |
| 48 | A8 | change | 26.69 points | 2.30 | 36 | not stated; modified itt; registry:outcomes | |
| 48 | A8 | change | 15.27 t-score | 1.97 | 34 | not stated; modified itt; registry:outcomes | |
| 48 | A8 | change | 13.5 points | 2.1 | 56 | treatment policy; randomized; R0015266:Table 2 | |
| 48 | A9 | change | 22.96 points | 2.00 | 39 | not stated; modified itt; registry:outcomes | |
| 48 | A9 | change | 20.2 points | 2.4 | 57 | treatment policy; randomized; R0015266:Table 2 | |
| 48 | A9 | change | 16.6 points | 1.9 | 57 | treatment policy; randomized; R0015266:Table 2 | |
| 48 | A9 | change | 18.25 t-score | 2.19 | 39 | not stated; modified itt; registry:outcomes | |
| 72 | A3 | change | 19.34 points | 2.45 | 30 | not stated; modified itt; registry:outcomes | |
| 72 | A3 | change | 15.90 t-score | 1.62 | 28 | not stated; modified itt; registry:outcomes | |
| 72 | A4 | change | 22.05 points | 1.80 | 34 | not stated; modified itt; registry:outcomes | |
| 72 | A4 | change | 14.06 t-score | 1.75 | 35 | not stated; modified itt; registry:outcomes | |
| 72 | A5 | change | 13.52 t-score | 2.28 | 41 | not stated; modified itt; registry:outcomes | |
| 72 | A5 | change | 25.07 points | 2.50 | 41 | not stated; modified itt; registry:outcomes | |
| 72 | A6 | change | 19.85 points | 2.10 | 32 | not stated; modified itt; registry:outcomes | |
| 72 | A6 | change | 17.36 t-score | 1.77 | 31 | not stated; modified itt; registry:outcomes | |
| 72 | A7 | change | 19.30 points | 2.37 | 34 | not stated; modified itt; registry:outcomes | |
| 72 | A7 | change | 14.41 t-score | 1.97 | 31 | not stated; modified itt; registry:outcomes | |
| 72 | A8 | change | 28.31 points | 2.79 | 37 | not stated; modified itt; registry:outcomes | |
| 72 | A8 | change | 17.04 t-score | 2.20 | 35 | not stated; modified itt; registry:outcomes | |
| 72 | A9 | change | 29.85 points | 2.39 | 34 | not stated; modified itt; registry:outcomes | |
| 72 | A9 | change | 20.91 t-score | 1.76 | 34 | not stated; modified itt; registry:outcomes |
Health related quality of life total score (any instrument) (50 lines; O24C)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 24 | A1 | change | 8.142 points | 11.538 | 37 | not stated; modified itt; registry:outcomes | |
| 24 | A1 | change | 6.47 points | 2.11 | 37 | not stated; modified itt; registry:outcomes | |
| 24 | A2 | change | 10.789 points | 10.363 | 38 | not stated; modified itt; registry:outcomes | |
| 24 | A2 | change | 4.69 points | 1.98 | 38 | not stated; modified itt; registry:outcomes | |
| 24 | A3 | change | 15.513 points | 11.868 | 39 | not stated; modified itt; registry:outcomes | |
| 24 | A3 | change | 9.70 points | 1.65 | 38 | not stated; modified itt; registry:outcomes | |
| 24 | A4 | change | 17.639 points | 11.285 | 45 | not stated; modified itt; registry:outcomes | |
| 24 | A4 | change | 11.95 points | 1.56 | 46 | not stated; modified itt; registry:outcomes | |
| 24 | A5 | change | 19.468 points | 13.055 | 47 | not stated; modified itt; registry:outcomes | |
| 24 | A5 | change | 12.26 points | 1.49 | 46 | not stated; modified itt; registry:outcomes | |
| 24 | A6 | change | 18.977 points | 14.901 | 44 | not stated; modified itt; registry:outcomes | |
| 24 | A6 | change | 12.96 points | 2.02 | 41 | not stated; modified itt; registry:outcomes | |
| 24 | A7 | change | 14.671 points | 16.434 | 38 | not stated; modified itt; registry:outcomes | |
| 24 | A7 | change | 10.09 points | 2.11 | 34 | not stated; modified itt; registry:outcomes | |
| 24 | A8 | change | 17.113 points | 14.463 | 42 | not stated; modified itt; registry:outcomes | |
| 24 | A8 | change | 13.82 points | 1.62 | 39 | not stated; modified itt; registry:outcomes | |
| 24 | A9 | change | 22.917 points | 14.826 | 36 | not stated; modified itt; registry:outcomes | |
| 24 | A9 | change | 13.31 points | 1.45 | 36 | not stated; modified itt; registry:outcomes | |
| 48 | A1 | change | 13.44 points | 1.99 | 34 | not stated; modified itt; registry:outcomes | |
| 48 | A1 | change | 10.02 points | 2.08 | 33 | not stated; modified itt; registry:outcomes | |
| 48 | A2 | change | 15.62 points | 1.92 | 29 | not stated; modified itt; registry:outcomes | |
| 48 | A2 | change | 8.32 points | 2.00 | 29 | not stated; modified itt; registry:outcomes | |
| 48 | A3 | change | 18.52 points | 2.15 | 35 | not stated; modified itt; registry:outcomes | |
| 48 | A3 | change | 11.31 points | 1.77 | 34 | not stated; modified itt; registry:outcomes | |
| 48 | A4 | change | 13.62 points | 1.79 | 44 | not stated; modified itt; registry:outcomes | |
| 48 | A4 | change | 19.16 points | 1.98 | 43 | not stated; modified itt; registry:outcomes | |
| 48 | A5 | change | 23.43 points | 1.99 | 45 | not stated; modified itt; registry:outcomes | |
| 48 | A5 | change | 14.27 points | 1.67 | 45 | not stated; modified itt; registry:outcomes | |
| 48 | A6 | change | 24.33 points | 2.11 | 40 | not stated; modified itt; registry:outcomes | |
| 48 | A6 | change | 15.99 points | 1.90 | 39 | not stated; modified itt; registry:outcomes | |
| 48 | A7 | change | 22.91 points | 2.50 | 37 | not stated; modified itt; registry:outcomes | |
| 48 | A7 | change | 16.42 points | 1.92 | 34 | not stated; modified itt; registry:outcomes | |
| 48 | A8 | change | 24.42 points | 2.18 | 36 | not stated; modified itt; registry:outcomes | |
| 48 | A8 | change | 17.03 points | 1.60 | 34 | not stated; modified itt; registry:outcomes | |
| 48 | A9 | change | 26.47 points | 2.29 | 39 | not stated; modified itt; registry:outcomes | |
| 48 | A9 | change | 17.69 points | 1.90 | 39 | not stated; modified itt; registry:outcomes | |
| 72 | A3 | change | 19.12 points | 2.23 | 30 | not stated; modified itt; registry:outcomes | |
| 72 | A3 | change | 12.28 points | 1.91 | 28 | not stated; modified itt; registry:outcomes | |
| 72 | A4 | change | 24.43 points | 1.91 | 34 | not stated; modified itt; registry:outcomes | |
| 72 | A4 | change | 13.84 points | 2.10 | 35 | not stated; modified itt; registry:outcomes | |
| 72 | A5 | change | 25.46 points | 2.07 | 41 | not stated; modified itt; registry:outcomes | |
| 72 | A5 | change | 13.96 points | 2.04 | 41 | not stated; modified itt; registry:outcomes | |
| 72 | A6 | change | 26.97 points | 2.41 | 32 | not stated; modified itt; registry:outcomes | |
| 72 | A6 | change | 16.98 points | 1.91 | 31 | not stated; modified itt; registry:outcomes | |
| 72 | A7 | change | 21.47 points | 2.49 | 34 | not stated; modified itt; registry:outcomes | |
| 72 | A7 | change | 14.37 points | 2.12 | 31 | not stated; modified itt; registry:outcomes | |
| 72 | A8 | change | 28.14 points | 2.78 | 37 | not stated; modified itt; registry:outcomes | |
| 72 | A8 | change | 18.26 points | 1.76 | 35 | not stated; modified itt; registry:outcomes | |
| 72 | A9 | change | 32.19 points | 2.21 | 34 | not stated; modified itt; registry:outcomes | |
| 72 | A9 | change | 17.85 points | 1.59 | 34 | not stated; modified itt; registry:outcomes |
Serious adverse events (16 lines; O25)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 2 / 55 | not stated; safety; R0015266:Table 3 | ||||
| A2 | events | 7 / 56 | not stated; safety; R0015266:Table 3 | ||||
| A3 | events | 8 / 57 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 5 / 57 | not stated; safety; R0015266:Table 3 | ||||
| A4 | events | 1 / 55 | not stated; safety; R0015266:Table 3 | ||||
| A4 | events | 4 / 55 | not stated; safety; registry:adverse_events | ||||
| A5 | events | 8 / 56 | not stated; safety; registry:adverse_events | ||||
| A5 | events | 6 / 56 | not stated; safety; R0015266:Table 3 | ||||
| A6 | events | 4 / 56 | not stated; safety; R0015266:Table 3 | ||||
| A6 | events | 7 / 56 | not stated; safety; registry:adverse_events | ||||
| A7 | events | 5 / 55 | not stated; safety; R0015266:Table 3 | ||||
| A7 | events | 8 / 55 | not stated; safety; registry:adverse_events | ||||
| A8 | events | 6 / 56 | not stated; safety; registry:adverse_events | ||||
| A8 | events | 2 / 56 | not stated; safety; R0015266:Table 3 | ||||
| A9 | events | 4 / 55 | not stated; safety; R0015266:Table 3 | ||||
| A9 | events | 7 / 55 | not stated; safety; registry:adverse_events |
Discontinuation due to adverse events (16 lines; O26)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 2 / 55 | not stated; safety; R0015266:Table 3 | ||||
| A2 | events | 12 / 56 | not stated; safety; R0015266:Table 3 | ||||
| A3 | events | 8 / 57 | not stated; safety; R0015266:Table 3 | ||||
| A3 | events | 9 / 57 | not stated; randomized; registry:flow | ||||
| A4 | events | 4 / 56 | not stated; randomized; registry:flow | ||||
| A4 | events | 2 / 55 | not stated; safety; R0015266:Table 3 | ||||
| A5 | events | 5 / 56 | not stated; safety; R0015266:Table 3 | ||||
| A5 | events | 6 / 57 | not stated; randomized; registry:flow | ||||
| A6 | events | 8 / 56 | not stated; randomized; registry:flow | ||||
| A6 | events | 6 / 56 | not stated; safety; R0015266:Table 3 | ||||
| A7 | events | 3 / 55 | not stated; safety; R0015266:Table 3 | ||||
| A7 | events | 3 / 56 | not stated; randomized; registry:flow | ||||
| A8 | events | 6 / 56 | not stated; randomized; registry:flow | ||||
| A8 | events | 7 / 56 | not stated; safety; R0015266:Table 3 | ||||
| A9 | events | 3 / 55 | not stated; safety; R0015266:Table 3 | ||||
| A9 | events | 1 / 57 | not stated; randomized; registry:flow |
Nausea (16 lines; O27A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 7 / 55 | not stated; safety; R0015266:Table 3 | ||||
| A2 | events | 14 / 56 | not stated; safety; R0015266:Table 3 | ||||
| A3 | events | 8 / 57 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 7 / 57 | not stated; safety; R0015266:Table 3 | ||||
| A4 | events | 25 / 55 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 25 / 55 | not stated; safety; R0015266:Table 3 | ||||
| A5 | events | 26 / 56 | not stated; safety; R0015266:Table 3 | ||||
| A5 | events | 26 / 56 | not stated; safety; registry:adverse_events | ||||
| A6 | events | 23 / 56 | not stated; safety; registry:adverse_events | ||||
| A6 | events | 23 / 56 | not stated; safety; R0015266:Table 3 | ||||
| A7 | events | 34 / 55 | not stated; safety; R0015266:Table 3 | ||||
| A7 | events | 34 / 55 | not stated; safety; registry:adverse_events | ||||
| A8 | events | 20 / 56 | not stated; safety; registry:adverse_events | ||||
| A8 | events | 21 / 56 | not stated; safety; R0015266:Table 3 | ||||
| A9 | events | 27 / 55 | not stated; safety; R0015266:Table 3 | ||||
| A9 | events | 27 / 55 | not stated; safety; registry:adverse_events |
Vomiting (16 lines; O27B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 1 / 55 | not stated; safety; R0015266:Table 3 | ||||
| A2 | events | 4 / 56 | not stated; safety; R0015266:Table 3 | ||||
| A3 | events | 3 / 57 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 3 / 57 | not stated; safety; R0015266:Table 3 | ||||
| A4 | events | 6 / 55 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 5 / 55 | not stated; safety; R0015266:Table 3 | ||||
| A5 | events | 10 / 56 | not stated; safety; registry:adverse_events | ||||
| A5 | events | 9 / 56 | not stated; safety; R0015266:Table 3 | ||||
| A6 | events | 6 / 56 | not stated; safety; R0015266:Table 3 | ||||
| A6 | events | 6 / 56 | not stated; safety; registry:adverse_events | ||||
| A7 | events | 10 / 55 | not stated; safety; registry:adverse_events | ||||
| A7 | events | 10 / 55 | not stated; safety; R0015266:Table 3 | ||||
| A8 | events | 7 / 56 | not stated; safety; registry:adverse_events | ||||
| A8 | events | 6 / 56 | not stated; safety; R0015266:Table 3 | ||||
| A9 | events | 8 / 55 | not stated; safety; registry:adverse_events | ||||
| A9 | events | 7 / 55 | not stated; safety; R0015266:Table 3 |
Diarrhea (37 lines; O27C)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 3 / 55 | not stated; safety; R0015266:Table 3 | ||||
| A2 | events | 23 / 56 | not stated; safety; R0015266:Table 3 | ||||
| A3 | events | 0 / 57 | not stated; safety; diarrhoea haemorrhagic; registry:adverse_events | ||||
| A3 | events | 0 / 57 | not stated; safety; diarrhoea haemorrhagic; registry:adverse_events | ||||
| A3 | events | 29 / 57 | not stated; safety; diarrhoea; registry:adverse_events | ||||
| A3 | events | 0 / 57 | not stated; safety; diarrhoea; registry:adverse_events | ||||
| A3 | events | 28 / 57 | not stated; safety; R0015266:Table 3 | ||||
| A4 | events | 0 / 55 | not stated; safety; diarrhoea; registry:adverse_events | ||||
| A4 | events | 0 / 55 | not stated; safety; diarrhoea haemorrhagic; registry:adverse_events | ||||
| A4 | events | 0 / 55 | not stated; safety; diarrhoea haemorrhagic; registry:adverse_events | ||||
| A4 | events | 19 / 55 | not stated; safety; R0015266:Table 3 | ||||
| A4 | events | 19 / 55 | not stated; safety; diarrhoea; registry:adverse_events | ||||
| A5 | events | 21 / 56 | not stated; safety; diarrhoea; registry:adverse_events | ||||
| A5 | events | 0 / 56 | not stated; safety; diarrhoea haemorrhagic; registry:adverse_events | ||||
| A5 | events | 0 / 56 | not stated; safety; diarrhoea haemorrhagic; registry:adverse_events | ||||
| A5 | events | 20 / 56 | not stated; safety; R0015266:Table 3 | ||||
| A5 | events | 0 / 56 | not stated; safety; diarrhoea; registry:adverse_events | ||||
| A6 | events | 0 / 56 | not stated; safety; diarrhoea haemorrhagic; registry:adverse_events | ||||
| A6 | events | 0 / 56 | not stated; safety; diarrhoea haemorrhagic; registry:adverse_events | ||||
| A6 | events | 27 / 56 | not stated; safety; diarrhoea; registry:adverse_events | ||||
| A6 | events | 0 / 56 | not stated; safety; diarrhoea; registry:adverse_events | ||||
| A6 | events | 24 / 56 | not stated; safety; R0015266:Table 3 | ||||
| A7 | events | 0 / 55 | not stated; safety; diarrhoea haemorrhagic; registry:adverse_events | ||||
| A7 | events | 1 / 55 | not stated; safety; diarrhoea; registry:adverse_events | ||||
| A7 | events | 29 / 55 | not stated; safety; diarrhoea; registry:adverse_events | ||||
| A7 | events | 0 / 55 | not stated; safety; diarrhoea haemorrhagic; registry:adverse_events | ||||
| A7 | events | 30 / 55 | not stated; safety; R0015266:Table 3 | ||||
| A8 | events | 0 / 56 | not stated; safety; diarrhoea haemorrhagic; registry:adverse_events | ||||
| A8 | events | 0 / 56 | not stated; safety; diarrhoea; registry:adverse_events | ||||
| A8 | events | 0 / 56 | not stated; safety; diarrhoea haemorrhagic; registry:adverse_events | ||||
| A8 | events | 24 / 56 | not stated; safety; R0015266:Table 3 | ||||
| A8 | events | 25 / 56 | not stated; safety; diarrhoea; registry:adverse_events | ||||
| A9 | events | 0 / 55 | not stated; safety; diarrhoea; registry:adverse_events | ||||
| A9 | events | 1 / 55 | not stated; safety; diarrhoea haemorrhagic; registry:adverse_events | ||||
| A9 | events | 0 / 55 | not stated; safety; diarrhoea haemorrhagic; registry:adverse_events | ||||
| A9 | events | 27 / 55 | not stated; safety; diarrhoea; registry:adverse_events | ||||
| A9 | events | 27 / 55 | not stated; safety; R0015266:Table 3 |
Constipation (16 lines; O27D)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 3 / 55 | not stated; safety; R0015266:Table 3 | ||||
| A2 | events | 2 / 56 | not stated; safety; R0015266:Table 3 | ||||
| A3 | events | 3 / 57 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 2 / 57 | not stated; safety; R0015266:Table 3 | ||||
| A4 | events | 11 / 55 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 11 / 55 | not stated; safety; R0015266:Table 3 | ||||
| A5 | events | 16 / 56 | not stated; safety; registry:adverse_events | ||||
| A5 | events | 16 / 56 | not stated; safety; R0015266:Table 3 | ||||
| A6 | events | 8 / 56 | not stated; safety; R0015266:Table 3 | ||||
| A6 | events | 8 / 56 | not stated; safety; registry:adverse_events | ||||
| A7 | events | 15 / 55 | not stated; safety; registry:adverse_events | ||||
| A7 | events | 15 / 55 | not stated; safety; R0015266:Table 3 | ||||
| A8 | events | 17 / 56 | not stated; safety; registry:adverse_events | ||||
| A8 | events | 15 / 56 | not stated; safety; R0015266:Table 3 | ||||
| A9 | events | 9 / 55 | not stated; safety; registry:adverse_events | ||||
| A9 | events | 9 / 55 | not stated; safety; R0015266:Table 3 |
Discontinuation due to gastrointestinal adverse events (36 lines; O27E)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 55 | not stated; safety; diarrhea; R0015266:Table 3 | ||||
| A1 | events | 0 / 55 | not stated; safety; constipation; R0015266:Table 3 | ||||
| A1 | events | 0 / 55 | not stated; safety; nausea; R0015266:Table 3 | ||||
| A1 | events | 0 / 55 | not stated; safety; pancreatitis; R0015266:Table 3 | ||||
| A2 | events | 0 / 56 | not stated; safety; constipation; R0015266:Table 3 | ||||
| A2 | events | 1 / 56 | not stated; safety; diarrhea; R0015266:Table 3 | ||||
| A2 | events | 0 / 56 | not stated; safety; nausea; R0015266:Table 3 | ||||
| A2 | events | 1 / 56 | not stated; safety; pancreatitis; R0015266:Table 3 | ||||
| A3 | events | 0 / 57 | not stated; safety; constipation; R0015266:Table 3 | ||||
| A3 | events | 1 / 57 | not stated; safety; diarrhea; R0015266:Table 3 | ||||
| A3 | events | 0 / 57 | not stated; safety; nausea; R0015266:Table 3 | ||||
| A3 | events | 0 / 57 | not stated; safety; pancreatitis; R0015266:Table 3 | ||||
| A4 | events | 0 / 55 | not stated; safety; constipation; R0015266:Table 3 | ||||
| A4 | events | 0 / 55 | not stated; safety; diarrhea; R0015266:Table 3 | ||||
| A4 | events | 0 / 55 | not stated; safety; nausea; R0015266:Table 3 | ||||
| A4 | events | 1 / 55 | not stated; safety; pancreatitis; R0015266:Table 3 | ||||
| A5 | events | 1 / 56 | not stated; safety; constipation; R0015266:Table 3 | ||||
| A5 | events | 0 / 56 | not stated; safety; diarrhea; R0015266:Table 3 | ||||
| A5 | events | 0 / 56 | not stated; safety; nausea; R0015266:Table 3 | ||||
| A5 | events | 0 / 56 | not stated; safety; pancreatitis; R0015266:Table 3 | ||||
| A6 | events | 0 / 56 | not stated; safety; constipation; R0015266:Table 3 | ||||
| A6 | events | 0 / 56 | not stated; safety; diarrhea; R0015266:Table 3 | ||||
| A6 | events | 1 / 56 | not stated; safety; nausea; R0015266:Table 3 | ||||
| A6 | events | 0 / 56 | not stated; safety; pancreatitis; R0015266:Table 3 | ||||
| A7 | events | 0 / 55 | not stated; safety; constipation; R0015266:Table 3 | ||||
| A7 | events | 0 / 55 | not stated; safety; diarrhea; R0015266:Table 3 | ||||
| A7 | events | 1 / 55 | not stated; safety; nausea; R0015266:Table 3 | ||||
| A7 | events | 0 / 55 | not stated; safety; pancreatitis; R0015266:Table 3 | ||||
| A8 | events | 0 / 56 | not stated; safety; constipation; R0015266:Table 3 | ||||
| A8 | events | 2 / 56 | not stated; safety; diarrhea; R0015266:Table 3 | ||||
| A8 | events | 2 / 56 | not stated; safety; nausea; R0015266:Table 3 | ||||
| A8 | events | 0 / 56 | not stated; safety; pancreatitis; R0015266:Table 3 | ||||
| A9 | events | 2 / 55 | not stated; safety; nausea; R0015266:Table 3 | ||||
| A9 | events | 1 / 55 | not stated; safety; constipation; R0015266:Table 3 | ||||
| A9 | events | 0 / 55 | not stated; safety; diarrhea; R0015266:Table 3 | ||||
| A9 | events | 0 / 55 | not stated; safety; pancreatitis; R0015266:Table 3 |
Gallbladder and biliary disease (63 lines; O28)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A3 | events | 1 / 57 | not stated; safety; gallbladder polyp; registry:adverse_events | ||||
| A3 | events | 1 / 57 | not stated; safety; gallbladder enlargement; registry:adverse_events | ||||
| A3 | events | 0 / 57 | not stated; safety; cholecystitis; registry:adverse_events | ||||
| A3 | events | 0 / 57 | not stated; safety; gallbladder disorder; registry:adverse_events | ||||
| A3 | events | 0 / 57 | not stated; safety; cholecystitis chronic; registry:adverse_events | ||||
| A3 | events | 0 / 57 | not stated; safety; cholelithiasis; registry:adverse_events | ||||
| A3 | events | 0 / 57 | not stated; safety; cholecystitis; registry:adverse_events | ||||
| A3 | events | 0 / 57 | not stated; safety; cholecystitis acute; registry:adverse_events | ||||
| A3 | events | 2 / 57 | not stated; safety; cholelithiasis; registry:adverse_events | ||||
| A4 | events | 0 / 55 | not stated; safety; cholecystitis; registry:adverse_events | ||||
| A4 | events | 0 / 55 | not stated; safety; cholecystitis; registry:adverse_events | ||||
| A4 | events | 0 / 55 | not stated; safety; cholelithiasis; registry:adverse_events | ||||
| A4 | events | 0 / 55 | not stated; safety; cholelithiasis; registry:adverse_events | ||||
| A4 | events | 0 / 55 | not stated; safety; gallbladder polyp; registry:adverse_events | ||||
| A4 | events | 0 / 55 | not stated; safety; gallbladder disorder; registry:adverse_events | ||||
| A4 | events | 0 / 55 | not stated; safety; gallbladder enlargement; registry:adverse_events | ||||
| A4 | events | 0 / 55 | not stated; safety; cholecystitis acute; registry:adverse_events | ||||
| A4 | events | 0 / 55 | not stated; safety; cholecystitis chronic; registry:adverse_events | ||||
| A5 | events | 0 / 56 | not stated; safety; cholecystitis acute; registry:adverse_events | ||||
| A5 | events | 0 / 56 | not stated; safety; cholecystitis; registry:adverse_events | ||||
| A5 | events | 0 / 56 | not stated; safety; gallbladder polyp; registry:adverse_events | ||||
| A5 | events | 0 / 56 | not stated; safety; gallbladder enlargement; registry:adverse_events | ||||
| A5 | events | 0 / 56 | not stated; safety; gallbladder disorder; registry:adverse_events | ||||
| A5 | events | 0 / 56 | not stated; safety; cholecystitis; registry:adverse_events | ||||
| A5 | events | 1 / 56 | not stated; safety; cholelithiasis; registry:adverse_events | ||||
| A5 | events | 1 / 56 | not stated; safety; cholelithiasis; registry:adverse_events | ||||
| A5 | events | 0 / 56 | not stated; safety; cholecystitis chronic; registry:adverse_events | ||||
| A6 | events | 0 / 56 | not stated; safety; cholecystitis chronic; registry:adverse_events | ||||
| A6 | events | 0 / 56 | not stated; safety; gallbladder disorder; registry:adverse_events | ||||
| A6 | events | 0 / 56 | not stated; safety; gallbladder enlargement; registry:adverse_events | ||||
| A6 | events | 0 / 56 | not stated; safety; gallbladder polyp; registry:adverse_events | ||||
| A6 | events | 1 / 56 | not stated; safety; cholelithiasis; registry:adverse_events | ||||
| A6 | events | 0 / 56 | not stated; safety; cholecystitis acute; registry:adverse_events | ||||
| A6 | events | 0 / 56 | not stated; safety; cholelithiasis; registry:adverse_events | ||||
| A6 | events | 1 / 56 | not stated; safety; cholecystitis; registry:adverse_events | ||||
| A6 | events | 0 / 56 | not stated; safety; cholecystitis; registry:adverse_events | ||||
| A7 | events | 0 / 55 | not stated; safety; gallbladder disorder; registry:adverse_events | ||||
| A7 | events | 1 / 55 | not stated; safety; cholecystitis acute; registry:adverse_events | ||||
| A7 | events | 0 / 55 | not stated; safety; cholecystitis chronic; registry:adverse_events | ||||
| A7 | events | 1 / 55 | not stated; safety; cholecystitis; registry:adverse_events | ||||
| A7 | events | 0 / 55 | not stated; safety; cholecystitis; registry:adverse_events | ||||
| A7 | events | 0 / 55 | not stated; safety; cholelithiasis; registry:adverse_events | ||||
| A7 | events | 0 / 55 | not stated; safety; cholelithiasis; registry:adverse_events | ||||
| A7 | events | 0 / 55 | not stated; safety; gallbladder polyp; registry:adverse_events | ||||
| A7 | events | 0 / 55 | not stated; safety; gallbladder enlargement; registry:adverse_events | ||||
| A8 | events | 1 / 56 | not stated; safety; cholecystitis; registry:adverse_events | ||||
| A8 | events | 0 / 56 | not stated; safety; gallbladder disorder; registry:adverse_events | ||||
| A8 | events | 0 / 56 | not stated; safety; gallbladder enlargement; registry:adverse_events | ||||
| A8 | events | 0 / 56 | not stated; safety; gallbladder polyp; registry:adverse_events | ||||
| A8 | events | 0 / 56 | not stated; safety; cholecystitis acute; registry:adverse_events | ||||
| A8 | events | 0 / 56 | not stated; safety; cholecystitis chronic; registry:adverse_events | ||||
| A8 | events | 0 / 56 | not stated; safety; cholecystitis; registry:adverse_events | ||||
| A8 | events | 1 / 56 | not stated; safety; cholelithiasis; registry:adverse_events | ||||
| A8 | events | 1 / 56 | not stated; safety; cholelithiasis; registry:adverse_events | ||||
| A9 | events | 0 / 55 | not stated; safety; cholecystitis acute; registry:adverse_events | ||||
| A9 | events | 0 / 55 | not stated; safety; cholecystitis chronic; registry:adverse_events | ||||
| A9 | events | 0 / 55 | not stated; safety; gallbladder polyp; registry:adverse_events | ||||
| A9 | events | 0 / 55 | not stated; safety; gallbladder enlargement; registry:adverse_events | ||||
| A9 | events | 0 / 55 | not stated; safety; gallbladder disorder; registry:adverse_events | ||||
| A9 | events | 0 / 55 | not stated; safety; cholecystitis; registry:adverse_events | ||||
| A9 | events | 0 / 55 | not stated; safety; cholecystitis; registry:adverse_events | ||||
| A9 | events | 0 / 55 | not stated; safety; cholelithiasis; registry:adverse_events | ||||
| A9 | events | 1 / 55 | not stated; safety; cholelithiasis; registry:adverse_events |
Acute pancreatitis (30 lines; O29)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 1 / 55 | not stated; safety; R0015266:Table 3 | ||||
| A2 | events | 1 / 56 | not stated; safety; R0015266:Table 3 | ||||
| A3 | events | 0 / 57 | not stated; safety; pancreatitis; registry:adverse_events | ||||
| A3 | events | 0 / 57 | not stated; safety; pancreatitis acute; registry:adverse_events | ||||
| A3 | events | 0 / 57 | not stated; safety; obstructive pancreatitis; registry:adverse_events | ||||
| A3 | events | 0 / 57 | not stated; safety; R0015266:Table 3 | ||||
| A4 | events | 0 / 55 | not stated; safety; pancreatitis acute; registry:adverse_events | ||||
| A4 | events | 0 / 55 | not stated; safety; obstructive pancreatitis; registry:adverse_events | ||||
| A4 | events | 1 / 55 | not stated; safety; R0015266:Table 3 | ||||
| A4 | events | 1 / 55 | not stated; safety; pancreatitis; registry:adverse_events | ||||
| A5 | events | 0 / 56 | not stated; safety; obstructive pancreatitis; registry:adverse_events | ||||
| A5 | events | 0 / 56 | not stated; safety; pancreatitis acute; registry:adverse_events | ||||
| A5 | events | 0 / 56 | not stated; safety; pancreatitis; registry:adverse_events | ||||
| A5 | events | 0 / 56 | not stated; safety; R0015266:Table 3 | ||||
| A6 | events | 0 / 56 | not stated; safety; obstructive pancreatitis; registry:adverse_events | ||||
| A6 | events | 0 / 56 | not stated; safety; pancreatitis; registry:adverse_events | ||||
| A6 | events | 1 / 56 | not stated; safety; pancreatitis acute; registry:adverse_events | ||||
| A6 | events | 0 / 56 | not stated; safety; R0015266:Table 3 | ||||
| A7 | events | 0 / 55 | not stated; safety; pancreatitis acute; registry:adverse_events | ||||
| A7 | events | 0 / 55 | not stated; safety; obstructive pancreatitis; registry:adverse_events | ||||
| A7 | events | 0 / 55 | not stated; safety; R0015266:Table 3 | ||||
| A7 | events | 0 / 55 | not stated; safety; pancreatitis; registry:adverse_events | ||||
| A8 | events | 0 / 56 | not stated; safety; obstructive pancreatitis; registry:adverse_events | ||||
| A8 | events | 0 / 56 | not stated; safety; pancreatitis acute; registry:adverse_events | ||||
| A8 | events | 0 / 56 | not stated; safety; pancreatitis; registry:adverse_events | ||||
| A8 | events | 0 / 56 | not stated; safety; R0015266:Table 3 | ||||
| A9 | events | 0 / 55 | not stated; safety; pancreatitis acute; registry:adverse_events | ||||
| A9 | events | 0 / 55 | not stated; safety; obstructive pancreatitis; registry:adverse_events | ||||
| A9 | events | 0 / 55 | not stated; safety; R0015266:Table 3 | ||||
| A9 | events | 0 / 55 | not stated; safety; pancreatitis; registry:adverse_events |
Suicidal ideation or behavior (7 lines; O35A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A3 | events | 0 / 57 | not stated; safety; suicidal ideation; registry:adverse_events | ||||
| A4 | events | 0 / 55 | not stated; safety; suicidal ideation; registry:adverse_events | ||||
| A5 | events | 0 / 56 | not stated; safety; suicidal ideation; registry:adverse_events | ||||
| A6 | events | 1 / 56 | not stated; safety; suicidal ideation; registry:adverse_events | ||||
| A7 | events | 0 / 55 | not stated; safety; suicidal ideation; registry:adverse_events | ||||
| A8 | events | 0 / 56 | not stated; safety; suicidal ideation; registry:adverse_events | ||||
| A9 | events | 0 / 55 | not stated; safety; suicidal ideation; registry:adverse_events |
Intestinal obstruction or ileus (7 lines; O37B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A3 | events | 0 / 57 | not stated; safety; small intestinal obstruction; registry:adverse_events | ||||
| A4 | events | 0 / 55 | not stated; safety; small intestinal obstruction; registry:adverse_events | ||||
| A5 | events | 1 / 56 | not stated; safety; small intestinal obstruction; registry:adverse_events | ||||
| A6 | events | 0 / 56 | not stated; safety; small intestinal obstruction; registry:adverse_events | ||||
| A7 | events | 0 / 55 | not stated; safety; small intestinal obstruction; registry:adverse_events | ||||
| A8 | events | 0 / 56 | not stated; safety; small intestinal obstruction; registry:adverse_events | ||||
| A9 | events | 0 / 55 | not stated; safety; small intestinal obstruction; registry:adverse_events |
Any cancer (9 lines; O39)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 55 | not stated; safety; R0015266:Table 3 | ||||
| A2 | events | 1 / 56 | not stated; safety; R0015266:Table 3 | ||||
| A3 | events | 1 / 57 | not stated; safety; R0015266:Table 3 | ||||
| A4 | events | 0 / 55 | not stated; safety; R0015266:Table 3 | ||||
| A5 | events | 2 / 56 | not stated; safety; R0015266:Table 3 | ||||
| A6 | events | 0 / 56 | not stated; safety; R0015266:Table 3 | ||||
| A7 | events | 0 / 55 | not stated; safety; R0015266:Table 3 | ||||
| A8 | events | 0 / 56 | not stated; safety; R0015266:Table 3 | ||||
| A9 | events | 0 / 55 | not stated; safety; R0015266:Table 3 |