parallel randomized trial
NCT03235050
A Phase IIb, Randomised, Parallel, Double-Blind Placebo-Controlled and Open-Label Active Comparator Study to Evaluate the Efficacy and Safety of MEDI0382 in the Treatment of Overweight and Obese Subjects With Type 2 Diabetes Mellitus
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | Placebo Placebo | metformin; lifestyle: not reported | 112 | 112 | 91 |
| A2 | Liraglutide 1.8 mg subcutaneous once daily Liraglutide 1.8 mg | metformin; lifestyle: not reported | 110 | 110 | 103 |
| A3 | Cotadutide 100 ug subcutaneous once daily Cotadutide 100 ug | metformin; lifestyle: not reported | 100 | 100 | 74 |
| A4 | Cotadutide 200 ug subcutaneous once daily Cotadutide 200 ug | metformin; lifestyle: not reported | 256 | 256 | 196 |
| A5 | Cotadutide 300 ug subcutaneous once daily Cotadutide 300 ug | metformin; lifestyle: not reported | 256 | 256 | 188 |
Baseline characteristics
As printed in the trial reports or registry, per arm or for the whole trial.
| Characteristic | Statistic | Placebo A1 | Liraglutide 1.8 mg subcutaneous once daily A2 | Cotadutide 100 ug subcutaneous once daily A3 | Cotadutide 200 ug subcutaneous once daily A4 | Cotadutide 300 ug subcutaneous once daily A5 |
|---|---|---|---|---|---|---|
| age | mean (years) | 57.3 | 55.5 | 57.6 | 57.3 | 56.3 |
| age | sd (years) | 9.5 | 9.8 | 9.9 | 9.9 | 10.2 |
| asian | n | 1 | 1 | 0 | 3 | 1 |
| black | n | 0 | 3 | 1 | 3 | 3 |
| female | n | 55 | 60 | 57 | 147 | 129 |
| other race american indian alaska native | n | 3 | 3 | 0 | 5 | 0 |
| other race other | n | 1 | 0 | 0 | 0 | 0 |
| white | n | 107 | 103 | 99 | 245 | 252 |
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
- Body weight change in kilograms (diabetes)Type 2 diabetes (adults); weeks 36 to 64 (target week 52); network meta-analysis
- Body weight change in kilograms (diabetes)Type 2 diabetes (adults); weeks 36 to 64 (target week 52); network meta-analysis
- Body weight change in kilograms (diabetes)Type 2 diabetes (adults); weeks 20 to 36 (target week 26); network meta-analysis
- Body weight change in kilograms (diabetes)Type 2 diabetes (adults); weeks 20 to 36 (target week 26); network meta-analysis
- HbA1c below 7 percentType 2 diabetes (adults); weeks 36 to 64 (target week 52); descriptive only
- HbA1c below 7 percentType 2 diabetes (adults); weeks 20 to 36 (target week 26); network meta-analysis
- HbA1c below 7 percentType 2 diabetes (adults); weeks 20 to 36 (target week 26); network meta-analysis
- HbA1c below 7 percentType 2 diabetes (adults); weeks 36 to 64 (target week 52); 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 40 to 104 (target week 68); network meta-analysis
- Percent body weight changeType 2 diabetes (adults); weeks 40 to 104 (target week 68); network meta-analysis
- Percent body weight changeType 2 diabetes (adults); weeks 20 to 40 (target week 26); network meta-analysis
- Weight loss of 5 percent or moreType 2 diabetes (adults); weeks 20 to 40 (target week 26); network meta-analysis
- Weight loss of 5 percent or moreType 2 diabetes (adults); weeks 40 to 104 (target week 68); network meta-analysis
- Weight loss of 5 percent or moreType 2 diabetes (adults); weeks 40 to 104 (target week 68); network meta-analysis
- Weight loss of 5 percent or moreType 2 diabetes (adults); weeks 20 to 40 (target week 26); network meta-analysis
- Weight loss of 10 percent or moreType 2 diabetes (adults); weeks 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 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
- Serious adverse eventsType 2 diabetes (adults); longest follow-up; network meta-analysis
- Serious adverse eventsType 2 diabetes (adults); longest follow-up; network meta-analysis
- Discontinuation due to adverse eventsType 2 diabetes (adults); longest follow-up; network meta-analysis
- Discontinuation due to adverse eventsType 2 diabetes (adults); longest follow-up; network meta-analysis
- NauseaType 2 diabetes (adults); longest follow-up; network meta-analysis
- NauseaType 2 diabetes (adults); longest follow-up; network meta-analysis
- VomitingType 2 diabetes (adults); longest follow-up; network meta-analysis
- VomitingType 2 diabetes (adults); longest follow-up; network meta-analysis
- DiarrheaType 2 diabetes (adults); longest follow-up; network meta-analysis
- DiarrheaType 2 diabetes (adults); longest follow-up; network meta-analysis
- ConstipationType 2 diabetes (adults); longest follow-up; network meta-analysis
- ConstipationType 2 diabetes (adults); longest follow-up; network meta-analysis
Results
189 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
HbA1c change (19 lines; O01)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26 | A1 | change | -0.40 percent | -0.58 to -0.22 | 112 | not stated; full analysis; registry:outcomes | |
| 26 | A3 | change | -1.06 percent | -1.25 to -0.87 | 100 | not stated; full analysis; registry:outcomes | |
| 26 | A3 vs A1 | md | -0.66 percent | -0.92 to -0.40 | not stated; full analysis; registry:outcomes | ||
| 26 | A4 | change | -1.22 percent | -1.34 to -1.10 | 256 | not stated; full analysis; registry:outcomes | |
| 26 | A4 vs A1 | md | -0.81 percent | -1.03 to -0.60 | not stated; full analysis; registry:outcomes | ||
| 26 | A5 | change | -1.12 percent | -1.24 to -1.00 | 256 | not stated; full analysis; registry:outcomes | |
| 26 | A5 vs A1 | md | -0.72 percent | -0.94 to -0.51 | not stated; full analysis; registry:outcomes | ||
| 54 | A1 | change | -0.45 percent | -0.65 to -0.24 | not stated; per protocol; R0016374:Figure 2 | ||
| 54 | A1 | change | -0.44 percent | -0.63 to -0.24 | 112 | not stated; full analysis; registry:outcomes | |
| 54 | A2 | change | -1.17 percent | -1.37 to -0.98 | not stated; per protocol; R0016374:Figure 2 | ||
| 54 | A3 | change | -1.03 percent | -1.25 to -0.80 | not stated; per protocol; R0016374:Figure 2 | ||
| 54 | A3 | change | -0.96 percent | -1.16 to -0.75 | 100 | not stated; full analysis; registry:outcomes | |
| 54 | A3 vs A1 | md | -0.52 percent | -0.80 to -0.24 | not stated; full analysis; registry:outcomes | ||
| 54 | A4 | change | -1.16 percent | -1.29 to -1.02 | not stated; per protocol; R0016374:Figure 2 | ||
| 54 | A4 | change | -1.06 percent | -1.19 to -0.93 | 256 | not stated; full analysis; registry:outcomes | |
| 54 | A4 vs A1 | md | -0.63 percent | -0.86 to -0.39 | not stated; full analysis; registry:outcomes | ||
| 54 | A5 | change | -1.19 percent | -1.34 to -1.05 | not stated; per protocol; R0016374:Figure 2 | ||
| 54 | A5 | change | -1.01 percent | -1.14 to -0.88 | 256 | not stated; full analysis; registry:outcomes | |
| 54 | A5 vs A1 | md | -0.57 percent | -0.80 to -0.34 | not stated; full analysis; registry:outcomes |
Body weight change in kilograms (diabetes) (22 lines; O02)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26 | A1 | change | -1.20 kg | -2.06 to -0.34 | 112 | not stated; full analysis; registry:outcomes | |
| 26 | A2 | change | -3.90 kg | -4.77 to -3.03 | 110 | not stated; full analysis; registry:outcomes | |
| 26 | A3 | change | -3.20 kg | -4.13 to -2.28 | 100 | not stated; full analysis; registry:outcomes | |
| 26 | A3 vs A1 | md | -2.01 kg | -3.27 to -0.74 | not stated; full analysis; registry:outcomes | ||
| 26 | A3 vs A2 | md | 0.70 kg | -0.57 to 1.97 | not stated; full analysis; registry:outcomes | ||
| 26 | A4 | change | -3.94 kg | -4.52 to -3.37 | 256 | not stated; full analysis; registry:outcomes | |
| 26 | A4 vs A1 | md | -2.74 kg | -3.78 to -1.71 | not stated; full analysis; registry:outcomes | ||
| 26 | A4 vs A2 | md | -0.04 kg | -1.08 to 1.00 | not stated; full analysis; registry:outcomes | ||
| 26 | A5 | change | -4.75 kg | -5.33 to -4.18 | 256 | not stated; full analysis; registry:outcomes | |
| 26 | A5 vs A1 | md | -3.55 kg | -4.59 to -2.52 | not stated; full analysis; registry:outcomes | ||
| 26 | A5 vs A2 | md | -0.85 kg | -1.89 to 0.19 | not stated; full analysis; registry:outcomes | ||
| 54 | A1 | change | -0.94 kg | -1.94 to 0.07 | 112 | not stated; full analysis; registry:outcomes | |
| 54 | A2 | change | -2.94 kg | -3.96 to -1.92 | 110 | not stated; full analysis; registry:outcomes | |
| 54 | A3 | change | -3.20 kg | -4.28 to -2.12 | 100 | not stated; full analysis; registry:outcomes | |
| 54 | A3 vs A1 | md | -2.27 kg | -3.74 to -0.79 | not stated; full analysis; registry:outcomes | ||
| 54 | A3 vs A2 | md | -0.26 kg | -1.74 to 1.22 | not stated; full analysis; registry:outcomes | ||
| 54 | A4 | change | -3.09 kg | -3.77 to -2.42 | 256 | not stated; full analysis; registry:outcomes | |
| 54 | A4 vs A1 | md | -2.16 kg | -3.37 to -0.95 | not stated; full analysis; registry:outcomes | ||
| 54 | A4 vs A2 | md | -0.15 kg | -1.38 to 1.07 | not stated; full analysis; registry:outcomes | ||
| 54 | A5 | change | -4.35 kg | -5.03 to -3.68 | 256 | not stated; full analysis; registry:outcomes | |
| 54 | A5 vs A1 | md | -3.42 kg | -4.63 to -2.20 | not stated; full analysis; registry:outcomes | ||
| 54 | A5 vs A2 | md | -1.41 kg | -2.63 to -0.19 | not stated; full analysis; registry:outcomes |
HbA1c below 7 percent (19 lines; O03)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26 | A1 | responders | 25 / 112 | not stated; full analysis; registry:outcomes | |||
| 26 | A3 | responders | 48 / 100 | not stated; full analysis; registry:outcomes | |||
| 26 | A3 vs A1 | or | 3.74 | 1.98 to 7.03 | not stated; full analysis; registry:outcomes | ||
| 26 | A4 | responders | 139 / 256 | not stated; full analysis; registry:outcomes | |||
| 26 | A4 vs A1 | or | 5.40 | 3.13 to 9.34 | not stated; full analysis; registry:outcomes | ||
| 26 | A5 | responders | 143 / 256 | not stated; full analysis; registry:outcomes | |||
| 26 | A5 vs A1 | or | 5.20 | 3.02 to 8.97 | not stated; full analysis; registry:outcomes | ||
| 54 | A1 | responders | 22 / 91 | not stated; per protocol; R0016374:Results | |||
| 54 | A1 | responders | 23 / 112 | not stated; full analysis; registry:outcomes | |||
| 54 | A2 | responders | 61.5 | not stated; per protocol; R0016374:Figure 2 | |||
| 54 | A3 | responders | 43 / 75 | not stated; per protocol; R0016374:Results | |||
| 54 | A3 | responders | 52 / 100 | not stated; full analysis; registry:outcomes | |||
| 54 | A3 vs A1 | or | 4.94 | 2.61 to 9.36 | not stated; full analysis; registry:outcomes | ||
| 54 | A4 | responders | 110 / 202 | not stated; per protocol; R0016374:Results | |||
| 54 | A4 | responders | 125 / 256 | not stated; full analysis; registry:outcomes | |||
| 54 | A4 vs A1 | or | 4.55 | 2.62 to 7.89 | not stated; full analysis; registry:outcomes | ||
| 54 | A5 | responders | 108 / 187 | not stated; per protocol; R0016374:Results | |||
| 54 | A5 | responders | 128 / 256 | not stated; full analysis; registry:outcomes | |||
| 54 | A5 vs A1 | or | 4.34 | 2.51 to 7.51 | not stated; full analysis; registry:outcomes |
Percent body weight change (27 lines; O10)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26 | A1 | percent change | -1.14 percent | -1.99 to -0.29 | 112 | not stated; full analysis; registry:outcomes | |
| 26 | A2 | percent change | -4.12 percent | -4.98 to -3.27 | 110 | not stated; full analysis; registry:outcomes | |
| 26 | A3 | percent change | -3.23 percent | -4.13 to -2.32 | 100 | not stated; full analysis; registry:outcomes | |
| 26 | A3 vs A1 | md | -2.09 percent | -3.32 to -0.85 | not stated; full analysis; registry:outcomes | ||
| 26 | A3 vs A2 | md | 0.90 percent | -0.35 to 2.14 | not stated; full analysis; registry:outcomes | ||
| 26 | A4 | percent change | -3.94 percent | -4.51 to -3.38 | 256 | not stated; full analysis; registry:outcomes | |
| 26 | A4 vs A1 | md | -2.80 percent | -3.82 to -1.79 | not stated; full analysis; registry:outcomes | ||
| 26 | A4 vs A2 | md | 0.18 percent | -0.85 to 1.20 | not stated; full analysis; registry:outcomes | ||
| 26 | A5 | percent change | -4.60 percent | -5.17 to -4.04 | 256 | not stated; full analysis; registry:outcomes | |
| 26 | A5 vs A1 | md | -3.46 percent | -4.48 to -2.44 | not stated; full analysis; registry:outcomes | ||
| 26 | A5 vs A2 | md | -0.48 percent | -1.51 to 0.54 | not stated; full analysis; registry:outcomes | ||
| 54 | A1 | percent change | -0.68 percent | -1.77 to 0.42 | not stated; per protocol; R0016374:Figure 2 | ||
| 54 | A1 | percent change | -0.84 percent | -1.82 to 0.14 | 112 | not stated; full analysis; registry:outcomes | |
| 54 | A2 | percent change | -3.33 percent | -4.35 to -2.31 | not stated; per protocol; R0016374:Figure 2 | ||
| 54 | A2 | percent change | -3.20 percent | -4.19 to -2.21 | 110 | not stated; full analysis; registry:outcomes | |
| 54 | A3 | percent change | -3.70 percent | -4.91 to -2.50 | not stated; per protocol; R0016374:Figure 2 | ||
| 54 | A3 | percent change | -3.27 percent | -4.32 to -2.22 | 100 | not stated; full analysis; registry:outcomes | |
| 54 | A3 vs A1 | md | -2.43 percent | -3.86 to -1.00 | not stated; full analysis; registry:outcomes | ||
| 54 | A3 vs A2 | md | -0.07 percent | -1.51 to 1.37 | not stated; full analysis; registry:outcomes | ||
| 54 | A4 | percent change | -3.22 percent | -3.96 to -2.48 | not stated; per protocol; R0016374:Figure 2 | ||
| 54 | A4 | percent change | -3.08 percent | -3.73 to -2.43 | 256 | not stated; full analysis; registry:outcomes | |
| 54 | A4 vs A1 | md | -2.24 percent | -3.41 to -1.06 | not stated; full analysis; registry:outcomes | ||
| 54 | A4 vs A2 | md | 0.12 percent | -1.07 to 1.30 | not stated; full analysis; registry:outcomes | ||
| 54 | A5 | percent change | -5.02 percent | -5.78 to -4.26 | not stated; per protocol; R0016374:Figure 2 | ||
| 54 | A5 | percent change | -4.16 percent | -4.81 to -3.50 | 256 | not stated; full analysis; registry:outcomes | |
| 54 | A5 vs A1 | md | -3.32 percent | -4.49 to -2.14 | not stated; full analysis; registry:outcomes | ||
| 54 | A5 vs A2 | md | -0.96 percent | -2.15 to 0.22 | not stated; full analysis; registry:outcomes |
Weight loss of 5 percent or more (19 lines; O11A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26 | A1 | responders | 11 / 112 | not stated; full analysis; registry:outcomes | |||
| 26 | A3 | responders | 28 / 100 | not stated; full analysis; registry:outcomes | |||
| 26 | A3 vs A1 | or | 3.68 | 1.72 to 7.89 | not stated; full analysis; registry:outcomes | ||
| 26 | A4 | responders | 76 / 256 | not stated; full analysis; registry:outcomes | |||
| 26 | A4 vs A1 | or | 3.95 | 2.00 to 7.78 | not stated; full analysis; registry:outcomes | ||
| 26 | A5 | responders | 110 / 256 | not stated; full analysis; registry:outcomes | |||
| 26 | A5 vs A1 | or | 7.28 | 3.72 to 14.24 | not stated; full analysis; registry:outcomes | ||
| 54 | A1 | responders | 9 / 91 | not stated; per protocol; R0016374:Results | |||
| 54 | A1 | responders | 14 / 112 | not stated; full analysis; registry:outcomes | |||
| 54 | A2 | responders | 32 / 104 | not stated; per protocol; R0016374:Results | |||
| 54 | A3 | responders | 30 / 75 | not stated; per protocol; R0016374:Results | |||
| 54 | A3 | responders | 34 / 100 | not stated; full analysis; registry:outcomes | |||
| 54 | A3 vs A1 | or | 3.71 | 1.84 to 7.45 | not stated; full analysis; registry:outcomes | ||
| 54 | A4 | responders | 59 / 199 | not stated; per protocol; R0016374:Results | |||
| 54 | A4 | responders | 71 / 256 | not stated; full analysis; registry:outcomes | |||
| 54 | A4 vs A1 | or | 2.73 | 1.46 to 5.09 | not stated; full analysis; registry:outcomes | ||
| 54 | A5 | responders | 87 / 187 | not stated; per protocol; R0016374:Results | |||
| 54 | A5 | responders | 98 / 256 | not stated; full analysis; registry:outcomes | |||
| 54 | A5 vs A1 | or | 4.48 | 2.42 to 8.30 | not stated; full analysis; registry:outcomes |
Weight loss of 10 percent or more (13 lines; O11B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26 | A1 | responders | 1 / 112 | not stated; full analysis; registry:outcomes | |||
| 26 | A3 | responders | 7 / 100 | not stated; full analysis; registry:outcomes | |||
| 26 | A4 | responders | 28 / 256 | not stated; full analysis; registry:outcomes | |||
| 26 | A5 | responders | 27 / 256 | not stated; full analysis; registry:outcomes | |||
| 54 | A1 | responders | 1.1 | not stated; per protocol; R0016374:Figure 2 | |||
| 54 | A1 | responders | 2 / 112 | not stated; full analysis; registry:outcomes | |||
| 54 | A2 | responders | 5.8 | not stated; per protocol; R0016374:Figure 2 | |||
| 54 | A3 | responders | 10.7 | not stated; per protocol; R0016374:Figure 2 | |||
| 54 | A3 | responders | 11 / 100 | not stated; full analysis; registry:outcomes | |||
| 54 | A4 | responders | 9.0 | not stated; per protocol; R0016374:Figure 2 | |||
| 54 | A4 | responders | 21 / 256 | not stated; full analysis; registry:outcomes | |||
| 54 | A5 | responders | 32 / 256 | not stated; full analysis; registry:outcomes | |||
| 54 | A5 | responders | 15.5 | not stated; per protocol; R0016374:Figure 2 |
Acute kidney injury (5 lines; O121)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 112 | not stated; safety; prerenal failure; registry:adverse_events | ||||
| A2 | events | 0 / 110 | not stated; safety; prerenal failure; registry:adverse_events | ||||
| A3 | events | 0 / 100 | not stated; safety; prerenal failure; registry:adverse_events | ||||
| A4 | events | 1 / 256 | not stated; safety; prerenal failure; registry:adverse_events | ||||
| A5 | events | 0 / 256 | not stated; safety; prerenal failure; registry:adverse_events |
All cause mortality (5 lines; O20)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 112 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 0 / 110 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 0 / 100 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 2 / 256 | not stated; safety; registry:adverse_events | ||||
| A5 | events | 1 / 256 | not stated; safety; registry:adverse_events |
Serious adverse events (5 lines; O25)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 12 / 112 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 8 / 110 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 12 / 100 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 33 / 256 | not stated; safety; registry:adverse_events | ||||
| A5 | events | 20 / 256 | not stated; safety; registry:adverse_events |
Discontinuation due to adverse events (10 lines; O26)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 112 | not stated; randomized; registry:flow | ||||
| A1 | events | 5 / 112 | not stated; randomized; R0016374:Figure 1 | ||||
| A2 | events | 0 / 110 | not stated; randomized; registry:flow | ||||
| A2 | events | 2 / 110 | not stated; randomized; R0016374:Figure 1 | ||||
| A3 | events | 13 / 100 | not stated; randomized; R0016374:Figure 1 | ||||
| A3 | events | 1 / 100 | not stated; randomized; registry:flow | ||||
| A4 | events | 4 / 256 | not stated; randomized; registry:flow | ||||
| A4 | events | 39 / 256 | not stated; randomized; R0016374:Figure 1 | ||||
| A5 | events | 55 / 256 | not stated; randomized; R0016374:Figure 1 | ||||
| A5 | events | 1 / 256 | not stated; randomized; registry:flow |
Nausea (5 lines; O27A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 12 / 112 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 17 / 110 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 23 / 100 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 85 / 256 | not stated; safety; registry:adverse_events | ||||
| A5 | events | 105 / 256 | not stated; safety; registry:adverse_events |
Vomiting (5 lines; O27B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 5 / 112 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 3 / 110 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 10 / 100 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 51 / 256 | not stated; safety; registry:adverse_events | ||||
| A5 | events | 43 / 256 | not stated; safety; registry:adverse_events |
Diarrhea (5 lines; O27C)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 10 / 112 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 4 / 110 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 13 / 100 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 49 / 256 | not stated; safety; registry:adverse_events | ||||
| A5 | events | 28 / 256 | not stated; safety; registry:adverse_events |
Constipation (5 lines; O27D)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 2 / 112 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 2 / 110 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 1 / 100 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 10 / 256 | not stated; safety; registry:adverse_events | ||||
| A5 | events | 13 / 256 | not stated; safety; registry:adverse_events |
Gallbladder and biliary disease (15 lines; O28)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 112 | not stated; safety; gallbladder polyp; registry:adverse_events | ||||
| A1 | events | 0 / 112 | not stated; safety; cholecystitis acute; registry:adverse_events | ||||
| A1 | events | 0 / 112 | not stated; safety; cholelithiasis; registry:adverse_events | ||||
| A2 | events | 0 / 110 | not stated; safety; cholecystitis acute; registry:adverse_events | ||||
| A2 | events | 0 / 110 | not stated; safety; gallbladder polyp; registry:adverse_events | ||||
| A2 | events | 0 / 110 | not stated; safety; cholelithiasis; registry:adverse_events | ||||
| A3 | events | 1 / 100 | not stated; safety; cholelithiasis; registry:adverse_events | ||||
| A3 | events | 0 / 100 | not stated; safety; cholecystitis acute; registry:adverse_events | ||||
| A3 | events | 0 / 100 | not stated; safety; gallbladder polyp; registry:adverse_events | ||||
| A4 | events | 2 / 256 | not stated; safety; cholelithiasis; registry:adverse_events | ||||
| A4 | events | 1 / 256 | not stated; safety; cholecystitis acute; registry:adverse_events | ||||
| A4 | events | 0 / 256 | not stated; safety; gallbladder polyp; registry:adverse_events | ||||
| A5 | events | 1 / 256 | not stated; safety; gallbladder polyp; registry:adverse_events | ||||
| A5 | events | 0 / 256 | not stated; safety; cholecystitis acute; registry:adverse_events | ||||
| A5 | events | 0 / 256 | not stated; safety; cholelithiasis; registry:adverse_events |
Acute pancreatitis (5 lines; O29)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 112 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 0 / 110 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 0 / 100 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 1 / 256 | not stated; safety; registry:adverse_events | ||||
| A5 | events | 1 / 256 | not stated; safety; registry:adverse_events |
Pancreatic cancer (5 lines; O38)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 112 | not stated; safety; pancreatic carcinoma; registry:adverse_events | ||||
| A2 | events | 0 / 110 | not stated; safety; pancreatic carcinoma; registry:adverse_events | ||||
| A3 | events | 0 / 100 | not stated; safety; pancreatic carcinoma; registry:adverse_events | ||||
| A4 | events | 0 / 256 | not stated; safety; pancreatic carcinoma; registry:adverse_events | ||||
| A5 | events | 1 / 256 | not stated; safety; pancreatic carcinoma; registry:adverse_events |