parallel randomized trial
NCT01126580
The Impact of LY2189265 Versus Metformin on Glycemic Control in Early Type 2 Diabetes Mellitus (AWARD-3: Assessment of Weekly AdministRation of LY2189265 in Diabetes-3)
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | Dulaglutide 1.5 mg subcutaneous once weekly Dulaglutide 1.5 mg | none (oral placebo); lifestyle: not reported | 269 | 265 | |
| A2 | Dulaglutide 0.75 mg subcutaneous once weekly Dulaglutide 0.75 mg | none (oral placebo); lifestyle: not reported | 270 | 265 | |
| A3 | Metformin Metformin | none (injectable placebo); lifestyle: not reported | 268 | 265 |
Baseline characteristics
As printed in the trial reports or registry, per arm or for the whole trial.
| Characteristic | Statistic | Dulaglutide 1.5 mg subcutaneous once weekly A1 | Dulaglutide 0.75 mg subcutaneous once weekly A2 | Metformin A3 | Whole trial ALL |
|---|---|---|---|---|---|
| age: under 65 | n | 664 | |||
| age: under 65 | percent | 82.3 | |||
| age | mean (years) | 55.51 | 55.90 | 55.26 | |
| age | sd (years) | 10.38 | 10.68 | 10.10 | |
| asian | n | 21 | 20 | 20 | |
| black | n | 17 | 22 | 14 | |
| bmi | mean (kg/m2) | 33.66 | 33.08 | 33.05 | |
| bmi | sd (kg/m2) | 5.65 | 5.84 | 5.06 | |
| diabetes duration | mean (years) | 2.65 | 2.60 | 2.63 | |
| diabetes duration | sd (years) | 1.50 | 2.17 | 1.77 | |
| egfr: less than 60 | n | 30 | |||
| egfr: less than 60 | percent | 3.7 | |||
| female | n | 155 | 152 | 147 | |
| hba1c | mean (percent) | 7.63 | 7.58 | 7.60 | |
| hba1c | sd (percent) | 0.92 | 0.87 | 0.82 | |
| hispanic | n | 90 | 87 | 95 | |
| other egfr lt60 | n | 30 | |||
| other egfr lt60 | percent | 3.7 | |||
| other fbg | mean (mmol/L) | 9.0 | |||
| other macroalbuminuria | n | 20 | |||
| other macroalbuminuria | percent | 2.5 | |||
| other multiple races | n | 1 | 2 | 4 | |
| other race american indian alaska native | n | 29 | 28 | 28 | |
| other race native hawaiian pacific islander | n | 0 | 0 | 1 | |
| weight | mean (kg) | 92.67 | 91.79 | 92.40 | |
| weight | sd (kg) | 18.79 | 18.67 | 19.23 | |
| white | n | 201 | 198 | 201 |
Analyses this trial contributes to
- HbA1c changeType 2 diabetes (adults); weeks 20 to 36 (target week 26); descriptive only
- HbA1c changeType 2 diabetes (adults); weeks 20 to 36 (target week 26); descriptive only
- HbA1c changeType 2 diabetes (adults); weeks 36 to 64 (target week 52); descriptive only
- HbA1c changeType 2 diabetes (adults); weeks 36 to 64 (target week 52); descriptive only
- 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
- Body weight change in kilograms (diabetes)Type 2 diabetes (adults); weeks 36 to 64 (target week 52); 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
- 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 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 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
- 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
- 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
- Acute pancreatitisType 2 diabetes (adults); longest follow-up; network meta-analysis
- Acute pancreatitisType 2 diabetes (adults); longest follow-up; network meta-analysis
Results
140 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
HbA1c change (33 lines; O01)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26 | A1 vs A3 | md | -0.22 percent | -0.36 to -0.08 | hypothetical; modified itt; registry:outcomes | ||
| 26 | A1 | change | -0.78 percent | 0.06 | 265 | hypothetical; modified itt; registry:outcomes | |
| 26 | A1 | change | -0.78 percent | 269 | not stated; modified itt; R0022281:Table 3 | ||
| 26 | A2 | change | -0.71 percent | 270 | not stated; modified itt; R0022281:Table 3 | ||
| 26 | A2 | change | -0.71 percent | 0.06 | 265 | hypothetical; modified itt; registry:outcomes | |
| 26 | A2 vs A3 | md | -0.15 percent | -0.29 to -0.01 | hypothetical; modified itt; registry:outcomes | ||
| 26 | A3 | change | -0.56 percent | 268 | not stated; modified itt; R0022281:Table 3 | ||
| 26 | A3 | change | -0.56 percent | 0.06 | 265 | hypothetical; modified itt; registry:outcomes | |
| 26.07 | A1 | change | -0.74 percent | -0.90 to -0.57 | 112 | not stated; modified itt; sex:male; R0014882:Supplement Table S3 | |
| 26.07 | A1 | change | -0.81 percent | -0.96 to -0.66 | 153 | not stated; modified itt; sex:female; R0014882:Supplement Table S3 | |
| 26.07 | A1 | change | -0.66 percent | -1.14 to -0.18 | 13 | not stated; modified itt; diabetes_duration:>=5_<10; R0014882:Supplement Table S3 | |
| 26.07 | A1 | change | -1.22 percent | -1.47 to -0.96 | 48 | not stated; modified itt; hba1c:>=8.5; R0014882:Supplement Table S3 | |
| 26.07 | A1 | change | -0.67 percent | -0.80 to -0.54 | 217 | not stated; modified itt; hba1c:<8.5; R0014882:Supplement Table S3 | |
| 26.07 | A1 | change | -0.71 percent | -0.84 to -0.58 | 252 | not stated; modified itt; diabetes_duration:<5; R0014882:Supplement Table S3 | |
| 26.07 | A2 | change | -0.67 percent | -0.83 to -0.51 | 117 | not stated; modified itt; sex:male; R0014882:Supplement Table S3 | |
| 26.07 | A2 | change | -0.64 percent | -0.77 to -0.51 | 254 | not stated; modified itt; diabetes_duration:<5; R0014882:Supplement Table S3 | |
| 26.07 | A2 | change | -0.51 percent | -1.49 to 0.47 | 3 | not stated; modified itt; diabetes_duration:>=10; R0014882:Supplement Table S3 | |
| 26.07 | A2 | change | -0.62 percent | -1.21 to -0.02 | 8 | not stated; modified itt; diabetes_duration:>=5_<10; R0014882:Supplement Table S3 | |
| 26.07 | A2 | change | -0.53 percent | -0.67 to -0.40 | 220 | not stated; modified itt; hba1c:<8.5; R0014882:Supplement Table S3 | |
| 26.07 | A2 | change | -1.37 percent | -1.63 to -1.10 | 45 | not stated; modified itt; hba1c:>=8.5; R0014882:Supplement Table S3 | |
| 26.07 | A2 | change | -0.74 percent | -0.89 to -0.59 | 148 | not stated; modified itt; sex:female; R0014882:Supplement Table S3 | |
| 26.07 | A3 | change | -0.48 percent | -0.61 to -0.35 | not stated; modified itt; diabetes_duration:<5; R0014882:Supplement Table S3 | ||
| 26.07 | A3 | change | -0.56 percent | -0.72 to -0.40 | not stated; modified itt; sex:male; R0014882:Supplement Table S3 | ||
| 26.07 | A3 | change | -0.42 percent | -0.55 to -0.29 | not stated; modified itt; hba1c:<8.5; R0014882:Supplement Table S3 | ||
| 26.07 | A3 | change | -0.56 percent | -0.71 to -0.41 | not stated; modified itt; sex:female; R0014882:Supplement Table S3 | ||
| 26.07 | A3 | change | -0.52 percent | -0.91 to -0.13 | not stated; modified itt; diabetes_duration:>=5_<10; R0014882:Supplement Table S3 | ||
| 26.07 | A3 | change | -0.64 percent | -2.37 to 1.09 | not stated; modified itt; diabetes_duration:>=10; R0014882:Supplement Table S3 | ||
| 26.07 | A3 | change | -1.04 percent | -1.29 to -0.79 | not stated; modified itt; hba1c:>=8.5; R0014882:Supplement Table S3 | ||
| 52 | A1 | change | -0.70 percent | 0.07 | 265 | hypothetical; modified itt; registry:outcomes | |
| 52 | A1 vs A3 | md | -0.19 percent | -0.35 to -0.02 | hypothetical; modified itt; registry:outcomes | ||
| 52 | A2 | change | -0.55 percent | 0.07 | 265 | hypothetical; modified itt; registry:outcomes | |
| 52 | A2 vs A3 | md | -0.04 percent | -0.20 to 0.12 | hypothetical; modified itt; registry:outcomes | ||
| 52 | A3 | change | -0.51 percent | 0.07 | 265 | hypothetical; modified itt; registry:outcomes |
Body weight change in kilograms (diabetes) (29 lines; O02)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26 | A1 | change | -2.29 kg | 0.24 | 267 | hypothetical; modified itt; registry:outcomes | |
| 26 | A1 | change | -2.29 kg | 269 | not stated; modified itt; R0022281:Table 3 | ||
| 26 | A2 | change | -1.36 kg | 0.24 | 269 | hypothetical; modified itt; registry:outcomes | |
| 26 | A2 | change | -1.36 kg | 270 | not stated; modified itt; R0022281:Table 3 | ||
| 26 | A3 | change | -2.22 kg | 268 | not stated; modified itt; R0022281:Table 3 | ||
| 26 | A3 | change | -2.22 kg | 0.24 | 267 | hypothetical; modified itt; registry:outcomes | |
| 26.07 | A1 | change | -1.97 kg | -2.95 to -0.99 | not stated; modified itt; hba1c:>=8.5; R0014882:Table 2 | ||
| 26.07 | A1 | change | -1.84 kg | -2.41 to -1.28 | not stated; modified itt; diabetes_duration:<5; R0014882:Table 2 | ||
| 26.07 | A1 | change | -2.71 kg | -3.31 to -2.11 | not stated; modified itt; sex:female; R0014882:Table 2 | ||
| 26.07 | A1 | change | -1.77 kg | -2.44 to -1.11 | not stated; modified itt; sex:male; R0014882:Table 2 | ||
| 26.07 | A1 | change | -2.15 kg | -4.00 to -0.29 | not stated; modified itt; diabetes_duration:>=5_<10; R0014882:Table 2 | ||
| 26.07 | A1 | change | -2.36 kg | -2.87 to -1.84 | not stated; modified itt; hba1c:<8.5; R0014882:Table 2 | ||
| 26.07 | A2 | change | -1.37 kg | -1.88 to -0.86 | not stated; modified itt; hba1c:<8.5; R0014882:Table 2 | ||
| 26.07 | A2 | change | -0.88 kg | -1.43 to -0.32 | not stated; modified itt; diabetes_duration:<5; R0014882:Table 2 | ||
| 26.07 | A2 | change | -1.77 kg | -5.65 to 2.10 | not stated; modified itt; diabetes_duration:>=10; R0014882:Table 2 | ||
| 26.07 | A2 | change | -2.05 kg | -4.28 to 0.19 | not stated; modified itt; diabetes_duration:>=5_<10; R0014882:Table 2 | ||
| 26.07 | A2 | change | -1.29 kg | -2.27 to -0.30 | not stated; modified itt; hba1c:>=8.5; R0014882:Table 2 | ||
| 26.07 | A2 | change | -1.75 kg | -2.35 to -1.16 | not stated; modified itt; sex:female; R0014882:Table 2 | ||
| 26.07 | A2 | change | -0.91 kg | -1.56 to -0.26 | not stated; modified itt; sex:male; R0014882:Table 2 | ||
| 26.07 | A3 | change | -3.98 kg | -10.8 to 2.87 | not stated; modified itt; diabetes_duration:>=10; R0014882:Table 2 | ||
| 26.07 | A3 | change | -2.38 kg | -2.89 to -1.86 | not stated; modified itt; hba1c:<8.5; R0014882:Table 2 | ||
| 26.07 | A3 | change | -2.53 kg | -3.12 to -1.93 | not stated; modified itt; sex:female; R0014882:Table 2 | ||
| 26.07 | A3 | change | -1.90 kg | -2.56 to -1.24 | not stated; modified itt; sex:male; R0014882:Table 2 | ||
| 26.07 | A3 | change | -1.82 kg | -2.37 to -1.27 | not stated; modified itt; diabetes_duration:<5; R0014882:Table 2 | ||
| 26.07 | A3 | change | -1.56 kg | -2.52 to -0.60 | not stated; modified itt; hba1c:>=8.5; R0014882:Table 2 | ||
| 26.07 | A3 | change | -1.47 kg | -3.04 to 0.09 | not stated; modified itt; diabetes_duration:>=5_<10; R0014882:Table 2 | ||
| 52 | A1 | change | -1.93 kg | 0.29 | 267 | hypothetical; modified itt; registry:outcomes | |
| 52 | A2 | change | -1.09 kg | 0.29 | 269 | hypothetical; modified itt; registry:outcomes | |
| 52 | A3 | change | -2.20 kg | 0.29 | 267 | hypothetical; modified itt; registry:outcomes |
HbA1c below 7 percent (9 lines; O03)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26 | A1 | responders | 61.5 | 265 | hypothetical; modified itt; registry:outcomes | ||
| 26 | A1 | responders | 61.5 | 269 | not stated; modified itt; R0022281:Table 3 | ||
| 26 | A2 | responders | 62.6 | 270 | not stated; modified itt; R0022281:Table 3 | ||
| 26 | A2 | responders | 62.6 | 265 | hypothetical; modified itt; registry:outcomes | ||
| 26 | A3 | responders | 53.6 | 268 | not stated; modified itt; R0022281:Table 3 | ||
| 26 | A3 | responders | 53.6 | 265 | hypothetical; modified itt; registry:outcomes | ||
| 52 | A1 | responders | 60.0 | 265 | hypothetical; modified itt; registry:outcomes | ||
| 52 | A2 | responders | 53.2 | 265 | hypothetical; modified itt; registry:outcomes | ||
| 52 | A3 | responders | 48.3 | 265 | hypothetical; modified itt; registry:outcomes |
Level 2 or 3 hypoglycemia (participants) (6 lines; O04)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 214 | hypothetical; safety; registry:outcomes | ||||
| A1 | events | 0 | 269 | not stated; modified itt; R0022281:Table 3 | |||
| A2 | events | 0 / 217 | hypothetical; safety; registry:outcomes | ||||
| A2 | events | 0.4 | 270 | not stated; modified itt; R0022281:Table 3 | |||
| A3 | events | 0 / 199 | hypothetical; safety; registry:outcomes | ||||
| A3 | events | 1.1 | 268 | not stated; modified itt; R0022281:Table 3 |
Systolic blood pressure change (6 lines; O05)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26 | A1 | change | -1.89 mmHg | 0.89 | 244 | not stated; modified itt; registry:outcomes | |
| 26 | A2 | change | -2.61 mmHg | 0.88 | 251 | not stated; modified itt; registry:outcomes | |
| 26 | A3 | change | -0.91 mmHg | 0.89 | 239 | not stated; modified itt; registry:outcomes | |
| 52 | A1 | change | -0.11 mmHg | 0.88 | 221 | not stated; modified itt; registry:outcomes | |
| 52 | A2 | change | -2.74 mmHg | 0.88 | 219 | not stated; modified itt; registry:outcomes | |
| 52 | A3 | change | -0.98 mmHg | 0.88 | 215 | not stated; modified itt; registry:outcomes |
Physical functioning (any instrument) (6 lines; O24B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26 | A1 | change | 0.09 points | 0.33 | 247 | hypothetical; modified itt; registry:outcomes | |
| 26 | A2 | change | 0.19 points | 0.32 | 251 | hypothetical; modified itt; registry:outcomes | |
| 26 | A3 | change | 0.02 points | 0.32 | 247 | hypothetical; modified itt; registry:outcomes | |
| 52 | A1 | change | 0.39 points | 0.33 | 247 | hypothetical; modified itt; registry:outcomes | |
| 52 | A2 | change | -0.05 points | 0.33 | 252 | hypothetical; modified itt; registry:outcomes | |
| 52 | A3 | change | 0.28 points | 0.33 | 248 | hypothetical; modified itt; registry:outcomes |
Health related quality of life total score (any instrument) (6 lines; O24C)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26 | A1 | change | 1.93 points | 0.39 | 244 | hypothetical; modified itt; registry:outcomes | |
| 26 | A2 | change | 1.81 points | 0.38 | 249 | hypothetical; modified itt; registry:outcomes | |
| 26 | A3 | change | 2.04 points | 0.39 | 241 | hypothetical; modified itt; registry:outcomes | |
| 52 | A1 | change | 1.82 points | 0.44 | 245 | hypothetical; modified itt; registry:outcomes | |
| 52 | A2 | change | 1.29 points | 0.43 | 251 | hypothetical; modified itt; registry:outcomes | |
| 52 | A3 | change | 1.94 points | 0.44 | 244 | hypothetical; modified itt; registry:outcomes |
Serious adverse events (3 lines; O25)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 15 / 269 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 20 / 270 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 16 / 268 | not stated; safety; registry:adverse_events |
Discontinuation due to adverse events (3 lines; O26)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 14 / 269 | not stated; randomized; registry:flow | ||||
| A2 | events | 8 / 270 | not stated; randomized; registry:flow | ||||
| A3 | events | 12 / 268 | not stated; randomized; registry:flow |
Nausea (3 lines; O27A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 53 / 269 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 31 / 270 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 43 / 268 | not stated; safety; registry:adverse_events |
Vomiting (3 lines; O27B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 26 / 269 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 20 / 270 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 14 / 268 | not stated; safety; registry:adverse_events |
Diarrhea (3 lines; O27C)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 31 / 269 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 26 / 270 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 39 / 268 | not stated; safety; registry:adverse_events |
Constipation (6 lines; O27D)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 269 | not stated; safety; registry:adverse_events | ||||
| A1 | events | 18 / 269 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 12 / 270 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 1 / 270 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 3 / 268 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 0 / 268 | 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 / 269 | not stated; safety; cholecystitis chronic; registry:adverse_events | ||||
| A1 | events | 0 / 269 | not stated; safety; gallbladder disorder; registry:adverse_events | ||||
| A1 | events | 1 / 269 | not stated; safety; cholelithiasis; registry:adverse_events | ||||
| A1 | events | 0 / 269 | not stated; safety; cholecystitis acute; registry:adverse_events | ||||
| A1 | events | 0 / 269 | not stated; safety; cholecystitis infective; registry:adverse_events | ||||
| A2 | events | 0 / 270 | not stated; safety; cholecystitis chronic; registry:adverse_events | ||||
| A2 | events | 0 / 270 | not stated; safety; gallbladder disorder; registry:adverse_events | ||||
| A2 | events | 1 / 270 | not stated; safety; cholecystitis acute; registry:adverse_events | ||||
| A2 | events | 1 / 270 | not stated; safety; cholecystitis infective; registry:adverse_events | ||||
| A2 | events | 0 / 270 | not stated; safety; cholelithiasis; registry:adverse_events | ||||
| A3 | events | 1 / 268 | not stated; safety; cholecystitis chronic; registry:adverse_events | ||||
| A3 | events | 0 / 268 | not stated; safety; cholecystitis infective; registry:adverse_events | ||||
| A3 | events | 1 / 268 | not stated; safety; gallbladder disorder; registry:adverse_events | ||||
| A3 | events | 0 / 268 | not stated; safety; cholelithiasis; registry:adverse_events | ||||
| A3 | events | 0 / 268 | not stated; safety; cholecystitis acute; registry:adverse_events |
Acute pancreatitis (3 lines; O29)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 269 | not stated; safety; registry:outcomes | ||||
| A2 | events | 0 / 270 | not stated; safety; registry:outcomes | ||||
| A3 | events | 0 / 268 | not stated; safety; registry:outcomes |
Suicidal ideation or behavior (3 lines; O35A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 269 | not stated; safety; suicidal ideation; registry:adverse_events | ||||
| A2 | events | 0 / 270 | not stated; safety; suicidal ideation; registry:adverse_events | ||||
| A3 | events | 1 / 268 | not stated; safety; suicidal ideation; registry:adverse_events |
Intestinal obstruction or ileus (3 lines; O37B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 269 | not stated; safety; ileus; registry:adverse_events | ||||
| A2 | events | 0 / 270 | not stated; safety; ileus; registry:adverse_events | ||||
| A3 | events | 1 / 268 | not stated; safety; ileus; registry:adverse_events |