parallel randomized trial
PIONEER 8
Efficacy and Safety of Oral Semaglutide Versus Placebo in Subjects With Type 2 Diabetes Mellitus Treated With Insulin. A 52-week, Randomised, Double-blind, Placebo-controlled Trial (PIONEER 8 - Insulin add-on)
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | Semaglutide 3 mg oral once daily (original tablet) Oral semaglutide 3 mg | insulin with or without metformin; lifestyle: not reported | 184 | 184 | |
| A2 | Semaglutide 7 mg oral once daily (original tablet) Oral semaglutide 7 mg | insulin with or without metformin; lifestyle: not reported | 182 | 182 | |
| A3 | Semaglutide 14 mg oral once daily (original tablet) Oral semaglutide 14 mg | insulin with or without metformin; lifestyle: not reported | 181 | 181 | |
| A4 | Placebo Placebo | insulin with or without metformin; lifestyle: not reported | 184 | 184 |
Baseline characteristics
As printed in the trial reports or registry, per arm or for the whole trial.
| Characteristic | Statistic | Semaglutide 3 mg oral once daily (original tablet) A1 | Semaglutide 7 mg oral once daily (original tablet) A2 | Semaglutide 14 mg oral once daily (original tablet) A3 | Placebo A4 | Whole trial ALL |
|---|---|---|---|---|---|---|
| age | mean (years) | 61 | 60 | 61 | 60 | |
| age | sd (years) | 9 | 10 | 10 | 10 | |
| asian | n | 66 | 66 | 66 | 65 | |
| black | n | 15 | 10 | 11 | 13 | |
| bmi: 25 to less than 30 | n | 217 | ||||
| bmi: 30 to less than 35 | n | 199 | ||||
| bmi: 35 or more | n | 176 | ||||
| bmi: less than 25 | n | 139 | ||||
| diabetes duration: 10 or more | n | 517 | ||||
| diabetes duration: 5 to less than 10 | n | 145 | ||||
| diabetes duration: less than 5 | n | 69 | ||||
| female | n | 82 | 79 | 96 | 79 | |
| hba1c | mean (percent) | 8.2 | 8.2 | 8.2 | 8.2 | |
| hba1c | sd (percent) | 0.7 | 0.7 | 0.7 | 0.7 | |
| hispanic | n | 18 | 24 | 30 | 25 | |
| other race american indian alaska native | n | 1 | 0 | 1 | 0 | |
| other race native hawaiian pacific islander | n | 0 | 0 | 0 | 0 | |
| other race not applicable | n | 12 | 10 | 8 | 8 | |
| other race other | n | 1 | 1 | 1 | 0 | |
| white | n | 89 | 95 | 94 | 98 |
Analyses this trial contributes to
- 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 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
- SF-36 physical component summary changeType 2 diabetes (adults); weeks 20 to 130 (target week 52); network meta-analysis
- SF-36 physical component summary changeType 2 diabetes (adults); weeks 20 to 130 (target week 52); network meta-analysis
- Serious adverse eventsType 2 diabetes (adults); longest follow-up; network meta-analysis
- Serious adverse eventsType 2 diabetes (adults); longest follow-up; network meta-analysis
- NauseaType 2 diabetes (adults); longest follow-up; network meta-analysis
- NauseaType 2 diabetes (adults); longest follow-up; network meta-analysis
- 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
169 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
HbA1c change (27 lines; O01)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26 | A1 | change | -0.6 percent | 1.1 | 184 | hypothetical; full analysis; registry:outcomes | |
| 26 | A1 vs A4 | md | -0.6 percent | -0.7 to -0.4 | hypothetical; full analysis; registry:outcomes | ||
| 26 | A1 | change | -0.5 percent | 1.0 | 184 | treatment policy; full analysis; registry:outcomes | |
| 26 | A1 vs A4 | md | -0.5 percent | -0.7 to -0.3 | treatment policy; full analysis; registry:outcomes | ||
| 26 | A2 vs A4 | md | -1.0 percent | -1.2 to -0.8 | hypothetical; full analysis; registry:outcomes | ||
| 26 | A2 | change | -1.0 percent | 1.1 | 182 | treatment policy; full analysis; registry:outcomes | |
| 26 | A2 vs A4 | md | -0.9 percent | -1.1 to -0.7 | treatment policy; full analysis; registry:outcomes | ||
| 26 | A2 | change | -1.1 percent | 1.0 | 182 | hypothetical; full analysis; registry:outcomes | |
| 26 | A3 | change | -1.4 percent | 0.9 | 181 | hypothetical; full analysis; registry:outcomes | |
| 26 | A3 | change | -1.3 percent | 1.1 | 181 | treatment policy; full analysis; registry:outcomes | |
| 26 | A3 vs A4 | md | -1.2 percent | -1.4 to -1.0 | treatment policy; full analysis; registry:outcomes | ||
| 26 | A3 vs A4 | md | -1.4 percent | -1.6 to -1.2 | hypothetical; full analysis; registry:outcomes | ||
| 26 | A4 | change | -0.1 percent | 0.8 | 184 | hypothetical; full analysis; registry:outcomes | |
| 26 | A4 | change | -0.1 percent | 0.9 | 184 | treatment policy; full analysis; registry:outcomes | |
| 52 | A1 | change | -0.6 percent | 1.0 | 173 | not stated; full analysis; registry:outcomes | |
| 52 | A2 | change | -0.9 percent | 1.1 | 169 | not stated; full analysis; registry:outcomes | |
| 52 | A3 | change | -1.2 percent | 1.0 | 168 | not stated; full analysis; registry:outcomes | |
| 52 | A3 | change | -1.5 percent | hypothetical; other; race:asian; R0008864:Table 1 | |||
| 52 | A3 vs A4 | md | -1.9 percent | -2.2 to -1.5 | hypothetical; other; race:asian; R0008864:Table 1 | ||
| 52 | A3 | change | -0.6 percent | hypothetical; other; race:black; R0008864:Table 1 | |||
| 52 | A3 vs A4 | md | -0.6 percent | -1.7 to 0.4 | hypothetical; other; race:black; R0008864:Table 1 | ||
| 52 | A3 | change | -1.1 percent | hypothetical; other; race:white; R0008864:Table 1 | |||
| 52 | A3 vs A4 | md | -0.9 percent | -1.1 to -0.8 | hypothetical; other; race:white; R0008864:Table 1 | ||
| 52 | A4 | change | -0.2 percent | 0.8 | 172 | not stated; full analysis; registry:outcomes | |
| 52 | A4 | change | 0.3 percent | hypothetical; other; race:asian; R0008864:Table 1 | |||
| 52 | A4 | change | 0.0 percent | hypothetical; other; race:black; R0008864:Table 1 | |||
| 52 | A4 | change | -0.1 percent | hypothetical; other; race:white; R0008864:Table 1 |
Body weight change in kilograms (diabetes) (18 lines; O02)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26 | A1 vs A4 | md | -0.9 kg | -1.8 to -0.0 | treatment policy; full analysis; registry:outcomes | ||
| 26 | A1 | change | -1.5 kg | 3.1 | 184 | hypothetical; full analysis; registry:outcomes | |
| 26 | A1 vs A4 | md | -0.9 kg | -1.6 to -0.2 | hypothetical; full analysis; registry:outcomes | ||
| 26 | A1 | change | -1.4 kg | 3.1 | 184 | treatment policy; full analysis; registry:outcomes | |
| 26 | A2 | change | -3.0 kg | 3.7 | 182 | hypothetical; full analysis; registry:outcomes | |
| 26 | A2 | change | -2.6 kg | 5.2 | 182 | treatment policy; full analysis; registry:outcomes | |
| 26 | A2 vs A4 | md | -2.0 kg | -3.0 to -1.0 | treatment policy; full analysis; registry:outcomes | ||
| 26 | A2 vs A4 | md | -2.5 kg | -3.2 to -1.8 | hypothetical; full analysis; registry:outcomes | ||
| 26 | A3 vs A4 | md | -3.3 kg | -4.2 to -2.3 | treatment policy; full analysis; registry:outcomes | ||
| 26 | A3 | change | -3.9 kg | 3.6 | 181 | hypothetical; full analysis; registry:outcomes | |
| 26 | A3 vs A4 | md | -3.7 kg | -4.4 to -3.0 | hypothetical; full analysis; registry:outcomes | ||
| 26 | A3 | change | -3.7 kg | 4.0 | 181 | treatment policy; full analysis; registry:outcomes | |
| 26 | A4 | change | -0.5 kg | 2.5 | 184 | treatment policy; full analysis; registry:outcomes | |
| 26 | A4 | change | -0.5 kg | 2.4 | 184 | hypothetical; full analysis; registry:outcomes | |
| 52 | A1 | change | -0.9 kg | 3.9 | 174 | not stated; full analysis; registry:outcomes | |
| 52 | A2 | change | -2.2 kg | 5.2 | 171 | not stated; full analysis; registry:outcomes | |
| 52 | A3 | change | -3.8 kg | 5.8 | 170 | not stated; full analysis; registry:outcomes | |
| 52 | A4 | change | 0.5 kg | 3.2 | 173 | not stated; full analysis; registry:outcomes |
HbA1c below 7 percent (8 lines; O03)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26 | A1 | responders | 50 / 184 | not stated; full analysis; registry:outcomes | |||
| 26 | A2 | responders | 74 / 182 | not stated; full analysis; registry:outcomes | |||
| 26 | A3 | responders | 101 / 181 | not stated; full analysis; registry:outcomes | |||
| 26 | A4 | responders | 12 / 184 | not stated; full analysis; registry:outcomes | |||
| 52 | A1 | responders | 50 / 184 | not stated; full analysis; registry:outcomes | |||
| 52 | A2 | responders | 67 / 182 | not stated; full analysis; registry:outcomes | |||
| 52 | A3 | responders | 91 / 181 | not stated; full analysis; registry:outcomes | |||
| 52 | A4 | responders | 16 / 184 | not stated; full analysis; registry:outcomes |
Level 2 or 3 hypoglycemia (participants) (4 lines; O04)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 52 / 184 | not stated; safety; registry:outcomes | ||||
| A2 | events | 47 / 181 | not stated; safety; registry:outcomes | ||||
| A3 | events | 48 / 181 | not stated; safety; registry:outcomes | ||||
| A4 | events | 54 / 184 | not stated; safety; registry:outcomes |
Systolic blood pressure change (8 lines; O05)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26 | A1 | change | -1 mmHg | 12 | 184 | not stated; safety; registry:outcomes | |
| 26 | A2 | change | -3 mmHg | 17 | 181 | not stated; safety; registry:outcomes | |
| 26 | A3 | change | -5 mmHg | 14 | 181 | not stated; safety; registry:outcomes | |
| 26 | A4 | change | 1 mmHg | 14 | 184 | not stated; safety; registry:outcomes | |
| 52 | A1 | change | -1 mmHg | 12 | 184 | not stated; safety; registry:outcomes | |
| 52 | A2 | change | -3 mmHg | 16 | 181 | not stated; safety; registry:outcomes | |
| 52 | A3 | change | -6 mmHg | 14 | 181 | not stated; safety; registry:outcomes | |
| 52 | A4 | change | 0 mmHg | 14 | 184 | not stated; safety; registry:outcomes |
Percent body weight change (8 lines; O10)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26 | A1 | percent change | -1.73 percent | 3.34 | 184 | not stated; full analysis; registry:outcomes | |
| 26 | A2 | percent change | -3.11 percent | 5.66 | 182 | not stated; full analysis; registry:outcomes | |
| 26 | A3 | percent change | -4.30 percent | 4.57 | 181 | not stated; full analysis; registry:outcomes | |
| 26 | A4 | percent change | -0.47 percent | 3.02 | 184 | not stated; full analysis; registry:outcomes | |
| 52 | A1 | percent change | -1.18 percent | 4.17 | 184 | not stated; full analysis; registry:outcomes | |
| 52 | A2 | percent change | -2.54 percent | 5.77 | 182 | not stated; full analysis; registry:outcomes | |
| 52 | A3 | percent change | -4.42 percent | 6.07 | 181 | not stated; full analysis; registry:outcomes | |
| 52 | A4 | percent change | 0.65 percent | 3.72 | 184 | not stated; full analysis; registry:outcomes |
Weight loss of 5 percent or more (8 lines; O11A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26 | A1 | responders | 23 / 184 | not stated; full analysis; registry:outcomes | |||
| 26 | A2 | responders | 53 / 182 | not stated; full analysis; registry:outcomes | |||
| 26 | A3 | responders | 67 / 181 | not stated; full analysis; registry:outcomes | |||
| 26 | A4 | responders | 5 / 184 | not stated; full analysis; registry:outcomes | |||
| 52 | A1 | responders | 30 / 184 | not stated; full analysis; registry:outcomes | |||
| 52 | A2 | responders | 48 / 182 | not stated; full analysis; registry:outcomes | |||
| 52 | A3 | responders | 67 / 181 | not stated; full analysis; registry:outcomes | |||
| 52 | A4 | responders | 9 / 184 | not stated; full analysis; registry:outcomes |
Weight loss of 10 percent or more (8 lines; O11B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26 | A1 | responders | 2 / 184 | not stated; full analysis; registry:outcomes | |||
| 26 | A2 | responders | 12 / 182 | not stated; full analysis; registry:outcomes | |||
| 26 | A3 | responders | 19 / 181 | not stated; full analysis; registry:outcomes | |||
| 26 | A4 | responders | 1 / 184 | not stated; full analysis; registry:outcomes | |||
| 52 | A1 | responders | 4 / 184 | not stated; full analysis; registry:outcomes | |||
| 52 | A2 | responders | 17 / 182 | not stated; full analysis; registry:outcomes | |||
| 52 | A3 | responders | 21 / 181 | not stated; full analysis; registry:outcomes | |||
| 52 | A4 | responders | 1 / 184 | not stated; full analysis; registry:outcomes |
Acute kidney injury (4 lines; O121)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 1 / 184 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 0 / 181 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 1 / 181 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 0 / 184 | not stated; safety; registry:adverse_events |
All cause mortality (4 lines; O20)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 184 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 0 / 181 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 3 / 181 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 0 / 184 | not stated; safety; registry:adverse_events |
SF-36 physical component summary change (8 lines; O24A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26 | A1 | change | 0.94 points | 6.20 | 184 | not stated; full analysis; registry:outcomes | |
| 26 | A2 | change | 0.75 points | 6.27 | 182 | not stated; full analysis; registry:outcomes | |
| 26 | A3 | change | -0.02 points | 4.81 | 181 | not stated; full analysis; registry:outcomes | |
| 26 | A4 | change | -0.05 points | 6.07 | 184 | not stated; full analysis; registry:outcomes | |
| 52 | A1 | change | 0.26 points | 6.78 | 184 | not stated; full analysis; registry:outcomes | |
| 52 | A2 | change | 0.12 points | 6.24 | 182 | not stated; full analysis; registry:outcomes | |
| 52 | A3 | change | -0.36 points | 6.09 | 181 | not stated; full analysis; registry:outcomes | |
| 52 | A4 | change | -0.41 points | 6.54 | 184 | not stated; full analysis; registry:outcomes |
Physical functioning (any instrument) (16 lines; O24B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26 | A1 | change | 1.88 points | 18.64 | 184 | not stated; full analysis; registry:outcomes | |
| 26 | A1 | change | 0.53 points | 7.58 | 184 | not stated; full analysis; registry:outcomes | |
| 26 | A2 | change | -0.35 points | 16.28 | 182 | not stated; full analysis; registry:outcomes | |
| 26 | A2 | change | 0.52 points | 6.61 | 182 | not stated; full analysis; registry:outcomes | |
| 26 | A3 | change | 2.51 points | 15.94 | 181 | not stated; full analysis; registry:outcomes | |
| 26 | A3 | change | -0.07 points | 6.75 | 181 | not stated; full analysis; registry:outcomes | |
| 26 | A4 | change | -1.70 points | 15.12 | 184 | not stated; full analysis; registry:outcomes | |
| 26 | A4 | change | -0.82 points | 7.25 | 184 | not stated; full analysis; registry:outcomes | |
| 52 | A1 | change | 3.45 points | 19.79 | 184 | not stated; full analysis; registry:outcomes | |
| 52 | A1 | change | 0.51 points | 8.27 | 184 | not stated; full analysis; registry:outcomes | |
| 52 | A2 | change | -0.59 points | 15.85 | 182 | not stated; full analysis; registry:outcomes | |
| 52 | A2 | change | -0.40 points | 6.69 | 182 | not stated; full analysis; registry:outcomes | |
| 52 | A3 | change | 2.59 points | 16.02 | 181 | not stated; full analysis; registry:outcomes | |
| 52 | A3 | change | -0.32 points | 7.55 | 181 | not stated; full analysis; registry:outcomes | |
| 52 | A4 | change | -0.98 points | 17.33 | 184 | not stated; full analysis; registry:outcomes | |
| 52 | A4 | change | -0.77 points | 6.31 | 184 | not stated; full analysis; registry:outcomes |
Health related quality of life total score (any instrument) (8 lines; O24C)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26 | A1 | change | 1.74 points | 13.37 | 184 | not stated; full analysis; registry:outcomes | |
| 26 | A2 | change | -0.45 points | 12.47 | 182 | not stated; full analysis; registry:outcomes | |
| 26 | A3 | change | 3.41 points | 12.19 | 181 | not stated; full analysis; registry:outcomes | |
| 26 | A4 | change | -0.94 points | 10.40 | 184 | not stated; full analysis; registry:outcomes | |
| 52 | A1 | change | 2.35 points | 14.50 | 184 | not stated; full analysis; registry:outcomes | |
| 52 | A2 | change | -0.79 points | 12.47 | 182 | not stated; full analysis; registry:outcomes | |
| 52 | A3 | change | 4.35 points | 13.82 | 181 | not stated; full analysis; registry:outcomes | |
| 52 | A4 | change | -0.73 points | 13.50 | 184 | not stated; full analysis; registry:outcomes |
Serious adverse events (4 lines; O25)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 25 / 184 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 19 / 181 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 12 / 181 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 17 / 184 | not stated; safety; registry:adverse_events |
Nausea (8 lines; O27A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 21 / 184 | not stated; safety; registry:adverse_events | ||||
| A1 | events | 0 / 184 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 30 / 181 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 0 / 181 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 41 / 181 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 2 / 181 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 13 / 184 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 0 / 184 | not stated; safety; registry:adverse_events |
Vomiting (8 lines; O27B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 11 / 184 | not stated; safety; registry:adverse_events | ||||
| A1 | events | 0 / 184 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 14 / 181 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 0 / 181 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 17 / 181 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 2 / 181 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 7 / 184 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 0 / 184 | not stated; safety; registry:adverse_events |
Diarrhea (8 lines; O27C)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 16 / 184 | not stated; safety; registry:adverse_events | ||||
| A1 | events | 0 / 184 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 22 / 181 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 0 / 181 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 26 / 181 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 1 / 181 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 11 / 184 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 0 / 184 | not stated; safety; registry:adverse_events |
Constipation (4 lines; O27D)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 8 / 184 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 15 / 181 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 12 / 181 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 5 / 184 | not stated; safety; registry:adverse_events |
Gallbladder and biliary disease (4 lines; O28)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 1 / 184 | not stated; safety; cholelithiasis; registry:adverse_events | ||||
| A2 | events | 1 / 181 | not stated; safety; cholelithiasis; registry:adverse_events | ||||
| A3 | events | 0 / 181 | not stated; safety; cholelithiasis; registry:adverse_events | ||||
| A4 | events | 0 / 184 | not stated; safety; cholelithiasis; registry:adverse_events |
Suicidal ideation or behavior (4 lines; O35A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 184 | not stated; safety; Depression suicidal; registry:adverse_events | ||||
| A2 | events | 0 / 181 | not stated; safety; Depression suicidal; registry:adverse_events | ||||
| A3 | events | 0 / 181 | not stated; safety; Depression suicidal; registry:adverse_events | ||||
| A4 | events | 1 / 184 | not stated; safety; Depression suicidal; registry:adverse_events |