parallel randomized trial
NCT04707313
A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-06882961 ADMINISTRATION IN ADULTS WITH OBESITY
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | Placebo Placebo cohorts 1 and 2 | lifestyle: standard | 71 | 71 | 44 |
| A10 | Danuglipron 200 mg oral twice daily Danuglipron 200 mg BID 2 week escalation | lifestyle: standard | 36 | 36 | 13 |
| A11 | Danuglipron 80 mg oral twice daily Danuglipron 80 mg BID 4 week escalation | lifestyle: standard | 37 | 37 | 13 |
| A12 | Danuglipron 140 mg tablet twice daily Danuglipron 140 mg BID 4 week escalation | lifestyle: standard | 37 | 37 | 15 |
| A13 | Danuglipron 200 mg oral twice daily Danuglipron 200 mg BID 4 week escalation | lifestyle: standard | 36 | 36 | 11 |
| A2 | Placebo Placebo cohort 3 | lifestyle: standard | 19 | 19 | 11 |
| A3 | Danuglipron 40 mg oral twice daily Danuglipron 40 mg BID 1 week escalation | lifestyle: standard | 62 | 62 | 27 |
| A4 | Danuglipron 80 mg oral twice daily Danuglipron 80 mg BID 1 week escalation | lifestyle: standard | 64 | 63 | 30 |
| A5 | Danuglipron 120 mg oral twice daily Danuglipron 120 mg BID 1 week escalation | lifestyle: standard | 64 | 64 | 26 |
| A6 | Danuglipron 120 mg oral twice daily Danuglipron 120 mg BID 2 week escalation | lifestyle: standard | 38 | 38 | 13 |
| A7 | Danuglipron 160 mg oral twice daily Danuglipron 160 mg BID 1 week escalation | lifestyle: standard | 63 | 63 | 18 |
| A8 | Danuglipron 160 mg oral twice daily Danuglipron 160 mg BID 2 week escalation | lifestyle: standard | 37 | 37 | 11 |
| A9 | Danuglipron 200 mg oral twice daily Danuglipron 200 mg BID 1 week escalation | lifestyle: standard | 64 | 63 | 14 |
Baseline characteristics
As printed in the trial reports or registry, per arm or for the whole trial.
| Characteristic | Statistic | Placebo A1 | Placebo A2 | Danuglipron 40 mg oral twice daily A3 | Danuglipron 80 mg oral twice daily A4 | Danuglipron 120 mg oral twice daily A5 | Danuglipron 120 mg oral twice daily A6 | Danuglipron 160 mg oral twice daily A7 | Danuglipron 160 mg oral twice daily A8 | Danuglipron 200 mg oral twice daily A9 | Danuglipron 200 mg oral twice daily A10 | Danuglipron 80 mg oral twice daily A11 | Danuglipron 140 mg tablet twice daily A12 | Danuglipron 200 mg oral twice daily A13 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| age | max (years) | 71 | 68 | 73 | 74 | 70 | 74 | 71 | 63 | 72 | 74 | 66 | 64 | 72 |
| age | median (years) | 49 | 48 | 47 | 47 | 52 | 50 | 48 | 45 | 48 | 52 | 49 | 51 | 48 |
| age | min (years) | 23 | 22 | 26 | 18 | 21 | 20 | 19 | 20 | 21 | 26 | 26 | 23 | 25 |
| asian | n | 11 | 0 | 8 | 10 | 8 | 3 | 10 | 2 | 13 | 2 | 0 | 0 | 0 |
| asian | percent | 15 | 13 | 16 | 13 | 8 | 16 | 5 | 21 | 6 | ||||
| black | n | 4 | 3 | 4 | 10 | 11 | 4 | 8 | 5 | 5 | 3 | 8 | 6 | 5 |
| black | percent | 6 | 16 | 6 | 16 | 17 | 11 | 13 | 14 | 8 | 8 | 22 | 16 | 14 |
| bmi | mean (kg/m2) | 38.7 | 40.9 | 38.7 | 38.8 | 37.5 | 39.4 | 38.4 | 38.6 | 38.2 | 40.1 | 39.2 | 39.9 | 40.5 |
| bmi | sd (kg/m2) | 5.7 | 7.8 | 7.0 | 5.9 | 5.1 | 6.5 | 5.8 | 8.1 | 6.4 | 7.0 | 4.7 | 9.3 | 6.4 |
| female | n | 45 | 12 | 40 | 41 | 42 | 22 | 41 | 22 | 41 | 23 | 23 | 23 | 22 |
| female | percent | 63 | 63 | 65 | 65 | 66 | 58 | 65 | 59 | 65 | 64 | 62 | 62 | 61 |
| hba1c | mean (percent) | 5.5 | 5.5 | 5.5 | 5.5 | 5.5 | 5.5 | 5.5 | 5.4 | 5.5 | 5.6 | 5.5 | 5.4 | 5.4 |
| hba1c | sd (percent) | 0.4 | 0.3 | 0.3 | 0.4 | 0.4 | 0.3 | 0.4 | 0.4 | 0.5 | 0.4 | 0.4 | 0.4 | 0.4 |
| hispanic | n | 6 | 0 | 7 | 8 | 7 | 3 | 2 | 4 | 2 | 5 | 2 | 3 | 2 |
| hispanic | percent | 8 | 11 | 13 | 11 | 8 | 3 | 11 | 3 | 14 | 5 | 8 | 6 | |
| other race other or not reported | n | 1 | 0 | 2 | 1 | 0 | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 3 |
| other race other or not reported | percent | 1 | 3 | 2 | 5 | 8 | ||||||||
| sbp | mean (mmHg) | 125.5 | 126.1 | 126.3 | 125.2 | 126.5 | 126.5 | 124.0 | 123.5 | 126.9 | 126.4 | 125.6 | 128.6 | 127.7 |
| sbp | sd (mmHg) | 11.9 | 11.8 | 10.9 | 10.8 | 14.7 | 10.3 | 12.8 | 12.2 | 10.8 | 10.4 | 12.7 | 12.4 | 12.9 |
| waist | mean (cm) | 116.1 | 122.1 | 114.4 | 115.9 | 112.3 | 120.3 | 114.7 | 116.7 | 116.1 | 119.0 | 121.9 | 122.2 | 124.3 |
| waist | sd (cm) | 13.4 | 16.9 | 15.7 | 13.3 | 12.5 | 13.8 | 13.3 | 16.0 | 14.5 | 17.9 | 15.2 | 20.6 | 16.3 |
| weight | mean (kg) | 109.1 | 119.2 | 109.6 | 107.6 | 103.8 | 113.2 | 106.0 | 113.4 | 106.9 | 114.6 | 112.5 | 115.1 | 117.6 |
| weight | sd (kg) | 20.8 | 29.8 | 24.0 | 22.2 | 16.4 | 22.9 | 20.1 | 26.8 | 18.8 | 28.5 | 19.5 | 28.3 | 20.2 |
| white | n | 55 | 16 | 48 | 42 | 45 | 31 | 42 | 30 | 45 | 31 | 29 | 31 | 28 |
| white | percent | 77 | 84 | 77 | 67 | 70 | 82 | 67 | 81 | 71 | 86 | 78 | 84 | 78 |
Analyses this trial contributes to
- Percent body weight changeOverweight or obesity without diabetes (adults); weeks 20 to 40 (target week 26); descriptive only
- Percent body weight changeOverweight or obesity without diabetes (adults); weeks 20 to 40 (target week 26); descriptive only
- Weight loss of 5 percent or moreOverweight or obesity without diabetes (adults); weeks 20 to 40 (target week 26); 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
Results
257 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
Percent body weight change (58 lines; O10)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 20 | A11 | percent change | -5.17 percent | 37 | while on treatment; modified itt; registry:outcomes | ||
| 20 | A12 | percent change | -5.25 percent | 37 | while on treatment; modified itt; registry:outcomes | ||
| 20 | A13 | percent change | -7.10 percent | 36 | while on treatment; modified itt; registry:outcomes | ||
| 20 | A2 | percent change | 0.38 percent | 19 | while on treatment; modified itt; registry:outcomes | ||
| 22 | A1 | percent change | -0.18 percent | 71 | while on treatment; modified itt; registry:outcomes | ||
| 22 | A10 | percent change | -6.60 percent | 36 | while on treatment; modified itt; registry:outcomes | ||
| 22 | A3 | percent change | -5.06 percent | 62 | while on treatment; modified itt; registry:outcomes | ||
| 22 | A4 | percent change | -5.00 percent | 63 | while on treatment; modified itt; registry:outcomes | ||
| 22 | A5 | percent change | -8.10 percent | 64 | while on treatment; modified itt; registry:outcomes | ||
| 22 | A6 | percent change | -6.43 percent | 38 | while on treatment; modified itt; registry:outcomes | ||
| 22 | A7 | percent change | -8.63 percent | 63 | while on treatment; modified itt; registry:outcomes | ||
| 22 | A8 | percent change | -6.57 percent | 37 | while on treatment; modified itt; registry:outcomes | ||
| 22 | A9 | percent change | -8.23 percent | 63 | while on treatment; modified itt; registry:outcomes | ||
| 24 | A11 | percent change | -5.65 percent | 37 | while on treatment; modified itt; registry:outcomes | ||
| 24 | A12 | percent change | -6.39 percent | 37 | while on treatment; modified itt; registry:outcomes | ||
| 24 | A13 | percent change | -9.20 percent | 36 | while on treatment; modified itt; registry:outcomes | ||
| 24 | A2 | percent change | 0.36 percent | 19 | while on treatment; modified itt; registry:outcomes | ||
| 26 | A1 | percent change | 0.2 percent | -1.1 to 1.5 | 71 | while on treatment; modified itt; R0005921:Supplement Table S1 | |
| 26 | A1 | percent change | -0.4 percent | 3.9 | 44 | while on treatment; completers; R0005921:Supplement Table S1 | |
| 26 | A10 | percent change | -7.0 percent | -8.8 to -5.2 | 36 | while on treatment; modified itt; R0005921:Supplement Table S1 | |
| 26 | A10 | percent change | -6.3 percent | 5.1 | 13 | while on treatment; completers; R0005921:Supplement Table S1 | |
| 26 | A10 vs A1 | md | -7.2 percent | -9.3 to -5.0 | while on treatment; modified itt; R0005921:Supplement Table S1 | ||
| 26 | A3 | percent change | -5.4 percent | -6.8 to -4.0 | 62 | while on treatment; modified itt; R0005921:Supplement Table S1 | |
| 26 | A3 | percent change | -6.5 percent | 4.7 | 27 | while on treatment; completers; R0005921:Supplement Table S1 | |
| 26 | A3 vs A1 | md | -5.6 percent | -7.4 to -3.7 | while on treatment; modified itt; R0005921:Supplement Table S1 | ||
| 26 | A4 | percent change | -4.8 percent | -6.2 to -3.5 | 63 | while on treatment; modified itt; R0005921:Supplement Table S1 | |
| 26 | A4 | percent change | -5.1 percent | 5.1 | 30 | while on treatment; completers; R0005921:Supplement Table S1 | |
| 26 | A4 vs A1 | md | -5.0 percent | -6.8 to -3.2 | while on treatment; modified itt; R0005921:Supplement Table S1 | ||
| 26 | A5 | percent change | -8.9 percent | -10.3 to -7.6 | 64 | while on treatment; modified itt; R0005921:Supplement Table S1 | |
| 26 | A5 | percent change | -8.8 percent | 6.1 | 26 | while on treatment; completers; R0005921:Supplement Table S1 | |
| 26 | A5 vs A1 | md | -9.1 percent | -10.9 to -7.3 | while on treatment; modified itt; R0005921:Supplement Table S1 | ||
| 26 | A6 | percent change | -6.4 percent | -8.3 to -4.6 | 38 | while on treatment; modified itt; R0005921:Supplement Table S1 | |
| 26 | A6 | percent change | -7.5 percent | 2.9 | 14 | while on treatment; completers; R0005921:Supplement Table S1 | |
| 26 | A6 vs A1 | md | -6.6 percent | -8.8 to -4.4 | while on treatment; modified itt; R0005921:Supplement Table S1 | ||
| 26 | A7 | percent change | -9.4 percent | -10.9 to -7.8 | 63 | while on treatment; modified itt; R0005921:Supplement Table S1 | |
| 26 | A7 | percent change | -9.9 percent | 6.0 | 18 | while on treatment; completers; R0005921:Supplement Table S1 | |
| 26 | A7 vs A1 | md | -9.5 percent | -11.4 to -7.6 | while on treatment; modified itt; R0005921:Supplement Table S1 | ||
| 26 | A8 | percent change | -7.0 percent | -8.9 to -4.9 | 37 | while on treatment; modified itt; R0005921:Supplement Table S1 | |
| 26 | A8 | percent change | -7.9 percent | 7.8 | 11 | while on treatment; completers; R0005921:Supplement Table S1 | |
| 26 | A8 vs A1 | md | -7.1 percent | -9.4 to -4.8 | while on treatment; modified itt; R0005921:Supplement Table S1 | ||
| 26 | A9 | percent change | -9.0 percent | -10.6 to -7.3 | 63 | while on treatment; modified itt; R0005921:Supplement Table S1 | |
| 26 | A9 | percent change | -9.5 percent | 4.9 | 14 | while on treatment; completers; R0005921:Supplement Table S1 | |
| 26 | A9 vs A1 | md | -9.1 percent | -11.1 to -7.1 | while on treatment; modified itt; R0005921:Supplement Table S1 | ||
| 28 | A11 | percent change | -6.37 percent | 37 | while on treatment; modified itt; registry:outcomes | ||
| 28 | A12 | percent change | -6.74 percent | 37 | while on treatment; modified itt; registry:outcomes | ||
| 28 | A13 | percent change | -10.44 percent | 36 | while on treatment; modified itt; registry:outcomes | ||
| 28 | A2 | percent change | 1.06 percent | 19 | while on treatment; modified itt; registry:outcomes | ||
| 32 | A11 | percent change | -6.9 percent | -9.1 to -4.7 | 37 | while on treatment; modified itt; R0005921:Supplement Table S1 | |
| 32 | A11 | percent change | -6.3 percent | 5.6 | 13 | while on treatment; completers; R0005921:Supplement Table S1 | |
| 32 | A11 vs A2 | md | -8.2 percent | -11.7 to -4.6 | while on treatment; modified itt; R0005921:Supplement Table S1 | ||
| 32 | A12 | percent change | -7.2 percent | -9.2 to -5.0 | 37 | while on treatment; modified itt; R0005921:Supplement Table S1 | |
| 32 | A12 | percent change | -8.1 percent | 7.0 | 15 | while on treatment; completers; R0005921:Supplement Table S1 | |
| 32 | A12 vs A2 | md | -8.4 percent | -11.8 to -4.9 | while on treatment; modified itt; R0005921:Supplement Table S1 | ||
| 32 | A13 | percent change | -11.7 percent | -13.7 to -9.6 | 36 | while on treatment; modified itt; R0005921:Supplement Table S1 | |
| 32 | A13 | percent change | -12.7 percent | 7.2 | 11 | while on treatment; completers; R0005921:Supplement Table S1 | |
| 32 | A13 vs A2 | md | -12.9 percent | -16.1 to -9.5 | while on treatment; modified itt; R0005921:Supplement Table S1 | ||
| 32 | A2 | percent change | 1.4 percent | -1.6 to 4.5 | 19 | while on treatment; modified itt; R0005921:Supplement Table S1 | |
| 32 | A2 | percent change | 0.5 percent | 3.0 | 11 | while on treatment; completers; R0005921:Supplement Table S1 |
Weight loss of 5 percent or more (30 lines; O11A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26 | A1 | responders | 13 | 71 | while on treatment; modified itt; R0005921:Results | ||
| 26 | A1 | responders | 6 / 44 | while on treatment; completers; registry:outcomes | |||
| 26 | A10 | responders | 8 / 13 | while on treatment; completers; registry:outcomes | |||
| 26 | A10 vs A1 | or | 12.65 | 4.56 to 35.08 | while on treatment; modified itt; registry:outcomes | ||
| 26 | A3 | responders | 16 / 27 | while on treatment; completers; registry:outcomes | |||
| 26 | A3 vs A1 | or | 7.37 | 2.81 to 19.30 | while on treatment; modified itt; registry:outcomes | ||
| 26 | A4 | responders | 48 | 63 | while on treatment; modified itt; R0005921:Results | ||
| 26 | A4 | responders | 15 / 30 | while on treatment; completers; registry:outcomes | |||
| 26 | A4 vs A1 | or | 6.58 | 2.62 to 16.53 | while on treatment; modified itt; registry:outcomes | ||
| 26 | A5 | responders | 17 / 26 | while on treatment; completers; registry:outcomes | |||
| 26 | A5 vs A1 | or | 16.33 | 6.47 to 41.24 | while on treatment; modified itt; registry:outcomes | ||
| 26 | A6 | responders | 12 / 14 | while on treatment; completers; registry:outcomes | |||
| 26 | A6 vs A1 | or | 14.24 | 5.39 to 37.66 | while on treatment; modified itt; registry:outcomes | ||
| 26 | A7 | responders | 80 | 63 | while on treatment; modified itt; R0005921:Results | ||
| 26 | A7 | responders | 15 / 18 | while on treatment; completers; registry:outcomes | |||
| 26 | A7 vs A1 | or | 30.17 | 11.35 to 80.20 | while on treatment; modified itt; registry:outcomes | ||
| 26 | A8 | responders | 6 / 11 | while on treatment; completers; registry:outcomes | |||
| 26 | A8 vs A1 | or | 9.88 | 2.91 to 33.53 | while on treatment; modified itt; registry:outcomes | ||
| 26 | A9 | responders | 12 / 14 | while on treatment; completers; registry:outcomes | |||
| 26 | A9 vs A1 | or | 24.41 | 8.28 to 71.95 | while on treatment; modified itt; registry:outcomes | ||
| 32 | A11 | responders | 64 | 37 | while on treatment; modified itt; R0005921:Results | ||
| 32 | A11 | responders | 9 / 13 | while on treatment; completers; registry:outcomes | |||
| 32 | A11 vs A2 | or | 33.43 | 3.05 to 366.64 | while on treatment; modified itt; registry:outcomes | ||
| 32 | A12 | responders | 11 / 15 | while on treatment; completers; registry:outcomes | |||
| 32 | A12 vs A2 | or | 34.04 | 3.10 to 373.85 | while on treatment; modified itt; registry:outcomes | ||
| 32 | A13 | responders | 88 | 36 | while on treatment; modified itt; R0005921:Results | ||
| 32 | A13 | responders | 10 / 11 | while on treatment; completers; registry:outcomes | |||
| 32 | A13 vs A2 | or | 127.21 | 10.55 to 1533.46 | while on treatment; modified itt; registry:outcomes | ||
| 32 | A2 | responders | 4 | 19 | while on treatment; modified itt; R0005921:Results | ||
| 32 | A2 | responders | 0 / 11 | while on treatment; completers; registry:outcomes |
All cause mortality (13 lines; O20)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 71 | not stated; safety; R0005921:Results | ||||
| A10 | events | 0 / 36 | not stated; safety; R0005921:Results | ||||
| A11 | events | 0 / 37 | not stated; safety; R0005921:Results | ||||
| A12 | events | 0 / 37 | not stated; safety; R0005921:Results | ||||
| A13 | events | 0 / 36 | not stated; safety; R0005921:Results | ||||
| A2 | events | 0 / 19 | not stated; safety; R0005921:Results | ||||
| A3 | events | 0 / 62 | not stated; safety; R0005921:Results | ||||
| A4 | events | 0 / 63 | not stated; safety; R0005921:Results | ||||
| A5 | events | 0 / 64 | not stated; safety; R0005921:Results | ||||
| A6 | events | 0 / 38 | not stated; safety; R0005921:Results | ||||
| A7 | events | 0 / 63 | not stated; safety; R0005921:Results | ||||
| A8 | events | 0 / 37 | not stated; safety; R0005921:Results | ||||
| A9 | events | 0 / 63 | not stated; safety; R0005921:Results |
Serious adverse events (13 lines; O25)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 1 / 71 | not stated; safety; R0005921:Table 2 | ||||
| A10 | events | 1 / 36 | not stated; safety; R0005921:Table 2 | ||||
| A11 | events | 2 / 37 | not stated; safety; R0005921:Table 2 | ||||
| A12 | events | 2 / 37 | not stated; safety; R0005921:Table 2 | ||||
| A13 | events | 3 / 36 | not stated; safety; R0005921:Table 2 | ||||
| A2 | events | 0 / 19 | not stated; safety; R0005921:Table 2 | ||||
| A3 | events | 2 / 62 | not stated; safety; R0005921:Table 2 | ||||
| A4 | events | 1 / 63 | not stated; safety; R0005921:Table 2 | ||||
| A5 | events | 0 / 64 | not stated; safety; R0005921:Table 2 | ||||
| A6 | events | 1 / 38 | not stated; safety; R0005921:Table 2 | ||||
| A7 | events | 1 / 63 | not stated; safety; R0005921:Table 2 | ||||
| A8 | events | 0 / 37 | not stated; safety; R0005921:Table 2 | ||||
| A9 | events | 5 / 63 | not stated; safety; R0005921:Table 2 |
Discontinuation due to adverse events (13 lines; O26)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 4 / 71 | not stated; safety; R0005921:Table 2 | ||||
| A10 | events | 16 / 36 | not stated; safety; R0005921:Table 2 | ||||
| A11 | events | 9 / 37 | not stated; safety; R0005921:Table 2 | ||||
| A12 | events | 16 / 37 | not stated; safety; R0005921:Table 2 | ||||
| A13 | events | 18 / 36 | not stated; safety; R0005921:Table 2 | ||||
| A2 | events | 0 / 19 | not stated; safety; R0005921:Table 2 | ||||
| A3 | events | 20 / 62 | not stated; safety; R0005921:Table 2 | ||||
| A4 | events | 23 / 63 | not stated; safety; R0005921:Table 2 | ||||
| A5 | events | 25 / 64 | not stated; safety; R0005921:Table 2 | ||||
| A6 | events | 15 / 38 | not stated; safety; R0005921:Table 2 | ||||
| A7 | events | 38 / 63 | not stated; safety; R0005921:Table 2 | ||||
| A8 | events | 15 / 37 | not stated; safety; R0005921:Table 2 | ||||
| A9 | events | 42 / 63 | not stated; safety; R0005921:Table 2 |
Nausea (13 lines; O27A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 11 / 71 | not stated; safety; R0005921:Table 2 | ||||
| A10 | events | 18 / 36 | not stated; safety; R0005921:Table 2 | ||||
| A11 | events | 14 / 37 | not stated; safety; R0005921:Table 2 | ||||
| A12 | events | 27 / 37 | not stated; safety; R0005921:Table 2 | ||||
| A13 | events | 25 / 36 | not stated; safety; R0005921:Table 2 | ||||
| A2 | events | 2 / 19 | not stated; safety; R0005921:Table 2 | ||||
| A3 | events | 28 / 62 | not stated; safety; R0005921:Table 2 | ||||
| A4 | events | 39 / 63 | not stated; safety; R0005921:Table 2 | ||||
| A5 | events | 41 / 64 | not stated; safety; R0005921:Table 2 | ||||
| A6 | events | 22 / 38 | not stated; safety; R0005921:Table 2 | ||||
| A7 | events | 36 / 63 | not stated; safety; R0005921:Table 2 | ||||
| A8 | events | 25 / 37 | not stated; safety; R0005921:Table 2 | ||||
| A9 | events | 34 / 63 | not stated; safety; R0005921:Table 2 |
Vomiting (13 lines; O27B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 2 / 71 | not stated; safety; R0005921:Table 2 | ||||
| A10 | events | 16 / 36 | not stated; safety; R0005921:Table 2 | ||||
| A11 | events | 3 / 37 | not stated; safety; R0005921:Table 2 | ||||
| A12 | events | 14 / 37 | not stated; safety; R0005921:Table 2 | ||||
| A13 | events | 17 / 36 | not stated; safety; R0005921:Table 2 | ||||
| A2 | events | 1 / 19 | not stated; safety; R0005921:Table 2 | ||||
| A3 | events | 10 / 62 | not stated; safety; R0005921:Table 2 | ||||
| A4 | events | 24 / 63 | not stated; safety; R0005921:Table 2 | ||||
| A5 | events | 26 / 64 | not stated; safety; R0005921:Table 2 | ||||
| A6 | events | 16 / 38 | not stated; safety; R0005921:Table 2 | ||||
| A7 | events | 27 / 63 | not stated; safety; R0005921:Table 2 | ||||
| A8 | events | 11 / 37 | not stated; safety; R0005921:Table 2 | ||||
| A9 | events | 29 / 63 | not stated; safety; R0005921:Table 2 |
Diarrhea (13 lines; O27C)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 7 / 71 | not stated; safety; R0005921:Table 2 | ||||
| A10 | events | 6 / 36 | not stated; safety; R0005921:Table 2 | ||||
| A11 | events | 8 / 37 | not stated; safety; R0005921:Table 2 | ||||
| A12 | events | 8 / 37 | not stated; safety; R0005921:Table 2 | ||||
| A13 | events | 9 / 36 | not stated; safety; R0005921:Table 2 | ||||
| A2 | events | 1 / 19 | not stated; safety; R0005921:Table 2 | ||||
| A3 | events | 5 / 62 | not stated; safety; R0005921:Table 2 | ||||
| A4 | events | 17 / 63 | not stated; safety; R0005921:Table 2 | ||||
| A5 | events | 12 / 64 | not stated; safety; R0005921:Table 2 | ||||
| A6 | events | 9 / 38 | not stated; safety; R0005921:Table 2 | ||||
| A7 | events | 13 / 63 | not stated; safety; R0005921:Table 2 | ||||
| A8 | events | 3 / 37 | not stated; safety; R0005921:Table 2 | ||||
| A9 | events | 11 / 63 | not stated; safety; R0005921:Table 2 |
Constipation (13 lines; O27D)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 3 / 71 | not stated; safety; R0005921:Table 2 | ||||
| A10 | events | 6 / 36 | not stated; safety; R0005921:Table 2 | ||||
| A11 | events | 7 / 37 | not stated; safety; R0005921:Table 2 | ||||
| A12 | events | 2 / 37 | not stated; safety; R0005921:Table 2 | ||||
| A13 | events | 5 / 36 | not stated; safety; R0005921:Table 2 | ||||
| A2 | events | 2 / 19 | not stated; safety; R0005921:Table 2 | ||||
| A3 | events | 8 / 62 | not stated; safety; R0005921:Table 2 | ||||
| A4 | events | 10 / 63 | not stated; safety; R0005921:Table 2 | ||||
| A5 | events | 7 / 64 | not stated; safety; R0005921:Table 2 | ||||
| A6 | events | 5 / 38 | not stated; safety; R0005921:Table 2 | ||||
| A7 | events | 12 / 63 | not stated; safety; R0005921:Table 2 | ||||
| A8 | events | 4 / 37 | not stated; safety; R0005921:Table 2 | ||||
| A9 | events | 9 / 63 | not stated; safety; R0005921:Table 2 |
Discontinuation due to gastrointestinal adverse events (52 lines; O27E)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 1 / 71 | not stated; safety; nausea; R0005921:Supplement Table S2 | ||||
| A1 | events | 0 / 71 | not stated; safety; diarrhea; R0005921:Supplement Table S2 | ||||
| A1 | events | 0 / 71 | not stated; safety; dyspepsia; R0005921:Supplement Table S2 | ||||
| A1 | events | 0 / 71 | not stated; safety; vomiting; R0005921:Supplement Table S2 | ||||
| A10 | events | 1 / 36 | not stated; safety; diarrhea; R0005921:Supplement Table S2 | ||||
| A10 | events | 1 / 36 | not stated; safety; dyspepsia; R0005921:Supplement Table S2 | ||||
| A10 | events | 9 / 36 | not stated; safety; nausea; R0005921:Supplement Table S2 | ||||
| A10 | events | 4 / 36 | not stated; safety; vomiting; R0005921:Supplement Table S2 | ||||
| A11 | events | 2 / 37 | not stated; safety; vomiting; R0005921:Supplement Table S2 | ||||
| A11 | events | 5 / 37 | not stated; safety; nausea; R0005921:Supplement Table S2 | ||||
| A11 | events | 1 / 37 | not stated; safety; dyspepsia; R0005921:Supplement Table S2 | ||||
| A11 | events | 0 / 37 | not stated; safety; diarrhea; R0005921:Supplement Table S2 | ||||
| A12 | events | 1 / 37 | not stated; safety; diarrhea; R0005921:Supplement Table S2 | ||||
| A12 | events | 3 / 37 | not stated; safety; vomiting; R0005921:Supplement Table S2 | ||||
| A12 | events | 7 / 37 | not stated; safety; nausea; R0005921:Supplement Table S2 | ||||
| A12 | events | 1 / 37 | not stated; safety; dyspepsia; R0005921:Supplement Table S2 | ||||
| A13 | events | 5 / 36 | not stated; safety; vomiting; R0005921:Supplement Table S2 | ||||
| A13 | events | 6 / 36 | not stated; safety; nausea; R0005921:Supplement Table S2 | ||||
| A13 | events | 1 / 36 | not stated; safety; dyspepsia; R0005921:Supplement Table S2 | ||||
| A13 | events | 1 / 36 | not stated; safety; diarrhea; R0005921:Supplement Table S2 | ||||
| A2 | events | 0 / 19 | not stated; safety; vomiting; R0005921:Supplement Table S2 | ||||
| A2 | events | 0 / 19 | not stated; safety; nausea; R0005921:Supplement Table S2 | ||||
| A2 | events | 0 / 19 | not stated; safety; dyspepsia; R0005921:Supplement Table S2 | ||||
| A2 | events | 0 / 19 | not stated; safety; diarrhea; R0005921:Supplement Table S2 | ||||
| A3 | events | 1 / 62 | not stated; safety; diarrhea; R0005921:Supplement Table S2 | ||||
| A3 | events | 4 / 62 | not stated; safety; vomiting; R0005921:Supplement Table S2 | ||||
| A3 | events | 8 / 62 | not stated; safety; nausea; R0005921:Supplement Table S2 | ||||
| A3 | events | 1 / 62 | not stated; safety; dyspepsia; R0005921:Supplement Table S2 | ||||
| A4 | events | 11 / 63 | not stated; safety; nausea; R0005921:Supplement Table S2 | ||||
| A4 | events | 1 / 63 | not stated; safety; diarrhea; R0005921:Supplement Table S2 | ||||
| A4 | events | 2 / 63 | not stated; safety; dyspepsia; R0005921:Supplement Table S2 | ||||
| A4 | events | 9 / 63 | not stated; safety; vomiting; R0005921:Supplement Table S2 | ||||
| A5 | events | 6 / 64 | not stated; safety; vomiting; R0005921:Supplement Table S2 | ||||
| A5 | events | 14 / 64 | not stated; safety; nausea; R0005921:Supplement Table S2 | ||||
| A5 | events | 0 / 64 | not stated; safety; dyspepsia; R0005921:Supplement Table S2 | ||||
| A5 | events | 2 / 64 | not stated; safety; diarrhea; R0005921:Supplement Table S2 | ||||
| A6 | events | 1 / 38 | not stated; safety; diarrhea; R0005921:Supplement Table S2 | ||||
| A6 | events | 3 / 38 | not stated; safety; vomiting; R0005921:Supplement Table S2 | ||||
| A6 | events | 6 / 38 | not stated; safety; nausea; R0005921:Supplement Table S2 | ||||
| A6 | events | 1 / 38 | not stated; safety; dyspepsia; R0005921:Supplement Table S2 | ||||
| A7 | events | 10 / 63 | not stated; safety; vomiting; R0005921:Supplement Table S2 | ||||
| A7 | events | 22 / 63 | not stated; safety; nausea; R0005921:Supplement Table S2 | ||||
| A7 | events | 3 / 63 | not stated; safety; dyspepsia; R0005921:Supplement Table S2 | ||||
| A7 | events | 3 / 63 | not stated; safety; diarrhea; R0005921:Supplement Table S2 | ||||
| A8 | events | 6 / 37 | not stated; safety; vomiting; R0005921:Supplement Table S2 | ||||
| A8 | events | 6 / 37 | not stated; safety; nausea; R0005921:Supplement Table S2 | ||||
| A8 | events | 1 / 37 | not stated; safety; dyspepsia; R0005921:Supplement Table S2 | ||||
| A8 | events | 0 / 37 | not stated; safety; diarrhea; R0005921:Supplement Table S2 | ||||
| A9 | events | 2 / 63 | not stated; safety; diarrhea; R0005921:Supplement Table S2 | ||||
| A9 | events | 4 / 63 | not stated; safety; dyspepsia; R0005921:Supplement Table S2 | ||||
| A9 | events | 18 / 63 | not stated; safety; nausea; R0005921:Supplement Table S2 | ||||
| A9 | events | 18 / 63 | not stated; safety; vomiting; R0005921:Supplement Table S2 |
Gallbladder and biliary disease (13 lines; O28)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 71 | not stated; safety; cholecystitis acute; registry:adverse_events | ||||
| A10 | events | 0 / 36 | not stated; safety; cholecystitis acute; registry:adverse_events | ||||
| A11 | events | 0 / 37 | not stated; safety; cholecystitis acute; registry:adverse_events | ||||
| A12 | events | 0 / 37 | not stated; safety; cholecystitis acute; registry:adverse_events | ||||
| A13 | events | 0 / 36 | not stated; safety; cholecystitis acute; registry:adverse_events | ||||
| A2 | events | 0 / 19 | not stated; safety; cholecystitis acute; registry:adverse_events | ||||
| A3 | events | 0 / 62 | not stated; safety; cholecystitis acute; registry:adverse_events | ||||
| A4 | events | 0 / 63 | not stated; safety; cholecystitis acute; registry:adverse_events | ||||
| A5 | events | 0 / 64 | not stated; safety; cholecystitis acute; registry:adverse_events | ||||
| A6 | events | 0 / 38 | not stated; safety; cholecystitis acute; registry:adverse_events | ||||
| A7 | events | 0 / 63 | not stated; safety; cholecystitis acute; registry:adverse_events | ||||
| A8 | events | 0 / 37 | not stated; safety; cholecystitis acute; registry:adverse_events | ||||
| A9 | events | 1 / 63 | not stated; safety; cholecystitis acute; registry:adverse_events |
Intestinal obstruction or ileus (13 lines; O37B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 71 | not stated; safety; small intestinal obstruction; registry:adverse_events | ||||
| A10 | events | 0 / 36 | not stated; safety; small intestinal obstruction; registry:adverse_events | ||||
| A11 | events | 0 / 37 | not stated; safety; small intestinal obstruction; registry:adverse_events | ||||
| A12 | events | 0 / 37 | not stated; safety; small intestinal obstruction; registry:adverse_events | ||||
| A13 | events | 0 / 36 | not stated; safety; small intestinal obstruction; registry:adverse_events | ||||
| A2 | events | 0 / 19 | not stated; safety; small intestinal obstruction; registry:adverse_events | ||||
| A3 | events | 0 / 62 | not stated; safety; small intestinal obstruction; registry:adverse_events | ||||
| A4 | events | 0 / 63 | not stated; safety; small intestinal obstruction; registry:adverse_events | ||||
| A5 | events | 0 / 64 | not stated; safety; small intestinal obstruction; registry:adverse_events | ||||
| A6 | events | 0 / 38 | not stated; safety; small intestinal obstruction; registry:adverse_events | ||||
| A7 | events | 1 / 63 | not stated; safety; small intestinal obstruction; registry:adverse_events | ||||
| A8 | events | 0 / 37 | not stated; safety; small intestinal obstruction; registry:adverse_events | ||||
| A9 | events | 0 / 63 | not stated; safety; small intestinal obstruction; registry:adverse_events |