Table 3.
Composite and individual symptom scores over 12 weeks: longitudinal analysis of reduction from baseline in arbitrary AUC (area under the curve relative to baseline expressed as positive values) units. (Pbo = placebo)
Symptom | Mean + SD | Placebo, N=88 | 10 μg RM, N=86 | 30 μg RM, N=91 | 100 μg RM, N=63 |
---|---|---|---|---|---|
4-Symptom Composite | 318.1 ±546.9 | 501.0 ±402.4 | 544.0 ±577.5 | 554.3 ±541.4 | |
LS Mean Δ from Pbo | 183.51 | 231.77 | 209.48 | ||
95% CI of difference | 24.11; 342.92 | 74.58; 388.96 | 35.68; 383.27 | ||
P-value | 0.02 | <0.01 | <0.02 | ||
Nausea | 94.9 ±161.2 | 128.0 ±145.6 | 149.9 ±157.8 | 152.0 ±157.6 | |
LS Mean Δ from Pbo | 34.32 | 57.01 | 50.38 | ||
95% CI of difference | −9.19; 77.83 | 14.11; 99.92 | 2.98; 97.77 | ||
P-value | 0.12 | <0.01 | 0.04 | ||
Post-prandial Fullness | 67.3 ±139.9 | 118.2 ±142.0 | 124.1 ±150.3 | 126.7 ±143.9 | |
LS Mean Δ from Pbo | 53.72 | 57.28 | 54.44 | ||
95% CI of difference | 11.64 ; 95.80 | 15.81; 98.75 | 8.60; 100.29 | ||
P-value | <0.01 | <0.01 | 0.02 | ||
Abdominal Pain | 81.7 ±148.3 | 127.4 ±141.1 | 133.3 ±151.9 | 145.2 ±140.1 | |
LS Mean Δ from Pbo | 43.09 | 54.42 | 56.47 | ||
95% CI of difference | 1.18 ; 84.99 | 13.09; 95.74 | 10.79; 102.15 | ||
P-value | 0.04 | <0.01 | 0.02 | ||
Bloating | 74.2 ±148.4 | 127.4 ±139.0 | 136.6 ±150.0 | 130.3 ± 142.5 | |
LS Mean Δ from Pbo | 52.18 | 63.21 | 48.39 | ||
95% CI of difference | 10.51; 93.86 | 22.12; 104.31 | 2.94; 93.84 | ||
P-value | <0.01 | <0.01 | 0.04 |