Table 5.

Changes in exploratory outcomes

Exploratory Secondary Outcomes: Changes from baseline at F4	Mean differences from baseline to 4-weeks: Baseline adjusted* [absolute (SD)]		Adjusted mean difference of differences or Odds ratio (Buspirone -Placebo) (95% CI)†§
	Buspirone	Placebo		P
No. evaluable patients‡	40	39
Gastroparesis symptoms inventories
PAGI-SYM Severity index symptom severities   (0=none to 5=very severe)
Retching severity	−0.46 (1.93)	−0.70 (1.51)	0.16 (−0.49, 0.81)	0.64
Stomach distension severity	−1.38 (1.58)	−1.20 (1.58)	−0.18 (−0.83, 0.47)	0.59
Upper abdominal discomfort	−0.87 (1.50)	−1.00 (1.61)	0.12 (−0.49, 0.73)	0.69
Lower abdominal pain severity	−0.31 (1.93)	−0.66 (1.39)	0.35 (−0.26, 0.96)	0.26
Lower abdominal discomfort	−0.48 (1.89)	−0.77 (1.51)	0.29 (−0.36, 0.94)	0.38
Constipation severity	−0.22 (1.61)	−0.57 (1.58)	0.35 (−0.27, 0.97)	0.27
Diarrhea severity	−0.54 (1.77)	−0.51 (1.64)	−0.03 (−0.71, 0.64)	0.91
Gastrointestinal Symptom Rating Scale (GSRS) subscores   (0=no to 7=very severe discomfort)
Reflux score	−0.72 (1.50)	−0.67 (1.56)	−0.04 (−0.64, 0.56)	0.89
Abdominal pain score	−0.97 (1.40)	−0.54 (1.55)	−0.42 (−0.98, 0.13)	0.14
Indigestion score	−0.67 (1.40)	−0.48 (1.13)	−0.19 (−0.70, 0.32)	0.46
Diarrhea score	−0.57 (1.98)	−0.35 (1.35)	−0.21 (−0.83, 0.40)	0.50
Constipation score	−0.23 (1.61)	−0.53 (1.82)	0.29 (−0.34, 0.93)	0.37
ANMS Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD) (all items scored 0 to 4, none to very severe)
GCSI total score	−0.73 (0.94)	−0.28 (0.56)	−0.45 (−0.79, −0.12)	0.007
Nausea severity	−0.65 (0.98)	−0.18 (0.76)	−0.48 (−0.86, −0.09)	0.01
Bloating severity	−0.82 (0.97)	−0.27 (0.87)	−0.55 (−0.93, −0.17)	0.004
Upper abdominal pain	−0.79 (0.93)	−0.34 (1.06)	−0.45 (−0.87, −0.04)	0.03
Vomiting (No. of episodes)	−0.001 (1.33)	0.37 (2.16)	−0.37 (−1.18, 0.43)	0.36
Overall symptom severity	−0.58 (1.00)	−0.26 (0.66)	−0.32 (−0.68, 0.04)	0.08
Physiologic test:
Electrogastrogram (EGG) results‖
Average power in frequency region, %
Bradygastria (1-<2.5 cpm)
Baseline	2.63 (25.78)	−2.52 (17.71)	5.15 (−3.89, 14.19)	0.26
0–30 post-satiety	3.98 (15.80)	0.36 (17.97)	3.62 (−3.00, 10.25)	0.28
Normogastria (2.5-<3.8 cpm)
Baseline	−0.23 (11.73)	−1.13 (12.03)	0.90 (−4.38, 6.189)	0.74
0–30 post-satiety	−1.71 (10.19)	−1.87 (7.24)	−0.52 (−4.20, 3.17)	0.78
Tachygastria (3.8–10 cpm)
Baseline	0.10 (16.76)	1.72 (11.06)	−1.62 (−6.16, 2.93)	0.49
0–30 post-satiety	0.92 (8.96)	−0.59 (11.87)	1.15 (−3.07, 6.10)	0.52
Duodenal (>10–15 cpm)
Baseline	−1.92 (15.51)	1.75 (10.87)	−3.66 (−9.58, 2.25)	0.22
0–30 post-satiety	−0.76 (8.26)	0.44 (11.92)	−1.20 (−4.47, 2.07)	0.47

^*Mean differences adjusted for the baseline value of the outcome and treatment group indicator are the Least Squares means (LS-means) (i.e., the predicted population margins) computed using a generalized linear ANCOVA model of the primary outcome on treatment group and baseline value.

^†Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Limits (CI) are reported; P (2-sided) determined from a Wald Chi-Square test.

^‡Number of evaluable patients (complete-case analysis) will vary with each outcome depending on the questionnaire or procedure. No. patients with 4-week satiety and EGG data: 26 Buspirone, 26 placebo. For DD analysis: 76 total patients (41 P, 35 B).

^§Odds ratio, 95% confidence intervals and P from an exact logistic regression of outcome on treatment group adjusted for the baseline value. For the 29 outcomes, the Bonferroni level of significance would be P≤0.0017; no P-values were significant by Bonferroni-Hochberg corrected significance levels either.

^‖Electrogastrogram (EGG) results for average percent power have been validated by central review.