Table 4

Clinical success rate and rate of patients with GCSI total score below two across the follow-up time points

1 month3 months6 months12 months
NumberPercent (95% CI)NumberPercent (95% CI)NumberPercent (95% CI)NumberPercent (95% CI)
Clinical success* (available date)42/7357.5 (46.1 to 68.2)40/6561.5 (49.4 to 72.4)38/6360.3 (48 to 71.5)42/7556 (44.8 to 66.7)
Clinical success* (imputed data†)45.8/8057.3 (46.3 to 67.5)46.8/8058.5 (47.6 to 68.7)49.7/8062.1 (51.2 to 72)45/8056.3 (45.3 to 66.6)
Patients with GCSI <2‡ (available date)49/7367.1 (55.7 to 76.8)40/6561.5 (49.4 to 72.4)38/6360.3 (48 to 71.5)51/7568 (56.8 to 77.5)
Patients with GCSI <2‡ (imputed data†)52.7/8065.8 (55 to 75.3)47.4/8059.3 (48.3 to 69.4)47/8058.8 (47.8 to 68.9)53.3/8066.6 (55.8 to 76)
  • *Clinical success was defined as one score decrease in the five-point GCSI Score plus at least 25% decrease in two of the three GCSI subscales. The collected data showed that 25% decrease equals to 0.62 for nausea/vomiting, 0.84 for fullness/early satiety and 0.66 for bloating subscales.

  • †No. of patients with imputed observations: 7 (8.8%) at 1 month, 15 (18.8%) at 3 months, 17 (21.3%) at 6 months and 5 (6.3%) at 12 months.

  • ‡The study’s initial primary endpoint.

  • GCSI, Gastroparesis Cardinal Symptom Index.