Clinical success rate and rate of patients with GCSI total score below two across the follow-up time points
| 1 month | 3 months | 6 months | 12 months | |||||
| Number | Percent (95% CI) | Number | Percent (95% CI) | Number | Percent (95% CI) | Number | Percent (95% CI) | |
| Clinical success* (available date) | 42/73 | 57.5 (46.1 to 68.2) | 40/65 | 61.5 (49.4 to 72.4) | 38/63 | 60.3 (48 to 71.5) | 42/75 | 56 (44.8 to 66.7) |
| Clinical success* (imputed data†) | 45.8/80 | 57.3 (46.3 to 67.5) | 46.8/80 | 58.5 (47.6 to 68.7) | 49.7/80 | 62.1 (51.2 to 72) | 45/80 | 56.3 (45.3 to 66.6) |
| Patients with GCSI <2‡ (available date) | 49/73 | 67.1 (55.7 to 76.8) | 40/65 | 61.5 (49.4 to 72.4) | 38/63 | 60.3 (48 to 71.5) | 51/75 | 68 (56.8 to 77.5) |
| Patients with GCSI <2‡ (imputed data†) | 52.7/80 | 65.8 (55 to 75.3) | 47.4/80 | 59.3 (48.3 to 69.4) | 47/80 | 58.8 (47.8 to 68.9) | 53.3/80 | 66.6 (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.