Table 10: Vomiting Frequency in WAVESS Phase 1 (N=33).
Vomiting Episodes per Week (diaries) |
Baseline | ON | OFF | Difference (OFF-ON) |
% Difference |
---|---|---|---|---|---|
Mean (+SD) | 47.6 ± 52.6 | 23.0 ± 35.5 | 29.0 ± 38.2 | 6.0 ± 22.4 | 21 |
Median | 26.3 | 12.0 | 14.0 | 2.0 | 14.3 |
Source: United States.Food and Drug Administration. Summary of Safety and Probably Benefit: Enterra Therapy System. 1999. Available at: http://www.fda.gov/cdrh/pdf/h990014b.pdf