Table 2.
Treatment-emergent adverse events (TEAE) through day 28.
| SNG001 (N = 110) |
Placebo (N = 110) |
Analysis result | |
|---|---|---|---|
| TEAEs, n (%) | |||
| Grade 1 | 14 (13) | 12 (11) | |
| Grade 2 | 20 (18) | 21 (19) | |
| Grade 3 | 4 (4) | 8 (7) | |
| Grade 4 | 0 (0) | 1 (1) | |
| Grade 5 (death) | 0 (0) | 0 (0) | |
| Serious adverse events, n (%) | 1 (1) | 7 (6) | |
| Adverse events of special interesta, n (%) | 0 (0) | 0 (0) | |
| Grade 3 or higher TEAE, n (%) | 4 (3.6) | 9 (8.2) | |
| Risk ratio | 0.44 | ||
| p-value (Fisher’s exact test) | p = 0.25 | ||
| Risk difference | −4.5% | ||
| Grade 2 or higher TEAE, n (%) | 24 (21.8) | 30 (27.3) | |
| Risk ratio [95% CI] | 0.80 [0.50, 1.28] | ||
| p-value (Wald test) | p = 0.35 | ||
| Risk difference [95% CI] | −5.5% [−16.8%, 5.9%] |
Table summarizes number of participants with at least one TEAE through day 28. Summaries by TEAE grade are based on the highest adverse event grade through day 28 for each participant.
The proportion of participants with Grade 3 or higher TEAEs was compared between arms using Fisher’s exact test. Risk ratios and risk differences were summarized, but confidence intervals were not calculated due to small number of events.
The proportion of participants with Grade 2 or higher TEAEs was compared using log-binomial regression and summarized with a risk ratio (RR), 95% Confidence Interval (CI), and p-value based on the Wald test. In addition, the difference in proportions was calculated, with 95% Wald CI based on the normal approximation to the binomial distribution.
Adverse Events of Special Interest included Grade ≥2 palpitations during the dosing period and up to 24 h after last dose and Grade ≥3 bronchospasm within 4 h of investigational agent/placebo administration.