Table 3.
Incidence of adverse events after randomization categorized by COSTART
| Placebo (n = 184) | DFMO/sulindac (n = 191) | |
|---|---|---|
| Serious adverse events, no. patients with adverse event (%)* | ||
| Adverse events requiring overnight hospitalizations | 31 (16.9) | 42 (22.0) |
| Risk ratio (95% CI) | 1.31 (0.86–1.98) | |
| P | 0.21 | |
| All adverse events with a grade ≥3 | 15 (8.2) | 21 (11.0) |
| Risk ratio (95% CI) | 1.35 (0.72–2.53) | |
| P | 0.35 | |
| Deaths† | 1 (0.5) | 2 (1.1) |
| Risk ratio (95%) | NA | |
| Any adverse event, no. patients with adverse events (%) | ||
| All patients | 153 (83.2) | 171 (89.5) |
| Risk ratio (95% CI) | 1.08 (1.00–1.17) | |
| P | 0.07 | |
| Cardiovascular (95% CI) | 22 (12.0) | 28 (14.7) |
| Risk ratio (95% CI) | 1.23 (0.73–2.06) | |
| P | 0.44 | |
| Gastrointestinal events, no. patients (%) | 14 (7.6) | 24 (12.6) |
| Risk ratio (95% CI) | 1.65 (0.88–3.09) | |
| P | 0.11 | |
| Audiometric evaluation, no. patients with adverse event/no. patients in cohort (%)* | ||
| Self-reported hearing complaint reported as an adverse event | 53 (28.8) | 67 (35.1) |
| Risk ratio (95% CI) | 1.22 (0.90–1.64) | |
| P | 0.19 | |
| Self-reported study-related hearing complaint reported as adverse event | 30 (16.3) | 36 (18.8) |
| Risk ratio (95% CI) | 1.16 (0.74–1.80) | |
| P | 0.52 | |
*
Relative risk estimation by log-binomial regression. Likelihood ratio test P values are reported.
†
Of the three deaths, one subject died during the trial due to traffic accident and the other subjects died 1 and 3 y, respectively, after study completion from causes judged by the investigator as unrelated to the intervention.