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 hospitalizations31 (16.9)42 (22.0)
  Risk ratio (95% CI)1.31 (0.86-1.98)
  P0.21
 All adverse events with a grade ≥315 (8.2)21 (11.0)
  Risk ratio (95% CI)1.35 (0.72-2.53)
  P0.35
 Deaths1 (0.5)2 (1.1)
  Risk ratio (95%)NA
 Any adverse event, no. patients with adverse events (%)
  All patients153 (83.2)171 (89.5)
  Risk ratio (95% CI)1.08 (1.00-1.17)
  P0.07
 Cardiovascular (95% CI)22 (12.0)28 (14.7)
  Risk ratio (95% CI)1.23 (0.73-2.06)
  P0.44
 Gastrointestinal events, no. patients (%)14 (7.6)24 (12.6)
  Risk ratio (95% CI)1.65 (0.88-3.09)
  P0.11
Audiometric evaluation, no. patients with adverse event / no. patients in cohort (%)*
 Self-reported hearing complaint reported as an adverse event53 (28.8)67 (35.1)
  Risk ratio (95% CI)1.22 (0.90-1.64)
  P0.19
 Self-reported study-related hearing complaint reported as adverse event30 (16.3)36 (18.8)
  Risk ratio (95% CI)1.16 (0.74-1.80)
  P0.52
  • *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.