Aernoud Fiolet

295 Predictors of early intolerance to low-dose colchicine in patients with coronary disease Statistical analysis Central tendencies and distribution of continuous parameters were displayed using means or medians with standard deviation or 25th and 75th percentile in case of normally and non-normally distributed variables respectively. Normality was assessed visually using histograms and Q-Q plots. Categorical variables were presented as counts and percentages.. Univariable association of variables were assessed using odds ratios and corresponding 95% confidence intervals. To identify independent predictors for intolerance due to any perceived side effects and due to gastro-intestinal upset, all parameterswere entered in a logistic regressionmodel as covariates. Predictorswere selected based on a presumed relation to intolerance, presumed pharmacokinetics and dynamics of the drug and on clinical relevance. A maximum of 1 predictor per 10 outcome events was used. Per the purpose of predictive modelling, no parameters were removed from the model. To identify independent predictors for intolerance due to myalgia, a similar process was followed with a limited number of parameters, chosen on clinical relevance. Formal hypothesis testing for univariable and multivariable was done by means of the Wald test when removing the variables from the model. The alpha level was set at 0.05. All statistical analyses were performed using R (The R Foundation for Statistical Computing, version 3.6.0). Ethical considerations and funding The study was approved by a central ethics committee (MEC-U, Nieuwegein, the Netherlands). All patients signed informed consent prior to participation. This work was supported by a governmental grant from The Netherlands Organisation for Health Research and Development [grant number 848015014]. The drug was supplied free of charge by TioPharma (Oud-Beijerland, the Netherlands). The funders and drug supplier had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. The main trial was registered in the Australian Clinical Trials Registry (ACTRN12614000093684). There are no conflicts of interests by the authors.