• Trial design (definition of primary and secondary end points, statistical power, duration, placebo or comparator) |
• Base risk rate, incident event rate (in annualized units), and cumulative events of the primary outcome, drop-out and drop-in rates, rescue treatments |
• Intent-to-treat and per-protocol analysis |
• RR and AR |
• Base rate and incident rate of all nonprimary outcomes, including all systematically collected clinical observations |
• Adverse events, in number and annualized rates |
• Kaplan-Meier plot of major or frequent adverse events |
• Context (comparison with other trials of the same or different pharmacological agent targeting the same or similar primary outcome) |
• Availability of RMST differences to allow the patient and the clinician to choose a given treatment in the context of the individual patient’s risk level and preferences |
• Trial design (definition of primary and secondary end points, statistical power, duration, placebo or comparator) |
• Base risk rate, incident event rate (in annualized units), and cumulative events of the primary outcome, drop-out and drop-in rates, rescue treatments |
• Intent-to-treat and per-protocol analysis |
• RR and AR |
• Base rate and incident rate of all nonprimary outcomes, including all systematically collected clinical observations |
• Adverse events, in number and annualized rates |
• Kaplan-Meier plot of major or frequent adverse events |
• Context (comparison with other trials of the same or different pharmacological agent targeting the same or similar primary outcome) |
• Availability of RMST differences to allow the patient and the clinician to choose a given treatment in the context of the individual patient’s risk level and preferences |