Table 2

Primary and secondary analyses
Analyses Population Subgroup Endpoints Framework
Primary ITT None Primary Univariate
Secondary PP None Primary Univariate
ITT None Secondary Univariate
ITT None Secondary Multivariate
ITT Baseline LVMI subgroups (observed median LVMI as the level boundary) Primary Univariate
ITT Baseline LVMI subgroups (observed median LVMI as the level boundary) Time-averaged blood pressure over months 3, 6, 9 and 12 (intra-dialytic, inter-dialytic), % maximum recommended daily dose of antihypertensives Multivariate, accounting for subgroup effect and treatment-subgroup interaction, FDR control to account for multiplicity
ITT Baseline intra-dialytic and inter-dialytic blood pressure subgroups (observed mean blood pressure as the level boundary) Primary Univariate, accounting for subgroup effect and treatment-subgroup interaction, and three-way interaction
ITT Baseline intra-dialytic and inter-dialytic blood pressure subgroups (observed mean blood pressure as the level boundary) Time-averaged blood pressure over months 3, 6, 9 and 12 (intra-dialytic, inter-dialytic), % max recommended daily dose of antihypertensives Univariate, accounting for subgroup effect and treatment-subgroup interaction, and three-way interaction, FDR control to account for multiplicity
ITT Baseline pre-dialysis plasma Na+ ionic activity subgroups (observed median plasma Na+ ionic activity as the level boundary) Primary Univariate, accounting for subgroup effect and treatment-subgroup interaction
ITT Baseline pre-dialysis plasma Na+ iIonic activity subgroups (observed median plasma Na+ ionic activity as the level boundary) Time-averaged blood pressure over months 3, 6, 9 and 12 (intra-dialytic, inter-dialytic), % maximum recommended daily dose of antihypertensives Univariate, accounting for subgroup effect and treatment-subgroup interaction, and three-way interaction, FDR control to account for multiplicity
Tolerability ITT None Hypotension event counts Multivariate, mixed effects, allowing for treatment time interaction

Abbreviations: PP per protocol, ITT intention to treat, LVMI left ventricular mass index, FDR False Discovery Rate.

Dunlop et al.

Dunlop et al. BMC Nephrology 2013 14:149   doi:10.1186/1471-2369-14-149

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