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Graphs for investigation and team sharing of clinical data with Spotfire Graphs for investigation and team sharing of clinical data with Spotfire Bruno M D Tran (TGRD) and Gerard Conway (TIBCO) Bruno M D Tran (TGRD) and Gerard Conway (TIBCO) Global Research & Development Adverse events: • by treatment group, • on a study time scale • with colour coding for MedDRA categories and • marker size for intensity of the event. Safety data Zooming in: • only treatment emergent AEs • paged by treatment group • study time scale • colour coding for MedDRA categories • marker size for event intensity. Dataset structure: • variables as columns and individuals as rows - similar to SAS, • multiple datasets can be used to produce different graphs, • subsets can provide link between graphs for dynamic selections. Datasets: SAS, Excel, csv , databases (etc.) datasets are opened directly. Data can be stored in the Spotfire file or linked to the original dataset. Data manipulation: • formulae can be used to derive new variables, • on screen dynamic filtering tools. ECG data: • 4 parameters displayed • subjects on x axis • marker shape for visit number: 2 visits • interpretation colour coded: red for abnormal • drill down on tooltip and on lower-right panel. PK data over studies: • PK parameter (AUC 0-inf ) versus subject age • marker shape for gender PK data: one parameter per page, with dose on the x axis. Cohorts colour coded and drill-down as tooltip and lower-right panel. PK data: log scales. Graphical options: accessed through common properties dialog box. PK data: trellis plots by parameter. Individual subjects, cohorts colour coded. PK data: average parameter value, over all cohorts. Trellised by parameter. Laboratory analyses: visit number colour coded, trellis by lab analysis. Drill-down on tooltip and lower-right panel Datasets PK data Lab data Datasets Dynamic team presentation Report TIBCO Spotfire provides a powerful yet easy to use platform for the inter- active visualisation of clinical data, leading to: • enhanced data exploration, • increased levels of information gained from clinical data • allowing for improved decision making and hypothesis generation. • studies colour coded • drill down on tooltip and on lower panel • outlier easily isolated. Workflow: a Spotfire file is typically made up of several pages and dynamic selection or filtering of subsets impacts other graphs and tables within the Spotfire file. Note: for validated output (e.g. CSR or other regulatory submission documents), graphs can be produced via Spotfire Clinical Graphics
