Sharing of clinical data with Spotfire (Takeda/Spotfire)

Graphs for investigation and team sharing of clinical data with Spotfire Bruno M D Tran (TGRD) and Gerard Conway (TIBCO)

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 Global Research & Development

Learn More About Spotfire Clinical Review