Graphs for investigation and team sharing of clinical data with SpotfireGraphs for investigation and team sharing of clinical data with SpotfireBruno 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 (AUC0-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

Learn More About Spotfire Clinical Review

• Watch 5 minute YouTube demoClinical Data Review with TIBCO Spotfire

http://www.youtube.com/watch?v=ZGLJOoNvT2A

• Watch a Webcast on how our customers are using Spotfire for Clinical ReviewAstraZeneca, Novartis and Roche speak about their use of Spotfire in clinical reviewhttp://goto.spotfire.com/g/?M09VO73KH7=clicksrc:eventpg