Section I

I. 1 Baseline Derived Variables

Description

This section contains baseline derived variables, including hypertension and diabetes status, presence of baseline frailty dyslipidaemia and chronic kidney disease, the baseline mental and physical components of the Short Form-12 questionnaire, smoking pack history for current and past smokers and polypharmacy status. Data from the Australian Bureau of Statistics has also been used to derive the following variables: participant suburb residential population, participant Index of Relative Socio-economic Advantage and Disadvantage (IRSAD) score, rank, decile and percentile and participant state and rurality (Australian participants only). The following GP practice variables have also been derived: IRSAD score, decile and percentile, state and rurality (Australian participants only).

Timing of Data Collection

Data used to derive these variables was collected at Visit 1 or Visit 2, which both occurred prior to randomisation during the screening process.

Summary of Data Dictionary

This section contains numerical data as well as ordinal and nominal data. Each relevant variable is linked with a commentary code that aims to provide additional data with regard to missing data, out of range data, alterations to data collection methods and other special considerations.

I. 2 Supplementary Endpoint Data (Select Adjudicated Secondary Endpoints Only)

Description

This section contains additional endpoint data including World Health Organization (WHO) brain cancer staging data for cancer events adjudicated using the ASPREE-XT protocol, derived cancer staging data for XT protocol events, and blood cancer categorisation data for both ASPREE and ASPREE-XT protocol events.

Brain cancer stage
The latest WHO classification system has combined tumour nomenclature with an associated grading system, so that the actual histologic diagnosis directly correlates with the histologic grade of the tumor, and this system has been utilised by ASPREE to stage tumours of the central nervous system (CNS) into WHO Stages I-IV for each brain cancer endpoint, and assign the CNS tumor type (available in the variable AdjOutcomeSubclass_Cancer_Type in Section F2). During the ASPREE Clinical Trial and Bridge period, staging of brain cancer events was completed through the ACES sub-study and exists in that sub-study’s own data set.

Derived cancer stage
The derived cancer stage was determined by an ASPREE-XT biostatistician for ASPREE-XT protocol endpoints that reached the metastatic or non-metastatic cancer endpoint outcome. The stage was derived using the primary tumor (T), lymph node involvement (N), and distant metastasis (M) information collected during the endpoint adjudication process. Clinical documents were used where TNM information was not available. Similar to CNS stage, derived cancer staging data for ASPREE protocol events relies on data captured as part of the ACES sub-study so can be found in the sub-study’s own data set.

Blood cancer categorisation
Blood cancer subtype was determined for all participants with a confirmed incident blood cancer endpoint or blood cancer-related death endpoint. This data was compiled by one or more hematologists with training in clinical and laboratory hematology, fellowship of the Royal Australasian College of Physicians (RACP) and Royal College of Pathologists of Australasia (RCPA).

Timing of Data Collection

CNS stage
During ASPREE-XT, brain cancer stage was collected during the endpoint adjudication process described here. During the ASPREE Clinical Trial and Bridge period, staging of brain cancer events was completed through the ACES sub-study and exists in that sub-study’s own data set.

Derived cancer stage
The derived cancer stage was determined during the preparation of the ASPREE-XT Longitudinal Data Set (XT04). Derived cancer staging data for ASPREE protocol events can be found in the ACES sub-study data set.

Blood cancer categorisation
Blood cancer subtype was determined during the preparation of the ASPREE-XT Longitudinal Data Set (XT04).

Summary of Data Dictionary

This section contains numerical data as well as ordinal and nominal data. This section does not contain commentary code variables.