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Background The example simulated data set is based on large phase III clinical trials in breast cancer such as the ALTTO trial https://ascopubs.org/doi/pdf/10.1200/JCO.2015.62.1797. The example “trial” aims to determine if a combination of two therapies tablemab (T) plus vismab (V) improves outcomes for metastatic human epidermal growth factor 2–positive breast cancer and increases the pathologic complete response in the neoadjuvant setting (i.e. treatment given as a first step to shrink a tumor before the main treatment or surgery).

Usage

adtte

Format

The data set contains the following variables:

STUDYID

The study identifier. A code unique to the clinical trial

SUBJID

subject identifier. Numeric ID unique to each patient

USUBJID

unique subject identifier. Text ID combining study and patient IDs

AGE

age at randomisation (years)

STR01

Hormone receptor status at randomisation

STR01N

Hormone receptor positive (Numeric)

STR01L

Hormone receptor positive (Long format)

STR02

Prior Radiotherapy at randomisation

STR02N

Prior Radiotherapy at randomisation (Numeric)

STR02L

Prior Radiotherapy at randomisation (Long format)

TRT01P

Planned treatment assigned at randomisation

TRT01PN

Planned treatment assigned at randomisation (Numeric)

PARAM

Analysis parameter: Progression free survival

PARAMCD

Analysis parameter code

AVAL

Analysis value (time to event (years)

CNSR

Censoring (0 = Event, 1 = Censored)

EVNTDESC

Event description

CNSDTDSC

Censoring description

DCTREAS

Discontinuation from study reason

Details

The trial has four treatment arms, patients with centrally confirmed human epidermal growth factor 2-positive early breast cancer were randomly assigned to 1 year of adjuvant therapy with V, T, their sequence (T to V), or their combination (T+V) for 52 weeks.

The primary end point was progression-free survival (PFS) as defined by Cancer.gov: '“the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse. In a clinical trial, measuring the progression-free survival is one way to see how well a new treatment works”'.

A number of baseline measurements (taken at randomization) are also included such as age, hormone receptor status and prior radiotherapy treatment.

Additional details on reasons for study discontinuation and censoring event description are also included.

The data set adopts an abridged version of the CDISC ADaM ADTTE time to event data model. See here for more info on CDISC ADaM data standards https://www.cdisc.org/standards/foundational/adam and specifically the ADTTE time to event data model here https://www.cdisc.org/standards/foundational/adam/adam-basic-data-structure-bds-time-event-tte-analyses-v1-0.