Example phase III clinical trial data setSource:
The example simulated data set is based on large phase III clinical trials in
breast cancer such as the ALTTO trial
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).
The data set contains the following variables:
The study identifier. A code unique to the clinical trial
subject identifier. Numeric ID unique to each patient
unique subject identifier. Text ID combining study and patient IDs
age at randomisation (years)
Hormone receptor status at randomisation
Hormone receptor positive (Numeric)
Hormone receptor positive (Long format)
Prior Radiotherapy at randomisation
Prior Radiotherapy at randomisation (Numeric)
Prior Radiotherapy at randomisation (Long format)
Planned treatment assigned at randomisation
Planned treatment assigned at randomisation (Numeric)
Analysis parameter: Progression free survival
Analysis parameter code
Analysis value (time to event (years)
Censoring (0 = Event, 1 = Censored)
Discontinuation from study reason
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.