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/abs/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).
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.