This dataset is a simplified, binary outcome version of a sample Phase 2 clinical trial dataset formatted according to the Analysis Data Model (ADaM) standards set by the Clinical Data Interchange Standards Consortium (CDISC). It is designed for training and educational purposes, showcasing how clinical trial data can be structured for statistical analysis.
Format
A data frame with 254 rows and 13 columns, representing trial participants and key variables:
- USUBJID
Unique subject identifier (alphanumeric code). A code unique to the clinical trial
- PARAM
Parameter name indicating the specific measurement or outcome assessed.
- AGE
Age of the participant at study enrollment, in years.
- AGEGR1
Categorical representation of age groups.
- AGEGR1N
Numeric code representing age groups, used for statistical modeling.
- RACE
Self-identified race of the participant
- RACEN
Numeric representation of race categories, used for statistical modeling.
- SEX
Participant's sex at birth.
- TRTP
Planned treatment assignment, indicating the specific intervention or control condition.
- TRTPN
Numeric code for the planned treatment, simplifying data analysis procedures.
- AVAL
Analysis value, representing the primary outcome measure for each participant.
- AVALC
Character representation of the analysis value, used in descriptive summaries.
- FASFL
Full analysis set flag, indicating if the participant's data is included in the full analysis set.
Source
This dataset has been reformatted for educational use from the
safetyData package, specifically adam_adtte. For the original data and
more detailed information, please refer to the
safetyData documentation.
Details
This dataset serves as an illustrative example for those learning about the ADaM standard in clinical trials. It includes common variables like demographic information, treatment assignments, and outcome measures.
Data privacy and ethical considerations have been addressed through the anonymization of subject identifiers and other sensitive information. The dataset is intended for educational and training purposes only.