Illustrates Domains
BDS
Illustrates Variables
PPROTFL
TRT01P
PARAM
PARAMCD
AVAL
STARTDT
CNSR
ADT
EVNTDESC
Illustrates Data Structures
BDS
Content
This is an example of ADTTE, an ADaM Basic Data Structure (BDS) dataset. It contains time-to-event information for time to death and the follow-up time associated with this time-to-event variable. It can be used in creating the figure and table in Section 7.2, Tables and Figures. Sponsors may include other related time-to-event endpoints (e.g., progression-free survival, time to progression) in this dataset, not shown here. The median follow-up is an estimate of the length of follow-up in a study for the event of interest. This example is based on a simple single-treatment period parallel study design. The start of the at-risk period is the randomization date and TRT01P was used as the treatment variable for analysis purposes. In a more complicated study design, TRTP might be used as the treatment variable for analysis purposes and other dates may be used to populate STARTDT. This example uses the reverse Kaplan-Meier estimator[16] by flipping the meaning of "event" and "censor."
ADTTE Dataset Metadata
Dataset Name | Dataset Description | Location | Class | Dataset Structure | Purpose | Keys | Documentation |
|---|---|---|---|---|---|---|---|
ADTTE | Time-to-Event Analysis Dataset | ADTTE.xpt | BASIC DATA STRUCTURE | One record per subject per parameter | Analysis | STUDYID, USUBJID, PARAMCD | ADTTE.SAS/SAP |
ADTTE Variable Metadata
Variable Name | Variable Label | Type | Codelist/Controlled Terms | Source/Derivation/Comment |
|---|---|---|---|---|
| STUDYID | Study Identifier | Char | ADSL.STUDYID | |
| USUBJID | Unique Subject Identifier | Char | ADSL.USUBJID | |
| PPROTFL | Per-Protocol Population Flag | Char | Y; N | ADSL.PPROTFL |
TRT01P | Planned Treatment for Period 01 | Char | TREAT A; TREAT B | ADSL.TRT01P |
| PARAM | Parameter | Char | Overall Survival (days); Follow-up Time - Overall Survival (days) | The description of the analysis parameter Set to the CT value for the corresponding PARAMCD: OS=Overall Survival (days) FUPTIMOS=Follow-up Time - Overall Survival (days) |
| PARAMCD | Parameter Code | Char | OS; FUPTIMOS | The short name of the analysis parameter in PARAM. |
| AVAL | Analysis Value | Num | Set to ADT-STARTDT+1. The numeric value represented the duration (in days) from the randomization date to the event or censoring date. | |
| STARTDT | Time-to-Event Origin Date for Subject | Num | ADSL.RANDDT | |
| CNSR | Censor | Num | 1; 0 | Set to 1 if censored based on censoring rules. Set to 0 for the event. |
| ADT | Analysis Date | Num | This is the event or censoring date. ADT is derived based on event/censoring rules per SAP. Event OS: (CNSR=0): Set to the date of death. (CNSR=1): Set to analysis cut-off date, or last date known alive. Event FUPTIMOS: (CNSR=0): Set to analysis cut-off date, or last date known alive: (CNSR)=1: Set to the date of death. | |
| EVNTDESC | Event or Censoring Description | Char | ANALYSIS CUT OFF; DEATH, LAST CONTACT | Description of the event of interest or censoring reason for the subject within the parameter. If subject died, set to "DEATH". If subject alive, set to "ANALYSIS CUT OFF" or "LAST CONTACT" based on the rules defined in the SAP. |
These tables represent parameter value-level lists for applicable variables.
ADTTE [CL.PARAM.ADTTE]
| Permitted Value (Code) |
|---|
| Overall Survival (days) |
Follow-up Time - Overall Survival (days) |
ADTTE Parameter Code [CL.PARAMCD.ADTTE]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| OS | Overall Survival (days) |
| FUPTIMOS | Follow-up Time - Overall Survival (days) |
Parameter Value List - ADTTE [AVAL]
| Variable | Where | Type | Length | Controlled Terms or Format | Origin | Derivation/Comment |
|---|---|---|---|---|---|---|
| AVAL | PARAMCD="OS" | integer | 8 | Derived | Set to ADT-STARTDT+1. | |
| AVAL | PARAMCD="FUPTIMOS" | integer | 8 | Derived | Set to ADT-STARTDT+1. |
Parameter Value List - ADTTE [ADT]
| Variable | Where | Type | Length | Controlled Terms or Format | Origin | Derivation/Comment |
|---|---|---|---|---|---|---|
| ADT | PARAMCD="OS" and CNSR=0 | integer | 8 | Derived | Set to the date of death. ISO value converted to numeric. | |
| ADT | PARAMCD="OS" and CNSR=1 | integer | 8 | Derived | Set to analysis cut-off date, or last date known alive. ISO value converted to numeric. | |
| ADT | PARAMCD="FUPTIMOS" and CNSR=1 | integer | 8 | Derived | Set to the date of death. ISO value converted to numeric. | |
| ADT | PARAMCD="FUPTIMOS" and CNSR=0 | integer | 8 | Derived | Set to analysis cut-off date, or last date known alive. ISO value converted to numeric. |
Parameter Value List - ADTTE [EVNTDESC]
| Variable | Where | Type | Length | Controlled Terms or Format | Origin | Derivation/Comment |
|---|---|---|---|---|---|---|
| EVNTDESC | PARAMCD="OS" and CNSR=0 | text | 26 | Derived | Set to "DEATH" | |
| EVNTDESC | PARAMCD="OS" and CNSR=1 | text | 26 | Derived | Set to "ANALYSIS CUT OFF" or "LAST CONTACT" based on the rules defined in the SAP. | |
| EVNTDESC | PARAMCD="FUPTIMOS" and CNSR=1 | text | 26 | Derived | Set to "DEATH" | |
| EVNTDESC | PARAMCD="FUPTIMOS" and CNSR=0 | text | 26 | Derived | Set to "ANALYSIS CUT OFF" or "LAST CONTACT" based on the rules defined in the SAP. |