2. Data and Settings Guidelines

Data

Required Data Domains

The Nephrotoxicity Explorer requires:

• subject-level demographics dataset (e.g. ADSL or DM)
• one-row-per-measure laboratary dataset (e.g. ADLB or LB)
• one-row-per-measure vital signs dataset. (e.g. ADVS or VS)

Example datasets for each of these in the required format is provided as part of this package under their ADaM CDISC Standard names ADSL, ADLB, and ADVS.

Column-level requirements are provided below for each domain along with the respective metadata setting used to tell nepExplorer how to map the data to chart aesthetics.

Subject-level Dataset (e.g. ADSL or DM)

When a subject is selected within the creatinine scatterplot, the subject-level dataset is used to provide demographic information for the selected subject. Column-level specifications can be found in the table below:

Column-level Specifications

Setting	ADAM Standard	Data Type	Description	Required?
id_col	USUBJID	character	Participant ID	Yes
treatment_col	TRT01P	string	Planned Study Treatment Group	No
sex_col	SEX	string	Participant Sex	No
race_col	RACE	string	Participant Race	No
age_col	AGE	string or number	Participant Age or Age Group	No

Lab Dataset (e.g. ADLB or LB)

Default Measures: Blah blah

Custom Fold Change Measures: nblah

Column-level Specifications

Setting	ADAM Standard	Data Type	Description	Required?
id_col	USUBJID	character	a variable that contains IDs for each participant
visit_col	VISIT	string	visit name
visitn_col	VISITNUM	number	sort order of visit
studyday_col	DY	number	study day of visit	Yes
measure_col	TEST	character	a variable that contains the names of each medical sign	Yes
value_col	STRESN	numeric	a variable that contains the results for each medical sign; non-numeric results are removed with a notification thrown to the log	Yes
unit_col	STRESU	character	a variable that contains the units of each medical sign
baseline_flag	ABLFL	character	Column for assigning baseline visits

Field-level Specifications

Vitals Dataset (e.g. ADVS or VS)

Column-level Specifications

Setting	ADAM Standard	Data Type	Description	Required?
id_col	USUBJID	character	a variable that contains IDs for each participant
visit_col	VISIT	string	visit name
visitn_col	VISITNUM	number	sort order of visit
studyday_col	DY	number	study day of visit	Yes
measure_col	TEST	character	a variable that contains the names of each medical sign	Yes
value_col	STRESN	numeric	a variable that contains the results for each medical sign; non-numeric results are removed with a notification thrown to the log	Yes
unit_col	STRESU	character	a variable that contains the units of each medical sign
baseline_flag	ABLFL	character	Column for assigning baseline visits

Field-level Specifications

Setting	Column	Description	Required?
SYSBP	measure_col	Value used for Systolic Blood Pressure in the specified measure column	No
DIABP	measure_col	Value used for Diastolic Blood Pressure in the specified measure column	No