| VARIABLE | LABEL | TYPE | CODES |
|---|---|---|---|
| C | Commented rows | character | . = Not a comment, C = Comment for exclusion |
| NUM | Row number | numeric | |
| ID | NONMEM ID number | numeric | |
| TIME | Time after first dose (unit: hour) | numeric | |
| SEQ | Data type | numeric | 0 = Dose, 1 = Observation |
| CMT | Compartment | numeric | 1 = Dose, 2 = Observation |
| EVID | Event identifier | numeric | 0 = Observation event, 1 = Dosing event |
| AMT | Dose amount (unit: mg) | numeric | |
| DV | Dependent variable | numeric | |
| AGE | Age (unit: years) | numeric | |
| WT | Weight (unit: kg) | numeric | |
| HT | Height (unit: cm) | numeric | |
| EGFR | Estimated glomerular filtration rate (unit: mL/min/1.73m2) | numeric | |
| ALB | Albumin (unit: g/dL) | numeric | |
| BMI | Body mass index (unit: kg/m2) | numeric | |
| SEX | Sex | numeric | 0 = Male, 1 = Female |
| AAG | Alpha-1-acid glycoprotein (unit: mg/dL) | numeric | |
| SCR | Serum creatinine (unit: mg/dL) | numeric | |
| AST | Aspartate aminotransferase (unit: U/L) | numeric | |
| ALT | Alanine aminotransferase (unit: U/L) | numeric | |
| CP | Child-Pugh score | numeric | 0 = normal, 1 = score=1, 2 = score=2, 3 = score=3 |
| TAFD | Time after first dose (unit: hour) | numeric | |
| TAD | Time after dose (unit: hour) | numeric | |
| LDOS | Last dose amount (unit: mg) | numeric | |
| MDV | Missing dependent variable | numeric | 0 = No, 1 = Yes |
| BLQ | Below limit of quantification | numeric | 1 = Above QL, 0 = Below QL |
| PHASE | Study phase indicator | numeric | values: 1 |
| STUDYN | Study number | numeric | values: 1, 2, 3, 4 |
| DOSE | Nominal dose amount | numeric | 5 = 5 mg, 10 = 10 mg, 25 = 25 mg, 50 = 50 mg, 75 = 75 mg, 100 = 100 mg, 150 = 150 mg, 200 = 200 mg |
| SUBJ | Subject identifer | character | |
| USUBJID | Unique subject identifier | character | |
| STUDY | Study name | character | values: 101-DEMO-001, 101-DEMO-002, 201-DEMO-003, 201-DEMO-004 |
| ACTARM | Treatment arm | character | values: DEMO 5 mg, DEMO 10 mg, DEMO 10 mg qd x7, DEMO 25 mg, DEMO 25 mg qd x7, DEMO 50 mg qd x7, DEMO 75 mg qd x7, DEMO 100 mg, DEMO 100 mg qd x7, DEMO 150 mg, DEMO 200 mg |
| RF | Renal function stage | character | norm = normal, mild, mod = moderate, sev = severe |
1 Definitions table
These are the data definitions for the pk.csv data set which is used for the population PK analysis in this Expo.
2 Definitions object
The data definitions can be loaded into your R session using the yspec package. We use the ys_load() function and point to the yaml file where definitions are coded.
library(yspec)
spec <- ys_load(here("data/derived/pk.yml"))
head(spec). name info unit short source
. 1 C cd- . Commented rows lookup
. 2 NUM --- . Row number lookup
. 3 ID --- . NONMEM ID number lookup
. 4 TIME --- hour Time after first dose lookup
. 5 SEQ -d- . Data type lookup
. 6 CMT -d- . Compartment lookup
. 7 EVID -d- . Event identifier lookup
. 8 AMT --- mg Dose amount lookup
. 9 DV --- . Dependent variable lookup
. 10 AGE --- years Age lookup3 Define pdf document
We can render a more formal data definitions document in .pdf format to support a more formal submission package.
The define.pdf document is a single listing of definitions for all data sets in the analysis, built from data definition objects for each analysis data set. In this example, there was only one data set.
Page 1
You won’t be able to click through the links since this content is being hosted on a website. The Description column under Datasets links to the header of the particular dataset and Location links to the SASxport file (.xpt) on disk.
Page 2
