A nif object based on the CDISCPILOT01 data set exported from the 'pharmaversesdtm' package including administration events for XAN and PLACEBO, and observations for XAN, ALT and HGB.
Format
nif object with 38475 rows and 29 columns:
- REF
row number
- ID
subject ID
- STUDYID
study ID
- USUBJID
unique subject ID
- AGE
age in years
- SEX
sex (0: male, 1, female)
- RACE
race
- WEIGHT
baseline body weight
- DTC
date time code for event
- TIME
time in hours
- NTIME
nominal time for event in hours
- TAFD
time after individual first dose
- TAD
time after last dose
- EVID
event ID (0: observation, 1: administration)
- AMT
amount in mg
- ANALYTE
analyte name
- CMT
analyte compartment
- PARENT
parent analyte
- TRTDY
treatment day
- METABOLITE
metabolite (0: no, 1: yes)
- DOSE
dose in mg
- MDV
missing dependent variable
- ACTARMCD
actual arm code
- IMPUTATION
imputation note
- DV
dependent variable
- BL_CREAT
baseline creatinine in umol/l
- BL_CRCL
baseline creatinine clearance in ml/min
- BL_RENAL
baseline renal function category
- DL
dose level in mg
Source
Created from https://github.com/pharmaverse/pharmaversesdtm
Details
----- NONMEM Input Format (NIF) data -----
8988 observations from 254 subjects across 1 study
Analytes: ALT, HGB, CFB_HGB, XAN and PLACEBO
111 males (43.7
Columns:
REF, ID, STUDYID, USUBJID, AGE, SEX, RACE, WEIGHT, DTC, TIME, NTIME, TAFD,
TAD, EVID, AMT, ANALYTE, CMT, PARENT, TRTDY, METABOLITE, DOSE, MDV, ACTARMCD,
IMPUTATION, DV, BL_CREAT, BL_CRCL, BL_RENAL, DL
Hash: f36650cc3aa5ecdad143a87e418b1439
Data (selected columns):
ID NTIME TIME TAD ANALYTE EVID CMT AMT DOSE DV
1 -192 0 -153.25 ALT 0 3 0 0 27
1 -192 0 -153.25 HGB 0 4 0 0 8.875
1 -192 0 -153.25 CFB_HGB 0 5 0 0 0
1 NA 152.75 -0.5 XAN 0 2 0 0 0
1 0 153.25 0 PLACEBO 1 1 0 0 NA
1 0.083 153.333 0.083 XAN 0 2 0 0 NA
1 0.5 153.75 0.5 XAN 0 2 0 0 NA
1 NA 154.25 1 XAN 0 2 0 0 NA
1 NA 154.75 1.5 XAN 0 2 0 0 NA
1 NA 155.25 2 XAN 0 2 0 0 NA
38465 more rows