Data / lanes

Source lanes

Two packagings of the same study exist. The pipeline's registry resolves every dataset to the study's own package (phuse-org/phuse-scripts) by default; the pharmaverse re-derivation (pharmaverseadam) stays reachable by name and is measured against it by qc/source-agreement.R, whose record is quality/data/source-agreement.json.

phuse
phuse-org/phuse-scripts:data/adam (CDISC pilot submission ADaM package)
pharmaverseadam
pharmaverseadam (pharmaverse re-derivation from SDTM)

Values compared as text after normalising empty string to NA. ADSL is aligned on USUBJID after removing the 52 pharmaverseadam screen failures; ADAE is aligned on USUBJID+AESEQ.

adsl

subjects identical
true
n subjects
phuse: 254 · pharmaverseadam: 254
screen failures
phuse: 0 · pharmaverseadam: 52
population flags only in phuse
0: COMP16FL · 1: COMP24FL · 2: COMP8FL · 3: DISCONFL · 4: DSRAEFL · 5: EFFFL · 6: ITTFL
discontinuation reason only in phuse
0: DCDECOD · 1: DCREASCD
baseline vitals
WEIGHT: {"phuse_var":"WEIGHTBL","n_phuse":253,"n_pharmaverseadam":254,"n_over_0_01":194,"max_abs_delta":0.05} · HEIGHT: {"phuse_var":"HEIGHTBL","n_phuse":254,"n_pharmaverseadam":254,"n_over_0_01":192,"max_abs_delta":0.05} · BMI: {"phuse_var":"BMIBL","n_phuse":253,"n_pharmaverseadam":254,"n_over_0_01":192,"max_abs_delta":0.069403}

10 variables agree on every record; 3 differ:

VariableRecords differingHow
AGEGR1254<65 > 18-64 (33); >80 > >64 (77); 65-80 > >64 (144)
TRT01A12Xanomeline High Dose > Xanomeline Low Dose (12)
TRTEDT62013-05-13 > <NA> (1); 2013-07-12 > <NA> (1); 2013-07-14 > 2013-04-04 (1); 2014-03-07 > 2014-01-25 (1); 2014-05-11 > 2013-12-18 (1); 2014-06-02 > 2013-12-30 (1)

adae

keys identical
true
n records
phuse: 1191 · pharmaverseadam: 1191
n subjects
phuse: 225 · pharmaverseadam: 225

9 variables agree on every record; 1 differ:

VariableRecords differingHow
TRTEMFL69N > <NA> (65); Y > <NA> (4)

advs

derived records pharmaverseadam
23084
derived records phuse
0
n records
phuse: 32139 · pharmaverseadam: 65032
parameters
phuse: ["DIABP","HEIGHT","PULSE","SYSBP","TEMP","WEIGHT"] · pharmaverseadam: ["BMI","BSA","DIABP","HEIGHT","MAP","PULSE","SYSBP","TEMP","WEIGHT"]

adcm

in cdiscpilot01 folder
false
in study define xml
false
relabelled subjects
118
remapped subjects found in adsl
229
remapped subjects matching adsl age sex arm
229
adsl subjects with no record
25
n records
CDISCPILOT01: 3625 · CDISCPILOT02: 3885