Data
What was measured
Every number in the report was computed from one of these datasets. Each page states where the file came from, byte for byte, what the preparation layer did to it, and every display whose current results were computed from it — with the row count and hash that display recorded. Nothing here is typed: the facts are the vendored package's provenance record and the provenance envelope every ARD carries.
The study's own data package
CDISCPILOT01's ADaM datasets and two SDTM domains, vendored from phuse-org/phuse-scripts at a pinned commit under its MIT licence; every file's git blob SHA-1 was recomputed from the downloaded bytes and matched against the commit's tree.
- Source repository
- https://github.com/phuse-org/phuse-scripts
- Pinned commit
- 398a6d33ced9359ffb58c46650a6d488811176b1
- Commit date
- 2025-08-25T14:48:53Z
- Retrieved
- 2026-09-02
- Licence
- MIT
- Files
- 13
- Vendored under
- pipeline/inst/extdata/phuse-cdiscpilot01
- Record
- pipeline/inst/extdata/phuse-cdiscpilot01/PROVENANCE.json
- Verification
- Each vendored file's git blob SHA-1 was recomputed from the downloaded bytes and matched against the SHA recorded in the commit's recursive tree.
- Verify
- Rscript qc/vendor-phuse-data.R --check
Subject-level analysis dataset
254 rows · read by 30 displays
Adverse events
1191 rows · read by 5 displays
Vital signs
32139 rows · read by 3 displays
Laboratory: chemistry
read by no display
Laboratory: haematology
read by no display
Laboratory: Hy's-law parameters
read by no display
ADAS-Cog (11)
12463 rows · read by 8 displays
CIBIC+
730 rows · read by 4 displays
NPI-X
31140 rows · read by 1 display
Time to first dermatologic event
254 rows · read by 1 display
Concomitant medications (analysis dataset)
7510 rows · read by 1 display
Concomitant medications (SDTM domain)
read by no display
Demographics (SDTM domain)
306 rows · read by 1 display
Concomitant medications: PHUSE's relabelled copy
read by no display
Exposure (pharmaverseadam only)
read by no display
Laboratory (pharmaverseadam only)
read by no display
adsl Subject-level analysis dataset 30 displays
One record per subject: demographics, the study's own population flags, baseline measures, treatment and disposition. The denominator for every display.
- Domain
- ADaM
- Source
- vendored file, prepared by the pipeline
- Lane
- the study's own package (phuse-org/phuse-scripts)
- Upstream path
- data/adam/cdiscpilot01/adsl.xpt
- Blob SHA-1
- 56e04ac80dab0d9bca3b48296a2c1eac654ccfb3
- SHA-256
- c5139f873a93ef6add77bc4297beb6460a398bbdd036874382a9f39dfc92091d
- Bytes
- 114640
- Vendored file
- pipeline/inst/extdata/phuse-cdiscpilot01/adsl.xpt.gz gz e01b4be
- Prepared rows
- 254
- Prepared hash
- b022f78 / 70c7278 / 1f6fa03 / 3139478
- Read by
- 30 displays
- data/adam/cdiscpilot01/adsl.xptblob 56e04ac · 114640 bytes
- vendor + verifyRscript qc/vendor-phuse-data.R --check
- prepare_data()4 derivations
- prepared frame254 rows · b022f78 / 70c7278 / 1f6fa03 / 3139478
- 30 displayscomputed from it
Derivations and notes
- SAFFL, ITTFL and EFFFL as the study states them, blank recoded to N; no population flag is guessed.
- Baseline weight, height and BMI and the study's own age groups (<65, 65-80, >80) as shipped.
- RACEOR, the race-with-origin recode the reference report prints (ethnicity first, then race), added for the demographics table; the CDISC-coded RACE stays.
- SITEID kept as a factor in the site order the reference report uses.
The preparation layer's derivations are documented in the contracts, §4.
Read by
Every display whose current iteration names this dataset in its ARD's provenance envelope, with the row count and hash that iteration recorded for the prepared frame.
adae Adverse events 5 displays
One record per reported event; treatment-emergent, serious and relationship flags as shipped.
- Domain
- ADaM
- Source
- vendored file, prepared by the pipeline
- Lane
- the study's own package (phuse-org/phuse-scripts)
- Upstream path
- data/adam/cdiscpilot01/adae.xpt
- Blob SHA-1
- 95129e67e73963d182bf2c5fef46e49898edfee0
- SHA-256
- b8678e70946473a753bb01d002917f478bf51b59bdd0dc19587b97128059b6a0
- Bytes
- 713600
- Vendored file
- pipeline/inst/extdata/phuse-cdiscpilot01/adae.xpt.gz gz 3bffe9c
- Prepared rows
- 1191
- Prepared hash
- 4ffe4e4
- Read by
- 5 displays
- data/adam/cdiscpilot01/adae.xptblob 95129e6 · 713600 bytes
- vendor + verifyRscript qc/vendor-phuse-data.R --check
- prepare_data()2 derivations
- prepared frame1191 rows · 4ffe4e4
- 5 displayscomputed from it
Derivations and notes
- TRT01A is taken from the prepared ADSL by USUBJID, never from the dataset's own treatment columns.
- The treatment-emergent flag is the study's own; nothing is re-derived.
The preparation layer's derivations are documented in the contracts, §4.
Read by
Every display whose current iteration names this dataset in its ARD's provenance envelope, with the row count and hash that iteration recorded for the prepared frame.
| Display | Iteration | Rows | Prepared hash | ARD hash |
|---|---|---|---|---|
| Listing of Serious Adverse Events l-ae-serious | v003 | 1191 | 4ffe4e4 | cde8256 |
| Treatment-Emergent Adverse Events by System Organ Class and Preferred Term t-ae-common | v004 | 1191 | 4ffe4e4 | adf6d63 |
| Incidence of Treatment Emergent Adverse Events by Treatment Group t-ae-incidence | v007 | 1191 | 4ffe4e4 | 091de51 |
| Overview of Treatment-Emergent Adverse Events t-ae-overview | v003 | 1191 | 4ffe4e4 | c428956 |
| Incidence of Treatment Emergent Serious Adverse Events by Treatment Group t-sae-incidence | v006 | 1191 | 4ffe4e4 | 94a983c |
advs Vital signs 3 displays
Six parameters over every visit; the input to the vital-sign and weight displays.
- Domain
- ADaM
- Source
- vendored file, prepared by the pipeline
- Lane
- the study's own package (phuse-org/phuse-scripts)
- Upstream path
- data/adam/cdiscpilot01/advs.xpt
- Blob SHA-1
- 59641d0a8939f4026086106dcfba245cbb8986f7
- SHA-256
- 28233c8ed038d0f315a9538d910beb43cf1bb4b69f8f1c39b32463c7b018dff1
- Bytes
- 13632480
- Vendored file
- pipeline/inst/extdata/phuse-cdiscpilot01/advs.xpt.gz gz 832916f
- Prepared rows
- 32139
- Prepared hash
- ccc9f70
- Read by
- 3 displays
- data/adam/cdiscpilot01/advs.xptblob 59641d0 · 13632480 bytes
- vendor + verifyRscript qc/vendor-phuse-data.R --check
- prepare_data()2 derivations
- prepared frame32139 rows · ccc9f70
- 3 displayscomputed from it
Derivations and notes
- TRT01A from the prepared ADSL by USUBJID.
- A DTYPE column is added as all-missing when the package ships none, so filters on derived records apply the same way on both lanes; blank AVISIT and ATPT are treated as unset.
The preparation layer's derivations are documented in the contracts, §4.
Read by
Every display whose current iteration names this dataset in its ARD's provenance envelope, with the row count and hash that iteration recorded for the prepared frame.
| Display | Iteration | Rows | Prepared hash | ARD hash |
|---|---|---|---|---|
| Summary of Vital Signs at Baseline and End of Treatment t-vitals | v002 | 32139 | ccc9f70 | 80334ea |
| Summary of Vital Signs Change from Baseline at End of Treatment t-vitals-change | v002 | 32139 | ccc9f70 | 4a0f857 |
| Summary of Weight and Weight Change from Baseline at End of Treatment t-weight | v004 | 32139 | ccc9f70 | 39d684c |
adlbc Laboratory: chemistry read by no display
Vendored for the laboratory families; read by no display until v0.4.1.
- Domain
- ADaM
- Source
- vendored file, prepared by the pipeline
- Lane
- —
- Upstream path
- data/adam/cdiscpilot01/adlbc.xpt
- Blob SHA-1
- 7c6061f0eea450f671c0632434c111326b028fde
- SHA-256
- b9f6b5106965b5e2e3b33062a18710b58ceecc0c8cf1e54271849653037998ea
- Bytes
- 34242960
- Vendored file
- pipeline/inst/extdata/phuse-cdiscpilot01/adlbc.xpt.gz gz 977eaf2
- Read by
- no display
- data/adam/cdiscpilot01/adlbc.xptblob 7c6061f · 34242960 bytes
- vendor + verifyRscript qc/vendor-phuse-data.R --check
- prepare_data()read as shipped
- prepared framenot read by any display
Read by
No display's current iteration names this dataset in its ARD.
adlbh Laboratory: haematology read by no display
Vendored for the laboratory families; read by no display until v0.4.1.
- Domain
- ADaM
- Source
- vendored file, prepared by the pipeline
- Lane
- —
- Upstream path
- data/adam/cdiscpilot01/adlbh.xpt
- Blob SHA-1
- a7cbba0389c4e5055fc6194d72cfc27724b6ddd9
- SHA-256
- de568850f5585266844abe6eb7ef0290ea130d90c3f023efcb9f13c2a586455b
- Bytes
- 23025920
- Vendored file
- pipeline/inst/extdata/phuse-cdiscpilot01/adlbh.xpt.gz gz 87337a0
- Read by
- no display
- data/adam/cdiscpilot01/adlbh.xptblob a7cbba0 · 23025920 bytes
- vendor + verifyRscript qc/vendor-phuse-data.R --check
- prepare_data()read as shipped
- prepared framenot read by any display
Read by
No display's current iteration names this dataset in its ARD.
adlbhy Laboratory: Hy's-law parameters read by no display
Derived by the study from its chemistry data; vendored for the laboratory families; read by no display until v0.4.1.
- Domain
- ADaM
- Source
- vendored file, prepared by the pipeline
- Lane
- —
- Upstream path
- data/adam/cdiscpilot01/adlbhy.xpt
- Blob SHA-1
- 546e5354599c15c15a566012bb909f4d3a497226
- SHA-256
- bb1c0c020aa1ef5af0a4b35467ad5bbdf2f4234dc8b97a333877182e62370682
- Bytes
- 4675280
- Vendored file
- pipeline/inst/extdata/phuse-cdiscpilot01/adlbhy.xpt.gz gz eb66fd3
- Read by
- no display
- data/adam/cdiscpilot01/adlbhy.xptblob 546e535 · 4675280 bytes
- vendor + verifyRscript qc/vendor-phuse-data.R --check
- prepare_data()read as shipped
- prepared framenot read by any display
Read by
No display's current iteration names this dataset in its ARD.
adqsadas ADAS-Cog (11) 8 displays
The study's first primary efficacy endpoint at Week 24; the input to the ADAS-Cog displays.
- Domain
- ADaM
- Source
- vendored file, prepared by the pipeline
- Lane
- the study's own package (phuse-org/phuse-scripts)
- Upstream path
- data/adam/cdiscpilot01/adqsadas.xpt
- Blob SHA-1
- 76a3cb59e2cb3e7ba35803fd44f469131f56ccc5
- SHA-256
- ac3fa1217651810b0f15fe489fdda7d99eff10553ded025156ad7c1b89f84608
- Bytes
- 5178480
- Vendored file
- pipeline/inst/extdata/phuse-cdiscpilot01/adqsadas.xpt.gz gz f4b493f
- Prepared rows
- 12463
- Prepared hash
- d6ee9a3
- Read by
- 8 displays
- data/adam/cdiscpilot01/adqsadas.xptblob 76a3cb5 · 5178480 bytes
- vendor + verifyRscript qc/vendor-phuse-data.R --check
- prepare_data()2 derivations
- prepared frame12463 rows · d6ee9a3
- 8 displayscomputed from it
Derivations and notes
- TRT01A from the prepared ADSL by USUBJID.
- Visits are selected by AVISITN in every specification.
The preparation layer's derivations are documented in the contracts, §4.
Read by
Every display whose current iteration names this dataset in its ARD's provenance envelope, with the row count and hash that iteration recorded for the prepared frame.
| Display | Iteration | Rows | Prepared hash | ARD hash |
|---|---|---|---|---|
| ADAS-Cog (11) - Repeated Measures Analysis of Change from Baseline to Week 24 t-eff-adas-mmrm | v004 | 12463 | d6ee9a3 | 8953a87 |
| ADAS-Cog (11) - Mean and Mean Change from Baseline over Time t-eff-adas-overtime | v002 | 12463 | d6ee9a3 | ae89465 |
| ADAS-Cog (11) - Change from Baseline to Week 16 - LOCF t-eff-adas-wk16 | v002 | 12463 | d6ee9a3 | dd7d1cd |
| Primary Endpoint Analysis: ADAS-Cog (11) - Change from Baseline to Week 24 - LOCF t-eff-adas-wk24 | v002 | 12463 | d6ee9a3 | 6e4dd40 |
| ADAS-Cog (11) - Change from Baseline to Week 24 - Completers at Week 24, Observed Cases, Windowed t-eff-adas-wk24-completers | v002 | 12463 | d6ee9a3 | 9c9aef7 |
| ADAS-Cog (11) - Change from Baseline to Week 24 in Female Subjects - LOCF t-eff-adas-wk24-female | v002 | 12463 | d6ee9a3 | 92e3885 |
| ADAS-Cog (11) - Change from Baseline to Week 24 in Male Subjects - LOCF t-eff-adas-wk24-male | v002 | 12463 | d6ee9a3 | bf57631 |
| ADAS-Cog (11) - Change from Baseline to Week 8 - LOCF t-eff-adas-wk8 | v002 | 12463 | d6ee9a3 | ec13102 |
adqscibc CIBIC+ 4 displays
The study's second primary efficacy endpoint at Week 24; the input to the CIBIC+ displays.
- Domain
- ADaM
- Source
- vendored file, prepared by the pipeline
- Lane
- the study's own package (phuse-org/phuse-scripts)
- Upstream path
- data/adam/cdiscpilot01/adqscibc.xpt
- Blob SHA-1
- 4c5aa553ca7b4141f7c7748d0d7b3fb6bd4d3d3a
- SHA-256
- 16e7118f606d907e817f0a5885d662c2e7177c430d2b3ec6c0ba9096cb3d7bc1
- Bytes
- 290480
- Vendored file
- pipeline/inst/extdata/phuse-cdiscpilot01/adqscibc.xpt.gz gz d22ef74
- Prepared rows
- 730
- Prepared hash
- f6461f4
- Read by
- 4 displays
- data/adam/cdiscpilot01/adqscibc.xptblob 4c5aa55 · 290480 bytes
- vendor + verifyRscript qc/vendor-phuse-data.R --check
- prepare_data()1 derivation
- prepared frame730 rows · f6461f4
- 4 displayscomputed from it
Derivations and notes
- TRT01A from the prepared ADSL by USUBJID.
The preparation layer's derivations are documented in the contracts, §4.
Read by
Every display whose current iteration names this dataset in its ARD's provenance envelope, with the row count and hash that iteration recorded for the prepared frame.
| Display | Iteration | Rows | Prepared hash | ARD hash |
|---|---|---|---|---|
| CIBIC+ — Categorical Analysis — LOCF t-cibic-categorical | v002 | 730 | f6461f4 | 4847131 |
| CIBIC+ — Summary at Week 16 — LOCF t-cibic-week16 | v002 | 730 | f6461f4 | 4f25a6b |
| Primary Endpoint Analysis: CIBIC+ — Summary at Week 24 — LOCF t-cibic-week24 | v004 | 730 | f6461f4 | a8f78f3 |
| CIBIC+ — Summary at Week 8 — LOCF t-cibic-week8 | v002 | 730 | f6461f4 | 3073ee5 |
adqsnpix NPI-X 1 display
The secondary efficacy endpoint; the input to the NPI-X mean display.
- Domain
- ADaM
- Source
- vendored file, prepared by the pipeline
- Lane
- the study's own package (phuse-org/phuse-scripts)
- Upstream path
- data/adam/cdiscpilot01/adqsnpix.xpt
- Blob SHA-1
- 12dbd8c03ea5675f0a924b7a37cb19b3fd169405
- SHA-256
- 90cf438913cfb976a34e9cf6c44291eab7a65c5c0146f8df092cd9ce2bd8c44a
- Bytes
- 13147600
- Vendored file
- pipeline/inst/extdata/phuse-cdiscpilot01/adqsnpix.xpt.gz gz 7d82c42
- Prepared rows
- 31140
- Prepared hash
- a8db42f
- Read by
- 1 display
- data/adam/cdiscpilot01/adqsnpix.xptblob 12dbd8c · 13147600 bytes
- vendor + verifyRscript qc/vendor-phuse-data.R --check
- prepare_data()2 derivations
- prepared frame31140 rows · a8db42f
- 1 displaycomputed from it
Derivations and notes
- TRT01A from the prepared ADSL by USUBJID.
- AVISIT ships right-aligned in a sixteen-character field, so the specification selects visits by AVISITN.
The preparation layer's derivations are documented in the contracts, §4.
Read by
Every display whose current iteration names this dataset in its ARD's provenance envelope, with the row count and hash that iteration recorded for the prepared frame.
| Display | Iteration | Rows | Prepared hash | ARD hash |
|---|---|---|---|---|
| Mean NPI-X Total Score from Week 4 through Week 24 - Windowed t-eff-npix-mean | v003 | 31140 | a8db42f | 670210c |
adtte Time to first dermatologic event 1 display
A safety analysis: dermatologic events are the study's adverse events of special interest; the input to the one time-to-event figure.
- Domain
- ADaM
- Source
- vendored file, prepared by the pipeline
- Lane
- the study's own package (phuse-org/phuse-scripts)
- Upstream path
- data/adam/cdiscpilot01/adtte.xpt
- Blob SHA-1
- b813b60fe70fd50e0af4b8fa54a8695e772a48b8
- SHA-256
- 68513fc4126744b6b2c7328eb70eb7b9683865d12c58b36539325f3c0c0ab93d
- Bytes
- 91840
- Vendored file
- pipeline/inst/extdata/phuse-cdiscpilot01/adtte.xpt.gz gz f832936
- Prepared rows
- 254
- Prepared hash
- 82a036b
- Read by
- 1 display
- data/adam/cdiscpilot01/adtte.xptblob b813b60 · 91840 bytes
- vendor + verifyRscript qc/vendor-phuse-data.R --check
- prepare_data()1 derivation
- prepared frame254 rows · 82a036b
- 1 displaycomputed from it
Derivations and notes
- TRT01A from the prepared ADSL by USUBJID.
The preparation layer's derivations are documented in the contracts, §4.
Read by
Every display whose current iteration names this dataset in its ARD's provenance envelope, with the row count and hash that iteration recorded for the prepared frame.
| Display | Iteration | Rows | Prepared hash | ARD hash |
|---|---|---|---|---|
| Time to Dermatologic Event by Treatment Group f-derm-time-to-event | v002 | 254 | 82a036b | dae95ac |
adcm Concomitant medications (analysis dataset) 1 display
Derived by the pipeline from the study's SDTM CM domain; the input to the medication table.
- Domain
- ADaM
- Source
- derived by the pipeline from another dataset
- Lane
- the study's own package (phuse-org/phuse-scripts)
- Derived from
- cm
- Prepared rows
- 7510
- Prepared hash
- 78178a0
- Read by
- 1 display
- cmprepared
- prepare_data()derive_adcm()
- prepared frame7510 rows · 78178a0
- 1 displaycomputed from it
Derivations and notes
- derive_adcm(): every CM column as published; ASTDT and AENDT only where the source states a full date; CMFL = Y on every record.
- SAFFL and TRT01A from the prepared ADSL by USUBJID.
- Reproduces every one of the 414 statistics the medication table published from the relabelled copy (TFL-PREP-018).
The preparation layer's derivations are documented in the contracts, §4.
Read by
Every display whose current iteration names this dataset in its ARD's provenance envelope, with the row count and hash that iteration recorded for the prepared frame.
| Display | Iteration | Rows | Prepared hash | ARD hash |
|---|---|---|---|---|
| Summary of Concomitant Medications t-conmeds | v003 | 7510 | 78178a0 | 95799f7 |
cm Concomitant medications (SDTM domain) read by no display
The study's SDTM CM domain, 7,510 records for 229 subjects; the input to adcm.
- Domain
- SDTM
- Source
- vendored file, prepared by the pipeline
- Lane
- —
- Upstream path
- data/sdtm/cdiscpilot01/cm.xpt
- Blob SHA-1
- 37bb289b965a1d47537b3d4de95e8ab0ca009d87
- SHA-256
- bb31e91b93a8e4854bd66270cb4d1677a4ab59add30ec8cdbebb3491c18f1582
- Bytes
- 3758720
- Vendored file
- pipeline/inst/extdata/phuse-cdiscpilot01/cm.xpt.gz gz 1b0f83f
- Read by
- no display
- data/sdtm/cdiscpilot01/cm.xptblob 37bb289 · 3758720 bytes
- vendor + verifyRscript qc/vendor-phuse-data.R --check
- prepare_data()1 derivation
- prepared framenot read by any display
Derivations and notes
- Read whole; the derivation to adcm is the only preparation.
The preparation layer's derivations are documented in the contracts, §4.
Read by
No display's current iteration names this dataset in its ARD.
dm Demographics (SDTM domain) 1 display
All 306 screened subjects, including the 52 screen failures the ADaM package does not carry; the input to the disposition flow.
- Domain
- SDTM
- Source
- vendored file, prepared by the pipeline
- Lane
- the study's own package (phuse-org/phuse-scripts)
- Upstream path
- data/sdtm/cdiscpilot01/dm.xpt
- Blob SHA-1
- dda76664a1c139270e1545856c45402aacb5193b
- SHA-256
- 7327baea97fd532d02385248da0c7240402e770099507e2c3a88e2ac706c02a6
- Bytes
- 110800
- Vendored file
- pipeline/inst/extdata/phuse-cdiscpilot01/dm.xpt.gz gz 4fee768
- Prepared rows
- 306
- Prepared hash
- 6f25948
- Read by
- 1 display
- data/sdtm/cdiscpilot01/dm.xptblob dda7666 · 110800 bytes
- vendor + verifyRscript qc/vendor-phuse-data.R --check
- prepare_data()1 derivation
- prepared frame306 rows · 6f25948
- 1 displaycomputed from it
Derivations and notes
- The one dataset prepare_data() keeps whole: screen failures are not removed, because the screened population is what this domain is for.
The preparation layer's derivations are documented in the contracts, §4.
Read by
Every display whose current iteration names this dataset in its ARD's provenance envelope, with the row count and hash that iteration recorded for the prepared frame.
| Display | Iteration | Rows | Prepared hash | ARD hash |
|---|---|---|---|---|
| Subject Disposition f-disposition | v001 | 306 | 6f25948 | 700d5e7 |
adcm-copy Concomitant medications: PHUSE's relabelled copy read by no display
Not part of the CDISC pilot package: a copy from a folder the upstream README calls out of place, with half its subjects relabelled into a second study. Read by no display since v0.4.0.
- Domain
- ADaM
- Source
- vendored file, prepared by the pipeline
- Lane
- —
- Upstream path
- data/adam/cdisc/adcm.xpt
- Blob SHA-1
- 8e60b80239505897086923c1ef3c546920488544
- SHA-256
- 7a82e955bcd5714228122bb803bb98d5678c4a92fb994f30fccc43bd43efe710
- Bytes
- 4542720
- Vendored file
- pipeline/inst/extdata/phuse-cdiscpilot01/adcm.xpt.gz gz 1a2bca2
- Read by
- no display
- data/adam/cdisc/adcm.xptblob 8e60b80 · 4542720 bytes
- vendor + verifyRscript qc/vendor-phuse-data.R --check
- prepare_data()1 derivation
- prepared framenot read by any display
Derivations and notes
- Kept for the check that the derived adcm reproduces its 414 statistics (TFL-PREP-018); whether to remove it is a question for the v0.4.0 review.
The preparation layer's derivations are documented in the contracts, §4.
Read by
No display's current iteration names this dataset in its ARD.
adex Exposure (pharmaverseadam only) read by no display
Served only by the alternate lane; the exposure display reads ADSL's own dose columns instead. Read by no display.
- Domain
- ADaM
- Source
- served only by the alternate lane
- Lane
- the pharmaverse re-derivation (pharmaverseadam)
- Upstream path
- the pharmaverseadam package, not vendored
- Read by
- no display
- pharmaverseadamthe alternate lane
- prepare_data()sources = "pharmaverseadam"
- prepared framenot read by any display
Read by
No display's current iteration names this dataset in its ARD.
adlb Laboratory (pharmaverseadam only) read by no display
Served only by the alternate lane; the study's own package carries adlbc, adlbh and adlbhy instead. Read by no display.
- Domain
- ADaM
- Source
- served only by the alternate lane
- Lane
- the pharmaverse re-derivation (pharmaverseadam)
- Upstream path
- the pharmaverseadam package, not vendored
- Read by
- no display
- pharmaverseadamthe alternate lane
- prepare_data()sources = "pharmaverseadam"
- prepared framenot read by any display
Read by
No display's current iteration names this dataset in its ARD.
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:
| Variable | Records differing | How |
|---|---|---|
| AGEGR1 | 254 | <65 > 18-64 (33); >80 > >64 (77); 65-80 > >64 (144) |
| TRT01A | 12 | Xanomeline High Dose > Xanomeline Low Dose (12) |
| TRTEDT | 6 | 2013-05-13 > <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:
| Variable | Records differing | How |
|---|---|---|
| TRTEMFL | 69 | N > <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