Traceable ADaM derivation: every exclusion documented
Row-level data provenance for a Phase III atopic dermatitis trial
Ndoh Penn
2026-06-26
Source:vignettes/articles/lineager-dermatology.Rmd
lineager-dermatology.RmdOverview
Every ADaM derivation involves exclusions — screen failures, protocol deviations, missing baselines, assessment windows. In most trials these are documented in aggregate: “47 subjects were excluded from the per-protocol population.” But regulators increasingly ask for more: which rows? Why? And can you trace any subject through the complete derivation pipeline?
lineager answers these questions at the row level. Every
row in every dataset carries a lineage ID (lineage_id) that
survives filters, joins, and derivations. Every lg_filter()
call requires a documented reason, and the session automatically
accumulates an exclusion registry as the pipeline runs — no manual
disposition tracking needed.
This article builds an ADEFF dataset for a Phase III atopic dermatitis trial — starting from raw ADSL and ADLB, deriving baseline and change from baseline, tracking every exclusion, and producing a CDISC Reviewer’s Guide-aligned provenance report.
Setup
#>
#> Attaching package: 'dplyr'#> The following objects are masked from 'package:stats':
#>
#> filter, lag#> The following objects are masked from 'package:base':
#>
#> intersect, setdiff, setequal, unionSimulate source datasets
We simulate CDISC ADaM-structured ADSL (subject-level) and ADLB (lab/ assessment) datasets for a Phase III trial of dupilumab in moderate-to-severe atopic dermatitis. 320 randomised subjects, primary endpoint EASI score.
n_total <- 320L
# ── ADSL ──────────────────────────────────────────────────────────────────
adsl_raw <- data.frame(
STUDYID = "DERM-DUP-301",
USUBJID = sprintf("DUP301-%04d", seq_len(n_total)),
TRT01P = rep(c("Dupilumab 300mg Q2W", "Placebo Q2W"), each = n_total / 2),
AGE = round(rnorm(n_total, mean = 36, sd = 14)),
SEX = sample(c("M", "F"), n_total, replace = TRUE),
ITTFL = ifelse(runif(n_total) < 0.97, "Y", "N"),
SAFFL = ifelse(runif(n_total) < 0.98, "Y", "N"),
PPROTFL = ifelse(runif(n_total) < 0.91, "Y", "N"),
EASISCAT = sample(c("MODERATE", "SEVERE"), n_total, replace = TRUE, prob = c(0.55, 0.45)),
stringsAsFactors = FALSE
)
# ── ADLB: EASI scores at baseline and Week 16 ──────────────────────────────
adlb_raw <- expand.grid(
USUBJID = adsl_raw$USUBJID,
AVISITN = c(0L, 16L),
stringsAsFactors = FALSE
) |>
merge(adsl_raw[, c("USUBJID", "TRT01P", "EASISCAT")], by = "USUBJID") |>
arrange(USUBJID, AVISITN)
set.seed(2026)
adlb_raw$AVAL <- mapply(function(trt, vis, scat) {
base_mean <- if (scat == "SEVERE") 45 else 30
if (vis == 0L) return(round(pmax(0, rnorm(1, base_mean, 8)), 1))
reduction <- if (trt == "Dupilumab 300mg Q2W") 0.55 else 0.12
round(pmax(0, base_mean * (1 - reduction) + rnorm(1, 0, 5)), 1)
}, adlb_raw$TRT01P, adlb_raw$AVISITN, adlb_raw$EASISCAT)
# Missingness at Week 16 (~6%)
post_bl <- adlb_raw$AVISITN > 0
miss_idx <- which(post_bl)[sample(sum(post_bl), round(sum(post_bl) * 0.06))]
adlb_raw$AVAL[miss_idx] <- NA_real_
adlb_raw$PARAMCD <- "EASI"
cat(sprintf(
"ADSL: %d subjects | ADLB: %d records\n", nrow(adsl_raw), nrow(adlb_raw)
))#> ADSL: 320 subjects | ADLB: 640 recordsStart the lineager session
lg_start() initialises the session store. All
lg_* functions write to this store automatically.
lg_start(study_id = "DERM-DUP-301", analysis_id = "ADEFF-primary-efficacy")#> lineager: session started [study: DERM-DUP-301] [analysis: ADEFF-primary-efficacy]Tag source datasets
lg_tag() assigns a unique lineage ID
(lineage_id) to every row. The USUBJID is
embedded automatically when present, making IDs human-readable.
adsl <- lg_tag(adsl_raw, dataset_id = "ADSL", domain = "DM", label = "Subject-Level")#> lineager: tagged 'ADSL' — 320 rows, 9 cols
adlb <- lg_tag(adlb_raw, dataset_id = "ADLB", domain = "LB", label = "Laboratory/Efficacy")#> lineager: tagged 'ADLB' — 640 rows, 6 cols#> <lg_df> 'ADSL' (domain: DM) [4 × 4]
#> USUBJID TRT01P ITTFL
#> 1 DUP301-0001 Dupilumab 300mg Q2W Y
#> 2 DUP301-0002 Dupilumab 300mg Q2W Y
#> 3 DUP301-0003 Dupilumab 300mg Q2W Y
#> 4 DUP301-0004 Dupilumab 300mg Q2W YBuild the ADEFF derivation pipeline
Step 1: Document and apply the safety population
lg_population() registers the population flag definition
— inclusion criteria, exclusion criteria, and a plain-English
description — directly linking to the flag already present in the
data.
lg_population(
adsl,
flag_var = "SAFFL",
label = "Safety Analysis Flag",
definition = "All randomised subjects who received at least one dose of study treatment",
incl_criteria = c("Randomised", "Received >= 1 dose of study treatment"),
excl_criteria = "No study drug administered"
)#> lineager: population 'SAFFL' (Safety Analysis Flag) — 314 included, 6 excluded
adsl_saf <- lg_filter(
adsl, SAFFL == "Y",
reason = "Restrict to safety analysis set (SAFFL = Y) per SAP Section 4.1",
population = "SAFFL"
)#> lineager: [ADSL] filter 'Restrict to safety analysis set (SAFFL = Y) per SAP Section 4.1' — 320 in, 314 out, 6 excludedStep 2: ITT population
adsl_itt <- lg_filter(
adsl_saf, ITTFL == "Y",
reason = "Restrict to ITT population (ITTFL = Y) per SAP Section 4.2",
population = "ITTFL"
)#> lineager: [ADSL] filter 'Restrict to ITT population (ITTFL = Y) per SAP Section 4.2' — 314 in, 304 out, 10 excluded#> After ITT filter: 304 subjectsStep 3: Join EASI assessments to ADSL covariates
adeff <- lg_join(
adlb, adsl_itt[, c("USUBJID", "TRT01P", "EASISCAT")],
by = "USUBJID",
type = "inner",
description = "Join ADLB EASI assessments to ITT-restricted ADSL covariates"
)#> lineager: [ADLB + ADSL] inner join — 608 rows out#> After join: 608 recordsStep 4: Derive baseline and change from baseline
adeff <- adeff |>
group_by(USUBJID) |>
mutate(BASE = AVAL[AVISITN == 0L][1L]) |>
ungroup()
# Re-tag after the dplyr grouping pipeline to keep lg_df class intact
# Drop any existing lineage_id before re-tagging to avoid duplicate columns
adeff_df <- as.data.frame(adeff)
adeff_df <- adeff_df[, !names(adeff_df) %in% "lineage_id"]
adeff <- lg_tag(adeff_df, dataset_id = "ADEFF", domain = "ADLB",
label = "Efficacy Analysis Dataset")#> lineager: tagged 'ADEFF' — 608 rows, 9 cols
n_miss_base <- sum(is.na(adeff$BASE[adeff$AVISITN == 0L]))
adeff <- lg_filter(
adeff, !is.na(BASE),
reason = "Exclude records with missing baseline EASI score per SAP Section 5.1",
population = "ITTFL"
)#> lineager: [ADEFF] filter 'Exclude records with missing baseline EASI score per SAP Section 5.1' — 608 in, 608 out, 0 excluded
adeff <- lg_derive(
adeff,
CHG = AVAL - BASE,
PCHG = (AVAL - BASE) / BASE * 100,
description = "Derive change from baseline (CHG) and percent change (PCHG) per CDISC ADaM IG Section 3.2.7"
)#> lineager: [ADEFF] derive — Derive change from baseline (CHG) and percent change (PCHG) per CDISC ADaM IG Section 3.2.7Step 5: Restrict to Week 16, non-missing
adeff_w16 <- lg_filter(
adeff, AVISITN == 16L, !is.na(AVAL),
reason = "Restrict to Week 16 primary timepoint with non-missing EASI assessment",
population = "ITTFL"
)#> lineager: [ADEFF] filter 'Restrict to Week 16 primary timepoint with non-missing EASI assessment' — 608 in, 285 out, 323 excluded#> Week 16 primary analysis records: 285Step 6: Derive EASI-75 responder flag
adeff_final <- lg_derive(
adeff_w16,
EASI75FL = ifelse(PCHG <= -75, "Y", "N"),
description = "Derive EASI-75 responder flag: Y if percent change <= -75% per SAP Section 5.3"
)#> lineager: [ADEFF] derive — Derive EASI-75 responder flag: Y if percent change <= -75% per SAP Section 5.3Document the SDTM-to-ADaM derivation
lg_spec() records the structured derivation
specification linking the ADaM variable back to its SDTM source — the
basis for the CDISC Reviewer’s Guide derivation section.
lg_spec(
adam_dataset = "ADEFF",
adam_var = "CHG",
label = "Change from Baseline EASI Score",
source_domain = "LB",
source_var = "LBSTRESN",
derivation = "AVAL - BASE, where BASE is the Visit 0 (Baseline) EASI assessment",
conditions = "Subjects with non-missing baseline EASI score"
)Subject disposition
lg_disposition() summarises the exclusion registry
automatically — no manual group definitions needed. Every
lg_filter() call above contributed its exclusions to this
summary.
lg_disposition(by = "reason")#> step reason
#> 1 1 Restrict to safety analysis set (SAFFL = Y) per SAP Section 4.1
#> 2 2 Restrict to ITT population (ITTFL = Y) per SAP Section 4.2
#> 3 3 Join ADLB EASI assessments to ITT-restricted ADSL covariates
#> 4 4 Exclude records with missing baseline EASI score per SAP Section 5.1
#> 5 5 Restrict to Week 16 primary timepoint with non-missing EASI assessment
#> n_excluded n_remaining
#> 1 6 314
#> 2 10 304
#> 3 32 608
#> 4 0 608
#> 5 323 285Exclusion registry
excl <- lg_exclusions()#> lineager: 371 exclusion(s) retrieved
excl |>
select(dataset_id, reason, population) |>
knitr::kable(caption = "ADEFF derivation exclusion registry — DERM-DUP-301")| dataset_id | reason | population |
|---|---|---|
| ADSL | Restrict to safety analysis set (SAFFL = Y) per SAP Section 4.1 | SAFFL |
| ADSL | Restrict to safety analysis set (SAFFL = Y) per SAP Section 4.1 | SAFFL |
| ADSL | Restrict to safety analysis set (SAFFL = Y) per SAP Section 4.1 | SAFFL |
| ADSL | Restrict to safety analysis set (SAFFL = Y) per SAP Section 4.1 | SAFFL |
| ADSL | Restrict to safety analysis set (SAFFL = Y) per SAP Section 4.1 | SAFFL |
| ADSL | Restrict to safety analysis set (SAFFL = Y) per SAP Section 4.1 | SAFFL |
| ADSL | Restrict to ITT population (ITTFL = Y) per SAP Section 4.2 | ITTFL |
| ADSL | Restrict to ITT population (ITTFL = Y) per SAP Section 4.2 | ITTFL |
| ADSL | Restrict to ITT population (ITTFL = Y) per SAP Section 4.2 | ITTFL |
| ADSL | Restrict to ITT population (ITTFL = Y) per SAP Section 4.2 | ITTFL |
| ADSL | Restrict to ITT population (ITTFL = Y) per SAP Section 4.2 | ITTFL |
| ADSL | Restrict to ITT population (ITTFL = Y) per SAP Section 4.2 | ITTFL |
| ADSL | Restrict to ITT population (ITTFL = Y) per SAP Section 4.2 | ITTFL |
| ADSL | Restrict to ITT population (ITTFL = Y) per SAP Section 4.2 | ITTFL |
| ADSL | Restrict to ITT population (ITTFL = Y) per SAP Section 4.2 | ITTFL |
| ADSL | Restrict to ITT population (ITTFL = Y) per SAP Section 4.2 | ITTFL |
| ADLB | Join ADLB EASI assessments to ITT-restricted ADSL covariates | NA |
| ADLB | Join ADLB EASI assessments to ITT-restricted ADSL covariates | NA |
| ADLB | Join ADLB EASI assessments to ITT-restricted ADSL covariates | NA |
| ADLB | Join ADLB EASI assessments to ITT-restricted ADSL covariates | NA |
| ADLB | Join ADLB EASI assessments to ITT-restricted ADSL covariates | NA |
| ADLB | Join ADLB EASI assessments to ITT-restricted ADSL covariates | NA |
| ADLB | Join ADLB EASI assessments to ITT-restricted ADSL covariates | NA |
| ADLB | Join ADLB EASI assessments to ITT-restricted ADSL covariates | NA |
| ADLB | Join ADLB EASI assessments to ITT-restricted ADSL covariates | NA |
| ADLB | Join ADLB EASI assessments to ITT-restricted ADSL covariates | NA |
| ADLB | Join ADLB EASI assessments to ITT-restricted ADSL covariates | NA |
| ADLB | Join ADLB EASI assessments to ITT-restricted ADSL covariates | NA |
| ADLB | Join ADLB EASI assessments to ITT-restricted ADSL covariates | NA |
| ADLB | Join ADLB EASI assessments to ITT-restricted ADSL covariates | NA |
| ADLB | Join ADLB EASI assessments to ITT-restricted ADSL covariates | NA |
| ADLB | Join ADLB EASI assessments to ITT-restricted ADSL covariates | NA |
| ADLB | Join ADLB EASI assessments to ITT-restricted ADSL covariates | NA |
| ADLB | Join ADLB EASI assessments to ITT-restricted ADSL covariates | NA |
| ADLB | Join ADLB EASI assessments to ITT-restricted ADSL covariates | NA |
| ADLB | Join ADLB EASI assessments to ITT-restricted ADSL covariates | NA |
| ADLB | Join ADLB EASI assessments to ITT-restricted ADSL covariates | NA |
| ADLB | Join ADLB EASI assessments to ITT-restricted ADSL covariates | NA |
| ADLB | Join ADLB EASI assessments to ITT-restricted ADSL covariates | NA |
| ADLB | Join ADLB EASI assessments to ITT-restricted ADSL covariates | NA |
| ADLB | Join ADLB EASI assessments to ITT-restricted ADSL covariates | NA |
| ADLB | Join ADLB EASI assessments to ITT-restricted ADSL covariates | NA |
| ADLB | Join ADLB EASI assessments to ITT-restricted ADSL covariates | NA |
| ADLB | Join ADLB EASI assessments to ITT-restricted ADSL covariates | NA |
| ADLB | Join ADLB EASI assessments to ITT-restricted ADSL covariates | NA |
| ADLB | Join ADLB EASI assessments to ITT-restricted ADSL covariates | NA |
| ADLB | Join ADLB EASI assessments to ITT-restricted ADSL covariates | NA |
| ADLB | Join ADLB EASI assessments to ITT-restricted ADSL covariates | NA |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
| ADEFF | Restrict to Week 16 primary timepoint with non-missing EASI assessment | ITTFL |
Trace a subject through the pipeline
lg_trace() returns the complete provenance history for
any subject — every dataset it appeared in, every operation that touched
it, and any exclusion records.
example_subj <- adeff_final$USUBJID[1L]
lg_trace(example_subj)#>
#> ── lineager trace: USUBJID 'DUP301-0001' ──
#>
#> Appears in: ADSL, ADLB, ADEFF
#>
#> Operations:
#> [FILTER] ADSL: Restrict to safety analysis set (SAFFL = Y) per SAP Section (320→314)
#> [FILTER] ADSL: Restrict to ITT population (ITTFL = Y) per SAP Section 4.2 (314→304)
#> [JOIN_INNER] ADLB: Join ADLB EASI assessments to ITT-restricted ADSL covariates (640→608)
#> [FILTER] ADEFF: Exclude records with missing baseline EASI score per SAP Sec (608→608)
#> [DERIVE] ADEFF: Derive change from baseline (CHG) and percent change (PCHG) (608→608)
#> [FILTER] ADEFF: Restrict to Week 16 primary timepoint with non-missing EASI (608→285)
#> [DERIVE] ADEFF: Derive EASI-75 responder flag: Y if percent change <= -75% p (285→285)
#>
#> Exclusions (1):
#> ✗ [ADEFF] Restrict to Week 16 primary timepoint with non-missing EASI assessment [pop: ITTFL]
#>
#> Registered populations:
#> SAFFL: Safety Analysis Flag
excluded_subj <- adsl_raw$USUBJID[adsl_raw$ITTFL == "N"][1L]
if (!is.na(excluded_subj)) lg_trace(excluded_subj)#>
#> ── lineager trace: USUBJID 'DUP301-0021' ──
#>
#> Appears in: ADSL, ADLB
#>
#> Operations:
#> [FILTER] ADSL: Restrict to safety analysis set (SAFFL = Y) per SAP Section (320→314)
#> [FILTER] ADSL: Restrict to ITT population (ITTFL = Y) per SAP Section 4.2 (314→304)
#> [JOIN_INNER] ADLB: Join ADLB EASI assessments to ITT-restricted ADSL covariates (640→608)
#>
#> Exclusions (3):
#> ✗ [ADSL] Restrict to ITT population (ITTFL = Y) per SAP Section 4.2 [pop: ITTFL]
#> ✗ [ADLB] Join ADLB EASI assessments to ITT-restricted ADSL covariates
#> ✗ [ADLB] Join ADLB EASI assessments to ITT-restricted ADSL covariates
#>
#> Registered populations:
#> SAFFL: Safety Analysis FlagPipeline lineage graph
lin <- lg_lineage()
print(lin)#> <lg_lineage> 3 source dataset(s), 7 operation(s), 3 exclusion branch(es)
#> Use lg_plot(lin) to render. DOT source:
#>
#> digraph lineage {
#> rankdir = TB;
#> graph [fontname="Helvetica", splines=ortho, nodesep=0.4, ranksep=0.6];
#> node [fontname="Helvetica", fontsize=10, margin="0.15,0.08"];
#> edge [fontname="Helvetica", fontsize=9, color="#6b6f80"];
#>
#> SRC_ADSL [label="ADSL\nn = 320", shape=box, style="filled,rounded", fillcolor="#e8effe", color="#1a56db", fontcolor="#0f1117"];
#> SRC_ADLB [label="ADLB\nn = 640", shape=box, style="filled,rounded", fillcolor="#e8effe", color="#1a56db", fontcolor="#0f1117"];
#> SRC_ADEFF [label="ADEFF\nn = 608", shape=box, style="filled,rounded", fillcolor="#e8effe", color="#1a56db", fontcolor="#0f1117"];
#> OP_op_0001 [label="FILTER\nRestrict to safety analysis set ...\n−6 rows", shape=ellipse, style="filled,rounded", fillcolor="#fff3e0", color="#ea8c00", fontcolor="#0f1117"];
#> DS_ADSL_op_0001 [label="ADSL\nn = 314", shape=box, style="filled,rounded", fillcolor="#ffffff", color="#6b6f80", fontcolor="#0f1117"];
#> EXCL_op_0001 [label="excluded\nn = 6", shape=plaintext, fontcolor="#dc2626", fontsize=9];
#> OP_op_0002 [label="FILTER\nRestrict to ITT population (ITTF...\n−10 rows", shape=ellipse, style="filled,rounded", fillcolor="#fff3e0", color="#ea8c00", fontcolor="#0f1117"];
#> DS_ADSL_op_0002 [label="ADSL\nn = 304", shape=box, style="filled,rounded", fillcolor="#ffffff", color="#6b6f80", fontcolor="#0f1117"];
#> EXCL_op_0002 [label="excluded\nn = 10", shape=plaintext, fontcolor="#dc2626", fontsize=9];
#> OP_op_0003 [label="JOIN (inner)\nby: USUBJID", shape=diamond, style="filled,rounded", fillcolor="#e8f5e9", color="#0e7a4f", fontcolor="#0f1117"];
#> DS_ADLB_op_0003 [label="ADLB\nn = 608", shape=box, style="filled,rounded", fillcolor="#ffffff", color="#6b6f80", fontcolor="#0f1117"];
#> OP_op_0004 [label="FILTER\nExclude records with missing bas...\n−0 rows", shape=ellipse, style="filled,rounded", fillcolor="#fff3e0", color="#ea8c00", fontcolor="#0f1117"];
#> DS_ADEFF_op_0004 [label="ADEFF\nn = 608", shape=box, style="filled,rounded", fillcolor="#ffffff", color="#6b6f80", fontcolor="#0f1117"];
#> OP_op_0005 [label="DERIVE\nDerive change from baseline (CHG...", shape=ellipse, style="filled,rounded", fillcolor="#fff8e1", color="#f59e0b", fontcolor="#0f1117"];
#> DS_ADEFF_op_0005 [label="ADEFF\nn = 608", shape=box, style="filled,rounded", fillcolor="#ffffff", color="#6b6f80", fontcolor="#0f1117"];
#> OP_op_0006 [label="FILTER\nRestrict to Week 16 primary time...\n−323 rows", shape=ellipse, style="filled,rounded", fillcolor="#fff3e0", color="#ea8c00", fontcolor="#0f1117"];
#> DS_ADEFF_op_0006 [label="ADEFF\nn = 285", shape=box, style="filled,rounded", fillcolor="#ffffff", color="#6b6f80", fontcolor="#0f1117"];
#> EXCL_op_0006 [label="excluded\nn = 323", shape=plaintext, fontcolor="#dc2626", fontsize=9];
#> OP_op_0007 [label="DERIVE\nDerive EASI-75 responder flag: Y...", shape=ellipse, style="filled,rounded", fillcolor="#fff8e1", color="#f59e0b", fontcolor="#0f1117"];
#> DS_ADEFF_op_0007 [label="ADEFF\nn = 285", shape=box, style="filled,rounded", fillcolor="#ffffff", color="#6b6f80", fontcolor="#0f1117"];
#>
#> SRC_ADSL -> OP_op_0001 [label=" n=320 "];
#> OP_op_0001 -> DS_ADSL_op_0001;
#> OP_op_0001 -> EXCL_op_0001;
#> DS_ADSL_op_0001 -> OP_op_0002 [label=" n=314 "];
#> OP_op_0002 -> DS_ADSL_op_0002;
#> OP_op_0002 -> EXCL_op_0002;
#> SRC_ADLB -> OP_op_0003 [label=" x "];
#> DS_ADSL_op_0002 -> OP_op_0003 [label=" y "];
#> OP_op_0003 -> DS_ADLB_op_0003;
#> SRC_ADEFF -> OP_op_0004 [label=" n=608 "];
#> OP_op_0004 -> DS_ADEFF_op_0004;
#> DS_ADEFF_op_0004 -> OP_op_0005;
#> OP_op_0005 -> DS_ADEFF_op_0005;
#> DS_ADEFF_op_0005 -> OP_op_0006 [label=" n=608 "];
#> OP_op_0006 -> DS_ADEFF_op_0006;
#> OP_op_0006 -> EXCL_op_0006;
#> DS_ADEFF_op_0006 -> OP_op_0007;
#> OP_op_0007 -> DS_ADEFF_op_0007;
#> }Provenance report
lg_report(
output = "outputs/DERM-DUP-301_ADEFF_provenance_v1.html",
title = "ADEFF Provenance Report — DERM-DUP-301",
study_id = "DERM-DUP-301",
sponsor = "Example Pharma Ltd",
author = "J. Smith, Biostatistician"
)End the session
lg_end()#> lineager: session ended — 7 operation(s), 371 exclusion(s), 1 population(s), 1 var spec(s)What the provenance record proves
Every row in the final ADEFF dataset carries a lineage ID tracing it
to its source record in ADSL or ADLB. The exclusion registry — built
automatically from each lg_filter() call, not maintained
separately — documents which subjects were excluded at each step, why,
and which population the exclusion relates to.
lg_disposition() produces the population flow table
directly from these records, so the numbers can never drift out of sync
with the derivation code that produced them.
Session information
#> R version 4.6.1 (2026-06-24)
#> Platform: x86_64-pc-linux-gnu
#> Running under: Ubuntu 24.04.4 LTS
#>
#> Matrix products: default
#> BLAS: /usr/lib/x86_64-linux-gnu/openblas-pthread/libblas.so.3
#> LAPACK: /usr/lib/x86_64-linux-gnu/openblas-pthread/libopenblasp-r0.3.26.so; LAPACK version 3.12.0
#>
#> locale:
#> [1] LC_CTYPE=C.UTF-8 LC_NUMERIC=C LC_TIME=C.UTF-8
#> [4] LC_COLLATE=C.UTF-8 LC_MONETARY=C.UTF-8 LC_MESSAGES=C.UTF-8
#> [7] LC_PAPER=C.UTF-8 LC_NAME=C LC_ADDRESS=C
#> [10] LC_TELEPHONE=C LC_MEASUREMENT=C.UTF-8 LC_IDENTIFICATION=C
#>
#> time zone: UTC
#> tzcode source: system (glibc)
#>
#> attached base packages:
#> [1] stats graphics grDevices utils datasets methods base
#>
#> other attached packages:
#> [1] dplyr_1.2.1 lineager_0.1.0
#>
#> loaded via a namespace (and not attached):
#> [1] vctrs_0.7.3 cli_3.6.6 knitr_1.51 rlang_1.3.0
#> [5] xfun_0.60 otel_0.2.0 generics_0.1.4 textshaping_1.0.5
#> [9] jsonlite_2.0.0 glue_1.8.1 htmltools_0.5.9 ragg_1.5.2
#> [13] sass_0.4.10 rmarkdown_2.31 tibble_3.3.1 evaluate_1.0.5
#> [17] jquerylib_0.1.4 fastmap_1.2.0 yaml_2.3.12 lifecycle_1.0.5
#> [21] compiler_4.6.1 fs_2.1.0 pkgconfig_2.0.3 htmlwidgets_1.6.4
#> [25] systemfonts_1.3.2 digest_0.6.39 R6_2.6.1 tidyselect_1.2.1
#> [29] pillar_1.11.1 magrittr_2.0.5 bslib_0.12.0 withr_3.0.3
#> [33] tools_4.6.1 pkgdown_2.2.1 cachem_1.1.0 desc_1.4.3