SAS TLF Pseudocode Library 217 TLF PROGRAMS

ADaM-based SAS pseudocode for every Table, Listing, and Figure in an early-phase clinical-pharmacology study — a complete, separate set per study design (parallel, crossover, single-sequence, SAD, MAD) plus the shared setup macros.

Status — illustrative pseudocode / skeleton, not validated software. These programs are spec / double-programming scaffolds, not validated production code. Nothing here originates a number: reported numbers come only from validated ADaM + double-programmed code per SOP, never from an LLM. All deliverables use participant (CDISC USUBJID/SUBJID preserved in code only).

ADaM-based SAS pseudocode for every Table, Listing, and Figure (TLF) in an early-phase clin-pharm study, with a complete separate set per study design. Illustrative structure for spec / double-programming — not validated production code. Reported numbers come from validated ADaM + double-programmed code per SOP; nothing here originates a number.

🧰 Before you start ▶ How to run 📁 Designs 🔧 How each program runs 📋 TLF inventory 🆘 Troubleshooting 💻 Browse the code

Before you start

You'll need: SAS 9.4+ (or SAS Studio) on a machine that can reach your study's CDISC ADaM datasets · the relevant ADaM tables for the TLF you're running — at minimum ADSL, plus the domain the program reads (ADAE for AE tables, ADLB for labs, ADVS/ADEG for vitals/ECG, ADPC/ADPP for PK, ADPD for PD, ADIS for immunogenicity, ADEX for exposure) · write access to an output folder for the result datasets · the study's format catalog (treatment order, AE severity, lab ranges) referenced by %setup. No internet, no install beyond SAS itself. These are pseudocode skeletons — open one, point a LIBNAME at your ADaM, and complete the spec; don't expect a clean run out of the box.

How to run a program

There's no single command-line driver — each .sas is one self-contained TLF program. The pattern is the same for all 217: open it in SAS → point a LIBNAME at your ADaM → submit the program. Each program already %includes the shared macros and calls %setup / %designvars for you, so the two things you edit are the ADaM path and the output path in the %setup call near the top.

Quick-start checklist — click each as you finish it:

Open the program for the TLF you want, in the folder for your study's design (e.g. parallel/t_demographics.sas)
Edit the %setup(...) line: set adam= to your ADaM library path and out= to your output folder
Confirm %designvars(design=...) matches the folder (e.g. PARALLEL for parallel/)
Make sure your study format catalog is available to %setup (treatment order, severity, lab ranges)
Submit the program in SAS; check the log for %include/%setup/%designvars resolving cleanly
Open the output dataset / TLF and reconcile it against the validated (double-programmed) result per SOP

Run it

Either edit the %setup line inside the program and submit it directly, or drive it from a tiny wrapper that sets the libname and %includes the program. Both do the same thing:

/* --- run one TLF program from a wrapper (SAS 9.4+) --------------- */
libname adam "/data/cp101/adam" access=readonly;   /* your ADaM datasets   */
libname tfl  "/data/cp101/tfl";                     /* your output folder   */

/* submit a program from the folder for your study's design:               *
 *   parallel/  crossover/  single_sequence/  sad/  mad/                    */
%include "parallel/t_demographics.sas";   /* one program -> one output      */

/* — or, equivalently, open parallel/t_demographics.sas in SAS, edit its    *
 *   %setup(study=CP-101, adam=/data/cp101/adam, out=/data/cp101/tfl);       *
 *   line to your paths, and just submit the whole program. —               */

Each program's own header shows the canonical call sequence: %include "../00_setup_macros.sas"; then %setup(study=, adam=, out=); then %designvars(design=<folder>); then the TLF body. Run from the design folder (or adjust the relative ../ path to 00_setup_macros.sas). Reported numbers always come from validated ADaM + double-programmed code per SOP — never from this scaffold or an LLM.

Designs (one folder each — full set per design)

Folder	Design	Key analysis differences
`parallel/`	Parallel-group	Between-group; treatment = `TRT01A`/`TRT01AN`
`crossover/`	Crossover (2×2, Williams)	Within-participant; by `APERIOD`/`TRTSEQP`; BE/ANOVA (mixed model, GMR + 90% CI)
`single_sequence/`	Single-/fixed-sequence (e.g. DDI)	By `APERIOD`; fixed order, no randomized sequence; ratio + 90% CI vs reference period
`sad/`	Single Ascending Dose	Parallel cohorts (dose = treatment); dose-proportionality (power model)
`mad/`	Multiple Ascending Dose	Parallel cohorts, repeated dosing; accumulation ratio (Rac), steady-state assessment

Design is also wired in code via %designvars(design=...) in 00_setup_macros.sas, so each design folder's programs differ only where the statistics genuinely differ (PK comparison, by-period/by-sequence safety, dose escalation) — Tables/Listings of safety are structurally identical, re-pointed to the design's treatment/period variables.

How each program runs

%include 00_setup_macros.sas → %setup → %designvars(design=<folder>) → TLF body (one program → one output)

TLF inventory (each = one program per design)

Disposition / Demographics / Exposure (ADSL, ADEX, ADCM, ADMH)

t_disposition · t_demographics · t_baseline_characteristics · t_exposure
t_protocol_deviations · t_prior_con_meds · t_medical_history · l_disposition

Safety — AE (ADAE)

t_ae_overview · t_ae_by_soc_pt · t_ae_by_severity · t_ae_by_relationship
t_ae_sae_death_withdrawal · l_ae · l_sae_death

Safety — Labs (ADLB)

t_lab_summary · t_lab_shift · t_lab_marked_abnormal · f_lab_lft_scatter · f_lab_change · l_lab_abnormal

Safety — Vitals / ECG (ADVS, ADEG)

t_vitals_summary · f_vitals_change · l_vitals
t_ecg_summary · t_ecg_qtc_categorical · f_qtc_change · l_ecg

PK (ADPC, ADPP)

t_pk_conc_summary · l_pk_conc · f_pk_conc_mean (linear+semilog) · f_pk_conc_individual
t_pk_param_summary · l_pk_param · f_pk_param_boxplot
design-specific: t_dose_proportionality (SAD) · t_accumulation (MAD) · t_be_anova (crossover/single-seq) · t_pk_param_by_period (crossover/single-seq) · t_dose_proportionality_ss (MAD)

PD / Biomarkers (ADPD)

t_pd_summary · f_pd_change · f_pkpd_overlay · l_pd

Immunogenicity (ADIS)

t_ada_summary · t_ada_impact_pk · l_ada

Naming convention

t_ table · l_ listing · f_ figure. One program → one output. Each program %includes 00_setup_macros.sas, calls %setup then %designvars(design=<folder>), then the TLF body.

ADaM variables relied on (no re-derivation here)

Treatment: TRT01A/TRT01AN (parallel), TRTA/TRTAN+APERIOD/APERIODC+TRTSEQP (crossover/seq)
Populations: SAFFL, PKFL, ITTFL, RANDFL
Analysis: PARAM/PARAMCD, AVAL, CHG, PCHG, BASE, AVISIT/AVISITN, ATPT/ATPTN, ANRIND, BNRIND
AE: TRTEMFL, AESOC, AEDECOD, ASEV/AESEVN, AREL, AESER, AESDTH, AEACN
PK: ADPC AVAL=conc, NRRELTM/ATPTN=nominal time; ADPP PARAMCD=Cmax/Tmax/AUClast/AUCinf/CL/Vz/t½/Rac

Geometric PK statistics are computed on the log scale (never exp(arithmetic mean)). AE counts are distinct participants. Single-sequence participant-level tables key on &SEQVAR/&SEQVARN while period tables denominate from a period-bearing source. The library is free of eDISH / Hy's Law terminology.

Quality status

Complete: 217 TLF programs across all five design folders + 00_setup_macros.sas (218 files total). Built by fan-out generation, then a two-pass adversarial QC (6 family reviewers → per-finding verification: 35 confirmed defects fixed, 2 reviewer false-positives rejected), then a deterministic sweep. All programs scaffold correctly (%include/%setup/%designvars), %designvars matches each folder. Pseudocode for spec / double-programming — not validated production code; reported numbers still come from validated tools per SOP.

Troubleshooting

Symptom	Why	Fix
`ERROR: Libref ADAM is not assigned` / `File ADAM.ADSL does not exist`	The `LIBNAME` in `%setup` doesn't point at your ADaM datasets	Set `adam=` in the `%setup(...)` call (or the wrapper `libname adam`) to the real folder holding `ADSL`/`ADAE`/…; it's opened `access=readonly`.
`ERROR: Physical file does not exist … 00_setup_macros.sas`	The program's `%include "../00_setup_macros.sas"` path is relative to where you submit from	Submit from inside the design folder, or change the `%include` to the absolute path of `00_setup_macros.sas`.
Columns/by-structure look wrong (e.g. no period split on a crossover)	`%designvars(design=...)` doesn't match the folder you opened	Set it to the folder's design: `PARALLEL`, `CROSSOVER`, `SINGLESEQ`, `SAD`, or `MAD`. It resolves `&TRTVAR`/`&SEQVAR`/`&BYPERIOD`.
`ERROR: Format … not found` in `PROC REPORT`/`FORMAT`	The study format catalog (treatment order, AE severity, lab ranges) isn't available to `%setup`	Build/point `tfl.formats` at your study format catalog (the `proc format library=tfl.formats` step in `00_setup_macros.sas`), then resubmit.
Geometric mean / Geo-CV% looks off vs the validated output	Expecting `exp(arithmetic mean)` — this library computes geo stats on the log scale	That's intended: geo mean = `exp(mean of logs)`, Geo-CV% = `100*sqrt(exp(var of logs)-1)` (see `%pkstats`). Reconcile against the double-programmed value, not `exp(mean)`.
AE counts higher than expected	Treating event rows as the unit instead of distinct participants	The AE macros count `count(distinct USUBJID)` per level (treatment-emergent via `TRTEMFL='Y'`). Reconcile participant counts, not row counts.
Period table denominators don't add up (crossover / single-sequence)	Denominating a per-period table from `ADSL` (one record per participant)	Per-period denominators must come from a period-bearing source (`ADEX`/`ADIS`/`ADPD`); participant-level tables key on `&SEQVAR`/`&SEQVARN`.
Looking for an eDISH / Hy's-Law panel	The library deliberately omits that terminology	Use `f_lab_lft_scatter.sas` + the lab tables for transaminase/bilirubin review; there is no `eDISH`/`Hy's Law` output by design.

Every program is a spec / double-programming scaffold, not validated production code. If a number here disagrees with the validated, double-programmed result, the validated result governs — always reconcile per SOP.

Browse the code

Every program below links to its actual .sas file by relative path. Start with the shared macros, then pick a design folder.

Shared setup

00_setup_macros.sas%setup + %designvars; included by every program

parallel/ PARALLEL-GROUP

Disposition / Demographics / Exposure

t_disposition.sas t_demographics.sas t_baseline_characteristics.sas t_exposure.sas t_protocol_deviations.sas t_prior_con_meds.sas t_medical_history.sas l_disposition.sas

Safety — AE

t_ae_overview.sas t_ae_by_soc_pt.sas t_ae_by_severity.sas t_ae_by_relationship.sas t_ae_sae_death_withdrawal.sas l_ae.sas l_sae_death.sas

Safety — Labs

t_lab_summary.sas t_lab_shift.sas t_lab_marked_abnormal.sas f_lab_lft_scatter.sas f_lab_change.sas l_lab_abnormal.sas

Vitals / ECG

t_vitals_summary.sas f_vitals_change.sas l_vitals.sas t_ecg_summary.sas t_ecg_qtc_categorical.sas f_qtc_change.sas l_ecg.sas

t_pk_conc_summary.sas l_pk_conc.sas f_pk_conc_mean.sas f_pk_conc_individual.sas t_pk_param_summary.sas l_pk_param.sas f_pk_param_boxplot.sas

PD / Biomarkers

t_pd_summary.sas f_pd_change.sas f_pkpd_overlay.sas l_pd.sas

Immunogenicity

t_ada_summary.sas t_ada_impact_pk.sas l_ada.sas

crossover/ 2×2 / WILLIAMS

Disposition / Demographics / Exposure

t_disposition.sas t_demographics.sas t_baseline_characteristics.sas t_exposure.sas t_protocol_deviations.sas t_prior_con_meds.sas t_medical_history.sas l_disposition.sas

Safety — AE

t_ae_overview.sas t_ae_by_soc_pt.sas t_ae_by_severity.sas t_ae_by_relationship.sas t_ae_sae_death_withdrawal.sas l_ae.sas l_sae_death.sas

Safety — Labs

t_lab_summary.sas t_lab_shift.sas t_lab_marked_abnormal.sas f_lab_lft_scatter.sas f_lab_change.sas l_lab_abnormal.sas

Vitals / ECG

t_vitals_summary.sas f_vitals_change.sas l_vitals.sas t_ecg_summary.sas t_ecg_qtc_categorical.sas f_qtc_change.sas l_ecg.sas

PK (incl. t_be_anova, t_pk_param_by_period)

t_pk_conc_summary.sas l_pk_conc.sas f_pk_conc_mean.sas f_pk_conc_individual.sas t_pk_param_summary.sas t_pk_param_by_period.sas l_pk_param.sas f_pk_param_boxplot.sas t_be_anova.sasBE/ANOVA mixed model, GMR + 90% CI

PD / Biomarkers

t_pd_summary.sas f_pd_change.sas f_pkpd_overlay.sas l_pd.sas

Immunogenicity

t_ada_summary.sas t_ada_impact_pk.sas l_ada.sas

single_sequence/ FIXED-SEQUENCE / DDI

Disposition / Demographics / Exposure

t_disposition.sas t_demographics.sas t_baseline_characteristics.sas t_exposure.sas t_protocol_deviations.sas t_prior_con_meds.sas t_medical_history.sas l_disposition.sas

Safety — AE

t_ae_overview.sas t_ae_by_soc_pt.sas t_ae_by_severity.sas t_ae_by_relationship.sas t_ae_sae_death_withdrawal.sas l_ae.sas l_sae_death.sas

Safety — Labs

t_lab_summary.sas t_lab_shift.sas t_lab_marked_abnormal.sas f_lab_lft_scatter.sas f_lab_change.sas l_lab_abnormal.sas

Vitals / ECG

t_vitals_summary.sas f_vitals_change.sas l_vitals.sas t_ecg_summary.sas t_ecg_qtc_categorical.sas f_qtc_change.sas l_ecg.sas

PK (incl. t_be_anova ratio + 90% CI vs reference period, t_pk_param_by_period)

PD / Biomarkers

t_pd_summary.sas f_pd_change.sas f_pkpd_overlay.sas l_pd.sas

Immunogenicity

t_ada_summary.sas t_ada_impact_pk.sas l_ada.sas

sad/ SINGLE ASCENDING DOSE

Disposition / Demographics / Exposure

t_disposition.sas t_demographics.sas t_baseline_characteristics.sas t_exposure.sas t_protocol_deviations.sas t_prior_con_meds.sas t_medical_history.sas l_disposition.sas

Safety — AE

t_ae_overview.sas t_ae_by_soc_pt.sas t_ae_by_severity.sas t_ae_by_relationship.sas t_ae_sae_death_withdrawal.sas l_ae.sas l_sae_death.sas

Safety — Labs

t_lab_summary.sas t_lab_shift.sas t_lab_marked_abnormal.sas f_lab_lft_scatter.sas f_lab_change.sas l_lab_abnormal.sas

Vitals / ECG

t_vitals_summary.sas f_vitals_change.sas l_vitals.sas t_ecg_summary.sas t_ecg_qtc_categorical.sas f_qtc_change.sas l_ecg.sas

PK (incl. t_dose_proportionality power model)

t_pk_conc_summary.sas l_pk_conc.sas f_pk_conc_mean.sas f_pk_conc_individual.sas t_pk_param_summary.sas l_pk_param.sas f_pk_param_boxplot.sas t_dose_proportionality.sasPower model

PD / Biomarkers

t_pd_summary.sas f_pd_change.sas f_pkpd_overlay.sas l_pd.sas

Immunogenicity

t_ada_summary.sas t_ada_impact_pk.sas l_ada.sas

mad/ MULTIPLE ASCENDING DOSE

Disposition / Demographics / Exposure

t_disposition.sas t_demographics.sas t_baseline_characteristics.sas t_exposure.sas t_protocol_deviations.sas t_prior_con_meds.sas t_medical_history.sas l_disposition.sas

Safety — AE

t_ae_overview.sas t_ae_by_soc_pt.sas t_ae_by_severity.sas t_ae_by_relationship.sas t_ae_sae_death_withdrawal.sas l_ae.sas l_sae_death.sas

Safety — Labs

t_lab_summary.sas t_lab_shift.sas t_lab_marked_abnormal.sas f_lab_lft_scatter.sas f_lab_change.sas l_lab_abnormal.sas

Vitals / ECG

t_vitals_summary.sas f_vitals_change.sas l_vitals.sas t_ecg_summary.sas t_ecg_qtc_categorical.sas f_qtc_change.sas l_ecg.sas

PK (incl. t_accumulation Rac / steady-state, t_dose_proportionality_ss)

t_pk_conc_summary.sas l_pk_conc.sas f_pk_conc_mean.sas f_pk_conc_individual.sas t_pk_param_summary.sas l_pk_param.sas f_pk_param_boxplot.sas t_accumulation.sasAccumulation ratio (Rac), steady-state t_dose_proportionality_ss.sasDose-proportionality at steady state

PD / Biomarkers

t_pd_summary.sas f_pd_change.sas f_pkpd_overlay.sas l_pd.sas

Immunogenicity

t_ada_summary.sas t_ada_impact_pk.sas l_ada.sas

SAS TLF Pseudocode Library — 218 files (217 TLF programs + 00_setup_macros.sas) across 5 design folders. Illustrative pseudocode for spec / double-programming, not validated production code; reported numbers come only from validated tools per SOP. Terminology: participant. ← Program home