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TRIALMON - Safety Screening Snapshot

Read-only screening snapshot, computed from the safety data (participants.csv, aes.csv, cohorts.csv). Every panel is a screening lens: it flags a position for the medical monitor / SRC / DSMB, it never reports a clinical number or adjudicates. The interactive tool is the run & build the Shiny app page; the visual guide explains the rules. Synthetic, no PHI.

RED

Safety status

22

Participants

2

RED flags

2

AMBER flags

1

Grade >=3 AE

2

SAEs

eDISH / Hy’s-Law screen

Screening worklist (ranked)

CP101-014 · eDISH / Hy’s-Law screen

ALT 5.6x & TBili 3.1x (R 4.0 mixed)

CP101-018 · QTcF (ICH E14 screen)

503 ms, d41

CP101-006 · QTcF (ICH E14 screen)

486 ms, d33

C4 cohort · Adjudicated DLT vs 3+3

1/6 evaluable

3+3 DLT ladder

AE by SOC x max grade

eDISH AND-gate: (ALT or AST > 3x) AND TBili > 2x. CP101-009 (ALT 4.2x, TBili 1.6x) is the near-miss the gate keeps green. Reported safety numbers come from the validated safety database, never this screen.