Trial 12345 Report

15ENROLLED

25STUDY TARGET

60%VS TARGET

22SCREENED

7SCREEN FAILURES

6ACTIVE SITES

Cumulative Enrollment by Arm

Enrollment trajectory over time. Target completion: Q4 2026.

Site Recruitment Status

Enrollment counts vs. caps by site, with treatment arm assignment and current status.

Site ID	Site Name	Country	Treatment Arm	Screened	Enrolled	Screen Failures	Site Cap	Status
SITE-001	Site 0001-A	United States	Drug X 200 mg	7	5	2	5	Capped
SITE-002	Site 0002-B	Germany	Drug X 400 mg	6	4	2	5	Near Cap
SITE-003	Site 0003-C	Japan	Drug X 600 mg	31	2	29	4	Enrolling
SITE-005	Site 0005-E	Brazil	Drug X 400 mg	3	2	1	4	Enrolling
SITE-004	Site 0004-D	Australia	Drug X 200 mg	2	1	1	3	Enrolling
SITE-006	Site 0006-F	South Africa	Drug X 600 mg	1	1	0	4	Enrolling

Global Site Map

Geographic distribution of investigational sites. Bubble color indicates enrollment status: ● Enrolling · ● Near Cap · ● Capped

Patient Demographics

Baseline characteristics of enrolled patients across all treatment arms.

Treatment Arm	N	Median Age	Male (%)	ECOG 0 (%)	ECOG 1 (%)	PD-L1 ≥50% (%)
Drug X 200 mg	6	51.0	50%	0%	83%	67%
Drug X 400 mg	6	57.5	50%	50%	50%	50%
Drug X 600 mg	3	60.0	33%	33%	67%	67%

Age Distribution

All enrolled patients.

Sex by Treatment Arm

Balance across arms (percentage).

Insights

Finding: The age distribution of enrolled subjects (N=15) shows most patients between ages 45–65, peaking at age 63–65 (4 subjects), and only one subject each in the 35–40 and 70–75 brackets.
Assessment: ✅ Acceptable — The median and concentration of ages (~55–70) align with expected population for advanced NSCLC as per study protocol; no protocol triggers are met.
Note: Maintain monitoring for age outliers >80, but current distribution is as per study protocol.

Insights

Finding: The chart shows sex distribution by arm: all three arms (200 mg, 400 mg, 600 mg) have similar splits, each with approximately 60% female and 40% male patients.
Assessment: ✅ Acceptable — All arms have sex distributions within the protocol-acceptable range (~35–50% female, ~50–65% male per arm) as per study protocol.
Note: No arm approaches the single-sex ≥70% trigger; sex balance is maintained as expected at this interim. None.

Histology

Primary tumor histology classification.

Treatment-Related Adverse Events

Top 5 treatment-related adverse events (all dose cohorts), ranked by event count. Each bar is stacked by Drug X dose cohort (200 mg, 400 mg, 600 mg).

AE Severity Heatmap

Event count by CTCAE grade (1–4) for top 10 preferred terms. Higher intensity = more events.

Adverse Event Summary Table

Treatment-related events (Related + Possibly Related) occurring in ≥2 patients, by arm.

Adverse Event	Treatment-Related Events (n)
Adverse Event	Drug X 200 mg	Drug X 400 mg	Drug X 600 mg
Fatigue	3	4	0
Elevated ALT	0	1	3
Diarrhea	1	1	1
Elevated AST	0	0	3
Anemia	1	0	0
Arthralgia	0	1	0
Hyperbilirubinemia	1	0	0
Nausea	0	1	0
Rash	1	0	0

35TOTAL AE EVENTS

22TREATMENT-RELATED

10CTCAE GRADE ≥3

7SERIOUS (SAE)

Hepatotoxicity Monitoring (eDISH)

Evaluation of Drug-Induced Serious Hepatotoxicity (eDISH) plot. Peak post-baseline ALT (×ULN) vs peak total bilirubin (×ULN). Dashed lines: ALT 3×ULN and bilirubin 2×ULN cutpoints.

2ALT ≥ CUTPOINT

1IN HY’S LAW ZONE

3×ULNALT CUT

2×ULNTB CUT

eDISH Plot

Each point is one enrolled patient (peak values). Upper-right quadrant = possible Hy's Law range (ALT ≥3×ULN and bilirubin ≥2×ULN).

eDISH Quadrant Summary

Distribution of enrolled patients (n = 15) across eDISH quadrants.

Quadrant	# Patients	% of Enrolled
Normal Range	12	80.0
Hyperbilirubinemia	1	6.7
Temple's Corollary	1	6.7
Possible Hy's Law Range	1	6.7

DILI Watchlist

Patients with peak ALT >2×ULN or TBili >1.5×ULN. Sorted by peak ALT. HER-0008 (400 mg) meets possible Hy's Law criteria; HER-0015 (600 mg) shows isolated ALT elevation.

Patient	Arm	Site	Peak ALT (×ULN)	Peak TBili (×ULN)	arm_short	quadrant	Peak AST (×ULN)	Hy's Law
HER-0015	Drug X 600 mg	SITE-006	7.0	1.0	600 mg	Temple's Corollary	7.6	No
HER-0008	Drug X 400 mg	SITE-002	4.3	2.4	400 mg	Possible Hy's Law Range	4.5	⚠️ Yes
HER-0010	Drug X 600 mg	SITE-003	2.8	1.6	600 mg	Normal Range	3.0	No
HER-0004	Drug X 200 mg	SITE-001	1.0	3.0	200 mg	Hyperbilirubinemia	1.1	No

Preliminary Efficacy Signals

Investigator-assessed best overall response per RECIST v1.1. Early data — not powered for formal comparison.

17%ORR 200 MG

33%ORR 400 MG

33%ORR 600 MG

80%DCR (ALL)

Waterfall Plot

Best percentage change in sum of target lesion diameters from baseline (RECIST v1.1). One bar per evaluable patient; dashed lines = PR (−30%) and PD (+20%).

Response Summary by Arm

Investigator-assessed BOR (RECIST v1.1). ORR = CR + PR; DCR = CR + PR + SD.

Treatment Arm	N	Best Overall Response (n)					Rates
Treatment Arm	N	CR	PR	SD	PD	NE	ORR (%)	DCR (%)
Drug X 200 mg	6	0	1	4	1	0	16.7	83.3
Drug X 400 mg	6	1	1	3	1	0	33.3	83.3
Drug X 600 mg	3	0	1	1	1	0	33.3	66.7

Exploratory Biomarker: TGZ123-A

Continuous central-lab biomarker assay Biomarker TGZ123-A. Exploratory cutoff 42 dichotomizes patients into TGZ123-A Low vs TGZ123-A High for early signal checks.

12 / 15PATIENTS WITH BIOMARKER

80%ASSESSMENT RATE

1TGZ123-A HIGH (≥42)

11TGZ123-A LOW (<42)

Outcomes by TGZ123-A Group

Among biomarker-evaluable patients only. TGZ123-A Low (<42) vs TGZ123-A High (≥42) — early descriptive signals, not inferential.

Objective response (ORR)

Any treatment-related AE

Disease control (DCR)

About This Run

Execution timing and LLM token utilization for this render. Insights are generated fresh on every run via gpt-4.1 (Bayer internal API).

Generated: 2026-06-15 08:18:57 EDT

273.3sTOTAL RENDER

273.2sINTERPRETATION

0.0sHTML KNIT

$0.0000LLM COST (EST.)

91,720 / 3,337TOKENS IN / OUT

15 / 15ARTIFACTS INTERPRETED

Artifact	Total (s)	Snapshot (s)	LLM (s)	Tokens in	Tokens out
chart-enrollment	16.8	6.2	10.6	6,124	218
gt-sites	18.8	0.9	17.9	NA	NA
gt-demog	11.7	0.9	10.9	NA	NA
chart-age	17.2	2.4	14.8	NA	NA
chart-sex	11.9	2.3	9.6	NA	NA
chart-histology	15.7	2.4	13.3	NA	NA
chart-ae	14.5	2.3	12.3	NA	NA
chart-ae-grade	15.9	2.3	13.7	NA	NA
gt-ae	10.4	0.9	9.5	NA	NA
chart-edish	12.6	2.3	10.3	NA	NA
gt-edish	10.8	0.9	10.0	NA	NA
gt-dili	13.5	0.9	12.6	NA	NA
chart-waterfall	18.8	2.4	16.4	NA	NA
gt-response	15.8	1.0	14.8	NA	NA
biomarker-outcomes	67.7	3.6	64.1	NA	NA