Multicenter, Randomized, Placebo-controlled, Double-blind, Parallel Group, Dose-finding Phase 2 Study to Evaluate Efficacy and Safety of BAY2433334 in Patients Following an Acute Non-cardioembolic Ischemic Stroke

Source: Publicly Available
Added: 16 Jun 2026
Contributor: System
Produced by: USDM Template v12 12.0.0

Phase IIb Trial Interventional Study v1.0 USDM v4.0.0

Sponsor: Sponsor Organization
Protocol ID: 19766
Identifier: NCT04304508

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Synopsis

Multicenter, Randomized, Placebo-controlled, Double-blind, Parallel Group, Dose-finding Phase 2 Study to Evaluate Efficacy and Safety of BAY2433334 in Patients Following an Acute Non-cardioembolic Ischemic Stroke

Study

Study type: Interventional Study
Phase: Phase IIb Trial
Therapeutic area: Neurology
Protocol version: 1.0

Design

Design: Not stated
Model: Single Group Study
Blinding: Open Label Study
Intent: Treatment Study
Arms: 1
Epochs: 3

Participants

Population: Study population
Planned enrolment: 1800
Sex: Both
Age: 45 Year to 100 Year
Healthy participants: Patients only

Key dates

Protocol Approval: 01 Jan 2024

Objectives and endpoints

Primary

To assess the dose response of 3 different doses of BAY 2433334 compared to placebo in reducing the composite of symptomatic ischemic strokes and covert brain infarcts detected by MRI as well as other cerebro- and cardiovascular endpoints in participants with an acute noncardioembolic ischemic stroke and who are treated with antiplatelet therapy.

Primary
composite of symptomatic ischemic stroke and covert brain infarcts detected by MRI

Primary

To evaluate whether the incidence of bleeding is similar for BAY 2433334 compared to placebo in participants with an acute non-cardioembolic ischemic stroke and who are treated with antiplatelet therapy

Primary
composite of International Society on Thrombosis and Hemostasis (ISTH) major bleeding and clinically relevant non-major (CRNM) bleeding

Secondary

Secondary
composite of symptomatic ischemic stroke and covert brain infarcts detected by MRI, CV death, myocardial infarction and systemic embolism
Secondary
symptomatic ischemic stroke
Secondary
covert brain infarcts detected by MRI
Secondary
symptomatic ischemic stroke, CV death, myocardial infarction
Secondary
symptomatic ischemic and hemorrhagic stroke
Secondary
disabling stroke (mRS≥4)
Secondary
all-cause mortality

Secondary

to evaluate whether the incidence of bleeding is similar for BAY 2433334 compared to placebo in participants with an acute non-cardioembolic ischemic stroke and who are treated with antiplatelet therapy

Secondary
all bleeding
Secondary
ISTH major bleeding
Secondary
ISTH CRNM bleeding
Secondary
ISTH minor bleeding
Secondary
Intracerebral hemorrhage (non-traumatic)

Exploratory

Exploratory
TIMI clinically significant bleeding
Exploratory
TIMI major bleeding
Exploratory
TIMI minor bleeding
Exploratory
BARC bleeding definition Type 2, 3, 5
Exploratory
BARC bleeding definition Type 3, 5
Exploratory
BARC bleeding definition Type 1, 2, 3, 5

Exploratory

To explore additional pharmacokinetic and pharmacodynamic parameters, biomarkers and genetics

Exploratory
Pharmacokinetics
Exploratory
Various biomarkers and genetics may be explored (e.g. diagnostic, safety, PD, monitoring, or potentially predictive biomarkers)

Exploratory

To further investigate the study intervention (i.e. mode-of-action-related effects and / or safety) and to further investigate pathomechanisms deemed relevant to cardiovascular diseases and associated health problems

Exploratory
FXIa inhibition, aPTT
Exploratory
Various biomarkers and genetics may be explored (e.g. diagnostic, safety, PD, monitoring, or potentially predictive biomarkers)

Eligibility

Inclusion 12

1
Participant must be 45 years of age and older at the time of signing the informed consent Type of Participant and Disease Characteristics
2
Non-cardioembolic ischemic stroke with
3
persistent signs and symptoms of stroke lasting for ≥ 24 hours OR
4
acute brain infarction documented by computed tomography (CT) or MRI AND
5
with the intention to be treated with antiplatelet therapy during the study conduct
6
Imaging of brain (CT or MRI) ruling out hemorrhagic stroke or another pathology that could explain symptoms (e.g. brain tumor, abscess, vascular malformation)
7
Severity of index event nearest the time of randomization:
8
Part A: minor stroke (defined as NIHSS ≤ 7) can be enrolled
9
Part B: participants with minor or moderate stroke and NIHSS ≤ 15 can be enrolled. Participants undergoing thrombolysis or endovascular therapy (mechanical thrombectomy) can be enrolled but at the...
10
Randomization within 48 hours after the onset of symptoms of the index event (or after patients were last known to be without symptoms in case of wake-up stroke)
11
Ability to conduct an MRI either before randomization or within 72 hours after randomization Informed Consent
12
Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent...

Exclusion 21

13
Prior ischemic stroke within last 30 days of index event
14
History of atrial fibrillation* or suspicion of cardioembolic source of stroke (*12-lead ECG or documented during cardiac rhythm monitoring)
15
Dysphagia with inability to safely swallow study medication at time of randomization
16
Contraindication to perform brain MRI (e.g. certain types of aneurysm clips, claustrophobia, patients that cannot lie supine for 30 minutes, patients whose body structure exceeds the restrictions...
17
Part A only: thrombolysis or endovascular therapy (mechanical thrombectomy) performed for index event
18
Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg) at randomization
19
Active bleeding; known bleeding disorder, history of major bleeding (intracranial, retroperitoneal, intraocular) or clinically significant gastrointestinal bleeding within last 6 months of randomization
20
Known significant liver disease (e.g. acute hepatitis, chronic active hepatitis, cirrhosis) or hepatic insufficiency classified as Child-Pugh B or C, or ALT or AST > 2.5 x the upper limit,...
21
Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 calculated by Modification of Diet in Renal Disease (MDRD), determined between enrollment and randomization.
22
Major surgery during last 30 days or planned major surgery or intervention within study period (e.g. Carotid endarterectomy, CABG)
23
Known allergy, intolerance or hypersensitivity to the study intervention (active substance or excipients). Prior/Concomitant Therapy
24
Planned use or requirement of full dose and long term anticoagulation therapy during study conduct
25
Anticipated need for chronic (more than 4 weeks) therapy with NSAIDs
26
Concomitant use of any of the following therapies within 14 days (or at least five halflives of the active substance whatever is longer) before randomization and first study intervention administration:
27
Strong inhibitors of cytochrome P450 isoenzyme 3A4 (CYP3A4) e.g. human immunodeficiency virus protease inhibitors, systemically used azole-antimycotic agents, clarithromycin or telithromycin
28
Strong inducers of CYP3A4, e.g. phenytoin, carbamazepine, phenobarbital, rifampicin or St. John’s wort.Other
29
Known current alcohol and/or illicit drug abuse that may interfere with the participant’s safety and/or compliance at the discretion of the investigator
30
Women of childbearing potential (women are considered of childbearing potential if they are not surgically sterile or postmenopausal, defined as amenorrhea for > 12 months). Male participants not...
31
Close affiliation with the investigational site or sponsor; e.g. a close relative of the investigator, or a dependent person (e.g. employee or student of the investigational site or the sponsor)
32
Previous (within 30 days or 5 half-lives of the investigational drug, whichever is longer) or concomitant participation in another clinical study with investigational medicinal product(s) or...
33
Any condition or therapy, which would make the participant unsuitable for the study (e.g. non-compliance) or otherwise vulnerable (e.g. participant in custody by order of an authority or a court)...

No order is declared for these criteria, which USDM permits. Grouped by inclusion and exclusion, then by criterion number.

Study design

What each arm receives in each epoch of the study.
Arm	Screening	Intervention Period Treatment	Safety Follow-up (SFU) Follow Up
Main Protocol Treatment Arm	—	—	—

Interventions

Intervention 1

BAY 2433334 5mg (Route: Oral)

Intervention 2

BAY 2433334 15mg (Route: Oral)

Intervention 3

BAY 2433334 25mg (Route: Oral)

Placebo

Placebo (Route: Oral)

Schedule of Activities

14 visits 47 activities Entry: Subject enrolled in study arm

Schedule of Activities — 14 visits

Activities by visit. A dot marks a visit at which the activity takes place.
Activity	Screening	Intervention Period												Safety Follow-up (SFU)
Visit	1 Main Day 274	1 Main Day 183	15 Main Day 365	29 Main Day 92	57 Main Day 1	92 Main Day 14	141 Main Day 29	183 Main Day 1	225 Main Day 323	274 Main Day 141	323 Main Day 225	365 Main Day 15	Unknown Main Day 57	14 Main Day 14
From previous visit	◆ Intervention Period Day 1.0		+1 day	+1 day	+1 day	+1 day	+1 day	+1 day	+1 day	+1 day	+1 day	+1 day	+1 day	+1 day
IRT - Randomization		IRT - Randomization at 1
Investigational Product Accountability						Investigational Product Accountability at 92		Investigational Product Accountability at 183		Investigational Product Accountability at 274		Investigational Product Accountability at 365	Investigational Product Accountability at Unknown
CBC W Differential Panel (Automated)	CBC W Differential Panel (Automated) at 1	CBC W Differential Panel (Automated) at 1		CBC W Differential Panel (Automated) at 29		CBC W Differential Panel (Automated) at 92		CBC W Differential Panel (Automated) at 183		CBC W Differential Panel (Automated) at 274		CBC W Differential Panel (Automated) at 365	CBC W Differential Panel (Automated) at Unknown
Participant Contact Card	Participant Contact Card at 1
MRI, Brain W Contrast		MRI, Brain W Contrast at 1				MRI, Brain W Contrast at 92		MRI, Brain W Contrast at 183					MRI, Brain W Contrast at Unknown
Adverse Events	Adverse Events at 1	Adverse Events at 1	Adverse Events at 15	Adverse Events at 29	Adverse Events at 57	Adverse Events at 92	Adverse Events at 141	Adverse Events at 183	Adverse Events at 225	Adverse Events at 274	Adverse Events at 323	Adverse Events at 365	Adverse Events at Unknown	Adverse Events at 14
Thyrotropin (TSH) [Unit/Vol]	Thyrotropin (TSH) [Unit/Vol] at 1	Thyrotropin (TSH) [Unit/Vol] at 1		Thyrotropin (TSH) [Unit/Vol] at 29		Thyrotropin (TSH) [Unit/Vol] at 92		Thyrotropin (TSH) [Unit/Vol] at 183		Thyrotropin (TSH) [Unit/Vol] at 274		Thyrotropin (TSH) [Unit/Vol] at 365	Thyrotropin (TSH) [Unit/Vol] at Unknown
Investigational Product Return						Investigational Product Return at 92		Investigational Product Return at 183		Investigational Product Return at 274		Investigational Product Return at 365	Investigational Product Return at Unknown
Prior/Concomitant Medications	Prior/Concomitant Medications at 1
Medical History, General (Lifetime)	Medical History, General (Lifetime) at 1
12 Lead ECG	12 Lead ECG at 1	12 Lead ECG at 1				12 Lead ECG at 92						12 Lead ECG at 365	12 Lead ECG at Unknown
Lipase [Act/Vol]	Lipase [Act/Vol] at 1	Lipase [Act/Vol] at 1		Lipase [Act/Vol] at 29		Lipase [Act/Vol] at 92		Lipase [Act/Vol] at 183		Lipase [Act/Vol] at 274		Lipase [Act/Vol] at 365	Lipase [Act/Vol] at Unknown
Concomitant Medications		Concomitant Medications at 1	Concomitant Medications at 15	Concomitant Medications at 29	Concomitant Medications at 57	Concomitant Medications at 92	Concomitant Medications at 141	Concomitant Medications at 183	Concomitant Medications at 225	Concomitant Medications at 274	Concomitant Medications at 323	Concomitant Medications at 365	Concomitant Medications at Unknown	Concomitant Medications at 14
MRI, Brain, Diffusion Weighted Imaging (DWI)		MRI, Brain, Diffusion Weighted Imaging (DWI) at 1				MRI, Brain, Diffusion Weighted Imaging (DWI) at 92		MRI, Brain, Diffusion Weighted Imaging (DWI) at 183					MRI, Brain, Diffusion Weighted Imaging (DWI) at Unknown
Complement C1 Esterase Inhibitor [Mass/Vol]		Complement C1 Esterase Inhibitor [Mass/Vol] at 1						Complement C1 Esterase Inhibitor [Mass/Vol] at 183					Complement C1 Esterase Inhibitor [Mass/Vol] at Unknown
PD Sampling		PD Sampling at 1		PD Sampling at 29				PD Sampling at 183					PD Sampling at Unknown
IP Administration - Oral Tablet		IP Administration - Oral Tablet at 1		IP Administration - Oral Tablet at 29				IP Administration - Oral Tablet at 183
Body Weight	Body Weight at 1
vWf Ag [Unit/Vol] by Immunologics		vWf Ag [Unit/Vol] by Immunologics at 1		vWf Ag [Unit/Vol] by Immunologics at 29				vWf Ag [Unit/Vol] by Immunologics at 183					vWf Ag [Unit/Vol] by Immunologics at Unknown
Fibrin D-Dimer DDU [Mass/Vol]		Fibrin D-Dimer DDU [Mass/Vol] at 1		Fibrin D-Dimer DDU [Mass/Vol] at 29				Fibrin D-Dimer DDU [Mass/Vol] at 183					Fibrin D-Dimer DDU [Mass/Vol] at Unknown
Body Height	Body Height at 1
Prothrombin Fragment 1.2 Ag [Moles/Vol]		Prothrombin Fragment 1.2 Ag [Moles/Vol] at 1						Prothrombin Fragment 1.2 Ag [Moles/Vol] at 183					Prothrombin Fragment 1.2 Ag [Moles/Vol] at Unknown
Contact IXRS	Contact IXRS at 1					Contact IXRS at 92		Contact IXRS at 183		Contact IXRS at 274		Contact IXRS at 365	Contact IXRS at Unknown
C Reactive Protein [Mass/Vol] by HSM		C Reactive Protein [Mass/Vol] by HSM at 1						C Reactive Protein [Mass/Vol] by HSM at 183					C Reactive Protein [Mass/Vol] by HSM at Unknown
Informed Consent Obtained	Informed Consent Obtained at 1
vWf Ristocetin Cofactor Actual/Norm		vWf Ristocetin Cofactor Actual/Norm at 1		vWf Ristocetin Cofactor Actual/Norm at 29				vWf Ristocetin Cofactor Actual/Norm at 183					vWf Ristocetin Cofactor Actual/Norm at Unknown
Cardiovascular Clinical Events Assessment	Cardiovascular Clinical Events Assessment at 1	Cardiovascular Clinical Events Assessment at 1	Cardiovascular Clinical Events Assessment at 15	Cardiovascular Clinical Events Assessment at 29	Cardiovascular Clinical Events Assessment at 57	Cardiovascular Clinical Events Assessment at 92	Cardiovascular Clinical Events Assessment at 141	Cardiovascular Clinical Events Assessment at 183	Cardiovascular Clinical Events Assessment at 225	Cardiovascular Clinical Events Assessment at 274	Cardiovascular Clinical Events Assessment at 323	Cardiovascular Clinical Events Assessment at 365	Cardiovascular Clinical Events Assessment at Unknown	Cardiovascular Clinical Events Assessment at 14
Natriuretic Peptide B Prohormone N-Terminal [Mass/Vol]		Natriuretic Peptide B Prohormone N-Terminal [Mass/Vol] at 1						Natriuretic Peptide B Prohormone N-Terminal [Mass/Vol] at 183					Natriuretic Peptide B Prohormone N-Terminal [Mass/Vol] at Unknown
Vital Signs	Vital Signs at 1	Vital Signs at 1		Vital Signs at 29		Vital Signs at 92		Vital Signs at 183		Vital Signs at 274		Vital Signs at 365	Vital Signs at Unknown
Participant Contact			Participant Contact at 15		Participant Contact at 57		Participant Contact at 141		Participant Contact at 225		Participant Contact at 323
National Institute of Health Stroke Scale (NIHSS)	National Institute of Health Stroke Scale (NIHSS) at 1	National Institute of Health Stroke Scale (NIHSS) at 1				National Institute of Health Stroke Scale (NIHSS) at 92		National Institute of Health Stroke Scale (NIHSS) at 183				National Institute of Health Stroke Scale (NIHSS) at 365	National Institute of Health Stroke Scale (NIHSS) at Unknown
Informed Consent, Pharmacogenetic (PGx) Testing	Informed Consent, Pharmacogenetic (PGx) Testing at 1
Inclusion/Exclusion Criteria	Inclusion/Exclusion Criteria at 1	Inclusion/Exclusion Criteria at 1
Thrombin Activatable Fibrinolysis Inhibitor [Units/Vol] by Chromogenic Method		Thrombin Activatable Fibrinolysis Inhibitor [Units/Vol] by Chromogenic Method at 1						Thrombin Activatable Fibrinolysis Inhibitor [Units/Vol] by Chromogenic Method at 183					Thrombin Activatable Fibrinolysis Inhibitor [Units/Vol] by Chromogenic Method at Unknown
Demographics	Demographics at 1
aPTT by Coagulation Assay		aPTT by Coagulation Assay at 1		aPTT by Coagulation Assay at 29				aPTT by Coagulation Assay at 183					aPTT by Coagulation Assay at Unknown
Lipid Panel	Lipid Panel at 1	Lipid Panel at 1		Lipid Panel at 29		Lipid Panel at 92		Lipid Panel at 183		Lipid Panel at 274		Lipid Panel at 365	Lipid Panel at Unknown
Creatine Kinase [Act/Vol]	Creatine Kinase [Act/Vol] at 1	Creatine Kinase [Act/Vol] at 1		Creatine Kinase [Act/Vol] at 29		Creatine Kinase [Act/Vol] at 92		Creatine Kinase [Act/Vol] at 183		Creatine Kinase [Act/Vol] at 274		Creatine Kinase [Act/Vol] at 365	Creatine Kinase [Act/Vol] at Unknown
Amylase [Act/Vol]	Amylase [Act/Vol] at 1	Amylase [Act/Vol] at 1		Amylase [Act/Vol] at 29		Amylase [Act/Vol] at 92		Amylase [Act/Vol] at 183		Amylase [Act/Vol] at 274		Amylase [Act/Vol] at 365	Amylase [Act/Vol] at Unknown
Factor XII Ag [Unit/Vol]		Factor XII Ag [Unit/Vol] at 1		Factor XII Ag [Unit/Vol] at 29				Factor XII Ag [Unit/Vol] at 183					Factor XII Ag [Unit/Vol] at Unknown
Investigational Product Dispensation		Investigational Product Dispensation at 1				Investigational Product Dispensation at 92		Investigational Product Dispensation at 183		Investigational Product Dispensation at 274
Chemistry Panel (CHEM-20)	Chemistry Panel (CHEM-20) at 1	Chemistry Panel (CHEM-20) at 1		Chemistry Panel (CHEM-20) at 29		Chemistry Panel (CHEM-20) at 92		Chemistry Panel (CHEM-20) at 183		Chemistry Panel (CHEM-20) at 274		Chemistry Panel (CHEM-20) at 365	Chemistry Panel (CHEM-20) at Unknown
Coagulation Factor XI Ag [Units/volume] by Immunoassay		Coagulation Factor XI Ag [Units/volume] by Immunoassay at 1		Coagulation Factor XI Ag [Units/volume] by Immunoassay at 29				Coagulation Factor XI Ag [Units/volume] by Immunoassay at 183					Coagulation Factor XI Ag [Units/volume] by Immunoassay at Unknown
Modified Rankin Scale	Modified Rankin Scale at 1	Modified Rankin Scale at 1				Modified Rankin Scale at 92		Modified Rankin Scale at 183				Modified Rankin Scale at 365	Modified Rankin Scale at Unknown
Thrombin Antithrombin Complex Ag [Mass/Vol]		Thrombin Antithrombin Complex Ag [Mass/Vol] at 1						Thrombin Antithrombin Complex Ag [Mass/Vol] at 183					Thrombin Antithrombin Complex Ag [Mass/Vol] at Unknown
PK Sampling				PK Sampling at 29				PK Sampling at 183					PK Sampling at Unknown
Pharmacogenetic DNA Analysis Panel		Pharmacogenetic DNA Analysis Panel at 1						Pharmacogenetic DNA Analysis Panel at 183

◆ marks the fixed reference the other visits are timed from. Study days are not shown: the timings in this schedule do not connect every visit to it.

No entry point is declared, which USDM requires. The first visit is inferred as the only one nothing else leads to.

Conformance CDISC CORE CDISC Open Rules Engine 22 rules reported issues 207 rules 132 passed 17 with errors 4 with warnings 1 unrated 53 not evaluated 741 issues, most against Estimand, Activity and Code Engine 0.15.0 USDM v4.0 rules Run 16 Jun 2026

CDISC CORE

CDISC Open Rules Engine

22 rules reported issues 207 rules 132 passed 17 with errors 4 with warnings 1 unrated 53 not evaluated 741 issues, most against Estimand, Activity and Code Engine 0.15.0 USDM v4.0 rules Run 16 Jun 2026

JSON report Excel report

Partially executable: CDISC notes this rule may report issues that are not present. Engine wording: “partially executable - possible overreporting”.

In this document

Object	Location in the file	Values
Code Code_501	/study/versions/0/studyDesigns/0/objectives/0/level	codeSystem http://www.cdisc.org codeSystemVersion 2025-09-26 code C98772 decode Primary Objective
Code Code_601	/study/versions/0/studyDesigns/0/objectives/0/endpoints/0/level	codeSystem http://www.cdisc.org codeSystemVersion 2025-09-26 code C98772 decode Primary Endpoint
Code Code_502	/study/versions/0/studyDesigns/0/objectives/1/level	codeSystem http://www.cdisc.org codeSystemVersion 2025-09-26 code C98772 decode Primary Objective
Code Code_601	/study/versions/0/studyDesigns/0/objectives/1/endpoints/0/level	codeSystem http://www.cdisc.org codeSystemVersion 2025-09-26 code C98772 decode Primary Endpoint
Code Code_503	/study/versions/0/studyDesigns/0/objectives/2/level	codeSystem http://www.cdisc.org codeSystemVersion 2025-09-26 code C98781 decode Secondary Objective
Code Code_601	/study/versions/0/studyDesigns/0/objectives/2/endpoints/0/level	codeSystem http://www.cdisc.org codeSystemVersion 2025-09-26 code C98781 decode Secondary Endpoint
Code Code_602	/study/versions/0/studyDesigns/0/objectives/2/endpoints/1/level	codeSystem http://www.cdisc.org codeSystemVersion 2025-09-26 code C98781 decode Secondary Endpoint
Code Code_603	/study/versions/0/studyDesigns/0/objectives/2/endpoints/2/level	codeSystem http://www.cdisc.org codeSystemVersion 2025-09-26 code C98781 decode Secondary Endpoint
Code Code_604	/study/versions/0/studyDesigns/0/objectives/2/endpoints/3/level	codeSystem http://www.cdisc.org codeSystemVersion 2025-09-26 code C98781 decode Secondary Endpoint
Code Code_605	/study/versions/0/studyDesigns/0/objectives/2/endpoints/4/level	codeSystem http://www.cdisc.org codeSystemVersion 2025-09-26 code C98781 decode Secondary Endpoint
Code Code_606	/study/versions/0/studyDesigns/0/objectives/2/endpoints/5/level	codeSystem http://www.cdisc.org codeSystemVersion 2025-09-26 code C98781 decode Secondary Endpoint
Code Code_607	/study/versions/0/studyDesigns/0/objectives/2/endpoints/6/level	codeSystem http://www.cdisc.org codeSystemVersion 2025-09-26 code C98781 decode Secondary Endpoint
Code Code_504	/study/versions/0/studyDesigns/0/objectives/3/level	codeSystem http://www.cdisc.org codeSystemVersion 2025-09-26 code C98781 decode Secondary Objective
Code Code_601	/study/versions/0/studyDesigns/0/objectives/3/endpoints/0/level	codeSystem http://www.cdisc.org codeSystemVersion 2025-09-26 code C98781 decode Secondary Endpoint
Code Code_602	/study/versions/0/studyDesigns/0/objectives/3/endpoints/1/level	codeSystem http://www.cdisc.org codeSystemVersion 2025-09-26 code C98781 decode Secondary Endpoint
Code Code_603	/study/versions/0/studyDesigns/0/objectives/3/endpoints/2/level	codeSystem http://www.cdisc.org codeSystemVersion 2025-09-26 code C98781 decode Secondary Endpoint
Code Code_604	/study/versions/0/studyDesigns/0/objectives/3/endpoints/3/level	codeSystem http://www.cdisc.org codeSystemVersion 2025-09-26 code C98781 decode Secondary Endpoint
Code Code_605	/study/versions/0/studyDesigns/0/objectives/3/endpoints/4/level	codeSystem http://www.cdisc.org codeSystemVersion 2025-09-26 code C98781 decode Secondary Endpoint
Code Code_505	/study/versions/0/studyDesigns/0/objectives/4/level	codeSystem http://www.cdisc.org codeSystemVersion 2025-09-26 code C98783 decode Exploratory Objective
Code Code_601	/study/versions/0/studyDesigns/0/objectives/4/endpoints/0/level	codeSystem http://www.cdisc.org codeSystemVersion 2025-09-26 code C98783 decode Exploratory Endpoint
Code Code_602	/study/versions/0/studyDesigns/0/objectives/4/endpoints/1/level	codeSystem http://www.cdisc.org codeSystemVersion 2025-09-26 code C98783 decode Exploratory Endpoint
Code Code_603	/study/versions/0/studyDesigns/0/objectives/4/endpoints/2/level	codeSystem http://www.cdisc.org codeSystemVersion 2025-09-26 code C98783 decode Exploratory Endpoint
Code Code_604	/study/versions/0/studyDesigns/0/objectives/4/endpoints/3/level	codeSystem http://www.cdisc.org codeSystemVersion 2025-09-26 code C98783 decode Exploratory Endpoint
Code Code_605	/study/versions/0/studyDesigns/0/objectives/4/endpoints/4/level	codeSystem http://www.cdisc.org codeSystemVersion 2025-09-26 code C98783 decode Exploratory Endpoint
Code Code_606	/study/versions/0/studyDesigns/0/objectives/4/endpoints/5/level	codeSystem http://www.cdisc.org codeSystemVersion 2025-09-26 code C98783 decode Exploratory Endpoint
Code Code_506	/study/versions/0/studyDesigns/0/objectives/5/level	codeSystem http://www.cdisc.org codeSystemVersion 2025-09-26 code C98783 decode Exploratory Objective
Code Code_601	/study/versions/0/studyDesigns/0/objectives/5/endpoints/0/level	codeSystem http://www.cdisc.org codeSystemVersion 2025-09-26 code C98783 decode Exploratory Endpoint
Code Code_602	/study/versions/0/studyDesigns/0/objectives/5/endpoints/1/level	codeSystem http://www.cdisc.org codeSystemVersion 2025-09-26 code C98783 decode Exploratory Endpoint
Code Code_507	/study/versions/0/studyDesigns/0/objectives/6/level	codeSystem http://www.cdisc.org codeSystemVersion 2025-09-26 code C98783 decode Exploratory Objective
Code Code_601	/study/versions/0/studyDesigns/0/objectives/6/endpoints/0/level	codeSystem http://www.cdisc.org codeSystemVersion 2025-09-26 code C98783 decode Exploratory Endpoint
Code Code_602	/study/versions/0/studyDesigns/0/objectives/6/endpoints/1/level	codeSystem http://www.cdisc.org codeSystemVersion 2025-09-26 code C98783 decode Exploratory Endpoint

Not evaluated 53

48 skipped · 5 engine errors 53 rules

DDF00084 Engine error There is not exactly one objective with a level of 'Primary Objective' within the study design. Failed to execute rule operation. Operation: distinct, Target: text, Domain: Objective, Error: 'Column not found: text'
DDF00107 Engine error The scheduled activity instance has a sub-timeline that is not defined within the same study design. Failed to execute rule operation. Operation: distinct, Target: parent_id, Domain: ScheduleTimeline, Error: 'timelineId'
DDF00114 Engine error The specified context of the condition is not a valid instance of either the Activity or ScheduledActivityInstance class (the value of the condition's contextIds attribute either matches the id of an instance that is not an Activity or ScheduledActivityInstance, or it does not match the id of any class instance). Failed to execute rule operation. Operation: record_count, Target: None, Domain: Condition, Error: Failed to execute rule operation. Domain Condition does not exist. Operation: record_count, Target: None, Core ID: CORE-000878
DDF00181 Engine error The study definition document version has more than one governance date with the same type and geographic scope. Cannot perform 'rand_' with a dtyped [float64] array and scalar of type [bool]
DDF00247 Engine error The text attribute contains non-conformant XHTML. Failed to execute rule operation. Operation: get_xhtml_errors, Target: text, Domain: Objective, Error: 'text'
DDF00006 Skipped One or more of the window attributes (windowLabel, windowLower, windowUpper) is missing.
DDF00013 Skipped A required biomedical concept property (isRequired=true) is not enabled (isEnabled is not true), or a disabled biomedical concept property (isEnabled=false) is required (isRequired is not false).
DDF00014 Skipped The biomedical concept category does not have any members or children.
DDF00020 Skipped Population of otherReason is not consistent with code - code.code is C17649 ('Other') but otherReason is blank, or otherReason is present but code.code is not C17649 ('Other').
DDF00024 Skipped The epoch references a previous or next epoch that is not specified within the same study design.
DDF00025 Skipped One or more of the window attributes (windowLabel, windowLower, windowUpper) contains a value for a Fixed Reference timing (type.code=C201358).
DDF00026 Skipped The scheduled activity instance is referencing its parent timeline as its sub-timeline.
DDF00028 Skipped The activity references a previous or next activity that is not specified within the same study design.
DDF00029 Skipped The encounter references a previous or next encounter that is not specified within the same study design.
DDF00034 Skipped The duration will vary (durationWillVary is not 'false' or reasonDurationWillVary is populated), but it is not fully defined (durationWillVary is not 'true' or reasonDurationWillVary is missing).
DDF00038 Skipped The scheduled decision instance does not refer to a default condition.
DDF00040 Skipped The study element is not referenced by any study cell.
DDF00044 Skipped The condition assignment's target is the same as its parent.
DDF00047 Skipped The study element is referenced by a study cell but was not defined within the same study design as the study cell: the parent_id of the study element ($parent_of_study_element) is not the same as parent_id of the study cell (parent_id.StudyCell).
DDF00061 Skipped The lower limit of the timing window (windowLower) is not a non-negative duration in ISO 8601 format.
DDF00062 Skipped The upper limit of the timing window (windowUpper) is not a non-negative duration in ISO 8601 format.
DDF00071 Skipped The study cell references an arm that is not defined within the same study design as the study cell.
DDF00072 Skipped The study cell references an epoch that is not defined within the same study design as the study cell.
DDF00090 Skipped The biomedical concept category is referenced more than once from the same activity.
DDF00102 Skipped The scheduled activity instance references a timeline exit that is not defined within the same schedule timeline as the scheduled activity instance.
DDF00112 Skipped The study intervention's role is not specified using the study intervention role (C207417) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive), and/or neither code nor decode is found in the codelist.
DDF00128 Skipped The study intervention's type is not specified using the Intervention Type Response (C99078) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive), and/or neither code nor decode is found in the codelist.
DDF00137 Skipped The reference is not a fixed value (it contains "usdm:ref") but it is not specified in the correct format.
DDF00143 Skipped The study amendment reason is not coded using the study amendment reason (C207415) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).
DDF00152 Skipped The activity references a timeline that is not specified within the same study design.
DDF00175 Skipped The administration's frequency is not specified according to the extensible Frequency (C71113) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).
DDF00176 Skipped The administration's route is not specified according to the extensible Route of Administration Response (C66729) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).
DDF00179 Skipped The administrable dose form is not specified according to the extensible Pharmaceutical Dosage Form (C66726) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).
DDF00180 Skipped The administrable product property type is not specified according to the extensible administrable product property type (C215479) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).
DDF00183 Skipped The reference identifier type is not specified according to the extensible reference identifier type (C215478) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).
DDF00187 Skipped The narrative content item text contains non-conformant XHTML.
DDF00199 Skipped The study impact type is not specified according to the extensible study amendment impact type (C215481) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).
DDF00207 Skipped The medical device identifier type is not specified according to the extensible medical device identifier type (C215484) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).
DDF00208 Skipped The administrable product sourcing is not specified according to the extensible administrable product sourcing (C215483) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).
DDF00209 Skipped The medical device sourcing is not specified according to the extensible medical device sourcing (C215482) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).
DDF00210 Skipped The administrable product's product designation is not specified using the product designation (C207418) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive), and/or neither code nor decode is found in the codelist.
DDF00214 Skipped The interventional study design's intent type is not specified according to the extensible Trial Intent Type Response (C66736) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).
DDF00215 Skipped The interventional study design's sub type is not specified according to the extensible Trial Type Response (C66739) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).
DDF00216 Skipped The study design's intervention model is not specified according to the extensible Intervention Model Response (C99076) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).
DDF00217 Skipped The study design's blinding schema is not specified according to the extensible Trial Blinding Schema Response (C66735) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).
DDF00218 Skipped The study design's characteristic is not specified according to the extensible study design characteristics (C207416) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).
DDF00223 Skipped The study design's observational model is not specified according to the extensible Observational Study Model (C127259) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).
DDF00224 Skipped The observational study design's time perspective is not specified according to the extensible Observational Study Time Perspective (C127261) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).
DDF00225 Skipped The observational study design's sampling method is not specified according to the extensible Observational Study Sampling Method (C127260) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).
DDF00226 Skipped The observational study design's sub type is not specified according to the extensible observational study design subtype (C215486) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).
DDF00229 Skipped The study design's study phase is not specified according to the extensible Trial Phase Response (C66737) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).
DDF00230 Skipped The study design's study type is not specified using the Study Type Response (C99077) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive), and/or neither code nor decode is found in the codelist.
DDF00259 Skipped The study role code is not specified using to the extensible study role code (C215480) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).

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