Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
358
Countries
13
Sites
62
Psychosis Associated with Alzheimer’s Disease
The main objectives of the trial are to evaluate the efficacy of KarXT compared with placebo in the treatment of psychosis in participants with psychosis associated with AD as measured by the Neuropsychiatric Inventory-Clinician (NPI-C):Hallucinations and Delusions (H+D) score
Key facts
- Sponsor
- Bristol-Myers Squibb Services Unlimited Company
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10], Psychiatry and Psychology [F] - Mental Disorders [F03]
- Trial duration
- 8 Apr 2025 → ongoing
- Decision date (initial)
- 2025-03-25
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Bristol-Myers Squibb Services Unlimited Company
External identifiers
- EU CT number
- 2024-516363-92-00
- WHO UTN
- U1111-1310-4139
- ClinicalTrials.gov
- NCT06585787
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety, Others, Pharmacokinetic, Therapy
The main objectives of the trial are to evaluate the efficacy of KarXT compared with placebo in the treatment of psychosis in participants with psychosis associated with AD as measured by the Neuropsychiatric Inventory-Clinician (NPI-C):Hallucinations and Delusions (H+D) score
Secondary objectives 1
- To evaluate the efficacy of KarXT compared with placebo in the treatment of psychosis in participants with psychosis associated with AD as measured by the CGI-S scale: CGI-S requires the assessor to consider aspects of the psychosis (hallucinations and delusions) prior to providing a global assessment of severity.
Conditions and MedDRA coding
Psychosis Associated with Alzheimer’s Disease
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10012271 | Dementia Alzheimer's type | 100000004852 |
| 20.0 | LLT | 10037234 | Psychosis | 10037175 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- • Patients who are 55-90 years old
- • Diagnosed with AD based on the 2024 National Institute on Aging – Alzheimer’s Association criteria with AD biomarker confirmation
- • Participants who have a magnetic resonance imaging (MRI) or computed tomography (CT) scan of the brain (completed within the past 5 years) taken during or subsequent to the onset of dementia to rule out other central nervous system (CNS) disease that could account for the dementia syndrome, eg, major stroke, neoplasm, subdural hematoma
- • Patient must have a history of psychotic symptoms (meeting International Psychogeriatric Association criteria) for at least 2 months prior to Screening (Visit 1) (participants may or may not have symptoms of agitation)
Exclusion criteria 3
- • Patients will not be able to participate if they have psychotic symptoms that are primarily attributable to a condition other than the AD causing the dementia, eg, schizophrenia, schizoaffective disorder, delusional disorder, or mood disorder with psychotic features.
- • History of major depressive episode with psychotic features during the 12 months prior to Screening, or history of bipolar disorder, schizophrenia, or schizoaffective disorder.
- • Patients are not able to participate if they have certain safety concerns, including certain laboratory test irregularities.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The main endpoint is the change from Baseline to End of Treatment in NPI-C: H+D score.
Secondary endpoints 1
- The key secondary endpoint is the change from Baseline to End of Treatment on CGI-S score.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 5
PRD10441534 · Product
- Active substance
- Trospium Chloride
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 15099915 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- KARUNA THERAPEUTICS INC.
- Paediatric formulation
- No
- Orphan designation
- No
PRD10441532 · Product
- Active substance
- Trospium Chloride
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 909999 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- KARUNA THERAPEUTICS INC.
- Paediatric formulation
- No
- Orphan designation
- No
PRD10441533 · Product
- Active substance
- Trospium Chloride
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 12099912 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- KARUNA THERAPEUTICS INC.
- Paediatric formulation
- No
- Orphan designation
- No
PRD10441535 · Product
- Active substance
- Trospium Chloride
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 20099920 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- KARUNA THERAPEUTICS INC.
- Paediatric formulation
- No
- Orphan designation
- No
PRD10441531 · Product
- Active substance
- Trospium Chloride
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 609996 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- KARUNA THERAPEUTICS INC.
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Bristol-Myers Squibb Services Unlimited Company
- Sponsor organisation
- Bristol-Myers Squibb Services Unlimited Company
- Address
- Plaza 254 Blanchardstown Corporate Park 2
- City
- Dublin 15
- Postcode
- D15 T867
- Country
- Ireland
Scientific contact point
- Organisation
- Bristol-Myers Squibb Services Unlimited Company
- Contact name
- GSM-CT
Public contact point
- Organisation
- Bristol-Myers Squibb Services Unlimited Company
- Contact name
- GSM-CT
Third parties 21
| Organisation | City, country | Duties |
|---|---|---|
| Pharmaceutical Product Development LLC ORG-100016999
|
Wilmington, United States | On site monitoring, Code 12, Other, Code 2, Data management, Code 8, Code 9 |
| Celerion Inc. ORG-100029202
|
Lincoln, United States | Other |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
| Elligo Health Research Inc. ORG-100044201
|
Austin, United States | Other |
| Eresearchtechnology Inc. ORG-100013039
|
Philadelphia, United States | Other |
| Suvoda LLC ORG-100043523
|
Conshohocken, United States | Interactive response technologies (IRT) |
| PPD Global Central Labs ORG-100046496
|
Zaventem, Belgium | Other |
| Scout Clinical ORG-100042228
|
Dallas, United States | Other |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | Data management |
| The Doctors Laboratory Limited ORG-100012670
|
London, United Kingdom | Other |
| Labcorp Development Japan K.K. ORG-100047151
|
Chuo, Japan | Other |
| PPD Global Ltd. ORG-100007531
|
Marousi, Greece | Other, Code 5 |
| Azenta Germany GmbH ORG-100022621
|
Griesheim, Germany | Other |
| Signant Health Global LLC ORG-100040604
|
Blue Bell, United States | Other |
| Azenta Singapore Pte Ltd ORG-100049467
|
Singapore, Singapore | Other |
| Azenta US Inc. ORG-100012907
|
Indianapolis, United States | Other |
| Quanterix Corp. ORG-100044008
|
Billerica, United States | Other |
| Labcorp Central Laboratory Services SARL ORG-100011524
|
Meyrin, Switzerland | Other |
| Catalyst Clinical Research LLC ORG-100043484
|
Wilmington, United States | Other |
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Other |
| Labcorp Development (Asia) Pte Ltd ORG-100050418
|
Singapore, Singapore | Other |
Locations
13 EU/EEA countries · 62 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 6 | 4 |
| Bulgaria | Ongoing, recruiting | 9 | 4 |
| Croatia | Ongoing, recruiting | 15 | 5 |
| France | Ongoing, recruiting | 6 | 3 |
| Germany | Ended | 5 | 2 |
| Greece | Ongoing, recruiting | 6 | 5 |
| Hungary | Ongoing, recruiting | 5 | 4 |
| Italy | Ongoing, recruiting | 7 | 6 |
| Poland | Ongoing, recruiting | 9 | 5 |
| Portugal | Ongoing, recruiting | 9 | 5 |
| Romania | Ongoing, recruiting | 8 | 5 |
| Slovakia | Ongoing, recruiting | 8 | 6 |
| Spain | Ongoing, recruiting | 9 | 8 |
| Rest of world
Brazil, United States, Argentina, India, Serbia, Japan, Turkey, Israel, Korea, Republic of, Puerto Rico
|
— | 256 | — |
Investigational sites
UZ Brussel
Geriatrics, Laarbeeklaan 101, 1090, Jette
Algemeen Ziekenhuis Delta
Neurology, Deltalaan 1, 8800, Roeselare
Algemeen Ziekenhuis Groeninge
Neurology, President Kennedylaan 4, 8500, Kortrijk
Anima
Psychiatry, Alkerstraat 28, 3570, Alken
University Multiprofile Hospital For Active Treatment Saint Georgi EAD
Neurology Clinic, Bulevard Peshtersko Shose 66, 4002, Plovdiv
Medical Center Medica 2005 EOOD
N/A, Ulitsa Milin Kamik 51, Lozenets District, Sofia
University Multiprofessional Hospital For Active Treatment Kanev AD
Department of General and Vascular Neurology, Ulitsa Tsirkovna Nezavisimost 2, 7000, Ruse
Medical Center Intermedica Ltd.
N/A, Belite Brezim, Ulitsa Nishava 62, Sofiya
Klinika za psihijatriju Vrapce
Biological Psychiatry and Psychogeriatrics, Bolnicka Cesta 32, Zagreb, Grad Zagreb
Clinic for psychiatry Sveti Ivan
Clinic for psychiatry, Jankomir 11, Zagreb, Grad Zagreb
Poliklinika Neuron
Psychiatry, Salata 12, 10000, Grad Zagreb
University Hospital Centre Zagreb
Neurology, Ulica Mije Kispatica 12, 10000, Zagreb
Poliklinika BONIFARM
Neurology, Ulica Aleksandra Hondla 2/11, 10000, Zagreb
Centre Hospitalier Universitaire De Toulouse
Centre de Recherche Clinique du Gérontopôle, 9 Place Lange, 31300, Toulouse
Centre Hospitalier Universitaire De Nice
Institut Claude Pompidou Centre Mémoire de Ressources et de Recherche (CM2R), 10 Rue Moliere, 06100, Nice
Centre Hospitalier Regional Universitaire De Tours
Centre Mémoire Ressources et Recherche (CMRR), 2 Boulevard Tonnelle, 37000, Tours
Neuro Centrum Science GmbH
Neurology, psychiatry and psychotherapy, Albert-Schweitzer-Strasse 8, 64711, Erbach
Goethe University Frankfurt
Psychiatry, psychosomatics and psychotherapy, Heinrich-Hoffmann-Strasse 10, Niederrad, Frankfurt Am Main
424 General Military Training Hospital
Outpatient Psychiatric Department, Gr. Lampraki 3, 54 636, Thessaloniki
Henry Dunant Hospital Center
B' Neurology Clinic, 107 Mesogeion Avenue, 115 26, Athens
General Oncological Hospital Of Kifissia Agioi Anargyroi
University Psychiatric Clinic, Timio Stavrou And 14 Noufaron, 145 64, Kifissia
University General Hospital Of Heraklion
Neurology Clinic, Stavrakia And Voutes, 715 00, Heraklion
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
B’ Psychiatry Dept, Rimini 1, 124 61, Chaidari
PsychoTech Kft.
n/a, Endresz Gyorgy Utca 2/2, 7633, Pecs
Eszak-Budai Szent Janos Centrumkorhaz
Budai Családközpontú Lelki Egészség Centrum, Dios Arok 1-3, 1125, Budapest XII
Semmelweis University
Pszichiátriai és Pszichoterápiás Klinika, Balassa J Utca 6, 1083, Budapest
Gyoengyosi Bugat Pal Koerhaz
Pszichiátriai rehabilitációs osztály, Dozsa Gyorgy Utca 20-22, 3200, Gyongyos
Azienda Sanitaria Locale Della Provincia Di Biella
SOC Neurologia, Via Dei Ponderanesi 2, 13875, Ponderano
Istituto Auxologico Italiano
Department of Neurology, Piazzale Brescia 20, 20149, Milan
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Department of Human Neuroscience, Viale Del Policlinico 155, 00161, Rome
Azienda Ospedaliero-Universitaria Sant Andre
NESMOS Department, Via Di Grottarossa 1035-1039, 00189, Rome
Provincia Lombardo Veneta Dell’Ordine Ospedaliero Di San Giovanni Di Dio Fatebenefratelli
Alzheimer and Rehabilitation, Via Pilastroni 4, 25125, Brescia
Azienda Ospedaliera Universitaria San Giovanni Di Dio E Ruggi d'Aragona
UOC Neurologia, Largo Citta' D'ippocrate 1, 84131, Salerno
Niepubliczny Zaklad Opieki Zdrowotnej Neuromed M. I M. Nastaj. sp.p.
n/a, Ul. Polnocna 8/3, 20-064, Lublin
Osrodek Badan Klinicznych Bd Research Sp. z o.o.
N/A, Ul. Gen. Wladyslawa Andersa 3, 14-200, Ilawa
Centrum Medyczne Hcp Sp. z o.o.
n/a, Ul. 28 Czerwca 1956 R. 194, 61-485, Poznan
Uniwersyteckie Centrum Kliniczne
Klinika Psychiatrii Dorosłych, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Pro Salus Sp. z o.o. sp.k.
n/a, Ul. Julianowska 54b, 91-473, Lodz
Unidade Local De Saude Do Alto Ave E.P.E.
Neurology, Rua Dos Cuteleiros De Guimaraes, 4835-044, Guimaraes
Unidade Local De Saude De Lisboa Ocidental E.P.E.
Neurology, Rua Da Junqueira 126, 1349-019, Lisbon
Unidade Local De Saude De Matosinhos E.P.E.
Neurology, Rua Doutor Eduardo Torres, 4464-513, Senhora Da Hora
CNS Saude Lda.
Neurology, Bairro De Santo Antonio 47, 2560-280, Torres Vedras
Unidade Local De Saude De Santa Maria E.P.E.
Neurosciences, Avenida Professor Egas Moniz, 1649-035, Lisbon
Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia
Centrul de Sanatate Mintala Spitalul Clinic De Psihiatrie, Strada Argeselu Nr 8, 040874, Bucharest
CMI Dr. Buhas Ramocea Elena Daniela - Cabinet Medical de Psihiarie
Psychiatry, Strada Rovine Nr. 17,, 410027, Oradea
Spitalul Clinic Cai Ferate Constanta
Neurology, Bulevardul 1 Mai 5-7, 900123, Constanta
Carpe Diem S.R.L.
Psychiatry, Strada Negruzzi Costache No.12, 550281, Sibiu
Institutul Privat de Cercetari Melchisedec pentru Boli Autoimune, Ereditare și Rare – I.P.C.M.
Psychiatry, Strada Amaradia Nr. 21,, 200157, Craiova
Crystal Comfort s.r.o.
n/a, M R Stefanika 2427, 093 01, Vranov Nad Toplou
Epamed s.r.o.
n/a, Topasova 9, Zapad, Kosice - Zapad
Psychiatricka Nemocnica Philippa Pinela Pezinok
n/a, Malacka Cesta 63, 902 01, Pezinok
MUDr. Beata Dupejova neurologicka ambulancia s.r.o.
n/a, Nova 21, Foncorda, Banska Bystrica
Konzilium s.r.o.
n/a, A. Kmeta 370/15, 018 41, Dubnica Nad Vahom
Univerzitna nemocnica L. Pasteura Kosice
n/a, Rastislavova 43, Juh, Kosice
Hospital Universitario De Salamanca
Psychiatry, Paseo De San Vicente 58-182, 37007, Salamanca
Hospital Universitario Puerta De Hierro De Majadahonda
Neurology, Calle De Joaquin Rodrigo 2, 28222, Majadahonda
Hospital Universitario Rio Hortega
Psychiatry, Calle Dulzaina 2, 47012, Valladolid
Hospital Universitari De Santa Maria
Neurology, Av Alcalde Rovira Roure 44, 25198, Lleida
Hospital Victoria Eugenia De La Cruz Roja Espanola
Neurology, Avenida La Cruz Roja 1, 41009, Sevilla
Hospital Clinico San Carlos
Neurology, Calle Del Profesor Martín Lagos S/n, 28040, Madrid
Clinica Montecanal S.L.
Neurology, Calle Franz Schubert 2, 50012, Zaragoza
Hospital Quironsalud Malaga
Neurology, Avenida Imperio Argentina 1, 29004, Malaga
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Belgium | 2025-04-15 | 2025-04-23 | |||
| Bulgaria | 2025-06-20 | 2025-07-10 | |||
| Croatia | 2025-04-29 | 2025-05-20 | |||
| France | 2025-05-06 | 2025-08-26 | |||
| Germany | 2025-04-14 | ||||
| Greece | 2025-04-30 | 2025-10-01 | |||
| Hungary | 2025-04-28 | 2025-06-18 | |||
| Italy | 2025-04-16 | 2025-11-05 | |||
| Poland | 2025-04-11 | 2025-05-09 | |||
| Portugal | 2025-04-16 | 2025-06-12 | |||
| Romania | 2025-05-09 | 2025-05-30 | |||
| Slovakia | 2025-04-11 | 2025-04-30 | |||
| Spain | 2025-04-08 | 2025-04-09 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 294 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_ Protocol_2024-516363-92-00_Redacted | 02 EU |
| Protocol (for publication) | D1_BMS_CN0120056_Protocol_2024-516363-92_GRC_Previous version_Public | 01 EU |
| Protocol (for publication) | D1_BMS_CN0120056_Protocol_2024-516363-92_GRC_Public | 02 EU |
| Protocol (for publication) | D4_Statement on copyrighted_ADAS Cog_MMSE_NPI-C and NPI-12 Response Card_AIMS_CMAI_C-SSRSLV_C-SSRSBS | 1 |
| Recruitment arrangements (for publication) | 2_CN0120056_FlipChart_Public | 2 |
| Recruitment arrangements (for publication) | 2_CN0120056_Patient_Caregiver_Brochure_Public | 2 |
| Recruitment arrangements (for publication) | 2_CN0120056_Patient-Letter_Public | 2 |
| Recruitment arrangements (for publication) | 2_CN0120056_Postcard_Public | 1 |
| Recruitment arrangements (for publication) | 2_CN0120056_Poster_Public | 1 |
| Recruitment arrangements (for publication) | K1_CN0120056_Justification-inclusion-vulnerable-patients_FR_Public | n/a |
| Recruitment arrangements (for publication) | K1_CN0120056_Physician_Letter_HU_Hungarian_Public | 2 |
| Recruitment arrangements (for publication) | K1_CN0120056_Recruitment Arrangements_BE_Public | 2.0 |
| Recruitment arrangements (for publication) | K1_CN0120056_Recruitment_Arrangements_Hungary_Public | N/A |
| Recruitment arrangements (for publication) | K1_CN0120056_Recruitment_Informed_Consent_Procedure_PL_Polish_Public | 3.0 |
| Recruitment arrangements (for publication) | K1_CN0120056_Recruitment-Arrangements_BGR_Bulgarian_Public | 2.0 |
| Recruitment arrangements (for publication) | K1_CN0120056_Recruitment-Arrangements_DE_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_CN0120056_Recruitment-Arrangements_EL_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_CN0120056_Recruitment-Arrangements_ES_Public | 2 |
| Recruitment arrangements (for publication) | K1_CN0120056_Recruitment-Arrangements_FR_French_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_CN0120056_Recruitment-Arrangements_HR_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_CN0120056_Recruitment-Arrangements_IT_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_CN0120056_Recruitment-Arrangements_RO_Public | 2.0 |
| Recruitment arrangements (for publication) | K1_CN0120056_Recruitment-Arrangements_SVK_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_CN0120056_Recruitment-Arrangements-Informed-Consent_Procedure_PT_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CN0120056_ FlipChart_HR_Croatian_Public | 2 |
| Recruitment arrangements (for publication) | K2_CN0120056__Patient-Letter_PT_Portuguese_Public | 2 |
| Recruitment arrangements (for publication) | K2_CN0120056__Postcard_PT_Portuguese_Public | 1 |
| Recruitment arrangements (for publication) | K2_CN0120056_BMS_ADEPT-4_DMC01_Trialbee_Digital_Marketing_Content_PL_Polish_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CN0120056_BMS_ADEPT-4_Elligo_FlipChart_PL_Polish_Public | 2.0 |
| Recruitment arrangements (for publication) | K2_CN0120056_BMS_ADEPT-4_Elligo_Patient_Caregiver_Brochure_PL_Polish_Public | 2.0 |
| Recruitment arrangements (for publication) | K2_CN0120056_BMS_ADEPT-4_Elligo_PatientLetter_PL_Polish_Public | 2.0 |
| Recruitment arrangements (for publication) | K2_CN0120056_BMS_ADEPT-4_FlipChart_PL_Polish_Public | 1 |
| Recruitment arrangements (for publication) | K2_CN0120056_BMS_ADEPT-4_GPP01_Trialbee_Global_Privacy_Policy_PL_Polish_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CN0120056_BMS_ADEPT-4_LP01_Trialbee_Landing_Page_PL_Polish_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CN0120056_BMS_ADEPT-4_Patient_Caregiver_Brochure_PL_Polish_Public | 1 |
| Recruitment arrangements (for publication) | K2_CN0120056_BMS_ADEPT-4_PatientLetter_PL_Polish_Public | 1 |
| Recruitment arrangements (for publication) | K2_CN0120056_BMS_ADEPT-4_Postcard_PL_Polish_Public | 1 |
| Recruitment arrangements (for publication) | K2_CN0120056_BMS_ADEPT-4_Poster_PL_Polish_Public | 1 |
| Recruitment arrangements (for publication) | K2_CN0120056_BMS_ADEPT-4_SA01_Trialbee_Self_Assessment_PL_Polish_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CN0120056_BMS_ADEPT-4_SAC01_Trialbee_SecondaryAssessment_Communication_PL_Polish_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CN0120056_Flip Chart_BE_Dutch_Public | 2 |
| Recruitment arrangements (for publication) | K2_CN0120056_Flip Chart_BE_English_Public | 2 |
| Recruitment arrangements (for publication) | K2_CN0120056_Flip Chart_BE_French_Public | 2 |
| Recruitment arrangements (for publication) | K2_CN0120056_FlipChart_BGR_Bulgarian_Public | 2 |
| Recruitment arrangements (for publication) | K2_CN0120056_FlipChart_DE_German_Public | 2 |
| Recruitment arrangements (for publication) | K2_CN0120056_FlipChart_ES_Spanish_Public | 2 |
| Recruitment arrangements (for publication) | K2_CN0120056_Flipchart_HU_Hungarian_Public | 2 |
| Recruitment arrangements (for publication) | K2_CN0120056_FlipChart_IT_Public | 2.0 |
| Recruitment arrangements (for publication) | K2_CN0120056_FlipChart_PT_Portuguese_Public | 2 |
| Recruitment arrangements (for publication) | K2_CN0120056_Flipchart_RO_English_Public | 2.1 |
| Recruitment arrangements (for publication) | K2_CN0120056_Flipchart_RO_Romanian_Public | 2.1 |
| Recruitment arrangements (for publication) | K2_CN0120056_FlipChart_SVK_Slovak_Public | 2 |
| Recruitment arrangements (for publication) | K2_CN0120056_Global-Privacy-Policy_DE_German_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CN0120056_Global-Privacy-Policy_ES_Spanish_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CN0120056_Global-Privacy-Policy_IT_Italian_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CN0120056_Informed-Consent-Flip-Chart_FR_French_Public | 2 |
| Recruitment arrangements (for publication) | K2_CN0120056_Patient Caregiver Brochure_BE_Dutch_Public | 2 |
| Recruitment arrangements (for publication) | K2_CN0120056_Patient Caregiver Brochure_BE_English_Public | 2 |
| Recruitment arrangements (for publication) | K2_CN0120056_Patient Caregiver Brochure_BE_French_Public | 2 |
| Recruitment arrangements (for publication) | K2_CN0120056_Patient Letter_BE_Dutch_Public | 2 |
| Recruitment arrangements (for publication) | K2_CN0120056_Patient Letter_BE_English_Public | 2 |
| Recruitment arrangements (for publication) | K2_CN0120056_Patient Letter_BE_French_Public | 2 |
| Recruitment arrangements (for publication) | K2_CN0120056_Patient_Caregiver_Brochure_DE_German_Public | 2 |
| Recruitment arrangements (for publication) | K2_CN0120056_Patient_Caregiver_Brochure_HR_Croatian_Public | 2 |
| Recruitment arrangements (for publication) | K2_CN0120056_Patient_Caregiver_Brochure_HU_Hungarian_Public | 2 |
| Recruitment arrangements (for publication) | K2_CN0120056_Patient_Caregiver_Brochure_RO_English_Public | 2.1 |
| Recruitment arrangements (for publication) | K2_CN0120056_Patient_Caregiver_Brochure_RO_Romanian_Public | 2.1 |
| Recruitment arrangements (for publication) | K2_CN0120056_Patient_Caregiver_Brochure_SVK_Slovak_Public | 2 |
| Recruitment arrangements (for publication) | K2_CN0120056_Patient_Letter_FR_French_Public | 2 |
| Recruitment arrangements (for publication) | K2_CN0120056_Patient_Letter_HU_Hungarian_Public | 2 |
| Recruitment arrangements (for publication) | K2_CN0120056_Patient_Letter_RO_English_Public | 2 |
| Recruitment arrangements (for publication) | K2_CN0120056_Patient_Letter_RO_Romanian_Public | 2 |
| Recruitment arrangements (for publication) | K2_CN0120056_Patient-Caregiver-Brochure_BGR_Bulgarian_Public | 2 |
| Recruitment arrangements (for publication) | K2_CN0120056_Patient-Caregiver-Brochure_ES_Spanish_Public | 2 |
| Recruitment arrangements (for publication) | K2_CN0120056_Patient-Caregiver-Brochure_FR_French_Public | 2 |
| Recruitment arrangements (for publication) | K2_CN0120056_Patient-Caregiver-Brochure_IT_Public | 2.0 |
| Recruitment arrangements (for publication) | K2_CN0120056_Patient-Caregiver-Brochure_PT_Portuguese_Public | 2 |
| Recruitment arrangements (for publication) | K2_CN0120056_Patient-Letter_BGR_Bulgarian_Public | 2 |
| Recruitment arrangements (for publication) | K2_CN0120056_Patient-Letter_ES_Spanish_Public | 2 |
| Recruitment arrangements (for publication) | K2_CN0120056_Patient-Letter_HR_Croatian_Public | 2 |
| Recruitment arrangements (for publication) | K2_CN0120056_Patient-Letter_IT_Public | 2.0 |
| Recruitment arrangements (for publication) | K2_CN0120056_Patient-Letter_SVK_Slovak_Public | 2 |
| Recruitment arrangements (for publication) | K2_CN0120056_PatientLetter_DE_German_Public | 2 |
| Recruitment arrangements (for publication) | K2_CN0120056_Postcard_BE_Dutch_Public | 1 |
| Recruitment arrangements (for publication) | K2_CN0120056_Postcard_BE_English_Public | 1 |
| Recruitment arrangements (for publication) | K2_CN0120056_Postcard_BE_French_Public | 1 |
| Recruitment arrangements (for publication) | K2_CN0120056_Postcard_BGR_Bulgarian_Public | 1 |
| Recruitment arrangements (for publication) | K2_CN0120056_Postcard_DE_German_Public | 1 |
| Recruitment arrangements (for publication) | K2_CN0120056_Postcard_ES_Spanish_Public | 1 |
| Recruitment arrangements (for publication) | K2_CN0120056_Postcard_FR_French_Public | 1 |
| Recruitment arrangements (for publication) | K2_CN0120056_Postcard_HR_Croatian_Public | 1 |
| Recruitment arrangements (for publication) | K2_CN0120056_Postcard_HU_Hungarian_Public | 1 |
| Recruitment arrangements (for publication) | K2_CN0120056_Postcard_IT_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CN0120056_Postcard_RO_English_Public | 1 |
| Recruitment arrangements (for publication) | K2_CN0120056_Postcard_RO_Romanian_Public | 1 |
| Recruitment arrangements (for publication) | K2_CN0120056_Postcard_SVK_Slovak_Public | 1 |
| Recruitment arrangements (for publication) | K2_CN0120056_Poster_BE_Dutch_Public | 1 |
| Recruitment arrangements (for publication) | K2_CN0120056_Poster_BE_English_Public | 1 |
| Recruitment arrangements (for publication) | K2_CN0120056_Poster_BE_French_Public | 1 |
| Recruitment arrangements (for publication) | K2_CN0120056_Poster_BGR_Bulgarian_Public | 1 |
| Recruitment arrangements (for publication) | K2_CN0120056_Poster_DE_German_Public | 1 |
| Recruitment arrangements (for publication) | K2_CN0120056_Poster_ES_Spanish_Public | 1 |
| Recruitment arrangements (for publication) | K2_CN0120056_Poster_FR_French_Public | 1 |
| Recruitment arrangements (for publication) | K2_CN0120056_Poster_HR_Croatian_Public | 1 |
| Recruitment arrangements (for publication) | K2_CN0120056_Poster_HU_Hungarian_Public | 1 |
| Recruitment arrangements (for publication) | K2_CN0120056_Poster_IT_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CN0120056_Poster_PT_Portuguese_Public | 1 |
| Recruitment arrangements (for publication) | K2_CN0120056_Poster_RO_English_Public | 1 |
| Recruitment arrangements (for publication) | K2_CN0120056_Poster_RO_Romanian_Public | 1 |
| Recruitment arrangements (for publication) | K2_CN0120056_Poster_SVK_Slovak_Public | 1 |
| Recruitment arrangements (for publication) | K2_CN0120056_Study_Connect_Description_PL_Polish_Public | 1 |
| Recruitment arrangements (for publication) | K2_CN0120056_Study-Connect-Description_ES_Spanish_Public | 1 |
| Recruitment arrangements (for publication) | K2_CN0120056_Study-Connect-Description_IT_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CN0120056_Study-Connect-Description-for-IRB-IEC_DE_German_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CN0120056_Trialbee_Campaign Overview_BE_English_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CN0120056_Trialbee_Digital Marketing Content_BE_Dutch_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CN0120056_Trialbee_Digital Marketing Content_BE_English_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CN0120056_Trialbee_Digital Marketing Content_BE_French_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CN0120056_Trialbee_Digital Marketing Content_BGR_BUL_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CN0120056_Trialbee_Global Privacy Policy_BE_Dutch_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CN0120056_Trialbee_Global Privacy Policy_BE_English_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CN0120056_Trialbee_Global Privacy Policy_BE_French_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CN0120056_Trialbee_Global Privacy Policy_BGR_BUL__Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CN0120056_Trialbee_Landing Page_BE_Dutch_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CN0120056_Trialbee_Landing Page_BE_English_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CN0120056_Trialbee_Landing Page_BE_French_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CN0120056_Trialbee_Landing Page_BGR_BUL_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CN0120056_Trialbee_Secondary Assessment_Communication_BGR_BUL_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CN0120056_Trialbee_SecondaryAssessmentCommunication_BE_Dutch_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CN0120056_Trialbee_SecondaryAssessmentCommunication_BE_English_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CN0120056_Trialbee_SecondaryAssessmentCommunication_BE_French_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CN0120056_Trialbee_Self Assessment_BE_Dutch_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CN0120056_Trialbee_Self Assessment_BE_English_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CN0120056_Trialbee_Self Assessment_BE_French_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CN0120056_Trialbee_Self-Assessment_BGR_BUL_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CN0120056_Trialbee-Digital-Marketing-Content_DE_German_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CN0120056_Trialbee-Digital-Marketing-Content_ES_Spanish_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CN0120056_Trialbee-Digital-Marketing-Content_IT_Italian_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CN0120056_Trialbee-Landing-Page_DE_German_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CN0120056_Trialbee-Landing-Page_ES_Spanish_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CN0120056_Trialbee-Landing-Page_IT_Italian_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CN0120056_Trialbee-Secondary-Assessment-Communication_ES_Spanish_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CN0120056_Trialbee-SecondaryAssessment-and-Communication_DE_German_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CN0120056_Trialbee-SecondaryAssessment-Communication_IT_italian_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CN0120056_Trialbee-Self-Assessment_DE_German_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CN0120056_Trialbee-Self-Assessment_ES_Spanish_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CN0120056_Trialbee-Self-Assessment_IT_italian_Public | 1.0 |
| Recruitment arrangements (for publication) | K3_CN0120056_Global-Privacy-Policy_SVK_Slovak_Public | 1.0 |
| Recruitment arrangements (for publication) | K3_CN0120056_Trialbee_Digital-Marketing-Content_SVK_Slovak-English_Public | 1.0 |
| Recruitment arrangements (for publication) | K3_CN0120056_Trialbee_Secondary-Assessment-Communication_SVK_Slovak-English_Public | 1.0 |
| Recruitment arrangements (for publication) | K3_CN0120056_Trialbee_Self-Assessment_SVK_Slovak-English_Public | 1.0 |
| Recruitment arrangements (for publication) | K3_CN0120056_Trialbee-Landing-Page_SVK_Slovak-English_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Assent Form_BE_Dutch_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Assent Form_BE_English_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Assent Form_BE_French_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Assent_HU_Hungarian_Public | 2 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Assent_IT_Italian_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Assent_PT_Portuguese_Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Assent-Form_BGR_Bulgarian_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Assent-Form_BGR_English_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Assent-Form_DE_German_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Assent-Form_ES_Spanish_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Assent-Form_RO_English_Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Assent-Form_RO_Romanian_Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Assent-ICF_FR_French_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Assent-ICF_HR_Croatian_Public | 1 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Assent-ICF_SVK_Slovak_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Future-Research-ICF_HR_Croatian_Public | 1 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Genomic-ICF_HR_Croatian_Public | 1 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Greenphire ICF_BE_Dutch_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Greenphire ICF_BE_English_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Greenphire ICF_BE_French_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Greenphire_Notice_Study_Participant_HU_Hungarian_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Greenphire_Notice_Study_Partner_HU_Hungarian_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Greenphire-ICF_HR_Croatian_Public | 1 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Greenphire-notice_ICF_DE_German_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Greenphire-Notice_PT_Portuguese_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_ICF_Assent_Pol-Pol_PL_Polish_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_ICF_Greenphire_PL_Polish_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_CN0120056_ICF_Main_HU_Hungarian_Public | 2 |
| Subject information and informed consent form (for publication) | L1_CN0120056_ICF_Main_PL_Polish_Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_CN0120056_ICF_Main_RO_English_Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_CN0120056_ICF_Main_RO_Romanian_Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_CN0120056_ICF_Optional_Future_Research_HU_Hungarian_Public | 1 |
| Subject information and informed consent form (for publication) | L1_CN0120056_ICF_Optional_Future_Research_PL_Polish_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_ICF_Pregnant_Participant_HU_Hungarian_Public | 1 |
| Subject information and informed consent form (for publication) | L1_CN0120056_ICF_Pregnant_Participant_PL_Polish_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_ICF_Pregnant_Participant_RO_English_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_ICF_Pregnant_Participant_RO_Romanian_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_ICF_Pregnant_Partner_HU_Hungarian_Public | 1 |
| Subject information and informed consent form (for publication) | L1_CN0120056_ICF_Pregnant_Partner_PL_Polish_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_ICF_Pregnant_Partner_RO_English_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_ICF_Pregnant_Partner_RO_Romanian_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_ICF_Study_Partner_Caregiver_PL_Polish_Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_CN0120056_ICF_Study_Partner_HU_Hungarian_Public | 2 |
| Subject information and informed consent form (for publication) | L1_CN0120056_ICF_Study_Partner_RO_English_Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_CN0120056_ICF_Study_Partner_RO_Romanian_Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_CN0120056_ICF-Optional-Future-Research_BGR_Bulgarian_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_ICF-Optional-Future-Research_BGR_English_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_ICF-Optional-Future-Research_RO_English_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_ICF-Optional-Future-Research_RO_Romanian_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_ICF-Pregnant-Participant_BGR_Bulgarian_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_ICF-Pregnant-Participant_BGR_English_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_ICF-Pregnant-Partner_BGR_Bulgarian_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_ICF-Pregnant-Partner_BGR_English_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Information-on-Personal-Data-Processing_SVK_Slovak_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Main ICF_BE_Dutch_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Main ICF_BE_English_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Main ICF_BE_French_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Main_ICF_DE_German_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Main-ICF_BGR_Bulgarian_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Main-ICF_BGR_English_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Main-ICF_EL-Greek_Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Main-ICF_ES_Spanish_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Main-ICF_FR_French_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Main-ICF_HR_Croatian_Public | 2 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Main-ICF_IT_Italian_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Main-ICF_PT_Portuguese_Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Main-ICF_SVK_Slovak_Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Opt-Future-Research_ICF_DE_German_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Optional Future Research-ICF_IT_Italian_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Optional_Future_Research-ICF_EL-Greek_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Optional-Future-Research-ICF_ES_Spanish_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Optional-Future-Research-ICF_FR_French_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Optional-Future-Research-ICF_PT_Portuguese_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Optional-Future-Research-ICF_SVK_Slovak_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Participant-Greenphire-Notice_SVK_Slovak_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Patient representative ICF_BE_Dutch_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Patient representative ICF_BE_English_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Patient representative ICF_BE_French_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Pregnant Participant ICF_BE_Dutch_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Pregnant Participant ICF_BE_English_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Pregnant Participant ICF_BE_French_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Pregnant Participant-ICF_IT_Italian_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Pregnant Partner ICF_BE_Dutch_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Pregnant Partner ICF_BE_English_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Pregnant Partner ICF_BE_French_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Pregnant Partner-ICF_IT_Italian_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Pregnant_Participant_ICF_DE_German_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Pregnant_Participant-ICF_EL-Greek_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Pregnant_Partner_ICF_DE_German_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Pregnant_Partner-ICF_EL-Greek_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Pregnant-Participant_FR_French_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Pregnant-Participant-ICF_ES_Spanish_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Pregnant-Participant-ICF_PT_Portuguese_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Pregnant-Participant-ICF_SVK_Slovak_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Pregnant-Partner_FR_French_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Pregnant-Partner-ICF_ES_Spanish_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Pregnant-Partner-ICF_HR_Croatian_Public | 1 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Pregnant-Partner-ICF_PT_Portuguese_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Pregnant-Partner-ICF_SVK_Slovak_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Pregnant-Subject-ICF_HR_Croatian_Public | 1 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Privacy notice-ICF_IT_Italian_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Sponsor Statement Main ICF_BE_English_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Study Partner_Caregiver_ICF_BGR_BUL_clean_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Study Partner-Caregiver_ICF_EL-Greek_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Study Partner-ICF_IT_Italian_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Study_Assent-ICF_EL-Greek_Public | 2.2 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Study-Partner_FR_French_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Study-Partner_ICF_DE_German_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Study-Partner-Caregiver-ICF_BGR_English_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Study-Partner-Greenphire-Notice_SVK_Slovak_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Study-Partner-ICF_ES_Spanish_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Study-Partner-ICF_HR_Croatian_Public | 2 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Study-Partner-ICF_PT_Portuguese_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Study-Partner-ICF_SVK_Slovak_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_CN0120056_Vendor Notice-ICF_IT_Italian_Public | 1.0 |
| Subject information and informed consent form (for publication) | L2_CN0120056_Greenphire_Notice_RO_English_Public | 2.0 |
| Subject information and informed consent form (for publication) | L2_CN0120056_Greenphire_Notice_RO_Romanian_Public | 2.0 |
| Subject information and informed consent form (for publication) | L2_CN0120056_Greenphire-ICF_ES_Spanish_Public | 1.0 |
| Subject information and informed consent form (for publication) | L2_CN0120056_Greenphire-Notice_BGR_Bulgarian_Public | 1.0 |
| Subject information and informed consent form (for publication) | L2_CN0120056_Greenphire-Notice_BGR_English_Public | 1.0 |
| Subject information and informed consent form (for publication) | L2_CN0120056_List_of_Part_II_Documents_HU_Hungarian_Public | N/A |
| Subject information and informed consent form (for publication) | L2_CN0120056_Participant_Agreement for travel expenses reimbursement_EL-Greek_Clean | 1.0 |
| Subject information and informed consent form (for publication) | L2_CN0120056_Patient_Card_HU_Hungarian_Public | 1.0.0 |
| Subject information and informed consent form (for publication) | L2_CN0120056_Patient-card_FR_French_Public | 1.0.0 |
| Subject information and informed consent form (for publication) | L2_CN0120056_Placebo-Mitigation-Video-Clarification-Note_PT | n/a |
| Subject information and informed consent form (for publication) | L2_CN0120056_Placebo-Mitigation-Video-Transcript_PT | n/a |
| Subject information and informed consent form (for publication) | L2_CN0120056_Study Partner-Agreement travel for expenses reimbursement_EL-Greek_Clean | 1.0 |
| Synopsis of the protocol (for publication) | D1_BMS_CN0120056_Protocol synopsis_2024-516363-92_BEL_Dutch_Public | 3.0 |
| Synopsis of the protocol (for publication) | D1_BMS_CN0120056_Protocol synopsis_2024-516363-92_BEL_French_Public | 3.0 |
| Synopsis of the protocol (for publication) | D1_BMS_CN0120056_Protocol synopsis_2024-516363-92_BEL_German_Public | 3.0 |
| Synopsis of the protocol (for publication) | D1_BMS_CN0120056_Protocol synopsis_2024-516363-92_BGR_Public | 3.0 |
| Synopsis of the protocol (for publication) | D1_BMS_CN0120056_Protocol synopsis_2024-516363-92_ESP_Public | 3.0 |
| Synopsis of the protocol (for publication) | D1_BMS_CN0120056_Protocol synopsis_2024-516363-92_FRA_Public | 3.0 |
| Synopsis of the protocol (for publication) | D1_BMS_CN0120056_Protocol synopsis_2024-516363-92_GRC_Public | 3.0 |
| Synopsis of the protocol (for publication) | D1_BMS_CN0120056_Protocol synopsis_2024-516363-92_HRV_Public | 3.0 |
| Synopsis of the protocol (for publication) | D1_BMS_CN0120056_Protocol synopsis_2024-516363-92_HUN_Public | 3.0 |
| Synopsis of the protocol (for publication) | D1_BMS_CN0120056_Protocol synopsis_2024-516363-92_ITA_Public | 3.0 |
| Synopsis of the protocol (for publication) | D1_BMS_CN0120056_Protocol synopsis_2024-516363-92_POL_Public | 3.0 |
| Synopsis of the protocol (for publication) | D1_BMS_CN0120056_Protocol synopsis_2024-516363-92_PRT_Public | 3.0 |
| Synopsis of the protocol (for publication) | D1_BMS_CN0120056_Protocol synopsis_2024-516363-92_ROU_Public | 3.0 |
| Synopsis of the protocol (for publication) | D1_BMS_CN0120056_Protocol synopsis_2024-516363-92_SVK_Public | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-516363-92-00_ENG | 03 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-15 | Poland | Acceptable 2025-03-24
|
2025-03-24 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-04-01 | Acceptable 2025-03-24
|
2025-04-01 | |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-05-14 | Acceptable 2025-03-24
|
2025-05-14 | |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-05-22 | Acceptable 2025-03-24
|
2025-05-22 | |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-05-22 | Acceptable 2025-03-24
|
2025-05-22 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-06-27 | Poland | Acceptable 2025-10-03
|
2025-10-03 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-7 | 2025-11-05 | Poland | Acceptable 2025-10-03
|
2025-11-05 |
| 8 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-11-14 | Poland | Acceptable 2026-01-26
|
2026-01-26 |