Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
531
Countries
17
Sites
68
Cancer
Continuation of darolutamide treatment, Safety of darolutamide
Key facts
- Sponsor
- Bayer Consumer Care AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 16 Oct 2020 → ongoing
- Decision date (initial)
- 2023-05-26
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Bayer Consumer Care AG
External identifiers
- EU CT number
- 2022-502084-38-00
- EudraCT number
- 2019-003618-15
- ClinicalTrials.gov
- NCT04464226
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Others
Continuation of darolutamide treatment, Safety of darolutamide
Secondary objectives 1
- Documentation of tolerability of darolutamide
Conditions and MedDRA coding
Cancer
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Overall Study Patients will be carried over from the previous studies and continue in this study with darolutamide treatment on the same dosage.
|
Not Applicable | None | Darolutamide (BAY1841788): Subjects enrolled in the current study will use the dose they were assigned to in the feeder study they come from. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- 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
- Participants enrolled in any Bayer-sponsored darolutamide feeder study at the time of study closure or primary completion, who are currently receiving darolutamide and are experiencing clinical benefit from treatment
- Participants who have not met any treatment discontinuation criteria outlined in the feeder study protocol
- Willingness to continue practicing acceptable methods of birth control during the study.
Exclusion criteria 3
- Participant is unable to comply with the requirements of the study.
- Negative benefit/ risk ratio as determined by the investigator.
- Meet any criteria for treatment discontinuation of the feeder study the participant is coming from.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 3
- Incidence of TEAEs (Treatment-emergent adverse events)
- Incidence of TESAEs (Treatment-emergent serious adverse events)
- Incidence of drug-related TEAEs and TESAEs
Secondary endpoints 1
- Frequency of dose modifications
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD1849573 · Product
- Active substance
- Darolutamide
- Other product name
- ODM-201 300 mg film-coated tablet
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 1200 mg milligram(s)
- Max total dose
- 2592 g gram(s)
- Max treatment duration
- 72 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- BAYER AG
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Bayer Consumer Care AG
- Sponsor organisation
- Bayer Consumer Care AG
- Address
- Peter Merian-Strasse 84
- City
- Basel
- Postcode
- 4052
- Country
- Switzerland
Scientific contact point
- Organisation
- Bayer Consumer Care AG
- Contact name
- Therapeutic Area Head
Public contact point
- Organisation
- Bayer Consumer Care AG
- Contact name
- Therapeutic Area Head
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| 4g Clinical LLC ORG-100042775
|
Wellesley, United States | Interactive response technologies (IRT) |
Sponsor responsibilities
- Article 77 compliance
- Bayer Consumer Care AG
- Article 77 implementation
- Bayer Consumer Care AG
Locations
17 EU/EEA countries · 68 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 3 | 1 |
| Bulgaria | Ended | 3 | 1 |
| Czechia | Ended | 15 | 5 |
| Estonia | Ended | 1 | 1 |
| Finland | Ended | 17 | 5 |
| France | Ended | 44 | 9 |
| Germany | Ended | 33 | 8 |
| Hungary | Ongoing, recruitment ended | 4 | 1 |
| Italy | Ended | 6 | 2 |
| Latvia | Ongoing, recruitment ended | 22 | 4 |
| Lithuania | Ongoing, recruitment ended | 15 | 3 |
| Netherlands | Ended | 8 | 7 |
| Poland | Ended | 6 | 4 |
| Romania | Ongoing, recruitment ended | 2 | 1 |
| Slovakia | Ended | 5 | 1 |
| Spain | Ended | 49 | 11 |
| Sweden | Ended | 17 | 4 |
| Rest of world
United States, Canada, Colombia, Ukraine, Serbia, Turkey, Peru, Belarus, Japan, Mexico, Argentina, Taiwan, South Africa, United Kingdom, China, Korea, Republic of, Australia, Israel, Brazil, Russian Federation
|
— | 281 | — |
Investigational sites
Complex Oncology Center Vratsa EOOD
Department of medical oncology, Bulevard Vtori Yuni 68, 3000, Vratsa
Masaryk Memorial Cancer Institute
Klinika komplexni onkologicke pece, Zluty Kopec 543/7, Stare Brno, Brno-Stred
Vseobecna Fakultni Nemocnice V Praze
Urologicka klinika, Ke Karlovu 6, 128 08, Prague 2
Androgeos spol. s r.o.
NA, Na Valech 289/4, Hradcany, Prague 6
Fakultni Nemocnice Kralovske Vinohrady
Radioterapeuticka a onkologicka klinika, Srobarova 1150/50, Vinohrady, Prague 10
Urocentrum Praha s.r.o.
NA, Karlovo Namesti 319/3, Nove Mesto, Prague
North Estonia Regional Hospital
Onkoloogia- ja hematoloogiakliinik, J. Sutiste Tee 19, 13419, Mustamae Linnaosa
HUS Helsinki University Hospital
Urologinen tutkimusyksikkö, Haartmaninkatu 4, 00290, Helsinki
Pohjois-Pohjanmaan Sairaanhoitopiirin kuntayhtyma
Urologian poliklinikka, Kajaanintie 50, 90220, Oulu
Central Finland Hospital District Central Finland Hospital Nova
Syöpätautien klinikka, Hoitajantie 3, 40620, Jyvaskyla
Etelae-Savon hyvinvointialue
Not Applicable, Porrassalmenkatu 35-37, 50100, Mikkeli
Turku University Hospital
Syöpätautien klinikka, Kiinamyllynkatu 4-8, 20520, Turku
Institut Godinot
Service d'Oncologie, 1 Rue Du General Koenig, 51100, Reims
Institut Bergonie
Service d'Oncologie, 229 Cours De L Argonne, 33000, Bordeaux
Institut Regional Du Cancer De Montpellier
Département d'Oncologie Médicale, 208 Avenue Des Apothicaires, 34298, Montpellier Cedex 5
Centre Hospitalier Universitaire De Poitiers
Service d'Oncologie, 2 Rue De La Miletrie, 86000, Poitiers
Clinique Pasteur Lanroze
Service d'Oncologie médicale, 32 Rue Auguste Kervern, 29200, Brest
Institut De Cancerologie De L Ouest
Service d'Oncologie médicale, Boulevard Jacques Monod, 44805, Saint Herblain
Institut Paoli-Calmettes
Service d'Oncologie, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Centre Jean Perrin
Service d'Oncologie, 58 Rue Montalembert, 63000, Clermont-Ferrand
Hospices Civils De Lyon
Service d'Oncologie médicale, 165 Chemin Du Grand Revoyet, 69310, Pierre-Benite
Medical Center - University Of Freiburg
Zentrum Urogenitale Tumore, Hugstetter Strasse 55, Stuehlinger, Freiburg Im Breisgau
Studienpraxis Urologie
Studienpraxis Urologie, Steinengrabenstrasse 17, 72622, Nuertingen
Universitatsklinikum Erlangen AöR
Urologie, Krankenhausstrasse 12, Innenstadt, Erlangen
Universitaetsklinikum Magdeburg AöR
Klinik für Urologie, Uroonkologie, Leipziger Strasse 44, 39120, Magdeburg
Staedtisches Klinikum Braunschweig gGmbH
Klinik für Urologie und Uroonkologie, Freisestrasse 9-10, 38118, Brunswick
Universitaetsklinikum Muenster AöR
Klinik für Urologie und Kinderurologie, Gebaeude A1, Albert-Schweitzer-Campus 1, Muenster
University Hospital Jena KöR
Klinik und Poliklinik für Urologie, Am Klinikum 1, Lobeda, Jena
Universitaetsklinikum Tuebingen
Klinik für Urologie, Hoppe-Seyler-Strasse 3, Nordstadt, Tuebingen
Tolna Varmegyei Balassa Janos Korhaz
Urológiai Osztály, Beri Balogh Adam Utca 5-7, 7100, Szekszard
Veneto Institute Of Oncology
Oncologia, Via Gattamelata 64, 35128, Padova
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Dip. area medica ed oncologia, Regione Gonzole 10, 10043, Orbassano
Vidzemes Slimnica SIA
NA, Jumaras Iela 195, 4201, Valmiera
Pauls Stradins Clinical University Hospital
Urologijas centrs, Pilsonu Iela 13, 1002, Riga
Daugavpils regionala slimnica SIA
NA, Vasarnicu Iela 20, 5417, Daugavpils
Rigas Austrumu kliniska universitates slimnica SIA
Urologijas un onkologiskas urologijas klinika, Hipokrata Iela 2, 1038, Riga
Lietuvos Sveikatos Mokslu Universiteto Ligonine Kauno Klinikos
Urologijos klinika, Eiveniu G. 2, Kauno M. Sav., Kaunas
Vilnius University Hospital
Urologijos centras, Santariskiu G. 2, Vilniaus M. Sav., Vilnius
Nacionalinis vezio institutas
Onkourologijos skyrius, Santariskiu G. 1, Vilniaus M. Sav., Vilnius
Haga Hospital
Internal Medicine / Oncology, Els Borst-Eilersplein 275, 2545 AA, 's-Gravenhage
Amsterdam UMC
Medical Oncology, De Boelelaan 1117, 1081 HV, Amsterdam
Spaarne Gasthuis
Internal Medicine / Oncology, Spaarnepoort 1, 2134 TM, Hoofddorp
Stichting Zuyderland Medisch Centrum
Internal Medicine / Oncology, Dr. H. Van Der Hoffplein 1, 6162 BG, Geleen
Elisabeth-TweeSteden Ziekenhuis
Medical Oncology, Dr. Deelenlaan 5, 5042 AD, Tilburg
Tergooiziekenhuizen
Internal Medicine / Oncology, Van Riebeeckweg 212, 1213 XZ, Hilversum
Albert Schweitzer Ziekenhuis
Internal Medicine / Oncology, Albert Schweitzerplaats 25, 3318 AT, Dordrecht
Europejskie Centrum Zdrowia Otwock Sp. z o.o.
Urology department, Ul. Borowa 14/18, 05-400, Otwock
Santa Sp. z o.o.
NA, Ul. Stanislawa Wigury 19, 90-368, Lodz
Ko-Med Centra Kliniczne Sp. z o.o.
NA, Ul. Kazimierza Przerwy-Tetmajera 21, 20-362, Lublin
Szpital Grochowski Im.Dr Med. Rafała Masztaka Sp. z o.o.
chemotherapy department, Ul. Grenadierow 51/59, 04-073, Warsaw
Spitalul Clinic Judetean Mures
Urology, Strada Marinescu Gheorghe Nr. 1, 540103, Targu Mures
J. Breza Medical s.r.o.
NA, Dankovskeho 6, 811 03, Bratislava 1
Hospital San Pedro de Alcantara
Oncología Médica, Avenida De Pablo Naranjo Porras S/n, 10002, Caceres
Hospital De La Santa Creu I Sant Pau
Oncología Médica, Calle De San Antonio Maria Claret 167, 08025, Barcelona
Hospital Universitario Ramon Y Cajal
Oncología Médica, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Universitario Reina Sofia
Oncología Médica, Avenida Menendez Pidal S/n, 14004, Cordoba
Hospital Universitari Vall D Hebron
Oncología Médica, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
University Hospital Virgen Del Rocio S.L.
Urología, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Del Mar
Oncología Médica, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
Hospital Universitario Virgen De La Victoria
Oncología Médica, Calle Del Arroyo Teatinos S N, 29010, Malaga
Servei De Salut De Les Illes Balears
Oncología Médica, Carretera Valldemossa 79, 07120, Palma
Hospital Universitario Fundacion Alcorcon
Urología, Calle Budapest 1, 28022, Madrid
Parc Tauli Hospital Universitari
Oncología Médica, Parc Del Tauli 1 Edifici Santa Fe Ala Izquierda Planta 2ª, 08208, Sabadell
Sahlgrenska University Hospital-Vastra Gotalandsregionen
Dept of Urology, Bla Straket 5, 413 46, Goteborg
Uppsala University Hospital
Dept of Urology, Akademiska Sjukhuset, 751 85, Uppsala
Region Vasterbotten
Dept of Oncology, Koksvagen 11, Alidhem, Umea
Karolinska University Hospital
Dept of Oncology, Eugeniavagen 3, 171 64, Solna
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 | 2021-01-04 | 2024-03-06 | 2021-01-13 | 2022-04-05 | |
| Bulgaria | 2021-01-13 | 2024-06-17 | 2021-01-19 | 2022-02-02 | |
| Czechia | 2020-10-16 | 2026-03-02 | 2020-10-21 | 2022-04-21 | |
| Estonia | 2021-03-31 | 2024-05-27 | 2021-04-01 | 2021-04-01 | |
| Finland | 2020-12-18 | 2024-04-10 | 2021-01-05 | 2022-05-03 | |
| France | 2020-10-16 | 2024-12-31 | 2020-10-21 | 2022-06-28 | |
| Germany | 2020-11-02 | 2023-10-17 | 2020-11-05 | 2022-05-09 | |
| Hungary | 2021-01-25 | 2021-01-27 | 2021-05-25 | ||
| Italy | 2020-11-24 | 2024-10-21 | 2020-12-04 | 2022-06-07 | |
| Latvia | 2020-11-20 | 2020-12-08 | 2025-09-23 | ||
| Lithuania | 2020-12-23 | 2020-12-29 | 2025-09-26 | ||
| Netherlands | 2022-02-15 | 2025-10-23 | 2022-02-17 | 2022-06-23 | |
| Poland | 2020-12-21 | 2026-04-30 | 2021-01-14 | 2022-02-08 | |
| Romania | 2021-03-19 | 2021-04-09 | 2021-06-02 | ||
| Slovakia | 2020-11-25 | 2023-07-11 | 2020-11-26 | 2021-04-26 | |
| Spain | 2020-10-22 | 2024-06-20 | 2020-10-27 | 2022-06-15 | |
| Sweden | 2021-03-01 | 2024-01-15 | 2021-03-16 | 2022-04-12 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 83 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Protocol amendment EN 20321_for publication | 2 |
| Protocol (for publication) | Protocol content approval form EN 20321_Clinical Lead_for publication | 1 |
| Recruitment arrangements (for publication) | EC-IRB submission EN 20321 List of planned sites_number of subjects_PI For publication | 1 |
| Recruitment arrangements (for publication) | EC-IRB submission EN 20321 Recruitment arrangements For publication | 1 |
| Recruitment arrangements (for publication) | IRBIEC Submission PL 20321 Arragement for recruitment For Pubication | 1 |
| Recruitment arrangements (for publication) | List of sites and Investigators_ES_ES_Public | NA |
| Recruitment arrangements (for publication) | Patient Information Bayer Address Change HU For publication | 1 |
| Recruitment arrangements (for publication) | Placeholder EC submission Recruitment and Informed consent procedure For publication | 1 |
| Recruitment arrangements (for publication) | Placeholder EC submission Recruitment and Informed consent procedure For publication | 1 |
| Subject information and informed consent form (for publication) | EC-IRB submission ES20321recruitment information for Publication | 1 |
| Subject information and informed consent form (for publication) | ICF Core CZ 20321 For publication_2 | 2 |
| Subject information and informed consent form (for publication) | ICF Core CZ 20321_1_For publication | 1 |
| Subject information and informed consent form (for publication) | ICF Core HU 20321 For publication_1 | 1 |
| Subject information and informed consent form (for publication) | ICF Core HU 20321 For publication_2 | 2 |
| Subject information and informed consent form (for publication) | ICF Core Supplemental Info on DP CZ 20321_For publication_1 | 1 |
| Subject information and informed consent form (for publication) | ICF Core Supplemental Info on DP CZ 20321_For publication_2 | 1 |
| Subject information and informed consent form (for publication) | ICF Expecting Parents - Male CZ20321 For Publication_1 | 1 |
| Subject information and informed consent form (for publication) | ICF Expecting Parents - Male CZ20321 For Publication_2 | 1 |
| Subject information and informed consent form (for publication) | ICF Expecting parents - male PL20321 polish For publication | 1.0 |
| Subject information and informed consent form (for publication) | ICF expecting parents - male RO 20321 For publication | 1.1 |
| Subject information and informed consent form (for publication) | ICF expecting parents male HU 20321 For publication | 2.1 |
| Subject information and informed consent form (for publication) | ICF expecting parents male_Translation certificate_EN20321_For publication | 1 |
| Subject information and informed consent form (for publication) | ICF for study updates ARAMIS PL20321 For publication | 1.0 |
| Subject information and informed consent form (for publication) | ICF for study updates ARASENS PL20321 For publication | 1.0 |
| Subject information and informed consent form (for publication) | ICF Other ES 20321 Study updates for patients from Arasens For Publication | 4 |
| Subject information and informed consent form (for publication) | ICF Other ES20321Expecting parents male participant For Publication | 1 |
| Subject information and informed consent form (for publication) | ICF Other ES20321Study updates for patients from Arasens For Publication | 3 |
| Subject information and informed consent form (for publication) | ICF Other PL 20321 Study updates Aramis For publication | 2 |
| Subject information and informed consent form (for publication) | ICF Other RO 20321 PIIC for study updates ARAMIS For publication | 1 |
| Subject information and informed consent form (for publication) | L1_ICF Core LT20321 For publication | 3.0 |
| Subject information and informed consent form (for publication) | L1_ICF Core LV20321 For publication | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF Core RU20321 For publication | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF Expecting parents-male LT20321 For publication | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF Expecting parents-male LV20321 For publication | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF Expecting parents-male RU20321 For publication | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF Other LT20321 Information correction For publication | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF Other LT20321 Specific version For publication | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF Other LT20321Study update For publicatio | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF Other LV20321 Study updates For publication | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF Other RU 20321 Study updates For publication | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_Core_1_Public_RO_RO | 3.1 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_Core_2_Public_RO_RO | 3.2 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_Core_Public_Latvian_LV_LV | 1 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_Core_Public_LT_LT | 1 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_Core_Public_Russian_LV_RU | 1 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_Study_Update_Public_Aramis_CZ_CS | 4 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_Study_Update_Public_Aranote_LV_LV | 1 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_Study_Update_Public_Aranote_LV_RU | 1 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_Study_Update_Public_Arasens_CZ_CS | 6 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_Study_Update_Public_ARASENS_PL_PL | 3 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_Study_Update_Public_HU_HU | 3 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_Study_Update_Public_LT_LT | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_Study_Update_Public_LV_LV | 3 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_Study_Update_Public_RO_RO | 2 |
| Subject information and informed consent form (for publication) | L2_Patient Contact Card LT 20321 For publication | 2 |
| Subject information and informed consent form (for publication) | L2_Patient Contact Card LV20321 For Publication | 2 |
| Subject information and informed consent form (for publication) | L2_Patient Contact Card RU20321 For publication | 1.0 |
| Subject information and informed consent form (for publication) | NtF_EN_20321_Justification for not updating Patient Contact Cards in CTIS_public | NA |
| Subject information and informed consent form (for publication) | NtF_EN_20321_Justification for not updating Patient Contact Cards in CTIS_public | NA |
| Subject information and informed consent form (for publication) | NtF_EN_20321_Justification for not updating Patient Contact Cards in CTIS_public | NA |
| Subject information and informed consent form (for publication) | NtF_EN_20321_Justification for not updating Patient Contact Cards in CTIS_public | NA |
| Subject information and informed consent form (for publication) | NtF_EN_20321_Justification for not updating Patient Contact Cards in CTIS_public | NA |
| Subject information and informed consent form (for publication) | NtF_EN_20321_Justification for not updating Patient Contact Cards in CTIS_public | NA |
| Subject information and informed consent form (for publication) | Patient Contact Card CZ 20321 For Publication_1 | 1 |
| Subject information and informed consent form (for publication) | Patient Contact Card CZ 20321 For Publication_2 | 1 |
| Subject information and informed consent form (for publication) | Patient contact card for publication | 2 |
| Subject information and informed consent form (for publication) | Patient Contact Card HU 20321 For publication_1 | 1 |
| Subject information and informed consent form (for publication) | Patient Contact Card HU 20321 For publication_3 | 3 |
| Subject information and informed consent form (for publication) | Patient Contact Card PL20321 For Publication | 1.0 |
| Subject information and informed consent form (for publication) | Patient contact card_Translation certificate_EN20321_for publication | 1 |
| Synopsis of the protocol (for publication) | Lay Protocol synopsis BE DE 20321_For publication | 1 |
| Synopsis of the protocol (for publication) | Lay Protocol synopsis BG BG 20321 For publication | 1 |
| Synopsis of the protocol (for publication) | Lay Protocol Synopsis CZ CZ 20321 For publication | 1 |
| Synopsis of the protocol (for publication) | Lay Protocol Synopsis EN 20321 For publication | 1 |
| Synopsis of the protocol (for publication) | Lay Protocol Synopsis ES ES 20321 For publication | 1 |
| Synopsis of the protocol (for publication) | Lay Protocol Synopsis FR FR 20321 For publication | 1 |
| Synopsis of the protocol (for publication) | Lay Protocol Synopsis HU HU 20321 For publication | 1 |
| Synopsis of the protocol (for publication) | Lay Protocol Synopsis IT 20321 For Publication | 1 |
| Synopsis of the protocol (for publication) | Lay Protocol Synopsis LT LT 20321 For Publication | 1 |
| Synopsis of the protocol (for publication) | Lay Protocol Synopsis NL NL 20321 For Publication | 1 |
| Synopsis of the protocol (for publication) | Lay Protocol Synopsis PL PL 20321 For publication | 1 |
| Synopsis of the protocol (for publication) | Lay Protocol synopsis RO 20321_For publication | 1 |
| Synopsis of the protocol (for publication) | Lay Protocol synopsis SV SE 20321_For publication | 1 |
Application history
10 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-03-06 | Romania | Acceptable 2023-05-22
|
2023-05-23 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-06-26 | Acceptable | 2023-08-11 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2023-10-30 | Romania | Acceptable 2024-01-15
|
2024-01-15 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-02-27 | Romania | Acceptable 2024-01-15
|
2024-02-27 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2024-09-12 | Romania | Acceptable 2024-01-15
|
2024-09-12 |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-10-17 | Acceptable | 2024-11-11 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-04-08 | Romania | Acceptable 2025-06-17
|
2025-06-18 |
| 8 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-10-20 | Romania | Acceptable 2025-12-19
|
2025-12-19 |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2026-02-12 | Romania | Acceptable 2025-12-19
|
2026-02-12 |
| 10 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2026-02-17 | Romania | Acceptable 2025-12-19
|
2026-02-17 |